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Soundbite Medical Solutions Receives FDA 510(k) Clearance for the SoundBite™ Crossing System – Peripheral (14P)

MONTREAL – April 22nd, 2021 – Soundbite announces the company has received Food and Drug Administration (FDA) 510(k) clearance for the SoundBite Crossing System ‐ Peripheral (SCS-P) with the 0.014” Active Wire (14P). The SoundBite® Crossing System – Peripheral (14P) is a recanalization tool, designed to help physician’s placement of conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions (CTOs) in patients suffering from heavily calcified above-the-knee (ATK) and below-the-knee (BTK) peripheral artery disease (PAD). “This clearance is an important step in furthering our mission of making a positive impact on the lives of patients with critical limb ischemia (CLI) and challenging calcified BTK disease. We believe that this clearance is very relevant as it represents the latest testament to...

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Soundbite Medical Solutions Announces Health Canada Approval for SoundBite® Crossing System ‐ Peripheral (14P)

MONTREAL – February 9th, 2021 – Soundbite announces Health Canada Approval for SoundBite Crossing System ‐ Peripheral (SCS-P) with the 0.014” Active Wire (14P). The SCS-P (14P) is intended for the treatment of patients suffering from peripheral artery disease (PAD) with heavily calcified above-the-knee (ATK) and below-the-knee (BTK) chronic total occlusions (CTO). Calcium remains the “Achilles heel” in the endovascular treatment of PAD, including critical limb ischemia (CLI). CLI is the most severe form of PAD and is associated with a high risk of major amputation, cardiovascular events and death.1 A mortality rate of 20% within 6 months after diagnosis and 50% at 5 years has been reported in patients diagnosed with CLI.2,3 Furthermore, CLI is associated with peripheral complications such as ulceration,...

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SoundBite Medical Solutions Announces First Use of its Novel 0.014” Active Wire to Successfully Treat Calcified Below-The-Knee CTOs

MONTREAL – Jan 26th, 2021 – Soundbite Medical Solutions Inc. (SBMS) announced today the first use of its novel Active Wire 0.014” platform in the successful treatment of patients suffering from critical limb ischemia (CLI) with heavily calcified below-the-knee (BTK) chronic total occlusions (CTO). The procedures were performed by Professor Marianne Brodmann, Head of the Clinical Division of Angiology, Department of Internal Medicine, and PD Dr Rief at the Medical University of Graz, Austria. “Vascular calcium poses a major challenge for the endovascular treatment of lesions. Our early experience with the 0.014” platform of the SoundBite® Crossing System in 5 patients with calcific BTK CTOs shows impressive crossing efficacy and handling with no procedural complications, including perforations, early recoil, or distal embolization in this difficult-to-treat...

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SoundBite Medical Solutions is the recipient of the 2020 “National Award for an Engineering Project or Achievement” by Engineers Canada

MONTREAL, June 17, 2020 – SoundBite Medical Solutions Inc. (SBMS) today announced that it was granted by Engineers Canada, the national organization of the 12 provincial and territorial associations that regulate the practice of engineering in Canada, the 2020 “National Award for an Engineering Project or Achievement”. The awards acknowledge exemplary community and professional involvement, contributions to engineering education, support for women in engineering, contributions by engineers and engineering students to Canadian society, and remarkable engineering projects or achievements. “The innovative SoundBite technology directly addresses the medical problem of chronic total occlusions by treating patients, who were incurable until now, with a low-cost technology that requires only a short hospital stay. The SoundBite technology will have a wide-reaching impact, including helping address the critical medical problem...

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SoundBite Receives FDA IDE Approval for the ACTIVE Clinical Study with the SoundBite™ Crossing System – Coronary

MONTREAL - February 3, 2020 – SoundBite Medical Solutions Inc. (SBMS) announced today that it has received FDA IDE (Investigational Device Exemption) approval to start the ACTIVE Clinical Study with the SoundBite™ Crossing System – Coronary in the USA, a unique and novel active guidewire technology for use in the treatment of coronary chronic total occlusions (CTOs). “After the recent 510(k) clearance for our SoundBite™ Crossing System – Peripheral, we are very pleased with this FDA approval which allows us to accelerate the development of the coronary application for our active wire technology in the USA, and to bring patients and physicians an innovative new tool to address calcific difficult-to-treat CTOs,” said Francis Bellido, CEO of SoundBite Medical. FDA IDE Approval indicates that SBMS has provided...

