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 dramatically change the way we deal with difficult to treat calcific disease in order to save limbs. Our experience with the 0.014” platform of the SoundBite^® Crossing System in eight (8) patients with severely calcified disease in both Below and Above the Knee (BTK and ATK) lesions shows impressive CTO performance with safety and simplicity. Treating CTOs now becomes a little boring with the Soundbite Active Wire. Amongst the treated lesions, 90% had severe calcium, with an average lesion length of 12.5 cm. Crossing was successful in all cases with patency of treated lesions. The average crossing time was only 12 min with an average Active Wire activation time of 2:11 min. We are looking forward to building upon our experience with this novel system” commented Dr Lichtenberg.

High calcium burden is present in up to 50% of PAD patients with severe claudication and in >65% of patients with Chronic Limb Ischemia (CLI,) especially in difficult to treat below-the-knee (BTK) disease. CTOs are encountered in up to 50% of PAD and CLI patients1,2. Within the first year of CLI diagnosis, 25% of patients die and 25% will have a major limb amputation as primary treatment, at a cost of $22 billion in the US alone3,4,5. Successful revascularization significantly reduces the need for amputations.

“We are pleased to see consistently strong performance of our Active Wire in severely calcified peripheral lesions across multiple centers and operators. We look forward to building upon this momentum and expanding our reach to the most vulnerable CLI patients worldwide,” commented Lori Chmura, President and CEO of Soundbite. The SoundBite^® Crossing System – Peripheral (SCS-P) consists of the reusable SoundBite^® Console, a single-use sterile SoundBite^®, Active Wire, and their respective accessories. 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 is now approved in major markets with CE mark, FDA (510(k)) clearance, and Health Canada approval in both 0.018” and 0.014’’ platforms.

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, PhD, Chief Business Officer, Soundbite Medical Solutions, 2300 Alfred Nobel, Montreal Québec H4S 2A4 ([email protected]).

References

1. Murabito JM et al. Am Heart J. 2002;143(6):961–965. [PubMed] [Google Scholar]
2. Fanelli, J Cardiovasc Surg 2014
3. Abu Dabrh AM, et al. J Vasc Surg. 2015;62(6):1642–1651. [PubMed] [Google Scholar]
4. Norgren L, et al. J Vasc Surg. 2007;45(suppl S):S5–S67. [PubMed] [Google Scholar]
5. The SAGE Group

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