Saranas, a Houston medical device company, expects to announce this week that it has raised $2.35 million to further develop a souped-up sheath that can detect blood leaks caused by catheters in real time.
The funding came from existing investors, including members of the GOOSE Society, such as Vanguard Ventures co-founder Jack Gill, and Houston Angel Network members.
The device works like any other sheath, says Alex Arevalos, Saranas’s co-founder and chief technology officer. (That’s the short tube inserted into a blood vessel, through which the doctor threads a catheter.) “If there is a problem, the device quickly alerts the doctor to the presence of the internal bleeding complications,” he says.
I first met with executives at Saranas last year when they told me about the device they were developing that could, within minutes, detect bleeding that occurred because a catheter had accidentally punctured a blood vessel. This occurs in about 5 percent of the approximately 20 million “vascular-access procedures” that are performed in the U.S. to treat cardiac ailments as well as to aid dialysis or chemotherapy. With existing methods, it can typically take hours to discover these leaks, making additional surgical procedures necessary to stem the blood loss.
Saranas has taken a standard sheath and has added sensors that can measure electrical resistance, which changes if there’s a rupture and blood begins to accumulate.
The sensors essentially create a signature for each patient at the start of a procedure, Saranas founder Mehdi Razavi told me. That signature changes when blood is introduced. The Saranas device can detect as little as 30 milliliters of blood accumulation, the company says.
Whereas last year’s version wirelessly sent the data to a display monitor, the current device has been remade so that it offers doctors an all-in-one approach. “There are a series of LEDs on the sheath itself, so there is no additional thing for the physician to keep track of,” Arevalos says. “We took all the analytics, all the hardware and the software, and integrated it onto the sheath itself. It’s a true off-the-shelf solution.”
With its redesigned device, Saranas is preparing to get regulatory approval as a 510k device and plans to conduct an animal study at Texas A&M University’s Institute for Preclinical Studies at the end of the year.
“The technology is stunningly simple for the amount of return in terms of value that it will give to patients in the healthcare system,” says Milton Morris, a former executive at Cyberonics who has joined Saranas’s board.