Kindbody Shakes Up C-Suite with Six New Hires

Who they are, where they came from, and what’s next for the New-York based company

The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.

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BY: ROSEMARY SCOTT

New York-based end-to-end fertility network Kindbody has undergone shifts in its leadership and financial landscape over the last year. On March 19, the company announced the appointment of six new executives onto its leadership team in an effort to support what the company called its “next stage of growth.” 

In the same press release, the company also announced expansion plans that include opening clinics in four cities: Charlotte, NC, Miami, FL, Newport Beach, CA and San Diego, CA. 

Of the new appointments, three were hired for previously existing roles, while the other three will be the first to hold their respective titles. Here’s the details on each new player, including who they’re replacing and how they fit in Kindbody’s strategy. 

New People in Existing Roles

Scott Bruckner, Chief Financial Officer (CFO)

Bruckner was able to get a head start on his role compared to the other new hires, as he left his role as CFO of Fluid Truck, a technology-based sharing platform, to start at Kindbody in June 2023. The role of CFO has been vacant since Debbie Markowitz, former Kindbody CFO, left the role in November 2020 after a little under two years at the company. Markowitz is now CFO at Spring Health.

Haleigh Tebben, Chief Revenue Officer (CRO) 

Tebben most recently served as Chief Commercial Officer at Brightline after leaving her role as CRO at Collective Health. Tebben is replacing Taryn Branca, former Kindbody CRO, who left the company in February and is now Chief Commercial Officer at Airvet, an employee benefit service for pets.

Jason Barritt, Chief Scientific Officer (CSO)

The appointment of a new CSO may seem like déjà vu, as it comes only a few months after Kindbody announced Alison Bartolucci, Ph.D., HCLD, had been hired for the position. However, Kindbody Spokesperson Margaret Ryan told Inside Reproductive Health that Bartolucci accepted a promotion from her employer, First Fertility, instead of taking on the role at Kindbody. 

For his part, Barritt brings relevant experience to the role, as he served over 10 years as CDO and Lab Director at Southern California Reproductive Center in Beverly Hills, CA.

Dr. Angie Beltsos’s title had been CEO, Clinical, and is now Chief Executive Physician (CEP). Kindbody explained to Inside Reproductive Health how Dr. Beltsos’ role interfaces with other medical leadership roles in the company. She leads clinical strategy across Kindbody national fertility clinic network. Dr. Beltsos is responsible for establishing and implementing superior clinical standards and patient care at Kindbody clinics to yield exceptional outcomes and high, patient satisfaction levels. As CEP, Dr. Beltsos provides strategic leadership to the Chief Medical Officers to ensure the execution of consistent clinical care and safety. Kindbody’s four Chief Medical Officers cover the following:

Dr. Lynn Westphal, Chief Medical Officer, Lead CMO, Medicine + Research

Dr. Amber Cooper, CMO, Genomics + Lab Operations

Dr. Roohi Jeelani, Chief Growth Officer

Dr. Kristin Bendikson, CMO, Clinical Development”

Newly-Created Roles

Gina Bruzzichesi, Chief Operating Officer (COO)

Bruzzichesi has a background in human resources and previously served as COO at Aspen Dental Management. Prior to that role, she held positions at CLEAR, WeWork and Avis. In her early career, Bruzzichesi worked as an employment attorney. 

Tim Springer, Chief Compliance Officer (CCO)

Prior to his role at Kindbody, Springer oversaw healthcare ethics and compliance programs at One Medical. Before that role, he ran financial services global anti-fraud programs at MetLife and John Hancock.

Matt Slepian, Chief Accounting Officer (CAO)

Though Slepian’s role as Chief Accounting Officer (CAO) sounds similar to the CFO role filled by Bruckner, Ryan told Inside Reproductive Health that Slepian’s role is “focused specifically on managing the company’s accounting functions, including audits, compliance and accounts receivable and payable.” 

In contrast, Bruckner “oversees the company’s financial strategy and operations and plays a critical role in scaling the finance, accounting, and revenue cycle management teams to support the [c]ompany’s rapid growth,” Ryan stated. Slepian brings over 25 years of finance experience to Kindbody, and most recently served as CAO at Casa Systems. 

What Happens Next

These new appointments are the latest in a series of changes Kindbody has made to its leadership team. 

In September, Kindbody president Gregory Poulos stepped down from his role and now works as a strategic advisor for the company. No replacement for this position has been announced. Two months later, Bloomberg reported that Kindbody is paying a search firm $750,000 to replace CEO Annbeth Eschbach, citing sources familiar with the matter.

Kindbody Spokesperson Margaret Ryan confirmed Eschbach will be leaving the company in a statement to Inside Reproductive Health.

“Annbeth and the Board have been working together to develop a succession plan which ensures that Kindbody remains responsive to its employees, patients and all stakeholders.”

Kate Krejci, current Vice President of Operations at The Fertility Partners, left her role as GVP, Growth Operations at Kindbody in October after working at the company for about two years. Prior to her role at Kindbody, she was Vice President of Operations at Vios, which Kindbody acquired in 2022. 

Krejci told Inside Reproductive Health that when she left, Kindbody was still trying to clearly define the responsibilities of each team following the acquisition. Krejci said she’s hopeful the new additions to the leadership team will help make expectations and strategy for each team more clear.

“I think there needed to be more guidance and expertise making those decisions and driving that change,” Krejci said. “I'm hopeful that it's the right direction for the organization to really bring expertise at a high level to drive each of those departments independently.” 

Though Krejci left before many of the new hires started their roles, she did spend time working with Scott Bruckner, CFO, and called him a “really good fit” for the role. 

Kindbody told Inside Reproductive Health it hopes these new players will help the company reach its goals of continued growth. 

“The expansion of our leadership team ensures we have the right leadership and dedicated resources in place to continue our focus on excellent patient experience and delivering successful outcomes for every patient and employer we serve,” Kindbody stated.

The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.

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UK Government Halts IVF at Clinic After Loss of Embryos

The Homerton Fertility Centre reported three incidents in seven months last year that led to the loss of embryos.

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BY RON SHINKMAN

A reproductive medicine practice in London had its license suspended by the United Kingdom’s top fertility regulator after three incidents in recent months where embryos were mishandled, authorities said.

The Homerton Fertility Centre had its license suspended by the United Kingdom’s Human Fertilisation & Embryology Authority on March 8. The suspension will remain in effect until at least May 8 while the clinic fixes issues cited by the regulator, according to a letter issued by the clinic’s parent organization, Homerton Healthcare.

“The HFEA License Committee made this decision because of the potential risk to patients, gametes and embryos if the clinic’s license is not suspended with immediate effect,” said HFEA Chief Executive Officer Peter Thompson in a statement.

The terms of the suspension did allow the clinic to continue to treat patients who were in the middle of IVF cycles, Homerton CEO Louise Ashley said in a letter to patients.

Homerton Healthcare is a regional healthcare provider affiliated with Britain’s National Health Service. It provides medical services in the Hackney and City of London neighborhoods in northeast London. Its fertility clinic has been licensed to operate since 1995.

According to Simon Lumsdon, who operates a consulting firm in the U.K. called Lighthouse Fertility, such suspensions of clinics are rare.

“It really doesn’t happen very often,” he said, adding that the U.K.’s regulation of fertility clinics is among the most robust in the world. “You have to have quite high standards just to be operating."

Shaun Rogers, a clinical scientist who has worked and consulted for numerous IVF laboratories in the United Kingdom, observed that fewer than five U.K. fertility clinics have had their licenses suspended or revoked in the 30 years he’s been in the business.

According to minutes of the March 7 HFEA License Committee meeting, the suspension was in the wake of three incidents at the clinic that took place last year that were reported to the regulator under NHS rules. The first incident occurred in May 2023 and involved not following the correct procedure for storing frozen embryos. The second incident, which took place in October, some frozen and stored embryos “displayed a lower rate of embryo thawing survival rate,” according to the minutes. The third incident, which took place in December, involved embryos missing from a cryogenic straw after the thawing process.

Additional details about the incidents were not available. The HFEA declined to comment beyond what is already in the public record, while a spokesperson for Homerton Healthcare did not respond to a request seeking comment. Ashley said in her letter to clinic patients that in each case other embryos were located and that the IVF cycles were completed

These incidents were not the first indication that Homerton Fertility’s operations were troubled. According to minutes from an HFEA License Committee meeting from May of last year, Homerton Fertility “has had a poor history of compliance in recent years and has been subject to considerable regulatory scrutiny.”  

An April 2021 inspection for the renewal of the clinic’s license turned up issues. That inspection “identified two critical areas of non-compliance relating to swab counts performed during surgical procedures and the reporting of adverse incidents and near misses.” A followup inspection in March 2022 indicated that some improvements had been made but that the HFEA was “made aware of several whistleblowing communications from various sources. The concerns raised included leadership, working conditions, the welfare of patients and staff, training, policies and procedures, decision-making, non-reporting of incidents, and information to be provided to patients.” The agency also noted that the center was short-staffed in comparison to the volume of procedures it performed.

Nevertheless, the HFEA License Committee agreed to renew Homerton’s license for three years with an interim inspection to take place one year after the approval was granted.

Lumsdon observed that these events along with the more recent mishaps is what led to the suspension.

“You have to almost repeatedly push and push and push to get to this point where your license is (suspended),” he said.

In response to the suspension, the clinic said in two separate letters to patients that all of its staffers now work in pairs; all of the licenses and competencies of the staff have been vetted and verified, and that the fertility clinic’s security had been improved.

Lumsdon believes the issues at Homerton partly reflect austere funding of the NHS over the past decade-and-a-half. Fifteen years ago, funding for Britain’s single-payer system routinely rose 5.5% per year. It’s been trending about half of that in recent years

Lumsdon did add that some NHS-operated fertility centers are able to overcome the wage disparity through their affiliations with prestigious teaching hospitals.

“Homerton didn’t really have that draw,” he said.

The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.

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ISO Certification Still Elludes Fertility Clinics, IVF Labs

Boston IVF may be only fertility center with ISO certification

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BY MALLIKA MITRA

There’s a certification and set of guidelines for maintaining and aligning standards that is common in many industries — but not in the fertility space. One fertility network that has had the International Organization for Standardization (ISO) certification since 2003, however, says it has been hugely beneficial to its organization and that other clinics could find it helpful as well. 

What is ISO? 

ISO is a non-governmental international organization made up of 170 national standard bodies that each represent ISO in their country. The organization — which was founded in 1947 and is headquartered in Geneva, Switzerland — brings together experts to develop standards that can be applied to various industries. ISO itself does not certify organizations; instead, external certification bodies use the ISO standards to certify organizations.

