ThermalTherapeutics wins FDA nod for hypothermia device

March 8, 2010 by MedCity News

ThermalTherapeutics Inc. wins clearance from the Food & Drug Administration to market its Veratherm portable hypothermic perfusion system.

By Brandon Glenn

ThermalTherapeutic Systems Inc. received clearance from the Food & Drug Administration to begin selling its flagship portable perfusion device, which is used to pump fluid into the abdomen or chest cavity of patients suffering from hypothermia.

FDA clearance of the Veratherm Portable Hyperthermic Perfusion System is a “critical step” for the company, which will begin selling the device next month, according to a press release.

ThermalTherapeutics 26-pound device is a foot high, about 15 inches deep and about a foot-and-a-half tall. It delivers sterile fluids into a hypothermia patient’s abdomen and chest cavity and can handle a variety of heated and unheated solutions.

Another potential use is to deliver chemotherapy drugs that could then effectively bathe tissue in the treatment. The device delivers drugs quickly, which can trim the length of a treatment, according to the company.

The device was submitted to the FDA for approval in July 2009. Founded in 2006, ThermalTherapeutic raised $2.75 million last year from Bethlehem, Pa.-based Originate Ventures. The company has also received $275,000 from economic development group Pittsburgh Life Sciences Greenhouse.

CEO Raymond Vennare didn’t immediately return a call seeking comment.