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, gangrene, infection and a high risk of lower limb amputation estimated in 10%–40% of patients at 6 months, especially in non-treatable patients.4,5
“Expanding our technology and product portfolio in Canada is an important milestone for our company in the journey to commercialize the SoundBite system. This is welcome news on the back of our recent positive experience with the system in the EU. We are looking forward to making a positive impact on patients by providing a novel and safe solution around the world” said Lori Chmura, President and CEO of SoundBite Medical.
The SCS-P 14P system comprises the SoundBite Console and the 0.014” SoundBite Active Wire. SCS-P leverages Soundbite’s proprietary method to produce and safely deliver shock waves via guidewire platforms to selectively ‘micro- jackhammer” through calcified lesions. SCS-P has CE marked and Health Canada approval in both 0.018” and 0.014’’ platforms; the 0.018” platform has also FDA (510k) approval.
About Soundbite Medical Solutions
Soundbite is a privately-held medical device company uniquely dedicated to developing meaningful solutions for the interventional treatment of calcific peripheral and coronary arterial diseases. Soundbite has developed and deployed a proprietary method to produce and safely deliver shock waves to calcified lesions using an array of guidewire-based devices to improve and transform the standard of care for treatment of patients suffering from calcified and occlusive cardiovascular disease. www.soundbitemedical.com
For information on Soundbite Medical Solutions, please contact Ashkan Haghighat (email@example.com), SoundBite Medical Solutions, 2300 Alfred Nobel, Technoparc St-Laurent, Montreal Québec H4S 2A4
Forward-Looking Statements This press release contains forward-looking statements and forward- looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management’s belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as “may”, “will”, “should”, “could”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate” or the negatives of these terms, or variations of them. Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond SoundBite Medical Solutions Inc.’s control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward looking statements. Forward- looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances.
1. Murabito JM et al. Am Heart J. 2002;143(6):961–965. [PubMed] [Google Scholar]
2. Adam DJ, et al. Lancet. 2005;366(9501):1925–1934. [PubMed] [Google Scholar]
3. Stoyioglou A, Jaff MR. J Vasc Interv Radiol. 2004;15(11):1197–1207. [PubMed] [Google Scholar]
4. Abu Dabrh AM, et al. J Vasc Surg. 2015;62(6):1642–1651. [PubMed] [Google Scholar]
5. Norgren L, et al. J Vasc Surg. 2007;45(suppl S):S5–S67. [PubMed] [Google Scholar]