This episode of Busine$$ of the V takes on a gynecological affliction that affects a significant number of women, can take years to diagnose and often leaves permanent scarring and even infertility. Dr. Dweck and Rachel welcome Somer Baburek, CEO and President of Hera Biotech, an early-stage women’s health company bringing to market a minimally invasive diagnostic for endometriosis. Tens of millions of reproductive-age women and girls globally are affected by the chronic, sometimes immobilizing pain of this disease, which on average takes clinicians seven years to identify. In the meanwhile, a huge percentage of sufferers endure scarring, with from 30 to 50 percent of cases ultimately leading to infertility.

This podcast breaks down not only the causes and signs of endometriosis, but also the science behind Hera’s novel genetic approach to diagnosis. A sample of the patient’s endometrium is collected during an in-office procedure, thereby eliminating the need for (and risks associated with) surgical biopsy. In addition to reducing the considerable time patients typically suffer before receiving a diagnosis, Hera will also serve an important data collection and tracking function

With a longtime passion for both biotech and femtech, Somer shares insights into Hera’s evolution and roadmap, where the company is with its clinical research and fundraising as well as what’s on the horizon for the company as it prepares to complete its FDA application and head into a soft launch, initially through fertility clinics and potentially as a standard testing option available widely at ob-gyn offices or, conceivably, even as a home test.

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HOT FLASH: About 25-50 percent of infertile women have endometriosis and, on the flip side, 30-50 percent of women with endometriosis are infertile.

TOPICS COVERED:

• Dr. Dweck provides the quick high-level on endometriosis, the diagnostic challenges and implications as well as discrepancies in availability of care.
• Somer shares her background as well as her long-term interest in women’s health, biotech and innovation.
• Defining Endometriosis in More Detail: Dr. Dweck breaks down the disease, its cyclical effects and associated pain as well as some of the factors that contribute to the average seven-year timeframe for reaching diagnosis. It affects as much as 10 percent of the female population and can lead to scarring and infertility.
• Hera’s New Approach: A diagnostic alternative to laparoscopic surgery, it uses genetic mapping to evaluate cells based on a sample taken from the endometrium.
• Endometriosis has shown strong familial links, which makes genetic testing (based on a soft tissue sample) a natural partner in identifying the disease.
• Somer explains the step-by-step after a sample is taken, including the lab tools and procedure focused on genomics and single-cell analysis.
• There is a possibility of eventual home testing, but hurdles remain at this point.
• About Hera’s two-pronged commercialization approach, including two small clinical trials in 2022 leading to an application for FDA clearance ideally by late 2024. A $1 million first  round of non-diluted investment is currently under way, with about 90 percent to goal.
• Explaining what it means to file “de novo” with the FDA, meaning that your device or product is unique in the marketplace and not comparable to any prior innovation.
• Approval versus Clearance: The former is the FDA’s designation of total sign-off whereas clearance is a first marketplace step in the process.
• Hera’s goal is to use early, non-invasive diagnostics to prevent the scarring that can occur due to lack of treatment or surgical intervention. Hera also plans to leverage data to understand the progression of endometriosis and establish tracking information that could be used to treat – rather than merely contain – the disease.
• Women of color frequently find it especially difficult to get adequate care and attention for their symptoms. 
• Prior to fundraising among outside investors, Hera was the beneficiary of grants from family foundations and nonprofits (such as the Endometriosis Foundation of America) which supported the scientific research behind Hera.
• The prime market for Hera’s soft launch will be with fertility clinics, where endometriosis is endemic and patients are in search of answers. A primary goal will be securing a reimbursement code to support insurance coverage as soon as possible.
• Why Endometriosis: Somer shares some of her own experience with menstrual pain and how it played into her journey within the femtech space.

QUOTES:

(04:40) – “We need better diagnostics and how better to track (gynecological) diseases so that we can treat women wholly and completely?”

(09:10) – “Oftentimes when trying to come up with (an endometriosis) diagnosis we ask about family history and it does tend to run in families. So it makes perfect sense to be looking for some sort of genetic marker.” (Dr. Dweck)

(12:00) – “When you break it down to the single-cell level you see these marked changes in neighboring cell types, which is very rare. It’s exciting and makes a robust analysis as well.”

(18:56) – “There’s some clinical data coming out that is showing that surgical intervention early may not be the best option … Women can suffer from scarring and surgery can make it worse.”

(19:27) – “What we’re hoping to do is save women a huge chunk of time and with that alleviate some of the co-morbidities that can result.”

(21:26) – “For years we have been telling women to suck it up, take pain meds, put a heating pad on – How bad could menstrual pain be? How bad could the pain of scarring in your pelvis be? And that’s really not fair. This could be a gamechanger.” (Dr. Dweck)

(26:10) – “Our goal is to very quickly get the proprietary laboratory assay code – the reimbursement code we’ll be using – and that will then make (Hera) very accessible.”

About Somer Baburek:

Somer is an achievement-oriented strategic thinker with strong communication, presentation and interpersonal skills. Adept at building and maintaining close relationships with key stakeholders, she’s able to work in all levels of an organization with a desire to find opportunities for improvement.

FURTHER RESOURCES:

Website: www.herabiotech.com

Somer @LinkedIn