February 1, 2016: It was 2008 when Dr. Irina Buhimschi, then a Yale faculty member, brought a picture of an array of red dots to the Office of Cooperative Research (OCR). Those dots represented a major discovery. Buhimschi had found a way to identify patients with preeclampsia—a devastating condition that arises late in pregnancy and which has been notoriously hard to diagnose—via a simple dye-on-paper test. Her husband, Catalin S. Buhimischi, Director of Maternal-Fetal Medicine at Ohio State University, is co-inventor. “This was remarkable for its simplicity,” says Chris Unsworth, Associate Director of Licensing at OCR. “Others were developing diagnostic tests on complicated and expensive platforms but no one was working on such a simple dye test.”
Now a startup based on that discovery called GestVision, led by founder and CEO Wendy Davis, a School of Management alumna, has closed an A round of investment with an initial tranche of $2 million from CooperSurgical in Trumbull. Dr. Robert Auerbach, Executive VP and Chief Medical Officer of CooperSurgical, a former Yale faculty member and current executive board member for the Center for Biomedical and Interventional Technology at Yale, helped facilitate the deal.
“Having practiced obstetrics for many years, I have firsthand knowledge regarding the importance of early detection in patients with preeclampsia,” Dr. Auerbach says. “While others have chased complex laboratory-based detection methods, it was the elegance and the suitability of this point-of-care solution coupled with a well constructed business plan that attracted Cooper’s investment dollars.”
The investment could mean that in the future, pregnant women and their doctors will be armed with greater certainty in diagnosing and managing preeclampsia, preventing unnecessary hospitalizations and related preterm birth and spurring life-saving interventions.
Preeclampsia impacts one in 20 pregnancies in the U.S. and puts tens of thousands of pregnant women and their unborn children at risk of death or serious health complications each year. High blood pressure and protein in urine indicate the possibility of preeclampsia, but doctors do not yet have a definitive test. Still, because the possible consequences of preeclampsia are so dire—including seizures, coma and death—an early delivery may be induced when preeclampsia cannot be ruled out. And delivering babies prematurely carries risks of various conditions to the infant as well including learning disabilities, cerebral palsy and blindness.
“In speaking with obstetricians it is clear that preeclampsia is a nightmare to manage,” Unsworth says. “Making the wrong treatment choice can have profound effects on the wellbeing of the mother, the newborn, or both. Whatever information they can get to assist in this decision is extremely valuable.”
FROM LAB DISCOVERY TO COMMERCIAL PRODUCT
Buhimschi had discovered that the Congo Red dye—commonly used in histology labs—could detect protein abnormalities in the urine of patients with preeclampsia, but not in urine from patients in the course of a normal pregnancy. OCR filed a patent application on this discovery for use of the dye to detect misfolded proteins specifically associated with preeclampsia. The theory is that these misfolded proteins are at least in part the result of protein aggregation—when protein levels build up in a particular tissue of the body and become toxic. In the case of Alzheimer’s disease, the most studied protein misfolding disorder, these errant proteins are found in the brain and affect memory. In preeclampsia, the toxic buildup happens in the mother’s placental circulation, resulting in increased blood pressure and blockage of oxygen transfer to the baby.
While the test seemed to hold enormous potential, Unsworth couldn’t find a corporate partner willing to engage in further development. Instead, he encouraged Buhimschi to consider refining her discovery into a commercial product.
“I had to transfer this original lab finding into a point-of-care diagnostic test,” says Buhimschi, who is now Director of the Center for Perinatal Research at Nationwide Children’s in Columbus, Ohio. “OCR really facilitated what I should be thinking about. Academic scientists think about papers and grants, but it’s seldom we see something we’ve done in lab as a commercial product. Chris and OCR thought we could find someone to develop it to a stage where there’s more value.”
A few years later, Wendy Davis, a student in School of Management’s Executive MBA program with an extensive background in the biotech industry, saw a presentation on this technology by Dr. Buhimschi at an event sponsored by the Yale Entrepreneurial Institute (YEI). Wendy came to OCR inquiring about this and other technologies that might be a fit for a new startup. Unsworth connected her to Buhimschi and the two women developed a strong rapport, critical for the founding of a startup company to advance a new technology. With a scientific and commercial plan outlined, OCR executed an exclusive license to this intellectual property with GestVision.
“Irina took a clinical problem against which state of the art assay technologies were having limited success and reduced it down to a solution that’s incredibly simple and readily applicable worldwide,” says Davis, who was VP of Intellectual Property for another Yale startup, HistoRx, before pursuing her MBA. “She’s been a tremendous partner. We share the same goals. The sooner we can get this in the hands of healthcare providers the sooner it can make a difference.”
“Wendy came up with commercial plan to make a high value, commercially viable product,” Buhimschi says. “If it works it has the opportunity to change the way pregnant women are followed across pregnancy.”
LAUNCHING A BUSINESS
Davis developed the business plan with colleagues as part of her Yale MBA program and then took the vision for GestVision to YEI where she was accepted into the Venture Creation Program. With the support of mentors and entrepreneurs-in-residence, she perfected the diagnostic test and honed a compelling pitch that led her to win a Yale Innovator Award at the 2015 Yale Biotech Entrepreneur Bootcamp. GestVision also went on to receive $100,000 from the YEI Innovation Fund, available to select startups that have participated in a YEI program.
Buhimschi and her team published results using an earlier iteration of the test in Science Translational Medicine showing an 89% accuracy rate. Clinical study results using the first point-of-care iteration of the test, conducted at Ohio State University, will be presented in February. While GestVision is currently focused on the development of the test for the United States, a USAID study with $2 million in funding from a Saving Lives at Birth grant is making the device available for testing in low-resource areas including Bangladesh, Mexico City and South Africa by a team of collaborators led by Dr. Buhimschi that includes, among others, Dr. Hemant Tagare and Dr. Michael Choma, both faculty members in the Department of Radiology and Biomedical Imaging at Yale School of Medicine.
“Preeclampsia is a problem globally but is especially deadly in remote areas of the world,” Unsworth says. “Improving clinical decision making in this space could have a real impact.”
“The problem is worldwide,” agrees Davis. “We still have women and babies that die in the U.S. due to preeclampsia. With better detection and diagnosis, many of these deaths are preventable. We can also impact the common occurrence of doctor-initiated preterm delivery for preeclampsia, or suspicion of preeclampsia, thereby reducing unnecessary preterm births.”
With tests underway, and initial funding secured, GestVision is moving forward with larger manufacturing—batches of 10,000 tests or more at a time that will establish the performance data of the final product. Meanwhile, they are hiring for several key positions—including a Lead Scientist, Regulatory and Chief Medical Officer—and looking forward to launch.
“This will be a collective effort,” Buhimschi says. “The science and medical community is excited to have a cost-effective test that’s driven by a compelling need to make a difference.”
CONTACT: Brita Belli, Communications Officer, Office of Cooperative Research and Yale Entrepreneurial Institute, (203) 804-1911, email@example.com.