While ISO certifications are popular in many industries, the certification is rare in the fertility space, which has its own standard certification and accreditation.  

ISO is different from accreditation from the College of American Pathologist (CAP) or Joint Commission — standards that are common for fertility clinics in the U.S. — as it focuses more on individual processes and safety such as documents control protocols and processes, said Dr. Steven Katz, CEO of REI Protect. While CAP assesses an organization’s competency to meet specific standards of care, the ISO is more specific in terms of how the laboratory personnel handle tasks and processes. 

The only ISO certified fertility center that could be confirmed by Inside Reproductive Health

Boston IVF became ISO-certified in 2003, said Michael Alper, founding partner of Boston IVF. 

“When an organization gets larger, you have to make a special effort to keep things organized,” Alper said. “[ISO] really helps you get control over things, especially documents.” 

Years ago, Alper asked his staff to send him every document bearing the Boston IVF name. He received thousands, many of which were older and outdated consent forms and brochures. The clinic’s documents were not organized — but Alper says ISO has helped Boston IVF implement guidelines for document control. Alper said the standards also require internal audit.

Every role has a clear job description with detailed workflows, which has “made us a better organization and much more transparent,” Alper said. Protocols, such as the process for transferring frozen embryos, are documented. 

To the best of his knowledge, Boston IVF is the sole ISO-certified IVF clinic in the U.S. even as more hospitals become ISO certified, Alper said. Because ISO certification is carried out by various national and international certification bodies, they could not confirm this.

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Why ISO certification isn’t more common in IVF labs 

Because there is a large focus on outcome in the fertility industry — including how many eggs are fertilized and how many people get pregnant — there also needs to be a focus on safety measurements, equipment and documentation, said Dr C. Brent Barrett, chief lab director at Boston IVF. 

“One of the really critical things that ISO continues to do for us is align everyone,” Barrett said. Barret, who inspects IVF labs, said he’s found that labs can be very siloed: the nurses are often separated from the administration workers, who are separated from the physicians. Document control, standardized by ISO, has everyone on the same page, he said.

ISO has also required Boston IVF to put a strict protocol in place to deal with errors, Barret said. 

Katz said fertility clinics may not have a clear understanding of the difference between ISO standards and those of the common certifications and accreditations in the fertility space. 

“For IVF labs around the country, I think they’re having trouble delineating between the ISO certification and the CAP or Joint Commission accreditation,” Katz said. IVF labs may view the certification and accreditation as duplicates, and therefore not consider ISO certification, he added.

“In order for labs to spend time, energy, money, capital resources, to get ISO certified, they really have to understand what it is and how it’s differentiated from CAP or the Joint Commission accreditation,” Katz said. 

ISO’s impact on the desirability of IVF labs in the marketplace 

Boston IVF has changed hands three times since 2019. In late 2023, reproductive medicine group IVI RMA announced it was acquiring the North American operations of Eugin Group, including the Boston IVF fertility network. Before that, the network was owned by European private healthcare provider Fresenius Helios, which bought Eugin Group in 2020. Prior to that, NMC Health plc acquired a majority stake in Boston IVF in 2019.

Alper says that while buyers are not necessarily looking at Boston IVF’s ISO certification when determining its desirability, the culture that the standard has brought to the clinic — such as the  transparency of the clinic, the team-approach to results and the focus on customer satisfaction — has helped establish the clinic’s strong position in the industry.

“Our position in the industry is partly related to that philosophy,” he added.

The content and themes expressed within the article are that of the news. The advertisers do not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the advertisers or of Inside Reproductive Health.

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Invitae Sells $10M in Assets to Natera, But Can’t Shrink $1B Debt Before Ch. 11 Bankruptcy

The company will auction off the rest of its assets under court’s supervision.

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BY Rosemary Scott

On Feb. 13, genetic testing company Invitae Corporation announced it had filed for Chapter 11 bankruptcy protection in New Jersey. 

At the time of the filing, the company had assets worth $500 million to $1 billion and debts of $1 billion to $10 billion. Invitae stated in the filing it plans to auction its assets under the court’s supervision.

On Jan. 22, Invitae announced it had sold its reproductive health assets, which include carrier screening and non-invasive prenatal screening, to genetic testing company Natera for $10 million upfront and up to $42.5 million in milestone payments and litigation credits. Weeks later, on Feb. 5, the Wall Street Journal reported Invitae would likely file for bankruptcy soon, citing anonymous sources familiar with the matter. 

The same day the WSJ article was published, Invitae’s stock dropped over 75% to about $0.10 per share. 

From the time of its launch, Invitae’s stock remained steady for years, hitting a high of about $55 per share in December 2020. Ever since, the stock has been on the decline, trading for less than $1.00 a share since August 2023. This prompted a warning from the New York Stock Exchange in September that the company may soon be removed from the exchange. 

Invitae offered its line of genetic carrier screening tests in the following areas: oncology, women's health, pediatric & rare diseases, cardiology and neurology. According to Invitae’s Q3 2023 earnings report, the company served 4.4 million patients over the quarter, with oncology generating the most revenue ($62 million), followed by women’s health ($27 million). 

Was Invitae’s Business Model Too Good to be True?

Launched in 2018, Invitae stated the tests provide “affordable, accessible information on genetic changes that pose a risk for parents of having a child with an inherited genetic disorder.” 

David Sher, founder and CEO of global fertility agency Elite IVF, told Inside Reproductive Health that Invitae’s average test price was about $200, versus about $1000 per test from some competitors.

As a former customer of Invitae, Sher was disappointed to hear of Invitae’s bankruptcy filing. Sher said the company’s low price allowed genetic testing to be more accessible for his patients. Now that the company is no more, Sher believes the rise in cost could keep many of his patients from being able to afford the service. 

“Invitae changed the way the world looks at testing,” Sher said. “Testing became more standardized as a result of its accessibility, and I wonder what’s going to happen now.” 

The business model and price point drove millions in annual sales for Invitae–in its 2022 full year financial report, the company reported $516 million in revenue, a 12% increase from the year prior. Still, the revenue couldn’t keep up with the money Invitae was spending. Despite a restructuring effort put in place by a new CEO that included laying off over 1,000 employees in July 2022, it lost over $654.4 million between Q3 of 2022 and the year before due to its total expenses of $1.3 billion. 

Additionally, with more than $1 billion of debt, interest payments may have been too high to maintain, and a loan would likely share a similarly high interest rate, given the company’s income to debt ratio at the time of the filing.

“As a customer of theirs, I was astonished by their excellent offering and their service–it was amazing,” Sher said. “I thought it was almost too good to be true, and unfortunately, it seems like it was.”

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Thousands of IVF Payments Frozen After Change Healthcare Cyber Attack

Other clearinghouses, cash-pay patients, insulate reproductive medicine sector from severe financial crunch.

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BY RON SHINKMAN

A ransomware breach of one of the nation’s largest clearinghouses for health insurance claims has likely caused some consternation to reproductive medicine practices, an expert familiar with the situation says.

The breach of Change Healthcare – a subsidiary of UnitedHealth Group, the nation’s largest medical insurer – occurred in late February. Change reportedly paid a $22 million ransom in bitcoin to regain control of its data and networks, but the company said it will not be able to start processing healthcare claims against until at least March 18. Change handles about 15 billion healthcare transactions a year, according to the U.S. Department of Health and Human Services.

“The hack affected not only (our customers), but the entire healthcare industry,” said Nimesh Shah, chief executive officer of eIVF, which provides services to about 140 fertility practices, although not all of them use its billing service. The company relies on Change Healthcare to process and pay claims to its clients. Shah said about 30 to 40% of the claims its processes for clinics are billable to insurance companies, and the company typically handles “thousands” of such claims each day.

The issue has become so serious that last Sunday, Health and Human Services (HHS) issued a letter urging UnitedHealth to “take responsibility to ensure no provider is compromised by their cash flow challenges stemming from this cyberattack” and “ensure expedited delivery of funds to impacted providers.” 

How the breach is impacting individual reproductive medicine clinics and their networks remains unclear. Executives and spokespersons with some of the largest fertility clinics in the U.S. – including Boston IVF, Shady Grove, the Prelude Network, Progyny and the University of California at San Francisco Center for Reproductive Health – have either declined to comment or did not immediately respond to requests seeking comment.

Taylor Stein, co-CEO of EngagedMD, which provides support services to clinics but does not handle their claims, suggested that fertility centers’ finances may not be as crimped as other medical practices, because of the number of self-pay IVF patients.

“Unless they’re operating in states (with mandated insurance coverage for IVF), most clinics have a lot of cash coming in the door,” Stein said.

Workarounds through other clearing houses

Meanwhile, other clearinghouses have been offering workarounds to providers who contract with Change Healthcare. Availity, another claims clearinghouse, is offering to process claims for Change clients, Shah said.

“Once a clinic registers with Availity and creates a relationship, we’re automating that into our (electronic medical records) or billing solution, so that they can do things in an automated fashion as opposed to a manual process (for submitting claims),” Shah said. He added that about half of eIVF’s clients – fewer than 100 in total – have signed onto the program, which is known as Availity Lifeline.

According to Availity spokesperson Matt Schlossberg, the company has "provided free digital connectivity to more than 300,000 providers—and that number continues to grow,” Schlossberg said in an email, adding that about $5 billion worth of claims had been processed through the program as of early this week. He was unable to immediately provide a breakdown on the number of reproductive medicine providers participating in the program.

Remaining concerns

Although Shah observed that his company wants “to create choice whenever possible,” he would not say directly whether eIVF would seek another clearinghouse for its clients.

“When this happens, nobody is claiming victory,” he said. "If you’re Availity or (other clearinghouses), you are not excited by what just happened. Probably their number one reaction is ‘thank God that wasn’t us.’”

However, the likelihood of clearinghouses and other players in the healthcare industry dodging such breaches appears to be diminishing, said Stein, whose expertise is in cybersecurity.

“They’re going to keep on happening,” he said. “It’s the new normal.”

The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.

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Pause and Go: What Alabama’s Four SART-affiliated Fertility Centers Are Doing Now

The pause, the unpause, and remaining challenges 

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BY: RON SHINKMAN

The decision from the Alabama Supreme Court giving a just-fertilized ovum the same legal rights as children has upended the IVF business in that state, with at least three of its SART-affiliated fertility clinics pausing such procedures and patients taking their embryos elsewhere.

Alabama’s highest court reversed the prohibition on seeking wrongful death damages late last month, concluding that a human life begins at fertilization. It also concluded that it was up to the state Legislature to make any accommodations regarding that issue.

