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

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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 to be issued around the approved Soundbite technology. Soundbite continues to enhance its patent portfolio with additional patent applications that will broaden and strengthen its patent protection in key markets throughout the world.

“The strength of our patent portfolio is a testament to our highly talented engineering team. The pursuit of excellence in serving our patients begins with medical devices that are unique, differentiated and of the highest quality. Protecting that work and preserving value will establish Soundbite as a leader in its field,” said Lori Chmura, President & 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.

High calcium burden is present in up to 50% of PAD patients with severe claudication and in >65% of patients with CLI, especially in difficult to treat below-the-knee disease. CTOs are encountered in up to 50% of PAD and CLI patients. CLI is associated with a high risk of lower limb amputation estimated in 10%–40% of patients at 6 months, especially in non-treatable patients.

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 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 (ashkan.haghighat@soundbitemedical.com), Chief Business Officer, SoundBite Medical Solutions, 2300 Alfred Nobel, 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.

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

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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 (ashkan.haghighat@soundbitemedical.com).

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

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.

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

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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® Crossing System in eight (8) patients with severely calcified disease shows impressive CTO crossing efficacy coupled with safety and simplicity. In several cases, crossing and treatment would not have been possible with standard techniques. With an increased demand for devices to aid in treatment algorithms for calcific plaque morphologies, we look forward to building on our experience with the system. The broader introduction of the Soundbite system holds promise to be game-changing in treating calcified CTOs and enabling better treatment outcomes in a difficult-to-treat patient population suffering from PAD and CLI,” commented Dr. Adams.

High calcium burden is present in up to 50% of PAD patients with severe claudication and in >65% of patients with 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 excited by the strong results we are seeing with our Active Wire in severely calcified peripheral lesions and look forward to the day when our unique technology platform and devices become the standard of care for all difficult-to-treat peripheral vascular lesions 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 (ashkan.haghighat@soundbitemedical.com).

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

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.

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

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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 around the approved Soundbite technology. A fourth US patent has recently been allowed. Soundbite continues to enhance its patent portfolio with additional patent applications that will broaden and strengthen its patent protection in other key markets throughout the world.

“Building a robust patent portfolio in the US and around the world, supported with clearances by regulatory bodies in the US, EU, Canada and eventually Japan strengthen our position in the cardiovascular intervention market” said Lori Chmura, President & 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.

“The cardiovascular community is primed for a new tool to help physicians treat these challenging and debilitating lesions safely and effectively”, said Dr. Martin Leon MD, Professor of Medicine at Columbia University Medical Center, Director of the Center for Interventional Vascular Therapy, Director of the Cardiac Catheterization Laboratories and Executive Board Member of the Columbia New York-Presbyterian Heart Valve Center, and Chair of Soundbite’s Medical Advisory Board. Dr. Leon added “The progress that Soundbite has made in its patent work, as well as its FDA clearances, is promising.”

High calcium burden is present in up to 50% of PAD patients with severe claudication and in >65% of patients with CLI, especially in difficult to treat below-the-knee (BTK) disease. CTOs are encountered in up to 50% of PAD and CLI patients. CLI is associated with a high risk of lower limb amputation estimated in 10%–40% of patients at 6 months, especially in non-treatable patients.

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 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 (ashkan.haghighat@soundbitemedical.com), Chief Business Officer, SoundBite Medical Solutions, 2300 Alfred Nobel, 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.

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

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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 our comprehensive and longterm commitment to revolutionizing the treatment of CTOs and PAD with our family of safe and effective Active solutions” said Lori Chmura, President and CEO of SoundBite Medical.

The presence of CTOs and calcified lesions pose significant challenges in the endovascular treatment of PAD, including CLI. Critical limb ischemia 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
The SoundBite® Crossing System – Peripheral (14P) consists of the reusable SoundBite® Console, a single-use sterile SoundBite® Active Wire 14P, 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 (510k) 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 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 (ashkan.haghighat@soundbitemedical.com), SoundBite Medical Solutions, 2300 Alfred Nobel, 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.

References
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]

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

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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 (ashkan.haghighat@soundbitemedical.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.

References
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]

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

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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 patient population. The Soundbite technology holds promise to significantly transform the treatment of calcified vascular occlusions in patients with peripheral artery disease.” commented Dr. Brodmann, MD.

