Prytime Medical Gets OK to Sell Anti-Hemorrhaging Device in Europe

Xconomy Texas — 

San Antonio — [Updated 11/15/16, 4:15 p.m. See below.] Prytime Medical Devices, a Texas-based company with a medical device that’s used in trauma patients, has received approval to sell its lead product in Europe.

Prytime, which is headquartered near San Antonio in Boerne, TX, sells a catheter that can be used in emergency and critical care situations to prevent patients from bleeding to death after a traumatic injury. The device, used by vascular and trauma surgeons, received FDA clearance for its device in October 2015, when Prytime was known as Pryor Medical Devices. [Updated to include the type of surgeon that uses the device.]

The device is intended for patients who are hemorrhaging blood after a traumatic injury. When there isn’t enough blood reaching the heart and the brain, it can lead to cardiovascular collapse and even death, Prytime says on its website. The catheter, which is inserted through the femoral artery, has a balloon attached to it that can be inflated in a large blood vessel, such as the aorta, helping blood flow to the organs instead of just out of the body. The device helps a clinician temporarily control the hemorrhaging, providing more time to operate in attempt to stem the hemorrhaging, Prytime says. [Updated to clarify that the device temporarily controls hemorrhaging.]

“Simply put, no one should bleed to death, and the sooner you stop bleeding the better,” David Spencer, CEO of Prytime, says in a prepared statement.

Another way to limit the impact of hemorrhaging is operating on patients, Prytime says, though the company claims those methods are more invasive and risky. Prytime’s device, which it calls the ER-REBOA Catheter, also has a pressure monitor. (REBOA stands for resuscitative endovascular balloon occlusion of the aorta.)

Prytime plans to begin selling the in Europe in 2017. The company is developing other versions of the catheter and other minimally invasive devices, it says.

The company licensed the device from the San Antonio Military Medical Center and has raised about $24.5 million, including a $5 million Series B funding round in September 2015 led by BriarPatch Partners. As Xconomy has previously reported, the device builds upon technology first used during the Korean War, such as a smaller balloon and catheter, as well as a softer catheter tip.

Hemorrhaging is the cause of about 40 percent of deaths that occur in the 24-hour period following a traumatic injury, according to the National Trauma Institute.