The decision puts many IVF clinics in a bind because the damages awarded in a wrongful death lawsuit can be much higher than for a breach-of-contract claim, as the latter only focuses on placing a dollar value on the services provided by the clinics and whether they made an earnest attempt to deliver IVF services as promised. Wrongful death litigation focuses more on emotional losses suffered by parents and other family members and could also include punitive damages – additional financial penalties for negligent or deliberate acts.

The state Supreme Court ruling could also lead to criminal prosecutions of clinics that destroyed embryos, although Alabama’s Attorney General promised that would not occur in connection with delivery of IVF services.

Alabama’s four SART-affiliated IVF centers, and what they’re doing

The decision immediately created ripple waves throughout Alabama’s reproductive medicine community, with most pausing procedures. Alabama Fertility Specialists, the University of Alabama at Birmingham health system and the Center for Reproductive Medicine  have all placed pauses on IVF procedures. They comprise three of the four providers in Alabama affiliated with the Society of Assisted Reproductive Technology. The fourth clinic, New Leaders in Fertility and Endocrinology, did not immediately respond to a query about the status of its IVF services.

“We are finishing out patients who are in stimulation and we are just trying to see what happens this week,” said Kathleen Miller, who is laboratory director for Alabama Fertility Specialists in Birmingham, specifically referring to a bill crafted by Alabama lawmakers that would exempt fertility clinics from liability under the Supreme Court ruling  The clinic previously announced that it is putting on hold any new IVF treatments or cycles.

The University of Alabama at Birmingham – which runs perhaps the biggest IVF program in the state, is also continuing to do some work. “Everything through egg retrieval remains in place,” the provider said in a statement. “Egg fertilization and embryo development is paused.”

A source indicated that the Alabama Center for Reproductive Medicine is continuing to perform IVF procedures, but that could not be independently confirmed. Practice founder Cecil Long, M.D. and practice administrator Emma Williams did not respond to phone and email queries.

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Impact on Non-Clinic Fertility Companies Doing Business in Alabama

Miller noted that the bill currently lacks a safe harbor for ancillary businesses, who she said are apparently balking at sending supplies and equipment to Alabama practices until that issue is addressed by lawmakers.

Meanwhile, there are signs that IVF patients in Alabama are taking steps to move their embryos out of the state. Louis Villalba, chief executive officer for New York City-based TMRW Life Sciences, noted that his company’s offer of one year of free storage to anyone wishing to remove their embryos from Alabama has received a strong response. Typically, the company receives about 50 phone calls a week about moving and storing embryos, Villalba said. That call volume has quadrupled since the offer was made. 

Moreover, moving requests are also coming from other nearby states, such as Texas. “It’s coming from all the Red states if you will, and from the Southeast in particular,” Villalba said.

Inception Fertility, which operates 48 clinics in nine states, also confirmed that IVF patients in Alabama have been moving embryos to its facilities in Tennessee and Georgia, according to an email from Chief Marketing Officer Lindsey Rabaut.

Remaining Challenges for IVF in Alabama

Igor Brusil, a former embryologist who now is an attorney in Texas, noted that while the high court’s decision will cause chaos in the short-term, there are feasible workarounds for IVF clinics in Alabama.

“There are things to be done to reduce the number of embryos that the clinic works with, which reduces the risk of any action” that might inadvertently damage them, said Brusil, who added that he is not involved in the Alabama case.

“Clinics can freeze unfertilized oocytes to reduce the number of oocytes that would be inseminated with sperm. This would result in fewer embryos created, thus reducing the number of embryos that potentially could be cryopreserved,” he added. “Alternatively, clinics may have to change stimulation protocols to decrease the number of oocytes collected.”

However, Brusil added that any changes to how the clinics approach the procedure will come at the expense of patients. “They will certainly suffer because whatever decision is made is not going to be the most effective IVF treatment possible,” he said.

The content and themes expressed within the article are that of the news. The advertisers do not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the advertisers or of Inside Reproductive Health.

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Correction: 2/29/24 The Inside Reproductive Health article ASRM, SART, SRBT Withdraw Proposal to Eliminate Doctoral Requirement for Embryology Lab Directors, stated that ELDs are governed by the Clinical Laboratory Improvement Amendments of 1988, better known as CLIA. The CLIA regulations govern andrology and endocrinology laboratories within a fertility clinic.

Regulations suggested by the Centers for Disease Control and Prevention and endorsed by the American Board of Bioanalysis and the American Society for Reproductive Medicine and its affiliates require that an ELD have a medical or osteopathic degree or an earned doctorate degree from an accredited institution in a chemical, physical, or biological science as the major subject. Alternatively, individuals may serve as ELD directors without a medical or doctoral degree if they were certified prior to July 20, 1999.

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ASRM, SART, SRBT Withdraw Proposal to Eliminate Doctoral Requirement For Embryology Lab Directors

Dropped after pressure from current IVF lab directors 

The content and themes expressed within the article are that of the news. The advertisers do not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the advertisers or of Inside Reproductive Health.

This News Digest Brought to You by
Future Fertility and Mind360

BY: RON SHINKMAN

The American Society for Reproductive Medicine (ASRM) and two of its affiliates proposed last year to eliminate the longstanding doctoral degree requirement for embryology laboratory directors, but withdrew it earlier this month after it came under criticism from current lab directors.

The proposal from the ASRM, the Society for Assisted Reproductive Technology (SART) and the Society of Reproductive Biologists Technologists (SRBT) was first submitted to the American Board of Bioanalysis (ABB) last April, according to followup correspondence the groups sent to ABB last September. The proposal was to reinstate an examination and certification pathway for non-doctoral technical supervisors to become embryology laboratory directors. The ABB oversees the certification of laboratory professionals in the United States.

A doctoral degree has been required for embryology lab directors since 1999. That’s when the federal Clinical Laboratory Improvement Amendments (CLIA) regulating labs in the U.S. were expanded to include embryology laboratories. The CLIA regulations also classified embryology labs as conducting “high complexity” testing. All labs with such a designation require physician or doctoral-holding directors. Non-doctoral embryology lab directors at the time were exempted from the new rule, and a small number still hold such jobs, according to Eva Schenkman, an embryology lab director and consultant based in Rocky Mount, N.C.

The September letter to the ABB mentioned “extreme staffing shortages” cited by the SRBT president at the time, Brad Milette. He referenced numerous job openings on the ASRM jobsite, LinkedIn and other sites. However, the letter does not clarify if the shortage includes embryology lab directors.

Milette, a laboratory supervisor and embryologist for the Women & Infants Fertility Center in Providence, R.I., did not respond to phone calls seeking comment.

Also signatory to the letter was past SART president Sangita Jindal. The letter noted that half of current embryology laboratory directors direct more than one lab, although she did not delve further into the average number of laboratories they supervise. Under CLIA, a single individual may direct as many as five high complexity laboratories simultaneously.

Jindal did not respond to emails seeking comment.

The third signatory to the letter was ASRM Chief Executive Officer Jared Robins, M.D. Neither he nor an ASRM spokesperson responded to emails seeking comment. ABB did not respond to a query sent through its website.

Current embryology lab directors believe there was an ulterior motive for the proposal: a concerted cost-cutting campaign among the owners of reproductive medicine practices.

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“There are people who are working for big venture capital and private equity firms (in the fertility business),” and I don’t think they want to pay for PhDs,” said Marlane Angle, director of the laboratory at the Caperton Fertility Institute in Albuquerque, N.M.

Schenkman concurred. She suggested that along with the presence of private equity, inflation and deteriorating margins may be pressuring practice owners to cut costs.

Another laboratory director who asked not to be identified said that the salary differential between someone in a supervisorial position with a doctorate degree and without could be as much as $60,000 per year. A recent salary survey conducted by ASRM and SRBT concluded that the large majority of experienced lab directors with doctorates working at private assisted reproductive technology labs received base salaries between $175,000 and $275,000 per year. But among those lacking a doctoral degree, the majority reported salaries of between $100,000 and $225,000.

“It’s just insane,” Schenkman said of the possibility that someone with a bachelor’s degree and a few years experience could direct an embryology lab.

When Schenkman discovered the proposal had been submitted, she launched a petition to have the proposal withdrawn. The multi-page petition also questioned the jobs data cited in the September letter to the ABB. It stated that the number of embryology lab director positions being posted were perhaps one or two per month. It also noted data from the Centers for Disease Control and Prevention of a 35% increase in cycles using assisted reproductive technology since 2018. Meanwhile, lab growth has been static; the petition also cited CDC data indicating that there are three fewer embryology labs operating in the U.S. now compared to 2018.

“This data aligns with the notion that the rise in cases, unaccompanied by a proportional increase in clinics, underscores a shortage of embryologists rather than laboratory directors,” the petition stated.

The campaign orchestrated by Schenkman appears to have had its impact: more than 400 individuals have signed the petition to date. And on Feb. 2., ASRM, SBRT and SART sent a joint email to ASRM members stating that it had withdrawn the proposal.

“We regret that this process has not been as transparent and inclusive as it should have been and has clearly caused polarized discussions among our SRBT members. Based on the number of comments from our members, we realize that this request was clearly premature and may not be representative of the broad SRBT membership,” read the email, which was signed by ASRM President Paula Amato, M.D., SART President Steven Spandorfer, M.D. and SRBT President Marina Gvakharia, M.D.

In addition to withdrawing the proposal, the email said it would conduct a survey of SART-affiliated laboratories regarding “the current status and future needs of lab directors.” It also planned to conduct a survey of SRBT members on the embryology lab director requirements, and “conduct a series of town hall meetings to present these findings and to listen to our members’ perspectives on addressing workforce challenges.”

The content and themes expressed within the article are that of the news. The advertisers do not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the advertisers or of Inside Reproductive Health.

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Future Fertility and Mind360

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Eight Fertility Clinic Employees Arrested, Clinic Shut Down By Greek Government

What We Know About What Was Alleged in Crete in August

The Greek clinicians were accused of working with illegal brokers to bring in surrogate mothers and egg donors from Eastern European and Balkan nations.

The content and themes expressed within the article are that of the news. The advertisers do not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the advertisers or of Inside Reproductive Health.

This News Digest Brought to You by
Future Fertility and LEVY Health

BY: RON SHINKMAN

The central European fertility sector was rocked in August when Greek police raided a long-established fertility clinic on the island of Crete as part of an investigation into the trafficking of surrogate mothers.

