Devices & Diagnostics

Thermedx looks to go national with surgical fluid management system

After a “soft launch” that brought its surgical fluid management system to 14 hospitals, medical device startup Thermedx is looking to go national. The Solon, Ohio-based company received U.S. Food and Drug Administration clearance on its 37-5 Fluid Management System last year and has rolled it out to hospitals in five states, including Ohio. Now […]

After a “soft launch” that brought its surgical fluid management system to 14 hospitals, medical device startup Thermedx is looking to go national.

The Solon, Ohio-based company received U.S. Food and Drug Administration clearance on its 37-5 Fluid Management System last year and has rolled it out to hospitals in five states, including Ohio.

Now Thermedx is looking to ink deals with distributors or strategic partners and raise $3 million to fund a national commercialization of the system, which enables users to manage and warm surgical irrigation fluids, according to Mike Haritakis, executive vice president with Thermedx.

A big key to getting the device into more clinicians’ hands will be boosting the number of distributors Thermedx works with. The company currently has distribution deals with two partners, Haritakis said.

Thermedx, which has pulled in more than $5 million in investment funding since 2007, would use the $3 million round to hire more sales and marketing employees, Haritakis said. The company has 16 employees.

The company markets its fluid management device as being both cost effective and beneficial to patient safety. By warming fluid to a patient’s core body temperature, the device can help prevent perioperative hypothermia. Though it’s unclear how many U.S. patients suffer from the condition annually, estimates run as high as 14 million. A 2007 Cleveland Clinic study found that less than a degree of hypothermia is enough to significantly increase blood loss during surgery.

Robin Chard, a perioperative nursing specialist with the Association of periOperative Registered Nurses (AORN), wasn’t aware of any statistics on how widespread hypothermia in surgery is, but acknowledged that “it is a concern.”

“It’s a real problem that needs to be considered for every patient, every surgery, every time,” she said.

Typically, surgical irrigation fluid is heated in warming cabinets, she said.

As for the cost savings Thermedx can bring, those flow from the “all-in-one” nature of the device — it warms up five fluids and contains several different types of pumps specific to gynecology, urology and laparoscopy, for example.

“It’s a better standard of care, combining five functionalities into one device,” Haritakis said.

With just one product on the market, Thermedx has plans to develop others, though Haritakis declined to go into a lot of detail for competitive reasons. He did elaborate on one product, though, for which the company is seeking development funding through Ohio’s (pdf) Third Frontier technology acceleration program. It’s called a “pulse lavage system” and would deliver irrigation fluid under high pressure for use in joint-replacement surgeries, opening up the orthopedics market to Thermedx, Haritakis said.

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