Graham Randall, Ph.D., CEO of Noninvasix is our latest interviewee. He is a serial entrepreneur with cross-industry experience in medical devices and Silicon Valley startups, having launched over a dozen products. Most recently, Randall served as president of Intubix LLC, a venture capital backed startup commercializing endotracheal tube holders for respiratory care. As an Entrepreneur-in-Residence at an early-stage life sciences development firm, he secured a $250,000 seed investment for the company and took the product from prototype to human testing within six months. Here’s what he had to say…
How would you pitch your company? What’s your elevator pitch?
Using light and sound, Noninvasix is developing a solution for the safe, accurate and non-invasive monitoring of fetal welfare during labor and delivery. In collaboration with obstetricians at University of Texas Medical Branch at Galveston, engineers have designed a small fetal probe that uses pulsed laser light to produce an acoustic wave response, which accurately measures the baby’s brain oxygenation levels.
The problem we’re addressing is the ineffective fetal heart rate monitor used in 99% of births. With an 89% false positive rate, fetal heart rate monitoring drives a lot of unnecessary cesarean surgeries — as many as 1 million in the U.S. yearly. That adds up to over $5 billion in healthcare costs.
What sets you apart from competitors?
Until now, no one has been able to noninvasively measure venous brain oxygenation and there are no commercially available monitors other than fetal heart rate that provide continuous information regarding fetal welfare during late-stage labor. The advantage of using optoacoustics to directly measure cerebral oxygenation are accurate readings and an absolute measurement in real time. The Noninvasix system does not require a normal baseline prior to hypoxia detection. Moreover, it is easy-to-use with minimal training required.
Can you share some numbers? How many users do you have?
We are targeting 80% of the four million yearly births in the U.S. There’s a yearly market opportunity of approximately $1.5 billion for those cases where the data from the fetal heart rate monitor is found to be indeterminate.
Where do you see the company going from here?
Our next step is to build the manufacturing prototype, which we’ll take to clinical trials and the FDA for regulatory clearance. FDA 510(k) clearance is expected in 2017. Ultimately, the most likely exit strategy is acquisition by a major patient monitoring company.
Where do you see the mHealth industry going?
Mobile health has been adopted by payors, providers and health institutions in the public and private sector, which have streamlined many aspects of patient care, but the adoption by consumers is behind pace for a litany of reasons. Healthcare organizations and technology innovators will need to focus on what patients really want from mobile health to truly deliver healthcare in new ways.
How long are we from seeing modern mHealth technologies going mainstream?
The hemoglobin blood test is the single most prescribed blood test, and in terms of optoacoustic monitoring, home hemoglobin monitoring could be a reality in the next five years. With a simple wrist strap, users could take a noninvasive reading of the radial artery and receive feedback within seconds.