Eight employees of the Mediterranean Fertility Institute (MFI) were arrested in the raid, along with a local midwife who also participated in the alleged scheme. Those taken into custody include the clinic’s founder, Ioannis Giakoumakis, an OBGYN who opened the clinic in 1992. Giakoumakis did not respond to a request seeking comment sent to him through LinkedIn. His attorney, Michalis Mavros, has told Greek media that once more facts about the case emerge, Giakoumakis will be vindicated.

According to the Hellenic Police, the national law enforcement agency that is Greece’s equivalent of the FBI, the clinic had pursued the “industrialization of births,” primarily by working with traffickers who brought foreign-born women living in northern Greece – many refugees from Balkan and Eastern European countries – to act as surrogates and egg donors.

The Hellenic Police said it had been investigating MFI since December 2022. It concluded that at least 98 women were allegedly trafficked by the clinic as surrogates, while another 71 women were “exploited” as egg donors. Many of the surrogates were being housed in 14 residences allegedly procured and operated by MFI. At least 30 pregnant surrogates were found in the residences, which were described as squalid.

In addition to the trafficking charges, Greek authorities also allege that MFI and the eight staffers, “falsified birth records, falsified medical documents, prepared fictitious leases and fictitious cohabitation agreements.” It also alleges that embryos were illegally sold and that as many as 400 patients who underwent IVF procedures may have been defrauded.

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The Hellenic Police claim that MFI paid its own employees bounties ranging from about $3,100 to $5,200 for each surrogate or egg donor they brought in, while the surrogates were paid anywhere from $315 to $630 a month while pregnant. Would-be parents, meanwhile, were charged anywhere from $73,000 to $126,000 for each surrogate birth.

A Hellenic Police spokesperson said that the investigation had recently been handed over to prosecutors in Chania, the city in Crete where MFI is located. A spokesperson for the prosecutor’s office did not respond to a request seeking comment. It is unknown when trials will take place.

The arrests have created an upheaval among would-be parents using the clinic, including as many as 150 from Australia. That nation bans payment for surrogacy, although it is legal if done for free. Greece is one of the few nations that permits surrogacy contracts with foreigners, a law that has been on the books since 2014. Georgia, which also permits overseas commercial surrogacy, is moving to ban the practice by next year.

According to Australian media reports, Greek police have kept newborns linked to the surrogacy scandal in a hospital in Crete, barring contact with their would-be parents until DNA testing can confirm genetic links to MFI clients. And with the clinic shuttered immediately after the raid, many other would-be parents have their eggs and embryos caught in legal limbo.

Along with the chaos created by the scandal, it has also shaken the region’s fertility sector to the core. Nikolaos Vrachnis, a distinguished OBGYN in Athens, was fired by the Greek government as president of the Hellenic National Authority for Medically Assisted Reproduction shortly after the arrests were announced.

The content and themes expressed within the article are that of the news. The advertisers do not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the advertisers or of Inside Reproductive Health.

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• 20% uplift in patient engagement. 

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This News Digest Brought to You by
Future Fertility and LEVY Health

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All external links active as of 2/22/24.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Northstar Fertility Expands Its Portfolio with Strategic Acquisitions

Include Surrogate Support and ‘Ethical’ Egg Donation

The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.

This News Digest Brought to You by
MyEggBank

BY: LISA MUNGER

In a move that expands its reach in the fertility sector, Boston-based Northstar Fertility has announced its latest acquisitions, Surrogacy.com and Everie in calendar 2023, in November and October, respectively. 

In addition to Everie and Surrogacy.com, Northstar's companies include Circle Surrogacy, Growing Generations and Reproductive Possibilities surrogacy agencies. Northstar companies also offer services related to fertility, like insurance coordination, financing and escrow management, according to the parent company, the CortecGroup. Key partners formed Northstar in 2019.

The price tags paired with the acquisitions have not been made publicly available as of this writing. Representatives of Northstar, Surrogacy.com and Everie declined to speak to Inside Reproductive Health for this article.  

These additions to Northstar's already portfolio signal a new era in the fertility space, catering to a growing and increasingly diverse fertility business portfolio, outside of fertility clinic consolidation.

Surrogacy.com, a new platform dedicated to the needs of surrogates, represents a shift in the approach to surrogacy. Niki Renslow, Surrogate Success Manager for Surrogacy.com, said in a prepared statement. 

Renslow said the web community promises to provide candid answers from people with experience in surrogacy, including support networks, education and help in determining if surrogacy itself is an appropriate avenue for consideration. 

A month before the Surrogacy.com acquisition, Northstar acquired Everie, a frozen egg donation company, launching “Mutual Match,” a system designed to foster transparency with donors and recipients. 

Aisha Lewis, president of Everie and a bioethicist, said in a prepared statement that she hopes the new relationship will foster growth and evolve with the field.

"The traditional egg bank system has previously lacked overt consent from donors on who the recipient parents are for their genetic lineage," said Steuart Botchford, CEO of Northstar Fertility in the same statement.

Everie said in the statement that their Medical Director is Dr. Mark P. Trolice, principal of Fertility Care: The IVF Center in Central Florida.

The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.

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External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

IVF centers moving from “pay per treatment” to “pay for baby” model

Fertility clinic pricing strategies enter a new era with assistance from AI company 

This News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by Inside Reproductive Health.

This News Digest Is Paid Sponsored Content From
AIVF™

BY NATASHA SPENCER-JOLLIFFE

With the prominence of sophisticated artificial intelligence (AI) systems like AIVF’s EMA progressing the fertility industry from standardization to personalization, fertility clinics can shift to a “pay for baby model” over the traditional “pay per treatment” pricing structure.

Today’s fertility industry has struggled to keep up with treatment demands. In the US, clinics are only serving 20% of the need for IVF, leaving 80% of patients giving up on starting the process of having a child, Daniella Gilboa, CEO and co-founder of AIVF, conveyed. 

However, as AI-powered scoring systems, such as AIVF’s EMA, lower uncertainties, expedite embryo evaluation, and provide clear, accurate information, clinics now have the potential to meet this demand. Clinics utilizing AIVF’s software have seen a 30% increase in success rates, Gilboa said in a July 2023 New York post article.

Non-invasive AI systems analyze multiple parameters that, when put together, give much more predictive information about embryo development. 

The in-depth operating systems help doctors understand implantation failures and multiple failed cycles. 

“The timing of the cell divisions, the evenness of the cell divisions and the amount fragmentation of certain features will give us ideas as to the embryo’s true quality and genetic potential,” Dr Conor Harrity, Consultant Gynecologist and Subspecialist in Reproductive Medicine at Rotunda and Beaumont hospitals in Dublin, Ireland, told Inside Reproductive Health. 

Predictive power

Dr. Harrity sought a non-invasive tool that would provide more information on blastocysts than standard morphology. “AIVF stands out because it gives us much more information about the potential of the embryo without the need to biopsy the embryo with the extra risk of embryo damage or the extra cost involved with preimplantation genetic testing technology (PGT),” said Dr. Harrity.

“If the embryo is not good enough, you can modify and personalize the regime,” said Dr Harrity. Therefore, AIVF helps clinicians identify scenarios where good embryos haven’t worked, and they need to modify the transfer regime. With AI scoring, the tool also lets clinicians see that embryos they thought were good morphologically weren’t as good as they had thought. 

“AIVF gives more confidence to both the doctor and the patient about how to shorten their journey to either success or to knowing why it’s not working, and then changing tack and doing something that will help them succeed,” said Dr. David Walsh, Director of FirstIVF.

The use of AI and tools like AIVF indicate a move to a 'pay per baby' pricing model over a 'pay per treatment' model, Walsh confirmed. “The closer you can get to a higher probability of outcome and shared risk between the fertility clinic and patient, the more likely we are to see the move to a ‘pay per baby model”, Walsh said. 

Due to its expense, clinics cannot afford to return this cost to patients, Walsh said, if treatment does not result in pregnancy. “Anything that gets closer to the prediction of outcome allows clinics to make calculated outcomes, therefore increasing their predictive power”. 

Time-lapse capabilities 

Progressing beyond PGT, AIVF enables retrospective use by recording time-lapse videos. Over the past year, Dr. Harrity confirmed that the industry has started to see instances where it has been very useful to look retrospectively at embryos and learn more about previous failed transfers.

AIVF’s EMA uses time-lapse monitoring to understand an embryo’s development. Several cameras record the embryo to give a multi-dimensional view of the embryo’s growth. The system shows how the embryo divides from a single cell into multiple cells until it forms a blastocyst.

Rather than just using snapshots at certain points of development, embryologists continuously monitor the embryo’s growth over five to six days until it reaches the blastocyst stage, providing much more information.

Non-clinical benefits

EMA’s automated embryo evaluation and quality scoring modules (AIVF Day-3, AIVF Day-5 and AIVF Genetics) automate the embryo evaluation process, entirely replacing manual steps, such as visual inspections, morphokinetic and morphological annotations, and manual data recording and transfer into the electronic medical record (EMR). 

The integrated system directly transfers all embryo evaluations and scores from the time-lapse incubator to the EMR through the EMA platform, eliminating redundant data recording and transfer between multiple operating systems within the IVF laboratory. “It is documented in the patient’s information record, another data point,” said Walsh.

A 2023 research study found the average manual evaluation and recording time without and with EMA was 3.1 minutes versus 30.9 seconds per embryo, respectively. Overall, using AIVF reduces the average embryo evaluation time per cycle by 83%, a case study on efficiency revealed.

By utilizing EMA's automated messaging dashboard, IVF analytics tool, and laboratory documentation for performance monitoring and calculation, clinics can also lower administrative time for each cycle from 9.0 hours to just 5.58 hours, a 38% reduction. (1)

AIVF audits field transfers; offering information about embryos that did not implant.

Developers are adding features to AVIF’s time-lapsed five-minute videos to increase predictive power. Standing out in a way that isn’t true for all other non-invasive programmes, Walsh said, “AIVF is constantly learning, so it is getting better over time”.

“The big thing about non-invasive testing is that it can become universal,” said Walsh. It is accessible to everybody going through a fertility lab because it is relatively low cost, particularly compared to genetic testing. As long as the information is stored securely, non-invasive testing enables clinicians to look back in time and use it in the future. Clinicians can receive that information and run the data. “It’s eternal,” said Walsh.

While a move to subscription pricing models is uncertain at the moment, Walsh said, “clinics may justify this move based on confidence and outcomes”. He said confidence in AI technology like AIVF and its outcomes will help clinics move to different financial models, with ‘pay for baby’ treatment a permissible and viable alternative to the 'pay for baby' treatment option.

(1) Validated by AIVF partners. Internal data on file

This News Digest Story is paid featured content. The advertiser has had editorial input and control over its creation. However, the views and opinions expressed in this article do not necessarily represent the views of Inside Reproductive Health. The sponsorship of this content does not imply an endorsement by Inside Reproductive Health.

