Velomedix Initiates Clinical Trial Enrollment for VELOCITY Pilot Study

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MENLO PARK, Calif.--Velomedix, a venture-backed medical device company advancing the field of therapeutic hypothermia, today announced the enrollment of the first patient in its VELOCITY pilot study. VELOCITY is a prospective, randomized, multi-center study designed to further evaluate the safety and feasibility of the Velomedix rapid therapeutic hypothermia system in patients with acute myocardial infarction (AMIs or heart attacks). The first patient was enrolled by David Shavelle, M.D., at the University Of Southern California Keck School Of Medicine in Los Angeles, CA.

The VELOCITY study will enroll 60 awake patients with ST segment elevation myocardial infarctions (STEMIs) at multiple U.S. and Canadian sites. Patients will be randomized to either primary percutaneous coronary intervention (PCI) or a combination of primary PCI and cooling to therapeutic temperatures before reperfusion.

"The case went very well, with no delay in door-to-balloon time," said Dr. Shavelle. "Any concerns we had with the peritoneal access are essentially gone and the patient has been doing well since his treatment. If this technology shows the expected benefit for these STEMI patients, I could see it become the standard of care for these patients."

The study's primary endpoint is a composite of specific new-onset, serious adverse events during the first thirty days following treatment. Several secondary endpoints will also be collected, including infarct size, myocardial salvage, left ventricular volumes, and left ventricular ejection fraction, assessed by cardiac magnetic resonance imaging (MRI). The study will thus gather initial efficacy information in addition to primary safety data.

Previous studies of therapeutic hypothermia in AMI patients have shown that cooling can significantly reduce the severity of STEMIs only if patients are cooled to temperatures of less than 35°C prior to PCI. The Velomedix approach may be unique in its ability to cool patients to this desired temperature in less than 15 minutes.

"Over the past ten years, we have seen several failed attempts to leverage therapeutic hypothermia to improve AMI patient outcomes. We now realize that a technology must be able to cool a patient to below 35°C without extending door-to-balloon times in order to be effective and adopted into today's time-sensitive AMI treatment workflows," said Gregg Stone, M.D., Columbia University Medical Center / New York-Presbyterian Hospital and co-principal investigator of the VELOCITY trial. "Velomedix appears to have developed an ultrafast cooling technology that might be effective without significantly delaying reperfusion."

About Acute Myocardial Infarction (AMI)

AMI affects 1,255,000 people in the U.S. yearly1, reducing the heart's ability to pump the needed amount of blood throughout the body. The most severe form of AMI, called ST segment elevation myocardial infarction (STEMI), often leads to heart failure, a substantially debilitating disease and one of the most costly conditions for our healthcare system.

While it is extremely important to restore blood flow to the heart as early as possible, the process (called reperfusion) may cause coincidental damage, known as reperfusion injury. Thus, (it is hypothesized that) an approach that not only restores blood flow quickly, but also minimizes reperfusion injury, could further improve AMI patient outcomes and substantially reduce overall healthcare costs.

About the Velomedix Mild Therapeutic Hypothermia System

The Velomedix mild therapeutic hypothermia system incorporates a peritoneal-based approach to rapidly cool patients from their core. Using tools and techniques similar to those for peritoneal dialysis, the physician first accesses the peritoneal cavity and then uses the Velomedix system to circulate cold fluid in the peritoneal cavity. This cavity provides a unique means of very rapidly removing heat (cooling) from the patient due to the fact that the cavity is in contact with a large part of the body's core and a high percentage of blood flows past it at any one time. This efficient "heat exchanger" enables the system to cool patients to less than 35°C in fewer than 15 minutes on average.