MONTREAL – September 21st, 2018 – SoundBite Medical Solutions Inc. (SBMS) announced today the successful start of its ACTIVE Trial, a recently approved study by Health Canada with the objective to demonstrate the potential of the SoundBite™ Active Wire to cross coronary chronic total occlusions (CTOs).
The first two patients who underwent this new procedure were treated by Dr. Stephane Rinfret, MD, SM, FRCPC, Chief of Interventional Cardiology at the McGill University Health Center (MUHC) in Montreal and principal investigator for the ACTIVE Trial. “Our team, at the MUHC is proud to be involved in the first coronary CTO crossing application of the revolutionary new SoundBite shock wave system. The positive results obtained with the first two patients launch this determinant clinical trial in the evaluation of this new technology for the treatment of complex calcified coronary occlusions,” commented Dr. Rinfret.
The ACTIVE Trial is a North American, multi-center, 154-patient, phased clinical trial that has started in Canada, and is expected to gain FDA IDE within the next few months. The objective of the trial is to evaluate the safety and efficacy of the SoundBite™ Crossing System in patients with coronary CTOs. “We are pleased to have started enrolling patients in the ACTIVE Trial and we are preparing to initiate other leading institutions in North America”, explained Mr. Denis Bilodeau, Vice-President, Clinical Operations at SBMS.
Francis Bellido, CEO of SBMS, stated, “The momentum gained in the peripheral artery space allows us to address the coronary indication with confidence. The positive early results of the first coronary patients treated with our technology by Dr. Rinfret certainly signals our capacity to address the unmet medical need of calcified coronary occlusions.”
CTOs continue to be a major technical challenge for interventional cardiologists. The primary difficulty of treating CTOs is the ability to cross the hardened, complete artery blockage with a guidewire. Once the guidewire has safely crossed the blockage, typical angioplasty equipment, such as balloons and stents, can be delivered and deployed for treatment.
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.
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