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With EMA™, clinics can harness the power of AI to navigate the intricacies of reproductive medicine with confidence and finesse

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All external links active as of 2/8/2024

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Kindbody and Bloomberg. What started the three article series and what journalist expects next

Media outlet’s coverage, company’s responses

The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.

This News Digest Brought to You by
AIVF™

BY: ROSEMARY SCOTT

On Oct. 13, 2023, Jackie Davalos of Bloomberg published her first article on Kindbody, the New-York based end-to-end fertility network, outlining the mishaps some patients reported experiencing at the company’s clinics. The second and third articles covered changes in Kindbody’s financial outlook and a procedure quota for providers, respectively.

These articles led to statements from Kindbody in response, as well as other announcements to defend their reputation in the fertility field.  

What Prompted Bloomberg Coverage

Davalos is a technology reporter at Bloomberg and has been with the company since January of 2020. She typically covers the intersection of tech and business, such as AI products in development and powerful tech companies experiencing financial issues. Davalos told Inside Reproductive Health that originally, Kindbody piqued her interest due to its unique business model–Kindbody states it is the only family-building benefits provider for employers that owns and operates fertility clinics.

“I didn't think that this was going to be as big of an investigation as it turned out to be,” Davalos said. 

In the first article, Davalos outlined alleged understaffing and inconsistent safety protocols that plague many Kindbody clinics, citing “three dozen current and former employees and patients interviewed by Bloomberg.”

Though Kindbody disputed claims of being understaffed, it acknowledged the mislabeling of embryos in at least one case, Davalos reported. In a statement sent to Bloomberg from an unidentified company spokesperson, Kindbody responded by stating that “no Kindbody laboratory has had an incident, accident or other issue that is unusual to what occurs in IVF laboratories generally.”

Cash Burn and C-Suite Shuffle

In November, Davalos published her second article on Kindbody, stating the startup had made significant changes to its 2023 revenue forecast, lowering its goal from $240 million to $186 million and seeking to raise an additional $50 million by the end of the year.

In March 2023, Kindbody founder Gina Bartasi stated in a press release that the company was valued at $1.8 billion. Now, Kindbody anticipates it will not be profitable until mid-2024, according to documents that Davalos says were given to her by unnamed sources. Bloomberg reported that according to these documents, Kindbody is losing an average of about $7 million each month of 2023 through September and spending about $60 million total in that time period.

Just after the November article in which this information was stated, Kindbody published a press release on Dec. 5 in which CEO Annbeth Eschbach said 2023 was an “exceptional year for Kindbody, highlighted by record levels of revenue.” On Dec. 14, the company published another press release detailing its “2023 Year in Review,” with a list of accomplishments over the year, including partnerships forged and positive financial statistics.

Kindbody is also experiencing leadership changes, according to Davalos’s investigation. Davalos stated Kindbody is paying a search firm $750,000 to replace Annbeth Eschbach, though no timeline has yet been determined for this search, and the new hire has yet to be announced. Additionally, she stated, Kindbody’s president, Gregory Poulos, stepped down from his role in September. 

One month later, Kindbody announced that they hired a new chief scientific officer in October. It is also planning to recruit new chief operating and people officers, the sources told Davalos.

Unreasonable Targets vs. Industry Standard, Expanding Access to Care

In an article published Dec. 22, Davalos reported that the company's internal practices have sparked ethical debates among its doctors. The article states that Kindbody executives, during a retreat in September, informed reproductive endocrinologists that they needed to increase their IVF volumes by 12 egg retrievals per month The article reports that the quota aims to increase net income and meet the company's goals for going public. 

According to Davalos, several physicians called the targets “unreasonable” and warned these new measures could result in physicians pushing IVF to women who may not need it. She did not specify exactly how many physicians spoke out. 

In response, Kindbody defended its practices in a statement sent to Bloomberg. Kindbody stated that tying monthly egg retrieval targets to compensation and revenue forecasts is an “industry standard.” Bloomberg did not report on what other fertility networks do or do not follow the same practices.

Shortly after that article was published, Kindbody announced the opening of a new office in the San Francisco Bay Area.

More Bloomberg Articles on Kindbody

For her part, Davalos told Inside Reproductive Health that as long as sources keep coming forward with information, she plans to continue reporting on Kindbody. 

“If there's fresh reporting, and if there's people coming forward, I'm certainly going to report on that as it comes through,” she said.

Neither Gina Bartasi, Kindbody’s founder, or Annbeth Eschbach, CEO, responded to Inside Reproductive Health’s request for comment through LinkedIn or through the company's general press email.

The content and themes expressed within the article are that of the news. The advertiser does not have editorial control over the content of this article, and Inside Reproductive Health maintains full editorial independence. The views and opinions expressed in this article do not represent the views of the Advertiser or of Inside Reproductive Health.

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With EMA™, clinics can harness the power of AI to navigate the intricacies of reproductive medicine with confidence and finesse

AIVF is at the vanguard of transforming reproductive medicine through cutting-edge AI technology. The EMA™ platform stands at the forefront of a technological revolution in reproductive medicine, offering fertility clinics an unparalleled advantage. This platform is not merely a tool; it's a groundbreaking innovation, reshaping the future of fertility treatments. By integrating advanced AI technology, EMA™ elevates the standard of care, bringing unmatched precision and significantly improved success rates to every treatment.

Free Cost Efficiency Calculator

To learn more on how to optimize your IVF clinic, click the link below.

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This News Digest Brought to You by
AIVF™

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All external links active as of 2/1/2024

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Law Firm Suing CooperSurgical Says More Lawsuits Forthcoming

Firm’s partner suggests that suits may combine into class-action.

This News Digest Brought to You by
MyEggBank

BY RON SHINKMAN 

The Los Angeles law firm of Peiffer Wolf, which is representing two couples suing Cooper Surgical, says that more lawsuits will be filed against the company, their attorney told Inside Reproductive Health.

Two Current Lawsuits Against Cooper Surgical for Destruction of Embryos

CooperSurgical is being sued by two Los Angeles couples who claim their attempts at conception through IVF were derailed by a faulty culturing solution that destroyed their developing embryos. 

The lawsuits were filed earlier this month in Los Angeles County Superior Court, records show. They essentially make identical allegations: CooperSurgical sold culturing media to fertility practices that did not undergo sufficient testing. Those lots of solution “turned out to be toxic to human embryos, eggs, and sperm.”

CooperSurgical issued a recall notice of three lots of culturing media to its customers and distributors on Dec. 5, 2023. Entitled “Urgent Media Recall: Field Safety Notice,” the recall noted “a high volume of customer complaints for the three associated lots.” It also warned that the lots pose a risk of “impaired embryo development prior to the blastocyst stage.”

The lawsuits allege CooperSurgical’s recall efforts “intentionally did not immediately disseminate notice of the recalled lots publicly or throughout the IVF community.”

The plaintiffs in the two cases were referred to by random initials to protect their privacy. The clinics that provided the IVF services were not disclosed and were not named as defendants in the lawsuits.

A.B. and C.D., the plaintiffs in one case, allege that faulty culturing media destroyed all but one of “numerous embryos” within a few days of a fertilized egg being cultured in November of last year. E.F. and G.H., the plaintiffs in the other case, claim that all of their embryos were destroyed last November. 

“Plaintiffs are devastated. They may no longer be able to have additional children with their genetic material as a result of defendants’ conduct,” the lawsuits state.

The litigation seeks damages for product liability regarding design and manufacturing defects and failure to warn, negligence and negligent failure to recall the defective culturing lots.

A spokesperson for CooperSurgical, a subsidiary of Pleasanton, Calif.-based medical device manufacturer The Cooper Companies, told Inside Reproductive Health it does not comment on pending litigation.

More Lawsuits Against Cooper Surgical Could Develop Into Class-Action

Peiffer Wolf partner Adam Wolf said that more lawsuits against CooperSurgical are forthcoming. He currently represents some 20 clients who claim the faulty culturing media damaged their embryos.

“It would not surprise me if we end up representing more than 100 people against Cooper. We will file those additional lawsuits in both state court and federal court.” Wolf said in an email. He noted that some clients are in other states outside of California, necessitating the use of federal courts. He added that he would not be surprised if any lawsuits filed in federal court are combined into a class-action, which could expose CooperSurgical to tens of millions of dollars in damages should the company take the case to trial and lose.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Fertility Clinics Across Globe Grow Egg Freezing Programs with AI-led Tool

Programs scale access to fertility preservation using Future Fertility’s oocyte assessment tool, Violet

This News Digest Is Paid Sponsored Content From
Future Fertility

BY Natasha Spencer-Jolliffe

The number of women electing to freeze their eggs in the US increased to 12,438 in 2020, up from 7,193 just four years prior in 2016, The Society for Assisted Reproductive Technology reported. 

However, a limiting factor to fertility clinics’ egg-freezing programs has remained: patient confidence. Practitioners could not tell patients the quality of their eggs, making egg freezing programs an expensive and stressful gamble.  

Some fertility clinics have been able to dramatically improve their egg freezing programs leveraging an AI-based oocyte assessment tool, Violet. This technology measures egg quality to gain an objective view of the probability of successful fertilization and blastocyst development to help clinics guide egg freezing cycles, empowering patients with personalized insights and improving confidence in clinic decision-making.

Growing clinics’ egg freezing programs through a stronger patient experience

The AI tool informs patients about their fertility health, helping to guide patients’ next steps and aiding practitioners in attracting patients to their egg freezing programs.

Professor Alison Campbell, Chief Scientific Officer at Care Fertility Group, first heard of Violet several years ago following a presentation by Future Fertility’s co-founder Dr. Dan Nayot, a reproductive endocrinologist. “I had to investigate!”, she shared. 

“I was very skeptical about the power of AI to predict quality or viability potential from a photograph of oocytes in the IVF laboratory,” Professor Campbell added. With no standardized visual scoring system in place, evaluating oocyte quality had previously not been possible by embryologists.

Professor Campbell’s clinic network, Care, went on to become the first in the UK to adopt Violet and is now using the tool in all egg freezing cycles. “Having data like this from Violet helps clinic staff have more meaningful conversations with patients to support their decision-making and fertility planning,” she continued.

“The first question all patients opting for the oocyte freezing programs have, is how many oocytes they need to freeze to have a viable embryo,” said Dr. Ernesto Escudero, Gynecology Fertility Specialist at Inmater, a fertility clinic in Peru that has been using Violet for over a year now.

