Under the Microscope: Raydiant Oximetry
By: Avestria Ventures
Tags: Maternal Health, Womens Health, Entrepreneurship, Childbirth, Medical Devices

In December, the U.S Department of Health and Human Services outlined its maternal health goals for the next few years: reducing maternal mortality rate by 50%, reducing low-risk Cesarean delivery rate by 25%, and achieving blood pressure control in 80% of reproductive-age women with hypertension.

One company already working to reduce Cesarean delivery (C-sections) rates, help improve maternal mortality, and keep mothers and babies safe is our portfolio company: Raydiant Oximetry.

Currently, standard care for surveillance of fetal safety during labor and delivery is electronic fetal heart rate (‘FHR’) monitoring, which tracks fetal heart rate in relation to contractions of the mother’s uterus. FHR monitors were introduced in the 1970s with the expectation that the information (or FHR ‘abnormalities’) provided to obstetricians would improve both detection of fetal distress (a fetus compromised by the stress of labor) and neonatal outcomes.

FHR information is thus the basis for critical decision-making by obstetricians about the best course of action during labor. For example, during labor, a fetus can become compromised by inadequate oxygen delivery from the placenta, possibly leading to significant health issues including cerebral palsy or hypoxic-ischemic encephalopathy (brain damage from hypoxia, often abbreviated as ‘HIE’). A 2018 study explained that HIE or hypoxia can cause fatality rates between 10–60%. Of babies who survive, 25% suffer “adverse long-term neurodevelopment outcomes,” including physical disabilities, cognitive impairment or brain damage. When FHR monitoring suggests risk of hypoxia, the mother often undergoes an emergency C-section to limit the amount of time the fetus is exposed to the possibly dangerous intrauterine environment and to allow resuscitation of the newborn after delivery.

In 1969, the prediction was FHR monitoring could save as many as 20,000 lives and reduce injuries for babies by 50%.

However, FHR monitoring’s high false positive rate actually brings increased risks to mothers and babies.

As of 2002, FHR monitoring was used for 85% of pregnant women in labor for intrapartum (occurring during the birth) fetal surveillance. FHR monitoring has also become a legal standard of care: the readings it generates provides “proof” in obstetric medical negligence litigation.

A fetal and maternal monitor. Source: Philips Healthcare.

But despite their ubiquity, interpretation of fetal heart rate patterns from FHR monitors is often inaccurate. As early as 1996, studies showed FHR monitoring’s “extremely high” false positive rate for cerebral palsy. A 2011 study on rising Cesarean delivery rates noted that so-called non-reassuring fetal status — as designated by FHR monitoring — was the leading indication for C-sections. A 2019 study reiterated that, over five decades of use, FHR monitoring “has been associated with a nearly 6-fold increase in the overall Cesarean delivery rate in the United States, from 5.5% in 1970 to the current 32%”. Most recently, in 2020, a report on fetal monitoring noted FHR monitoring has a 99% false-positive rate for hypoxia, cerebral palsy, and “impending fetal death during labor.” The “subjective, difficult to standardize, and poorly reproducible” data generated by FHR monitoring leads to these false positives and increased number of C-sections.

As the 1996 study concluded, “if these indications [from FHR monitors] were widely used, many Cesarean sections would be performed without benefit and with the potential for harm.” Even when medically necessary, C-sections (compared to vaginal births) are associated with increased risks both for mothers and babies (including infection, blood clots, hemorrhage, future pregnancy/labor complications, and maternal mortality for mothers and respiratory distress for babies). Cesarean deliveries also increase recovery times, duration of hospital stays, and healthcare costs.

Despite its inaccuracies, subjectivity, and role in medically unnecessary C-sections, FHR monitoring continues to be the standard of care.

Raydiant Oximetry is developing a novel solution for intrapartum fetal monitoring.

Raydiant is developing the Raydiant Oximetry Sensing System (ROSS): a low-cost, non-invasive biomedical device focused on monitoring fetal oxygenation and detecting fetal hypoxia during labor. The monitor is placed on the mother’s abdomen and uses a safe, light-based technology to perform a color analysis for measurement of fetal oxygen levels in the blood: blood with oxygen is red and blood without oxygen is blue.

In conjunction with FHR monitoring, ROSS will allow obstetricians to monitor fetal oxygenation directly and diagnose fetal hypoxemia, thereby enabling more precise monitoring of fetal well-being and earlier identification of potential fetal compromise than current tools allow. It is anticipated that ROSS can reduce the rate of medically unnecessary Cesarean deliveries, lower health care costs, and improve maternal and fetal outcomes.

In September 2018, the FDA granted the ROSS breakthrough device status, and Avestria invested in Raydiant’s Series A round in August 2019. Since then, the company was one of the six winners of the Children’s National Hospital and the National Capital Consortium for Pediatric Device Innovation, one of 15 startups chosen for MedTech Innovator and the National Capital Consortium for Pediatric Device Innovation’s Innovator Pediatric Accelerator program, and one of five early-stage companies chosen for the 2020 HealthTech Arkansas healthcare accelerator. In the past year, the company also was awarded a $203K Phase I NIH grant and $1M Phase II NSF SBIR grant. Like Avestria, these organizations and institutions recognize the need for new technologies to improve maternal and fetal outcomes, have confidence that Raydiant’s ROSS will be successful, and believe it can become the new standard of care.

Raydiant’s Co-Founder and CEO Neil Ray and his daughter Aryana. Source: Neil Ray

While many women’s health companies are founded and/or run by women, Raydiant is an exception. Neil Ray is Raydiant’s CEO and Co-Founder, and we’re proud to support a male founder who feels passionately about improving women’s health. While the number of women on public company’s boards remains below gender parity, Raydiant has two female board members to help it achieve parity and to take advantage of those diverse perspectives.

At Avestria, we don’t invest only in female-run women’s health companies but rather in women’s health companies — regardless of the founder’s gender — as long as the company can improve the quality of healthcare, empower patients, and lower costs. Raydiant checks all these boxes, and we hope that, as the HHS continues to take action to address critical needs in maternal health, it will also recognize, support, and utilize some of the companies already addressing those issues — including Raydiant Oximetry.