Saranas is Building a “Check Engine Light” For Internal Bleeding
This year about 20 million patients in the U.S. will undergo a procedure in which a doctor will thread a catheter into a blood vessel to treat a cardiac ailment, say, or provide dialysis or chemotherapy. But in five percent of these “vascular-access procedures,” the catheter accidentally punctures the vessel, causing a slow leak of blood that can be hard to detect—but which can wind up wreaking havoc. Houston medtech startup Saranas says it’s developed a device that can detect the bleeding within a matter of minutes.
“These bleeds are leaks,” says Mehdi Razavi, Saranas’s founder and the director of electrophysiology research at the Texas Heart Institute in Houston. “You’re not taking a scalpel and severing the artery. It’s a slow continuous ooze under conditions that are rife for trouble.”
Right now, such leaks can take hours to discover, and often require further medical procedures to stem the blood loss. To give surgeons a nearly real-time heads up that a puncture has occurred, Saranas added sensors to a standard sheath—the short tube that’s first inserted into the blood vessel, and through which the doctor threads the catheter. The souped-up sheath can measure electrical resistance, which changes if there’s a rupture and blood begins to accumulate around the vessel. The system is sensitive enough to detect as little as 30 milliliters of blood accumulation, the company says.
The system detects leaks where the puncture happens near the sheath itself, which is usually placed in the thigh, and as far as 7 centimeters away from that point, as the catheter advances toward the heart or other remote region of the body. “The sensors are picking up the characteristics of the tissue around the blood vessels, the fat, muscle, bone, to create a signature for every patient at the beginning of every procedure,” Razavi says. “If you start introducing blood, then those properties start changing. That’s what we can immediately detect.”
A wireless transmitter sends the data from the sheath to a display monitor. In essence, the device acts like a “check engine light” alerting surgeons to a possible vascular puncture. Getting that information in a matter of minutes instead of hours can mean the difference between a quick fix that allows the original procedure to continue and more costly and invasive medical procedures to repair the wound later on. “If you’re able to detect it early on, you plug up the first hole in the dike rather than waiting for dike to start cracking,” Razavi says.
To build out its prototype and conduct further animal testing, Saranas CEO Michael Magnani told me the company has just closed on a $1.2 million seed round, with a majority of funds from members of the Goose Society, a group of Houston entrepreneurs and investors including Nancy Chang, co-founder of Tanox, and Jack Gill, the Silicon Valley pioneer who started Vanguard Ventures and currently teaches entrepreneurship courses at Rice University, among other institutions. Three members of the Houston Angel Network also contributed $50,000 each.
“This is just the first generation,” says Gill, who will take a board seat at Saranas. “You can imagine the second and third generations of this product where the electrodes get more sophisticated in the way they are able to interpret the signals.”
The company is seeking FDA approval of the device under the 510(k) regulatory, which means it won’t have to conduct expensive clinical trials, and initially advocating its use for five high-risk procedures, including tandem-heart procedures, intra-aortic balloon pump placement, and transcatheter aortic valve replacement. Saranas plans to start selling its sensor-enabled sheaths for $250 apiece by 2016. Because Saranas’s system essentially is built on top of a sheath device already used by doctors, Magnani says, “they don’t have to learn a new system which helps adoption.”
Gill says he believes that Saranas will “look so attractive that one or two sheath manufacturers will acquire this company, sooner rather than later.”
Razavi says the inspiration for Saranas came from a particular vascular access procedure where his patient’s blood pressure suddenly dropped. “At this moment, I have no idea what is going on. It could be medicine; it could be bleeding. At that moment, I was thinking that I wish there was a way to figure this out.”
The next day, he says, the idea to be able to monitor a patient’s bioimpedance—a sort of fingerprint for tissue characteristics around vessels—came to mind. With Saranas’s device, he says surgeons like himself will have the information they need to detect and treat any bleeding from punctures quickly. “An ounce of prevention is worth a pound of cure really is our theme,” Razavi says.