Largest Real-World Registry Supporting Neovasc Reducer™ Safety and Efficacy Outcomes Published in International Journal of Cardiology

Rhea-AI Summary

Neovasc announced the publication of a significant article on the efficacy of its heart device, the Neovasc Reducer™, in treating chronic refractory angina, in the International Journal of Cardiology. The RESOURCE study involved 658 patients across Europe, showing a procedural success rate of 96.7% with 39.7% of patients reporting significant relief in symptoms. The Reducer is CE-marked for this condition in Europe, providing a minimally invasive treatment option. Despite not being approved in the U.S., it holds FDA Breakthrough Device designation, highlighting its potential in addressing a critical health issue affecting up to 1.8 million Americans.

Positive

• The RESOURCE study demonstrated a 96.7% procedural success rate for the Neovasc Reducer.
• 39.7% of patients reported at least a two-class improvement in CCS score, indicating significant symptom relief.
• The Reducer is CE-marked in the EU for treating refractory angina, offering a minimally invasive treatment option.
• FDA granted Breakthrough Device designation to the Reducer, expediting its development and review.

Negative

• The Reducer is not commercially available in the United States, limiting market potential.
• The company faces significant risks around delisting from NASDAQ or TSX, which may affect liquidity.
• There is a history of losses and an accumulated deficit impacting financial stability.

VANCOUVER and MINNEAPOLIS, June 18, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced the publication of an article entitled, “Safety and Efficacy of Coronary Sinus Narrowing in Chronic Refractory Angina: Insights from the RESOURCE Study” in the International Journal of Cardiology.

The article, authored by Francesco Ponticelli, M.D., Maria Cecilia Hospital, Cotignola, Italy, describes long-term outcomes of patients suffering from refractory angina treated with the Neovasc Reducer™ (“Reducer”) system. The RESOURCE study is an observational, retrospective registry that includes 658 patients with refractory angina from 20 centers in Europe, the United Kingdom and Israel. The prespecified endpoints of the trial were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score (a measure of chest pain severity) and the rates of procedural success and complications.

At a median follow-up of 502 days after Reducer implantation, 39.7% of patients improved by ≥2 CCS classes (primary endpoint), and 76% by ≥1 class. The procedure was safe and procedural success was achieved in 96.7% of attempts. No cases of intra- or periprocedural-death, myocardial infarction or cardiac tamponade were observed in the study population. No patient required bailout conversion to open surgery. The authors described the study as the largest international real-world registry of patients with refractory angina who were treated with the coronary sinus Reducer.

“The data presented in the RESOURCE study confirm the excellent safety profile of the Reducer device and support good clinical efficacy,” said Dr. Ponticelli. “It’s encouraging to see the results in this real-world registry are consistent with the randomized data on the Reducer. We can now more confidently tell our patients suffering from refractory angina that there is a safe therapy that may be able to help them feel better.” 

“We are grateful to the patients and the authors of the RESOURCE study,” stated Fred Colen, President & Chief Executive Officer of Neovasc. “The participants in the study represent the types of patients that cardiologists around the world have been struggling to treat. Patients that have tried medicines, by-pass surgery and stents still frequently suffer from debilitating chest pain and have frequently been told there is nothing else for them to try. We are delighted by the real-world evidence that supports our unique and innovative Reducer therapy as a safe and effective option that can now provide relief and an improved quality of life for many of these patients that previously had no further treatment options.”

About Reducer  

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure that is similar to implanting a coronary stent and is completed in approximately 20 minutes.  

While the Reducer is not approved for commercial use in the United States, the FDA granted Breakthrough Device designation to the Reducer in October 2018. This designation is granted by the FDA in order to expedite the development and review of a device that demonstrates compelling potential to provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. In addition, there must be no FDA approved treatments presently available, or the technology must offer significant advantages over existing approved alternatives.  

Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.  

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com.

Investors

Mike Cavanaugh

Westwicke/ICR

Phone: +1.646.877.9641

Mike.Cavanaugh@westwicke.com

Media

Sean Leous

Westwicke/ICR

Phone: +1.646.866.4012

Sean.Leous@westwicke.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words "expect", "anticipate", "estimate", "may", "will", "should", "intend," "believe", and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, Reducer’s safety and ability to help patients suffering from refractory angina feel better and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company's ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a "passive foreign investment company"; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company's officers and directors as a result of their involvement with other issuers; and risks relating to anti-takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the "Risk Factors" section of the Company's Annual Information Form and in the Management's Discussion and Analysis for the three months ended March 31, 2021 (copies of which may be obtained at www.sedar.com or www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law.

FAQ

What are the results of the RESOURCE study published by Neovasc on June 18, 2021?

The RESOURCE study reported a 96.7% procedural success rate for the Neovasc Reducer™, with 39.7% of patients showing significant improvement in angina symptoms.

What is the Neovasc Reducer and its current market status?

The Neovasc Reducer is CE-marked for the treatment of refractory angina in Europe but is not yet commercially available in the U.S.

How many patients were involved in the RESOURCE study by Neovasc?

The RESOURCE study included 658 patients suffering from refractory angina across Europe, the UK, and Israel.

What designation did the FDA grant to the Neovasc Reducer?

The FDA granted Breakthrough Device designation to the Neovasc Reducer to expedite its development due to its potential in treating refractory angina.

How significant is the issue of refractory angina in the U.S.?

Refractory angina affects an estimated 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases annually.