Calcification and CTO encounter is increasingly common in patients with peripheral artery disease (PAD) and CLI and represent important independent predictors of failure for current endovascular device strategies. The leading failure modality in PAD and CLI (especially BTK) interventions remains the inability to cross calcific CTOs and to enter into the true Lumen. CLI, a severe form of PAD, is a life-threatening condition associated with significant morbidity and mortality. Within the first year of CLI diagnosis, 25% of patients die and 30% will have a major limb amputation. Successful revascularization significantly reduces the need for amputations.

“There is significant unmet need for devices to safely and easily prepare calcified vessels in patients with occlusive peripheral vascular disease in general, and in patients with BTK disease in particular. We are encouraged by this early experience and are committed to bringing our technology to clinically enhance the way we tackle CTOs and complex calcified cases in this undertreated and challenging patient population.” commented Lori Chmura, President and CEO of Soundbite.

The SoundBite® Crossing System – Peripheral (SBCS-P) is a unique and novel first-in-class wire-based active device (Active Wires) for crossing CTOs. SBCS-P leverages Soundbite’s proprietary method to produce and safely deliver shock waves via guidewire platforms to selectively ‘micro- jackhammer” through calcified lesions. SBCS-P is CE marked and available in both 0.018” and 0.014 ’platforms; the 0.018” platform has also FDA (510k) and Health Canada approvals.

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 (ashkan.haghighat@soundbitemedical.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.

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

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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 of total chronic occlusions, and fostering a new wave of medical device entrepreneurs in Canada” wrote Engineers Canada in its announcement.

“This award is the direct product of the sustained efforts of our team of dedicated employees, and we are honored to contribute to the visibility of Québec’s engineering expertise at home and abroad” said Martin Brouillette, Founder and SoundBite’s Chief Technology Officer.

“It is a great honor to be recognized by its peers at the national level. This award validates the potential offered by SoundBite’s technology to become a game changer in the treatment of CTOs” said Francis Bellido, SoundBite’s CEO.

About SoundBite Medical Solutions
SoundBite is a privately held medical device company developing products in the field of vessel preparation for the management and treatment of calcified and occlusive lesions in coronary and peripheral arterial diseases. SoundBite will leverage its shockwave technology platform to clinically and commercially validate its calcium management medical devices with active wires and microcatheters. Peripheral artery disease (PAD) and coronary artery disease (CAD) affect more than 12 million & 16 million people in the US, respectively.
For additional information visit www.soundbitemedical.com or communicate with Francis Bellido, CEO (francis.bellido@soundbitemedical.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

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

artery

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 sufficient data to support initiating an IDE to evaluate the safety and effectiveness of the SoundBite Crossing System – Coronary through a multi-center study in the US as well as Canada, where the study has already started.

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 elegant combination of hardware and software, it can, in a very controllable manner, deliver high amplitude shock wave pulses through guidewires and other interventional tools, to specifically attack highly calcified and fibrotic tissue in the vascular system, while leaving healthy, elastic arterial walls unharmed.

For information on SoundBite Medical Solutions, please contact Mandy Di Lazzaro, Director, Human Resources & Communications (mandy.dilazzaro@soundbitemedical.com) or Francis Bellido, CEO (francis.bellido@soundbitemedical.com), SoundBite Medical Solutions, 2300 Alfred Nobel, Technoparc St-Laurent, Montreal Québec H4S 2A4
For additional information visit www.soundbitemedical.com

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.

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

artery

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. This also allows us to bring this innovative treatment solution to clinicians and their patients suffering from difficult-to-treat calcific PAD (Peripheral Artery Disease) in the US,” said Francis Bellido, CEO of SoundBite.

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 elegant combination of hardware and software, it can, in a very controllable manner, deliver high amplitude shock wave pulses through guidewires and other interventional tools, to specifically attack highly calcified and fibrotic tissue in the vascular system, while leaving healthy, elastic arterial walls unharmed.

For information on SoundBite Medical Solutions, please contact Mandy Di Lazzaro, Director, Human Resources & Communications (mandy.dilazzaro@soundbitemedical.com) or Francis Bellido, CEO (francis.bellido@soundbitemedical.com), SoundBite Medical Solutions, 2300 Alfred Nobel, Technoparc St-Laurent, Montreal Québec H4S 2A4
For additional information visit www.soundbitemedical.com

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.