First TCT Innovation Award Given for Novel Cooling System

Qool Therapeutics, a company that is developing a noninvasive system to rapidly induce therapeutic hypothermia through the inhalation of frozen saline, was honored on Monday as the first recipient of the inaugural TCT Innovation Award.

The purpose of the new award — presented by the Cardiovascular Research Foundation (CRF) Skirball Center for Innovation, Orangeburg, N.Y., in partnership with Stanford Biodesign of Stanford University, Stanford, Calif., and the Innovation in Cardiovascular Interventions 2014 meeting — is to provide exposure and feedback to promising new cardiovascular technologies, giving companies a boost in seeking partners and financing as they move through the early stages of development.

 “It’s very exciting because it’s recognition from some of the most esteemed clinicians in the world and peers in the med tech industry,” Beverly A. Huss, president and CEO of Qool Therapeutics, told TCT Daily. “It’s a vote of confidence for the work we’re doing.”

The cooling system works by exposing the lungs to aerosolized frozen saline. Blood is chilled as it passes through the lungs, and then it travels to the heart and brain, cooling those organs as well. The technique achieves cooling in 15 to 30 minutes depending on how much a patient weighs. Huss said the system could have applications in disease management — for conditions like STEMI, cardiac arrest, acute spinal cord injury, stroke and hypermetabolic disorders (heat stroke, burns and sepsis) — and as an adjunct to certain types of surgery for which patients already undergo therapeutic hypothermia, like neurosurgery, repair of abdominal aortic aneurysms and CABG.

What makes this system different from currently available therapeutic hypothermia techniques, such as cooling blankets and catheters, is that it is noninvasive, has a rapid effect and can be incorporated easily into the flow of patient care, Huss said.

Judged by a panel of eight international experts, the Qool Therapeutics system won in a competition that initially attracted more than 50 submissions of novel technologies, including nine that were selected to be presented at TCT 2014. The two other finalists were Kyma Medical Technologies, which is developing a remote monitoring system for chronic heart failure, and ControlRad, which is working on products to reduce radiation exposure in the cath lab.

“All of the nine novel, early-stage technologies presented at the innovation competition event have various elements that may enable them to disrupt the cardiovascular space,” said Juan F. Granada, MD, Executive Director and Chief Innovation Officer of the CRF Skirball Center for Innovation. The Qool Therapeutics system came out on top, however, because it “highly considers cost-effectiveness in today’s health care environment and improving patient outcomes, with global scalability.”

The company has 10 U.S. or international patents that have been allowed or issued and another 11 that are pending for the system, which is still in the early phase of development. Some animal studies have been completed with a prototype of the device, but first-in-man studies are probably about 18 to 24 months away, according to Todd J. Brinton, MD, of Stanford University Medical Center, Stanford, Calif.

“Winning this award is a recognition of not just what Qool has done,” said Brinton, who is a clinical consultant and member of the board of directors for the company, “but a recognition that both TCT and CRF believe that there’s value in what innovation does for medicine.”

Disclosures:

• Granada and Brinton report conflicts of interest with multiple device and pharmaceutical companies.