SoundBite Announces Successful Completion of First-In-Man Clinical Study for Peripheral Chronic Total Occlusions (CTO) Crossing Procedures
MONTREAL – December 20th, 2017 – SoundBite Medical Solutions Inc. (SBMS) announced today that its First-In-Human prospective, single-arm and multi-center clinical trial using SoundBite’s shock wave energy system has been successfully completed. Thirty-seven (37) patients suffering from chronic total occlusion (CTO) were treated in three sites (Montréal, Sherbrooke and Graz (Austria)) with a clinical success rate of 92% and no serious adverse events.
Dr. Andrew Benko, Chief of Angiography and Endovascular Therapy at the Sherbrooke University Hospital (CHUS) and Principal Investigator of the clinical trial, stated, “This technology fulfills an important need in the field of CTO intervention as it can convert failed procedures into successes, giving the patient relief from ischemic pain and even saving their limb”.
In total, 41 lesions from 37 patients were treated with an average CTO length of 9.8 cm and average activation time per lesion of 3min 37s. Dr. Éric Thérasse from the Department of Radiology, Radio-Oncology and Nuclear Medicine, Université de Montréal (CHUM) and Co-investigator of the clinical trial, declared, “I was very pleased with the clinical performance of the SoundBite Crossing System and the clinical outcome that resulted in the safe and effective reestablishment of blood flow in patients’ blocked arteries.”
More than a third of treated lesions were severely calcified. According to Dr. Marianne Brodmann, the European Principal Investigator from the Department of Internal Medicine of Medical University Graz, “With SoundBite guidewire technology we could achieve more CTO crossings, which might make it easier to treat this complex patient cohort through endovascular procedures instead of surgery”.
“The outcome of our first-in-man clinical trial is a significant milestone, not only for the Company but also for all patients who suffer from severe progression of peripheral or coronary artery disease,” said Co-Founder and CEO, Martin Brouillette and went on to say, “Our excellent clinical data has allowed us to initiate a pivotal study in November 2017, ultimately paving the way towards commercialization in the US, Europe and Canada thereafter. These results are the direct product of the efforts and dedication of our outstanding team of employees.”
CTOs are complete blockages of arteries, which are the result of severe progression of peripheral and coronary artery disease, two prevalent and growing cardiovascular conditions affecting over 25 million North Americans. Risk factors include: diabetes, smoking, obesity, high blood pressure and cholesterol. It is estimated that between 30 and 40% of the peripheral and coronary artery disease population possess CTOs.
About SoundBite Medical Solutions Inc.
Soundbite Medical Solutions Inc. is developing proprietary shock wave technology to address significant unmet clinical needs in interventional vascular treatment. Through an elegant combination of hardware and software, it can, in a very controllable manner, deliver high amplitude shock wave pulses through guidewires and other interventional tools, to specifically attack highly calcified and fibrotic tissue in the vascular system, while leaving healthy, elastic arterial walls unharmed.
For further information on Soundbite Medical Solutions, please contact: Martin Brouillette, CEO (firstname.lastname@example.org) or Francis Bellido, CFO (email@example.com), Soundbite Medical Solutions, 2300 Alfred Nobel, Technoparc St-Laurent, Montreal Quebec H4S 2A4
For more information, visit www.soundbitemedical.com
Across CTOs — Safe and Sound.