“Violet is a very helpful tool to show patients the real number of oocytes they need to store for, not just their age, but also for the viability of each oocyte,” he added.

These insights are guiding counselling conversations and helping patients connect the clinician’s treatment recommendations with their own personalized data – for example, when egg quality is lower than expected for their age and additional retrievals are recommended to give them the best chance of reaching their family planning goals. 

Violet is also filling a gap in ensuring patients have appropriate expectations for the usage of the frozen eggs in the future – information that, until now, has been shared only in terms of general estimates, based on population health statistics that consider only the patient’s age and number of mature eggs retrieved. 

Delivering this level of information and building a relationship of trust means these patients are more likely to return for future treatments, enabling clinics to grow their programs. This also helps create a positive reputation in the patient community, helping to attract new clients through differentiated service levels. 

Dr. Sergio Papier, Medical Director and CEO of CEGYR in Argentina, attests to this approach – his clinic has adopted Violet as part of every freezing cycle as the clinic expands its precision medicine program. “It is a tool that we have quickly incorporated for all patients,” he says. 

AI tools scale access to fertility preservation through standardization and repeatability

“AI has the potential to improve reliability, accuracy, efficiency, and reproducibility in the IVF lab and wider clinic,” Professor Campbell relayed. Using advanced deep learning technology to evaluate oocyte images, Violet answers the need for more certainty regarding oocyte quality. 

“My concern has always been to have an objective biomarker that can evaluate oocyte quality, the most important variable in the results of ART,” said Dr. Papier. It was this interest that led Dr. Papier to discover Violet. The AI tool not only informs treatment planning but also provides clinics with new research projects, exploring the impact of clinical and lab variables on oocyte quality.

“It’s very important in a lab to have tools that will help achieve better pregnancy rates and reduce time to pregnancy – AI is the future for that,” comments Dr. Escudero.

Future Fertility’s technology has also proven to integrate seamlessly with existing lab set-ups and workflows. “It doesn’t need to alter what the clinical embryologists do with the eggs, in terms of cryopreservation, and it can help the team counsel patients, set their expectations, and aid their decision-making,” said Professor Campbell.

“Future Fertility makes AI accessible to IVF laboratories,” she highlighted, detailing how the company stands out as the go-to AI egg-freezing tool. 

“They have a strong expert team and work closely with clinics to educate staff and implement their technology,” added Professor Campbell. Care Fertility has seen its egg freezing program grow since implementing the tech.

“Without a doubt, Violet is a very useful tool for evaluating oocyte quality and gives doctors, biologists and patients a more objective perspective of potential future results,” shared Dr. Papier.

This News Digest Story is paid featured sponsor content, where the Advertiser has editorial control. They do not reflect the views of Inside Reproductive Health.

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All external links active as of 1/18/24.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Red to Green: The UK's System for Rating IVF Add-Ons compared to US

Thirteen add-ons have been evaluated by a British public agency. In U.S., fertility patients and doctors are mostly on their own.

This News Digest Brought to You by
AIVF™

BY RON SHINKMAN

The United Kingdom is not only the birthplace of IVF, but of a distinctive ratings system of “add-on” services unique among developed countries.

In 2019, U.K.’s Human Fertilisation and Embryology Authority – an affiliate of its National Health Service – introduced a rating system on add-on services. First known as “Traffic Light,” the ratings initially followed a color-coded system of green, yellow and red. However, the ratings expanded earlier this year into five colors, according to an HFEA spokesperson.

A green rating means the add-on can improve the outcome; yellow means improvement is unclear. A black rating means the add-on has no impact on the treatment outcome. A red rating means the add-on could actually degrade the chance of a positive outcome, or even pose safety concerns for the patient. A gray rating means there is not enough clinical evidence to evaluate the add-on.

The ratings are based on research and analyses conducted by an HFEA subcommittee called the Scientific and Clinical Advances Committee. Currently, 13 add-ons have received grades. They include assisted hatching, endometrial scratching, PGT-A and time-lapse imaging and incubation. The ratings are for the procedures only, and do not apply to individual companies. However, “in line with the HFEA Code of Practice, clinics must give patients a clear idea of what any treatment add-on will involve, how likely it is to increase their chance of a successful pregnancy…how much it will cost, and link to the HFEA ratings system,” said HFEA CEO Peter Thompson said in a statement on the agency’s website.

No add-on has received a green rating. All-cycle elective freezing, endometrial scratching and a process known as “EmbryoGlue” have all received yellow ratings. IVIG, the use of glucocorticoids and endometrial receptivity testing have all received red ratings. IMSI, assisted hatching, immunological testing and treatments for fertility and intrauterine cultures all received gray ratings.

“I don’t think there is anything like this in any part of healthcare in the U.S.,” said Sean Tipton, chief advocacy and policy officer for the American Society for Reproductive Medicine. Tipton added that the fact the United Kingdom has a nationalized single-payer healthcare system means the government takes a much larger role compared to other countries in assessing and rating treatments.

Kate Devine, M.D., an OBGYN who works as medical director and chief research officer for Shady Grove Fertility, noted that patients and clinicians in the U.S. are largely on their own regarding the use of add-ons.

“Unfortunately, in the U.S. patients and their physicians must decide on a case by case basis whether there is enough evidence to warrant the additional cost, time, and/or discomfort entailed by IVF add-ons,” she said.

That’s further compounded by the fact that many fertility patients have done deep research on reproductive medicine and are highly driven to succeed. “They are often willing to try anything and everything, and sometimes beg for unvalidated add-ons,” Devine said.

As for Shady Grove, Devine said that it prefers to offer only add-ons that have a clear benefit, ideally proven through clinical trials. Devine said the practice conducted a randomized controlled trial on endometrial receptivity testing that was published in JAMA late last year.  Igenomix, the biotech company that created the add-on, collaborated, by providing free embryo genetic testing and endometrial receptivity testing to patients who participated in the study. The conclusion: Such testing doesn’t improve the chances of a pregnancy. “It should not be offered on a routine basis,” Devine said.

As for Shady Grove, Devine said that it prefers to offer only add-ons that have shown efficacious results in clinical studies. Devine said the practice sponsored and was the investigator for a study published in JAMA late last year on endometrial receptivity testing. The study was conducted with the cooperation of Igenomix, the biotech firm that created the add-on. The conclusion: Such testing doesn’t improve the chances of a pregnancy. “It’s not something that should probably be offered,” Devine said.

What guidance is offered to patients in the U.S. is more informational than advisory. For example, ASRM has materials on its website regarding add-ons and research about their outcomes, but none of the material is rated in any fashion.

“Our (medical) practice committees and other committees are in the business of trying to inform our members with the latest research so they can better inform their patients,” Tipton said.

However, translating such communications for the general public is complicated. Too high a level of detail overcomplicates the ability to make a decision about a specific add-on. But Tipton also believes that the Traffic Light system oversimplifies the issue.

“There is no way to control (for a specific patient),” he said. “Maybe it’s a green light for me, and maybe it’s a yellow light for somebody else, based on what the underlying conditions are.” Tipton noted that may be the “price to pay” to have a ratings system that is simple for everyone to understand.

Whether the U.S. ever gets an official rating system for add-ons remains in the air. But Devine noted that patients are going to keep coming in for treatment no matter what. 

“Until these things are proven, the better part of valor is to keep calm and transfer another embryo,” she said.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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All external links active as of 1/11/24.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Private Equity Backed Solutions to REI Shortage. ASRM, SREI Oppose Reducing Fellowship Length

Inside Reproductive Health follows up on fall Wall Street Journal article

This News Digest Brought to You by
The Prelude Network

BY: MALLIKA MITRA

Fertility clinics still face a shortage of specialists to meet the demand for their services. 

Proposed solutions include funding for REI fellowships from private equity-backed clinics — and shortening the length of Fellowship. Inside Reproductive Health followed up on the Wall Street Journal’s report of the debate, published in early October. 

Funding REI Fellowships 

There are just 49 reproductive endocrinology and infertility fellowship programs in the 2022-2023 academic year, according to the Accreditation Council for Graduate Medical Education (ACGME). In the past five years, there has not been an unfilled reproductive endocrinology position once matching algorithm was processed — every available REI position in the matching program was filled, data from the National Resident Matching Program shows. Data on obstetrics and gynecology fellowship matches for the 2024 appointment year show there is just one reproductive endocrinology fellowship unfilled. 

More recently, private-equity-backed private practices are showing an increased willingness to self-fund fellowship programs, said Rachel Weinerman, MD, of the University Hospitals Fertility Center. The challenge is that the goal of private equity may not align with that of academic practice, Weinerman said: The goal of private equity backed groups may be to increase profitability while the goal of an academic practice is to train a well-rounded fellow who is able to further scientific knowledge in the field.  

Dr. John Storment, an REI practicing in Louisiana, said there isn’t an issue with allowing private equity to help with the growing demand for REI fellowships as long as the fellowships and training remain pure and without any strings attached. 

“We have to maintain our integrity… and not let the industry dictate how we treat patients,” Storment said. Private-equity backed fellowships should not have different admission criteria, job benefits, salaries or opportunities than other fellowships, and they can’t be allowed to require a fellow to later join the private practice that’s providing the training, he added.  

Storment said he is not afraid that private equity funding is currently compromising integrity. But ensuring it stays that way should be a top priority, he added.   

Beth Zoneraich, CEO of Webster Equity Partners-backed Pinnacle Fertility, said multiple options need to be considered to meet demand. She is working on creating a program with key industry partners to train OBGYNs to assist REI physicians in practicing fertility treatment. She said that with appropriate training and REI supervision, OBGYNs could support REI physicians by performing initial fertility assessments, basic fertility workups and various REI procedures. They can also oversee routine follow-ups and monitor patient responses throughout the treatment process, guided by REI physicians, she adds. 

“When you look at needing to meet a supply-demand imbalance, certainly increasing the number of REIs — either through reducing the time of the fellowship or increasing the number of fellowships — are both options that should be considered. But also looking to OBGYNs to help is critically important,” Zoneraich said. 

Potential of Shortening the REI Fellowship

The REI fellowship was initially two years but was expanded to three years to account for an extra year of research. There is now talk in the industry of shortening the fellowship back to two years in an effort to increase the number of fellows. 

“The importance of training motivated, talented researchers in the field of REI should be maintained as a paramount goal,” said Kate Devine, M.D. and medical director and chief research officer at US Fertility, which is owned by Amulet Capital Partners. “That said, we can't turn people who are not researchers into researchers, and that is the rationale behind potentially shortening the fellowship to two years, rather than paying to support 18 months of research training for every REI in training.” 

