Recognized for its ability to avoid pain, scarring, and long recovery times, minimally invasive vascular access procedures (VAP) continues to gain popularity year over year. That said, VAP does have inherent risks, with patients in nearly 20 percent of cases seeing at least some negative impact related to bleeding. Saranas is a Texas-based company that is focused on minimizing these risks by providing early detection and monitoring of internal bleeding complications via bioimpedance measurements.
We recently had the chance to speak with Saranas CEO Zaffer Syed. He brought us up to speed with where the company is today, its future plans, and his thoughts on how to build a thriving medical startup.
The History of Saranas
Saranas was incorporated in 2013, with technology licensed out of the Texas Heart Institute. The technology was invented by Dr. Medhi Razavi at Texas Heart, when he identified that he could likely correlate changes in bioimpedence to serve as a proxy for internal bleeding. Dr. Razavi led the early pilot work while serving as an Adjunct Professor at Rice University, eventually finding enough traction to form the company.
Dr. Razavi helped lead the company through its early Seed and A rounds, working toward getting Saranas to its final product development stages. However, challenges in 2016 required a new developer for the product, and Dr. Razavi stepped back to a Director role when Syed took over as CEO.
Animal lab studies of Saranas’ Early Bird Bleed Monitoring System show that the product works fantastic as it is today. A recent study, completed in August, showed no false positives while still retaining the necessary sensitivity. The next steps, according to Syed, include a completion of the verification and validation stages, then continued testing of the product prior to FDA submission. Saranas is aiming to have these tests completed by the end of 2017.
Building the Team
One recent piece of news from Saranas was the company’s addition of Dr. Philippe Genereux as Chief Medical Officer (CMO). Dr. Genereux has worked as an Interventional Cardiologist since 2009, and is the Co-Director of the Structural Heart Disease Program at Morristown Medical Center.
I asked Syed about the value that Dr. Genereux adds to the team.
Dr. Genereux is very involved, especially from an innovation standpoint. He’s been involved with some of the leading clinical trials in the interventional cardiology (IC) space, and he’s been connected to Saranas as an advisor for a few years.
He holds a keen interest in what we’re doing because he knows first-hand not only the risks related to internal bleeding but also the impact that our product can have. He co-authored a paper published in JAMA that highlights the fact that bleeding occurs in 18-19 percent of IC cases, with significant impacts on mortality, length of stay, and cost to the patient.
Syed tells me that, as CMO, Dr. Genereux has not only been driving awareness, but he’s also made some significant changes in product positioning. He was able to identify ways to use the Saranas technology in the venous position that extends monitoring post procedurally as well as during the procedure.
“His ability to tie together both the business and medical sides is what attracted us to him in this position.”
The Future of Saranas
These are exciting times for the young company. The team continues to grow, while still keeping a focus on efficiency. At present, there are four full-time equivalent members, four consultants, and a team of four leading cardiologist on its Scientific Advisory Board.
Syed tells us that Saranas plans to submit its technology to the FDA soon after final testing, which is scheduled to end in December 2017 and expect to have first-in-human clinical experience in early 2018.
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Image Credit: Saranas