Category Archives: News

MONTREAL – November 29, 2022 – Soundbite Medical Solutions Inc. (SBMS), a medical device company leveraging its proprietary shock wave technology for the interventional treatment of calcific occlusive peripheral and coronary arterial diseases, today announced that the United States Patent and Trademark Office has issued two additional US patents.

Patent No. 11,419,619, entitled “Method and system for treating lesions” is directed to a medical procedure exploiting the use of externally-generated shock waves propagated through mechanical waveguides to treat lesions present within blood vessels. The patent is expected to expire in October 2037.

Patent No. 11,426,186, entitled “Catheter device for delivering mechanical waves” is directed to a catheter device, which mounts over a guidewire, comprising mechanical waveguides for the delivery of shock waves. The patent is expected to expire in November 2038.

Soundbite has been issued 8 US patents to date and continues to enhance its patent portfolio with additional patent applications that will broaden and strengthen its position to leverage shock wave technology in key markets throughout the world.

“The deployment of shock wave technology to treat highly calcific lesions in the cardiovascular system has been proven to be the most advantageous strategy for managing the most complex patients. Expanding our patent portfolio with a patent that protects our unique and differentiated treatment strategy provides a strong foundation from which development can continue and patient care is enhanced. 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, 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 crack calcium 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 ([email protected]), 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.

MONTREAL – November 15, 2022 – Soundbite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific occlusive peripheral and coronary arterial diseases, today announced that it has entered into an exclusive license agreement with VFLO Medical (VFLO).

Pursuant to the agreement, Soundbite has granted to VFLO an exclusive license for certain proprietary products including its SoundBite Crossing System and the Active Microcatheter System. Under the Agreement, VFLO is entitled to manufacture, develop, and commercialize the products in the Greater China region, including Mainland China, Hong Kong, Macau, and Taiwan. Soundbite is in return entitled to receive an upfront fee, subsequent milestone payments, plus royalties from sales of such products. The terms also allow cross-licensing on future improvements of the products, aligning both companies focus on innovation.

“The growing prevalence of atherosclerotic vascular disease burdened by calcium has become a serious public health problem in China. We are excited to partner with the Soundbite team and look forward to bringing the unique technology and portfolio of treatment solutions to patients in Greater China that suffer from calcified arterial disease.” Commented Dong Wu, President and CEO of VFLO.

“We are thrilled to work with VFLO to bring our revolutionary shock wave technology to patients in China, opening a key market for our company with experienced partners in VFLO. Bringing non-dilutive capital to our shareholders provides us with the opportunity to build meaningful value while serving patients in the growing Chinese market.” Said Lori Chmura, President and CEO of Soundbite.

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 ([email protected])

About VFLO Medical

VFLO is a medical device company based in China that was established in 2021 by a top tier cross-border healthcare fund and a team of prominent and experienced industry professionals to create a leading medical device platform with a focus on making innovative therapies available to Chinese patients.

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.

MONTREAL – November 30, 2021 – Soundbite Medical Solutions Inc. (SBMS), a medical device company dedicated to developing solutions for the interventional treatment of calcific occlusive peripheral and coronary arterial diseases, today announced that the United States Patent and Trademark Office has issued US patent No. 11,179,169, entitled “Device for delivering mechanical waves through a balloon catheter”.

The patent is directed to a device for delivering high amplitude broadband mechanical pulses (i.e., shock waves) to treat a lesion present in a blood vessel. The device includes a catheter body, an inflatable balloon and at least one mechanical waveguide connected to a source of high amplitude broadband mechanical pulses for propagating the pulses to the lesion. The patent protects novel Soundbite Active Balloon devices, intended for plaque modification of calcified arteries.

This is the fifth US patent to be issued around the Soundbite technology, further solidifying, and broadening the scope of protection for the Company’s technology platform. The patent allows Soundbite to compete in the plaque modification space with a broader array of active devices addressing a larger market and clinical challenge.

Calcification is a dominant hallmark of advanced atherosclerotic disease and is often underestimated and under-treated. Problematic calcium in the form of stenosis and chronic total occlusions (CTOs) are encountered frequently in patients with both coronary and peripheral artery disease. These occlusions are associated with a higher risk of adverse events, decreased quality of life, worse procedural success and treatment outcomes, and increased healthcare costs. Moderate to severe calcium is present in 50% of peripheral artery disease patients with severe claudication, and the numbers are even higher (>65%) in CLI patients. It is estimated that 30-40% of patients undergoing PCI have calcification as determined by coronary angiography.

“Building our patent portfolio to address complex calcium is a testament to our highly talented engineering team. The pursuit of excellence in serving our patients with clinical solutions begins with medical devices that are unique, differentiated, and of the highest quality. Protecting that work while innovating to meet the growing challenges inherent in calcific occlusive disease will establish Soundbite as a leader in its field,” said Lori Chmura, President & CEO of Soundbite.

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 ([email protected]), 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.

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 ([email protected]), 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.

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

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.

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 ([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

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.

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 ([email protected]), 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.

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 ([email protected]), 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]

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 protected]), 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]

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 ([email protected]), 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.