September 23, 2021

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Soundbite Medical’s proprietary shockwave technology now attacks arterial calcium in Germany, providing a promising solution for patients with critical lower limb ischemia.

Montreal, June 29, 2021– (work wire) – Today Soundbite Medical Solutions Inc. (SBMS), a company dedicated to developing solutions for the interventional treatment of peripheral arterial disease and coronary artery disease, has announced the use of the 0.014″ Active Wire platform at a famous hospital in Germany, with successful treatment of patients with severely calcified chronic total obstruction in the arteries above and below the knee.

Procedures using an active guide wire were performed at the Klinikum-Hochsauerland Hospital in Arnsberg by Dr. Michael Lichtenberg, who heads the vascular clinic. “In Germany, as in the rest of the world, we still perform a lot of lower limb amputations for patients with peripheral arterial disease, without prior attempt to revascularize. New safe and effective technologies such as the Soundbite system have the potential to change the way these patients are treated for limb rescue.Our experience with 0.014″ SoundBite® Crossing System (SCS) in eight (8) patients with severe arterial calcification demonstrated outstanding performance in simply and safely crossing the CTO. In fact, using Active Wire now makes CTOs very popular. Of the treated lesions, 90% were considered severe calcification with an average occlusion length of 12.5 cm. CTO can be successfully crossed and re-inducted into the arteries in all patients. PATIENTS: The total average time to pass through the blockages was 12 minutes, including 2:11 minutes of Active Wire activation, so we look forward to continuing to build on our experience with the Soundbite system,” commented Dr. Lichtenberg.

Severe calcifying lesions are present in approximately 50% of patients with peripheral arterial disease with severe claudication, and in more than 65% of patients with critical lower limb ischemia (CLI), especially in the arteries below the knee. In particular, CTO is found in these patients in approximately 50% of cases.1,2. In the first year of CLI diagnosis, 25% of patients die and 25% will have a major limb amputation, at a cost of $22 billion in the US alone3,4,5. However, successful revascularization greatly reduces the need for amputation.

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“We are pleased with the consistency of the excellent results with Active Wire in different hospitals for the treatment of severely calcifying peripheral lesions. We will continue this positive momentum to extend our innovative technology platform to all patients with hard-to-treat peripheral vascular injuries,” commented Lori Schmora, President and CEO of Soundbite.

SoundBite® Cross-Terminal System (SCS-P) includes the SoundBite® Controller, SoundBite® Active Wire and accessories. The SCS-P uses Soundbite’s proprietary method to safely generate and transmit shock waves that selectively cross calcifying lesions. The SCS-P bears the CE marking, is FDA approved (510(k)), approved by Health Canada, and is available for 0.018″guideline rigs.and 0.014″.

About Soundbite Medical Solutions

Soundbite is a privately owned medical device company dedicated to developing useful solutions for the treatment of calcifying and occlusive lesions in peripheral and coronary artery disease. Soundbite has developed and published a patented method for safely producing and delivering shock waves to calcifying lesions using a suite of active routers to improve and transform care for patients treated for cardiovascular disease. www.soundbitemedical.com

references

  1. Morabito JM et al. Am Hart c.200; 143 (6): 961–965. [PubMed] [Google Scholar]

  2. Vanelli, J. Cardiovasc Surg 2014

  3. Abu Dabra AM et al. J Vaxsurg. 2015; 62 (6): 1642–1651. [PubMed] [Google Scholar]

  4. Norgreen L, et al. J Vasek Surg. 2007; 45 (Appendix S): S5–S67. [PubMed] [Google Scholar]

  5. SAGE group

forward-looking statements This press release contains forward-looking statements and information, or collectively, forward-looking statements, within the meaning of applicable securities laws, based on the beliefs and assumptions of our management and on information currently available to our management. You may identify forward-looking statements with words such as “may,” “will,” “should,” “could,” “will,” “expect,” “believe,” “plan,” “expect,” “expect” or “expect” and The “estimate” or cons of these terms or variations thereof. Forward-looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are outside the control of SoundBite Medical Solutions Inc. and could cause actual results to differ materially from those disclosed or projected by this forward-looking information. Readers are encouraged to consider these and other risks and uncertainties carefully and not to place 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 assume no obligation to update or revise the information in this press release, whether as a result of new information or future events or conditions.

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See the source version on businesswire.com: https://www.businesswire.com/news/home/20210629005686/fr/

Contacts

For more information about Soundbite Medical Solutions Inc. , please contact:
Ashkan Haqiqat, Ph.D., Head of Business Administration
Soundbite Medical Solutions
[email protected]