Jay Rose, managing partner and co-founder at Amulet Capital Partners could not be reached for comment. 

Devine added that shortening the fellowship to two years could be a good solution if and only if two things were guaranteed: extra funds that would result from shortening the fellowship were used to train additional fellows, and that funds would be earmarked to provide the best possible training to those trainees who were motivated and talented in research. 

An ad hoc committee of the Society for Reproductive Endocrinology and Infertility (SREI) co-authored a white paper, which was endorsed by the American Society for Reproductive Medicine (ASRM), in September that recommended not shortening the fellowship to two years. 

“Our lens is that of what’s best for patients, what’s best for patient care and what’s best for our trainees so that they can go out and optimize patient care,” Erica Marsh, president of SREI and board member of ASRM, told Inside Reproductive Health. “That generally requires that they spend time learning about not only the physiology and pathophysiology of the diseases that we treat, but also understanding how to interpret research and apply research findings to clinical care independent of whether or not they ever conduct research.” 

OBGYN and Advanced Practice Provider (APP)’ roles 

TJ Farnsworth, CEO of Lee Equity Partners-backed Inception Fertility, said more practices have to better utilize APPs to the highest level of their licenses to try and improve the capacity of REIs. That would include more complex ultrasounds, IUIs, pre-consult workups and minor procedures. He added that there’s a move toward using generalist OBGYNs to provide fertility care, but his company has decided not to do that at this point. 

“Using generalists as part of fertility practices to me makes sense as long as you’re talking about them doing general care,” Farnsworth added. That may include hysteroscopies, HSGs, and surgical cases so that the REI can focus on fertility patients.

Zoneraich agreed that there are places where APPs can and should do tasks that they are able to do instead of having the physicians do them, such as monitoring ultrasounds, baseline testing, consultations for less complicated cases and intrauterine inseminations (IUI). That will give physicians the ability to do more new patient consults or follow-up consults, for example, she added.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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All external links active as of 1/4/24.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Simplified psychological evaluation for donors, gestational carriers, and intended parents revolutionizes third party IVF

Texas Fertility Center saves $100 per donor evaluation, Northstar Fertility portfolio company ensures compliance

This News Digest Is Paid Sponsored Content From
Mind360

BY: Rachel Leland

The lengthy, arduous process of conventional psychological evaluations often stalls fertility journeys for weeks or months, but a new telehealth platform is already speeding up the process while improving screening quality.  

You can send people to Labcorp to get a lab almost right away. You can get several screening tests done in a very short period of time, Mind360 executive director Julius Varzoni said. “[The psychological screening] was the only one that was taking weeks to get done…and we brought it down to a couple of days.”

Mind360 allows potential donors, gestational carriers, and intended parents to book a virtual psychological evaluation in 30 seconds with just a few clicks. Within two business days after the appointment, clients receive a comprehensive report of the assessment with all the ASRM criteria included.

As of November, roughly 167 million Americans live in an area with mental health provider shortages, with over 8,000 more providers needed to ensure adequate care. The average wait time to see a mental health professional is six weeks, according to the National Council for Mental Wellbeing.

Northstar Fertility portfolio company ensures compliance

Everie, the newest addition to Northstar Fertility’s portfolio, works with donors from across the country, which made finding qualified mental health professionals in every state a donor lived in cumbersome. 

“Before Mind360, we really had to make a lot of different relationships to ensure we were in compliance and then we had to nurture those relationships because we wanted to have reports that were similar even though we had been working with several businesses to get the job done,” Everie President Aisha Lewis said.

Furthermore, even available mental health professionals may be unfamiliar with the standards for third-party psychological evaluation set forth by the American Society for Reproductive Medicine. 

While Mind360 employs Ph.D. psychologists to conduct screenings, clinics often hire social workers, Varzoni said, adding that even then, thorough screenings are not guaranteed and some practitioners charge more for specialized services.

Silverberg: TFC saves $100 per mental health eval

Before partnering with Mind360, Texas Fertility Center would refer potential donors to local mental health professionals in Austin, but test results were not as specialized as desired, Dr. Kaylen Silverberg said. 

“It’s kind of like forcing a square peg into a round hole,” Silverberg said. “People don’t just do this, they do all kinds of therapy for different patients. We’ve allowed patients to use their own therapists and their own therapists who may not know anything about reproductive services or the questions we’re getting at. Here we see a lot more consistency.”

Silverberg estimated that Texas Fertility Center had saved up to $100 per evaluation since partnering with Mind360. 

In some areas of the country, the savings add up to 50% through utlizing Mind360’s services, Varazoni said.

Organic Growth

Since launching in August 2022, Mind360 has grown its business to 25 clients, including Cryos,  Fairfax EggBank, Nodal, and the recently launched Everie. By December, Mind360 will have conducted 2,500 psychological screenings in its first year, Varzoni said. 

Clients like Lewis said Mind360's most considerable value wasn't simply cost or time savings, but the personal attention its psychologists provide.

Often, when working with non-specialists in mental health, clinics or egg banks need to inform potential donors if they failed the screening, but Lewis prefers how Mind360 psychologists inform the donors directly. 

“I think, if the donor is not a good fit for the organization right now, that's a conversation that should be had at that level of the psychologist and donor, so they do that and I appreciate that. I really appreciate that,” Lewis said.

This News Digest Story is paid featured sponsor content, where the Advertiser has editorial control. They do not reflect the views of Inside Reproductive Health.

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Wait time for third party IVF mental health screening reduced from six weeks to a few days

Mind360 shares their average psychological evaluation wait times and cost savings for intended donors, recipients, and gestational carriers.

Don’t let cost or limited availability delay your patient’s cycle. Download Mind360’s informational report to find out how quickly this process can be completed and compare it to your own services.

Mind360 provides:

• Seamless online booking

• Immediate availability

• Telehealth appointments

• ASRM trained psychologists

• Compliance with ASRM and FDA recommendations 

Learn how your clinic’s process can be sped up and improved by clicking the button below.

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This News Digest Is Paid Sponsored Content From
Mind360

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All external links active as of 12/14/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

IVI RMA’s Plans for Boston IVF’s Stern, TRIO’s Condon, brands, staff, after $535M Eugin Sale

The two chains are part of the assets the KKR-owned IVI RMA and GED Capital has just bought from the Eugin Group.

This News Digest Brought to You by
Family Inceptions

BY: RON SHINKMAN

IVI RMA has pursued one of the largest acquisitions of a reproductive medicine group in the United States, agreeing to acquire the North American assets of the Eugin Group – including Boston IVF and TRIO – as part of a larger deal to buy the entire company.

The transaction sheds a little light on how private equity firm KKR – which owns IVI RMA  – will consolidate and manage its recent dive into reproductive medicine. KKR finalized its acquisition of the Spanish-based IVI RMA earlier this year for $3.2 billion.

In conjunction with Spanish private equity firm GED Capital, IVI RMA is acquiring the Eugin Group assets for around $535 million from Fresenius Helios, the German-based hospital operator and dialysis giant. 

While IVI RMA will own and operate the Eugin clinics in the U.S. and Canada, GED Capital will own and operate the three-dozen clinics in Spain, Italy, Sweden, Denmark, Latvia and Portugal. It will also operate the Latin American properties in Brazil, Argentina and Colombia, GED spokesperson Alicia Hernández told Inside Reproductive Health.

A spokesperson for IVI RMA told Inside Reproductive Health that the acquisition of both Eugin’s North American and global operations are part of the same transaction. He declined to break out terms for the U.S. portion of Eugin’s assets. Hernandez also declined to break out terms for the GED portion of the purchase, but noted that the European and Latin American operations generate about $110 million in annual revenue.

Fresenius acquired Eugin less than three years ago for around $460 million from NMC Health. 

A KKR spokesperson has not responded to a request seeking comment.

IVI RMA’s acquisition includes two fertility clinic chains: Boston IVF and the Toronto-based TRIO. IVI RMA’s footprint in North America will expand from its current 29 clinics and 10 laboratories to 62 clinics and offices and 23 laboratories. Altogether, the combined enterprise will have more than 4,000 employees in North America.

There are no plans to rebrand Boston IVF and TRIO. The IVI RMA spokesperson said both will continue to operate under the same names.

“IVI RMA in other parts of the world have multiple brands in countries like Spain and Italy, so it’s not unusual for them to do that,” Boston IVF CEO David Stern told Inside Reproductive Health. He added that he will continue with the company in the same position.

The IVI RMA spokesperson also confirmed that TRIO CEO Nicole Condon will remain with the company. Condon could not be reached for comment. Both Stern and the company spokesperson said there are no layoffs planned after the acquisition closes.

Meanwhile, IVI RMA’s U.S. division recently named Lynn Mason as its president. The spokesperson said she will oversee all of the operations for IVI RMA, TRIO and Boston IVF.

“We’re actually continuing to expand and grow our network,” Stern said. He noted that Boston IVF recently opened a new clinic in Rochester, N.Y. Another expansion is planned for Springfield, Mass. before the end of the year. That new clinic will be based at the Baystate Medical Center in Springfield and be called Boston IVF at Baystate, Stern said. He suggested that expansion would continue in conjunction with IVI RMA.

“We’re really excited, because IVI RMA already has a strong brand in the United States and globally,” Stern said. He added that IVI RMA is also very strong in terms of research and training, and that Boston IVF’s ongoing fellowship programs with Harvard Medical School and Beth Israel Deaconess Medical Center in Boston will complement IVI RMA’s existing fellowship programs.

Stern said he expects the acquisition of the Eugin Group’s North American assets to close during the first quarter of 2024, in line with when IVI RMA said the entire Eugin acquisition will close.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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Compare Your Third Party IVF Cycle Pricing

Family Inceptions reveals cost averages for IVF cycles with Gestational Carriers.

See How Your Center Compares on

• Surrogate and Partner Workup

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See Price Averages for IVF Centers in all four quadrants of US

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See how your Third Party IVF Program stacks up by clicking the button below

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This News Digest Brought to You by
Family Inceptions

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All external links active as of 11/16/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

The hidden threat to third party IVF. Are ethically sourced eggs being used in your clinic?

In an underregulated industry, its critical that clinics step up to ensure their practices are ethical

This News Digest Is Paid Sponsored Content From
The World Egg & Sperm Bank

BY: Rachel Leland

While human trafficking for sexual exploitation is widely acknowledged, exploitation in the fertility industry lurks under the radar.

In August, Greek authorities arrested eight suspects connected with a Crete fertility clinic for allegedly exploiting vulnerable foreign women who were used as egg donors and surrogate mothers. 

