SoundBite Medical Solutions Announces Successful Completion of its Pivotal PROSPECTOR Clinical Study at TCT Conference in San Diego
MONTREAL – SAN DIEGO – September 25th, 2018 – SoundBite Medical Solutions Inc. (SBMS) announced last Friday at TCT (Transcatheter Cardiovascular Therapeutics), a major conference in the Interventional cardiology space, that its Pivotal PROSPECTOR prospective, single-arm clinical trial using SoundBite’s shock wave energy system has been completed. Fifteen subjects suffering from Peripheral Arterial Disease (PAD) with chronic total occlusions (CTOs) were treated at two sites (Montréal and Ottawa) with a clinical success rate of 93% and no serious adverse events were reported.
Dr. Eric Therasse Professor at the Department of Radiology, Radio-Oncology and Nuclear Medicine at the University of Montreal (CHUM), Principal Investigator of the PROSPECTOR Clinical Trial and presenter at TCT, declared, “The technology showed an excellent efficacy and safety profile in treating a wide range of occlusions leading to revascularization for the patients who participated in the trial. The SoundBite Crossing System is easy to use and was able to open occlusions we would have had a hard time able to cross otherwise, typically because they are very calcified.”
“The results of the 15 subjects of the PROSPECTOR study were pooled with the 37 subjects of the First-In-Man study for a combined group of 52 cases presenting an average CTO length of 10 cm and a fairly even distribution of mild, moderate and severe calcifications. These pooled results will now be presented to Canadian and American regulatory authorities,” explained Mr. Denis Bilodeau, Vice-President, Clinical Operations at SBMS.
“These promising results set the stage for our technology to address increasingly complex, heavily calcified occlusions, a clear unmet need in today’s medical practice. From our early clinical work in North America and Europe, we are now preparing further studies that will test our technology in several other countries for the intended indication,” added Francis Bellido, CEO at SBMS
About SoundBite Medical Solutions
SoundBite is a privately-held medical device company developing products in the field of vessel preparation for the management and treatment of calcified and occlusive lesions in coronary and peripheral arterial diseases. SoundBite will leverage its shock wave technology platform to clinically and commercially validate its calcium management medical devices with active wires and microcatheters. Peripheral artery disease (PAD) and coronary artery disease (CAD) affect more than 12 million & 16 million people in the US, respectively.
For additional information visit www.soundbitemedical.com
For information on SoundBite Medical Solutions, please contact Mandy Di Lazzaro, Director, Human Resources & Communications (firstname.lastname@example.org) or Francis Bellido, CEO (email@example.com), SoundBite Medical Solutions, 2300 Alfred Nobel, Technoparc St-Laurent, Montreal Québec H4S 2A4
Transcatheter Cardiovascular Therapeutics (TCT) is the world’s largest educational meeting specializing in interventional cardiovascular medicine. For over 25 years, TCT has been the center of cutting-edge educational content. TCT showcases the latest advances in current therapies and clinical research.
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