Raydiant Oximetry Oversubscribes Series A3 Funding Round to Support Clinical Studies

by | Jun 7, 2024 | Companies, Fogarty Innovation, Funding

In a significant milestone, Raydiant Oximetry, Inc., a Fogarty Innovation graduate that is redefining maternal and fetal care during childbirth, recently raised a $7.5 million Series A3 extension round to support clinical studies of its two innovative technologies, Lumerah™ and Daisy™. The funding was led by Cross-Border Impact Ventures (CBIV) and syndicated by RH Capital, Global Health Impact Fund, VCapital and the March of Dimes Innovation Fund. This comes on the heels of Raydiant Oximetry obtaining FDA approval to conduct an Investigational Device Exemption (IDE) study for its flagship technology, Lumerah.

Raydiant solutions tackle unmet maternal health needs

Founded by pediatric anesthesiologist Dr. Neil P. Ray, Raydiant’s Lumerah is the first-of-its-kind non-invasive fetal pulse oximeter that measures fetal blood oxygen saturation and aims to address the limitations of traditional fetal heart rate monitoring. The study will explore the device’s efficacy in identifying fetal distress more accurately through improved sensitivity and specificity. 

  • Low sensitivity leads to unrecognized fetal distress and newborn neurological injury from oxygen deprivation during birth. “Each year, 36,000 babies in the United States suffer neurological damage, which could be prevented through better monitoring tools, such as Lumerah,” explained Ray.
  • Low specificity leads to the overuse of emergency C-section deliveries and adds risks to both mother and baby while increasing healthcare costs. “While C-sections are the most commonly performed major surgery, with 1.2 million annually, nearly half of them are medically unnecessary. Current fetal monitoring techniques play a large role in these emergency surgeries and have a lasting impact on babies and mothers,” said Ray.

Daisy is a novel surgical device designed to quantify blood loss, treat uterine atony and prevent post-partum hemorrhage (PPH) after a C-section delivery—a condition that claims the life of a new mother every four minutes around the world. 

Both clinical studies were launched last month at the Eastern Virginia Medical School (EVMS) in Norfolk, Virginia, and are being conducted under the leadership of Dr. George Saade, Chair of Obstetrics & Gynecology, Associate Dean for Women’s Health at EVMS and the editor-in-chief for the American Journal of Perinatology

“The current status quo is unacceptable given the progress we have made with technological advances in healthcare,” said Gary Goldman, MD, founder and current managing partner of Global Health Impact Network & Funds and a retired anesthesiologist. “I have little doubt that Lumerah and Daisy can become the standard of care for all childbirths worldwide.”

A wave of change in maternal health

One of the most significant aspects of these studies is the participation of pregnant women. In the U.S., women have been largely absent from clinical trials due to a 1977 FDA directive excluding women of childbearing potential from Phase 1 and 2 drug trials. It wasn’t until 1993, when Congress required the National Institutes of Health (NIH) to include women in funded studies, that more focus was given to this underrepresentation. But this prolonged disparity has led to a lack of critical health data specific to women and often resulted in healthcare practices that inadequately address female health issues. Raydiant Oximetry’s studies address this gap, ensuring that the technology is optimized for women’s unique health needs during childbirth. 

Acknowledging the historic lack of innovation in maternal and female healthcare, Ray sees Raydiant Oximetry’s work as the beginning of a new era. “While there are over 800 breakthrough devices, only four—including Raydiant’s—are in obstetrics. Women’s healthcare needs have largely been ignored, and we are excited to be at the forefront of this sea change,” he said.

“It’s always exciting to see our companies succeed, and we are proud of Raydiant Oximetry as it takes this next step, which represents a crucial milestone in making childbirth safer for both women and babies,” said Denise Zarins, Fogarty Innovation COO. “For too long women and their health issues have been underrepresented in clinical trials and research studies, and we are proud to see them take the lead in becoming a key part of the solution.”

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