Allegedly the directors of the clinic recruited brokers to locate and extract consent from vulnerable foreign women to transport them inside Greece where they were subjected to substandard treatment, and in some cases had their eggs harvested before becoming surrogate mothers according to a Greek police news release. 

Between 2015 and 2018, Indiana University Ph.D student Polina Vlasenko studied Ukraine’s ova market as part of her dissertation, interviewing over 100 egg donors, surrogates, medical professionals and fertility brokers. One egg donor admitted to donating 24 times across India, Georgia, Cyprus and Ukraine! 

More concerning, some U.S. fertility clinics and egg banks may be selling eggs retrieved from exploited donors in developing countries, without patient knowledge, Diana Thomas, Founder and CEO of The World Egg & Sperm Bank said.

Thomas said what first set off the alarm that stateside practitioners were entering foreign data into their CDC records that showed egg retrievals were not from U.S. donors. 

“It just struck me that this is rampant and it’s not being disclosed to potential parents, to doctors, to embryologists,” Thomas said. “You have these arrests going on around the world where they're walking into clinics and arresting the secretary, the embryologist, the doctor and then the organized criminals who are brokering the donors to get them there.”

Thomas performed an informal survey of 185 embryologists and asked them if they knew the origin of the eggs they were warming in the lab. Only half of respondents said they knew.

When it comes to accountability, the waters are murky. The FDA’s regulation of human tissues has a loophole that is widely abused in the industry according to Thomas. While the regulation requires foreign establishments that import human tissue register and list with the FDA, registration is not the same as pre-market review. 

Still, regulators are stepping up and industry professionals should take notice, Thomas said.

Clinics risk a huge financial loss in potentially using trafficked eggs. The U.S. ratified the UN’s human trafficking protocol which demands repatriation of profits made from human trafficking. 

In addition, to legal accountability the reputational consequences for a clinic that uses human trafficked eggs will be catastrophic. 

Though Thomas feels that the industry is not currently regulated sufficiently, she believes that individual egg banks and fertility clinics can take steps to ensure they aren’t using eggs from trafficked victims. At The World Egg & Sperm Bank all donors must provide two forms of ID, undergo internal and independent psychological and medical interviews and be a U.S. resident. 

“We’ve got to do something to save this industry,” Thomas said. “If we're labeled as human traffickers, we are going to start having all of this regulation come down and nobody really wants that when we can self regulate right now.”

This News Digest Story is paid featured sponsor content, where the Advertiser has editorial control. They do not reflect the views of Inside Reproductive Health.

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Protect Your IVF Program from Human Traffickers

Your practice and patients are vulnerable to using eggs from victims of human trafficking.

Without proper safeguards, fertility clinics like yours may unknowingly be selling the eggs of these trafficked victims, exposing your patients and your clinic to legal complications. 

There are precautions you can take to minimize your risk. The World Egg & Sperm Bank has created a free due diligence checklist that you can download now to ensure that your clinic only sells eggs from donors who have been safely and ethically protected.

This comprehensive checklist will help you determine the source, procurement process, and traceability of biological materials while also creating higher quality best practices for your patients in egg and sperm selection.

Protect your patients. Protect your practice. Protect the future of fertility by grabbing a copy of TWESB’s due diligence checklist today!

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This News Digest Is Paid Sponsored Content From
The World Egg & Sperm Bank

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All external links active as of 10/16/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

Meikle’s and Larkin’s New Roles at The Fertility Partners

Larkin one of two fertility CEOs to take top job at other network

This News Digest brought to you by
The World Egg & Sperm Bank

BY: Lisa Munger

The Fertility Partners (TFP) announced Derek Larkin as its new CEO on August 16, the same month that Cara Reyman took over as CEO of First Fertility, Larkin’s old post. Reyman was the CEO of a different fertility clinic network, Fertilitas, from July 2022 to July 2023.

Andrew Meikle, founder of TFP, served as the company’s first CEO from September 2019 to August 2023. Meikle will continue to serve as founder and executive chairman as the transition occurs to supporting partner relationships, corporate development and strategic decision-making. 

The Fertility Partners, founded in 2019, is a network of fertility practices with 36 clinic locations across North America, including 14 IVF centers. With more than 75 physicians and 1,000 employees, TFP operates in six provinces in Canada.

Larkin's experience extends beyond his time as CEO of First Fertility from May 2020 to July 2023. He held various leadership positions over a span of 12 years at Boston IVF, including CEO. In his roles at Boston IVF, Larkin demonstrated developed expertise in managing operations and guiding strategic direction, according to TFP. 

This background places him in an ideal position to lead TFP and further enhance its offerings to partner clinics, according to TFP. 

"My life's work has been in fertility, striving to improve the patient experience along their journey of family building," Larkin said in a statement. “I am excited to continue to lead this amazing organization with that purpose.” 

“This is a transformational time in our business, and we are very excited to have Derek guide the TFP team as we continue our growth across North America,” Meikle said in a statement.  “We have a tremendous alignment of vision and values, and his extensive operational expertise, sector knowledge and leadership will enhance our offering to partner clinics.”

Dr. Brijinder Minhas was a partner and COO at NewLIFE in Florida for 22 years before it was acquired by First Fertility in 2022. MidCap Advisors were investment bankers. After the sale, Minhas joined MidCap as vice president of healthcare.

“It is important that management companies truly understand the nuances of the practice they are dealing with,” Minhas said. 

“Having managers and C-suite folks with prior fertility experience, in my opinion, is essential and leads to a much more productive and profitable relationship … The reasons for the shake-up at First Fertility are not known. A good warning for other CEOs: ‘Hire the right team and keep both the practices and private equity bosses happy.’ Ultimately, clinicians want to provide the best patient care, and management partners want to maximize profitability. A good balancing act is required.”

Meikle and Larkin declined to comment on the transition for the purposes of this article.

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

Amplification:
10/4/23, KKR Moves to Acquire Eugin Group for $525M, Fresenius declined to comment about the Eugin deal.

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Protect Your IVF Program from Human Traffickers

Your practice and patients are vulnerable to using eggs from victims of human trafficking.

Without proper safeguards, fertility clinics like yours may unknowingly be selling the eggs of these trafficked victims, exposing your patients and your clinic to legal complications. 

There are precautions you can take to minimize your risk. The World Egg & Sperm Bank has created a free due diligence checklist that you can download now to ensure that your clinic only sells eggs from donors who have been safely and ethically protected.

This comprehensive checklist will help you determine the source, procurement process, and traceability of biological materials while also creating higher quality best practices for your patients in egg and sperm selection.

Protect your patients. Protect your practice. Protect the future of fertility by grabbing a copy of TWESB’s due diligence checklist today!

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This News Digest Is Paid Sponsored Content From
The World Egg & Sperm Bank

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All external links active as of 10/12/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.

KKR Moves to Acquire Eugin Group for $525M

The deal would make the investment banking firm one of the biggest global players in the fertility space.

This News Digest brought to you by
The World Egg & Sperm Bank

BY: RON SHINKMAN

Months of speculation as to which company would have the resources to purchase the massive fertility network the Eugin Group has narrowed down to a single candidate: Investment banking giant KKR. The deal could help it become one of the biggest global players in the fertility sector.

The Spanish media outlet CincoDías reported this week that KKR has entered into exclusive negotiations with Eugin’s parent company, Fresenius Helios, to make the purchase for an estimated $525 million. The investment banking firm Lazard is also involved in the transaction, according to CincoDías. Lazard helped Fresenius in consummating a $551 million biopharmaceutical acquisition last year.

KKR has been making significant inroads into the fertility space in the past couple of years. It acquired IVIRMA for about $3.2 billion earlier this year. It performed nearly 80,000 IVF cycles in 2021, primarily in Europe, but it also has clinics in the U.S. and Latin America. KKR also acquired the smaller GeneraLife Group last year, which performed some 25,000 cycles in 2021. It operates 30 clinics in Spain, Italy, the Czech Republic, Sweden and Portugal.

A KKR spokesperson declined to comment. Spokespersons for Fresenius and Lazard did not immediately respond to requests seeking comment.

Eugin operates 69 clinics in 11 countries on three continents, performing 45,000 cycles a year. And it is a big player in North America, owning and operating the Boston IVF network and TRIO, one of the biggest fertility practices in Canada. It also has a significant footprint in Latin America, with clinics in Colombia and Brazil. In Europe it has a large presence in Spain, along with clinics in Italy, Latvia and Sweden. 

Although Fresenius has only owned Eugin since late 2020, it is not a core business for the company, which is a leading dialysis provider in the U.S. and operates more than 80 hospitals in Europe. It has been under pressure to divest Eugin after Elliott Investment Management acquired a large stake in the company about a year ago and its management expressed dissatisfaction with Fresenius’ financial performance. The company’s stock has risen by about 33% since Elliott purchased the stake, although shares dropped about 7% since the news of a potential sale to KKR was made public.

Robert Goodman, vice president in charge of healthcare for New York City-based MidCap Advisors, said a sale to KKR makes sense. 

“It is a very large, very savvy firm that has made some big inroads into healthcare, and they are clearly a company with the capacity to do this,” Goodman said. He added that if KKR were to close the deal, it would likely use all its recent acquisitions to become the predominant player in the fertility space. 

“They will have a big footprint to get it started, and if they have their eyes on that prize, they have the capability,” Goodman said. “There’s no question about that.”

The themes reported in this publication are those of the news. They do not reflect the views of Inside Reproductive Health, nor of the Advertiser

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Protect Your IVF Program from Human Traffickers

Your practice and patients are vulnerable to using eggs from victims of human trafficking.

Without proper safeguards, fertility clinics like yours may unknowingly be selling the eggs of these trafficked victims, exposing your patients and your clinic to legal complications. 

There are precautions you can take to minimize your risk. The World Egg & Sperm Bank has created a free due diligence checklist that you can download now to ensure that your clinic only sells eggs from donors who have been safely and ethically protected.

This comprehensive checklist will help you determine the source, procurement process, and traceability of biological materials while also creating higher quality best practices for your patients in egg and sperm selection.

Protect your patients. Protect your practice. Protect the future of fertility by grabbing a copy of TWESB’s due diligence checklist today!

---

This News Digest Is Paid Sponsored Content From
The World Egg & Sperm Bank

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All external links active as of 10/5/23.

External links are being provided as a convenience and for informational purposes only; they do not constitute an endorsement or an approval by Fertility Bridge or Inside Reproductive Health of any of the products, services or opinions of the corporation or organization or individual. Neither Fertility Bridge nor Inside Reproductive Health bears responsibility for the accuracy, legality or content of the external site or for that of subsequent links. Contact the external site for answers to questions regarding its content.