ThermalTherapeutic Systems Inc. has received clearance from the U.S. Food and 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 hyperthermia.
Obtaining 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 statement from the company.
ThermalTherapeutic’s 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 hyperthermia patient’s abdomen and chest cavity, and can handle a variety of heated and unheated solutions.
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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. In the future, the company may look to commercialize the device for use in chemotherapy, but doing so would require funding often-expensive clinical trials.
The device was submitted to the FDA for approval in July. 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.
Chief Executive Raymond Vennare said the company has raised about $3.5 million since its inception. ThermalTherapeutic focuses only on product development, allowing it to to keep overhead costs low. The company has four employees and outsources much of its operations including manufacturing and engineering. Much of the engineering and manufacturing work for the Veratherm was performed in Northeast Ohio, Vennare said.
