As C-sections continue to rise worldwide, more mothers and babies are at risk from perinatal complications. Raydiant Oximetry, a Fogarty Innovation graduate, is developing an innovative fetal monitor to improve outcomes for mothers and babies during childbirth and recently received a grant from the government of Ireland for approximately $3 million. In Ireland, C-section births have risen 50% since 2002, and key European stakeholders have a similar goal to the U.S. in reducing the number of medically unnecessary C-sections and more accurately identifying fetal distress during labor.
In 2019, Raydiant Oximetry secured Series A funding, and this summer plans to launch a pilot study that had been delayed due to COVID-19. The aim of the study is to show an improvement in sensitivity and specificity for detecting fetal distress over the current method of heart rate monitoring. Low sensitivity leads to high false negatives and the failed recognition of newborn birth injury. Low specificity leads to high false positives, which in turn leads to unnecessary emergency C-sections. To date, animal studies with the Raydiant Oximetry technology have shown a specificity of 95%, nearly tripling current standard of care’s specificity of 29%.
Irish collaboration brings impressive progress One of the key reasons for the improvement in sensitivity and specificity is signal processing work Raydiant has been collaborating with the Tyndall National Institute in Cork, Ireland, for the past three years. The new Disruptive Technologies Innovation Fund grant received from Ireland’s Department of Enterprise, Trade and Employment will allow them to continue their collaboration as they refine these algorithms and conduct market research on the European opportunity.
“The pandemic and Brexit have combined to bring unprecedented economic challenges and volatility to our enterprise sector. But with every challenge comes new opportunities and the Disruptive Technologies Innovation Fund is dedicated to entrepreneurs and researchers working on some really exciting ideas to develop solutions to the problems we face,” said the Tánaiste and Minister for Enterprise, Trade and Employment, Leo Varadkar TD, in a statement.
“This partnership is an example of innovation at its finest, as we work to improve the outcomes for mothers and babies on a global scale,” said Declan O’Mahoney, a Raydiant advisory board member and entrepreneur-in-residence at the Tyndall National Institute who is helping spearhead these efforts.
Raydiant Oximetry intends to build a team in Ireland to take advantage of resources that include a 25% rebate for all qualifying R&D efforts. They also expect to reap significant European investments due to the impact their innovation will have on an entrenched issue as they work to prevent unnecessary C-section and identify babies at risk for birth injury.
“The inability to reliably assess fetal well-being during labor is, in my view, the single biggest deficit in modern obstetric practice,” said John Higgins, OB/GYN at Cork University Maternity Hospital (CUMH) and professor and head of the OB/GYN department at University College Cork. “The inherent limitations of cardiotocography (CTG) monitoring are creating an impossible environment in which to provide a consistent, safe service for women and babies,” he said, adding that Raydiant’s innovation could “profoundly change how fetuses are monitored during labor, with the potential to move the needle on many outcome metrics.”
The repercussions are extensive, as there are approximately 7 million births a year in Europe, compared with just 4 million in the U.S. Failure to properly monitor the mother and the fetus can result in traumatic outcomes, such as a recent case in Ireland which left a baby girl with permanent profound neurological disabilities and resulted in the largest malpractice settlement recorded in Ireland.
“While we in Silicon Valley sometimes think we have a corner on technology-related advances, I have always been very impressed with Ireland’s leadership in healthcare and innovation; a country with which I have closely collaborated to help develop the next generation of medtech entrepreneurs,” said Dr. Fogarty. “Raydiant’s technology is critical to creating life-changing solutions for moms and babies, and I look forward to continue following their successes here and overseas.”