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Soundbite Medical Solutions Announces Issuance of a Fourth U.S. Patent Further Expanding Coverage of its Core Technology

MONTREAL – July 27, 2021 – Soundbite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific peripheral and coronary arterial diseases, today announced that the United States Patent and Trademark Office has issued US patent No. 11,065,645, entitled “Method and system for generating mechanical pulses”. The patent is directed to a general system comprising a shock wave generator connected to a mechanical waveguide, for the treatment of lesions in blood vessels. It protects the novel Soundbite system architecture, which is used in all products of the company's burgeoning portfolio. The patent is expected to expire in December 2036 and will continue to provide key intellectual property protection for the Company's technology platform. This is the fourth US patent...

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Soundbite Medical’s Proprietary Shock Wave Technology Now Cracks Calcium In Germany, a Promising Solution for CLI Patients

MONTREAL – June 29th, 2021 – Soundbite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific peripheral and coronary arterial diseases, today announced the use of its novel Active Wire 0.014” platform at a prominent site in Germany with the successful treatment of patients suffering from heavily calcified lower limb chronic total occlusions (CTO). The Active Wire was used in procedures by Dr Michael Lichtenberg, Director of the Department of Angiology at the Vascular Centre Clinic in Arnsberg, Germany. “In Germany, and around the world, we still perform far too many amputations in patients with PAD without considering revascularization before amputation. Novel, safe, and effective technologies such as the Soundbite CTO crossing system have the potential to...

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Soundbite Medical’s Shock Wave Technology Continues to Crack Through Severe Calcium with the Addition of its First US Site

MONTREAL – June 2nd, 2021 Soundbite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific peripheral and coronary arterial diseases, today announced the use of its novel Active Wire 0.014” platform at a first site in the United States in the successful treatment of patients suffering from critical limb ischemia (CLI) with heavily calcified lower limb chronic total occlusions (CTO). The Active Wire was used in procedures at the UNC REX Hospital (NC) by Dr. George Adams, MD, MHS, FACC, Director, Cardiovascular and Peripheral Vascular Research; Associate Professor, Cardiology, UNC School of Medicine. “Peripheral Artery Disease (PAD) and CLI in particular are a threat to life and limb. Our early experience with the 0.014” platform of the SoundBite®...

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Soundbite Medical Solutions Announces Issuance of a Third U.S. Patent Expanding Coverage of its Core Technology

MONTREAL – May 18th, 2021 – Soundbite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific peripheral and coronary arterial diseases, today announced that the United States Patent and Trademark Office (USPTO) has issued US patent No. 11,000,880, entitled “Mechanical Waveguide Provided With A Marker Thereon”. The patent is directed to a proprietary waveguide specially designed for the transmission of shock waves used in the treatment of cardiovascular disease. It covers the Active Wire, Soundbite’s proprietary guidewire, and the rest of the company's burgeoning product portfolio. The patent is expected to expire no earlier than January 2039 and will provide key intellectual property protection for the Company's technology platform. This is the third US patent to be issued...

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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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