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SoundBite Receives FDA 510(k) Clearance of the SoundBite™ Crossing System – Peripheral

MONTREAL January 21, 2020 – SoundBite Medical Solutions Inc. (SBMS) today announces it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SoundBite™ Crossing System, a unique active wire technology for use in the treatment of peripheral chronic total occlusions (CTOs). “Through our collaborative approach with the FDA, we met the regulatory requirements and transformed a novel technology into a commercial product,” said Marc-André Côté, Director, Regulatory Affairs of SoundBite. FDA 510(k) clearance indicates that the product complies with the requirements of 21 CFR 807 Subpart E and is authorized to be distributed and commercialized in the USA market. “This significant milestone is very gratifying for all SoundBite employees who deployed an incredible amount of dedication and effort to make it happen....

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SoundBite Announces Health Canada Approval of the SoundBite™ Crossing System – Peripheral

MONTREAL December 4, 2019 – SoundBite Medical Solutions Inc. (SBMS) is pleased to announce that it has received a Health Canada Medical Device License for the SoundBite™ Crossing System – Peripheral. “We are pleased to have obtained our first approval in North America for the clinical use of the SoundBite™ Crossing System – Peripheral and thank the employees, clinicians, patients and other stakeholders that made this possible,” said Francis Bellido, CEO of SoundBite. “This approval allows us to commercialize this innovative technology in its country of origin, Canada, which will also facilitate our ability to pursue approval in other countries.” 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...

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SoundBite Medical Solutions Inc. and Asahi Intecc Sign Distribution Agreement for Japan

Asahi Intecc will be Exclusive Japanese Provider of the SoundBite™ Crossing System – Peripheral MONTREAL – December 3, 2019 – SoundBite Medical Solutions Inc. (SBMS) has signed an exclusive distribution agreement with Asahi Intecc Co., Ltd. (“Asahi Intecc”) to sell its SoundBiteTM Crossing System in Japan. Asahi Intecc is recognized globally as a leading manufacturer and provider of guidewires and catheters among other medical devices used by hospitals for cardiovascular interventions in over 108 countries and regions across the globe. “We are excited to build on our strategic partnership with Asahi Intecc and to bring the SoundBite system to patients suffering from peripheral vascular disease in Japan. We look forward to this collaboration and to leveraging Asahi Intecc’s market leadership and experience to expand our...

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SoundBite Medical Solutions Announces $8M Loan Agreement with Investissement Québec

MONTREAL – September 24, 2019 – SoundBite Medical Solutions Inc. (SBMS) today announced that it has entered into an $8 million loan agreement (the “Agreement”) with Investissement Québec (IQ) as part of the Biomed Propulsion Program. The terms of the Agreement were not disclosed. SoundBite intends to use the proceeds to support the development and early market introduction of its SoundBiteTM Crossing System (SCS). The first application, the SCS-Peripheral has received CE Mark, and SoundBite has filed for market authorization in Canada and the US. The Biomed Propulsion Program, which is under the responsibility of the “Ministère de l’Economie et de l’innovation du Québec” is administered by IQ. “We are excited to have the support of Investissement Québec, a high-profile Canadian investment institution, as...

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SoundBite Medical Solutions Announces New Appointments to its Board of Directors

MONTREAL – September 23, 2019 – SoundBite Medical Solutions Inc. (SBMS) today announced the appointments of William L Hunter, MD, Azin Parhizgar, PhD and Rick Geoffrion to the Board of Directors. “We are extremely excited and pleased to welcome these three medical device industry veterans. Their deep business expertise in Interventional Cardiology will be invaluable to SoundBite and we are confident that their broad experiences with both emerging and multinational healthcare companies will significantly strengthen and extend the reach of our Board,” said Dr. Francis Bellido, President and Chief Executive Officer of SoundBite Medical. “We are also very pleased that Dr. Hunter has accepted to act as Chairman of the Board,” added Dr. Bellido. Bill Hunter, MD is Founder, President & Chief Executive Officer of Canary...

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