VANCOUVER and MINNEAPOLIS - (NewMediaWire) - July 26, 2022 - Neovasc, Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN) today announced the United States Food and Drug Administration (“FDA”) has approved a protocol supplement to the COSIRA-II Investigational Device Exemption (“IDE”) Trial. The approval expands the number of patients eligible for treatment in the trial and adds two previously planned imaging sub-studies designed to provide insights into the safety and mechanism of action of the Neovasc Reducer™ (“Reducer”). The timing of the approval is ahead of the Company’s internal target and will allow for additional patients to be treated.
The newly approved supplement adds a single, non-randomized arm to the existing protocol that allows enrollment of patients who are believed to benefit from Reducer implantation to reduce their angina symptoms, but who do not otherwise qualify for the randomized arm. These patients are well defined within the protocol and include patients with non-obstructive coronary artery disease who were previously ineligible for treatment. In addition, the expansion allows patients with predominantly right-sided ischemia, and those unable to perform a treadmill test due to amputation, to be included. All patients in the newly approved arm will receive a Reducer device per protocol. The two imaging sub-studies, utilizing Computed Tomography (CT) and Positron Emission Tomography (PET), aim to provide further support for the Reducer’s safety profile and mechanism of action.
There are over two million angiograms performed per year in the United States, most of which are performed on patients with angina. Nearly 40% of patients receiving angiograms do not have obstructive coronary artery disease. While approximately 35% of patients with obstructive coronary disease are women, the percentage of patients with non-obstructive disease that are women approaches 55%.1 The newly added arm in the COSIRA-II study provides an opportunity to study the Reducer in the non-obstructive population.
“Today’s news is a big win for patients suffering from refractory angina,” National Co-principal Investigator Tim Henry, M.D., Christ Hospital, Cincinnati, commented. “I’m pleased that these specific patients previously ineligible for the Trial will now be able to be treated with the Reducer. The PET and CT sub-studies will give us important insights into the mechanism of action and safety of the Reducer, and the addition of patients with non-obstructive coronary disease will enable us to treat a much broader patient population.”
COSIRA-II is a randomized, double-blind, placebo-controlled trial investigating the safety and effectiveness of the Reducer for patients suffering from refractory angina. The primary endpoint of the trial is change in exercise tolerance testing time via a modified Bruce protocol between baseline and six-month follow-up. The study is planned to randomize 380 patients at up to 50 sites in the United States and Canada and the primary study analysis will still be performed on the randomized population. The newly added arm allows for up to 270 additional patients. There is no change to the sample size in the original randomized arm and Neovasc still expects to complete enrollment on schedule by the end of 2023.
“FDA approval of this IDE Supplement is another important milestone for Neovasc and for patients suffering from angina,” commented Lisa Becker, Neovasc Vice President of Regulatory Affairs. “We are particularly encouraged to investigate the Reducer in a population that disproportionately affects women. We appreciate the collaboration and rigor of FDA in the advancement of this important addition to the COSIRA-II trial.”
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. Reducer is investigational in the United States in the COSIRA-II clinical trial. Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, affects millions of patients worldwide, who typically lead severely restricted lives because of their disabling symptoms. The Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms.
About Neovasc Inc.
Neovasc is a specialty medical device company that develops 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.
1 Patel et al, N Engl J Med 2010; 362:886-895
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, the aim of the COSIRA-II sub-studies to provide further support for the Reducer’s safety profile and mechanism of action, the opportunity the COSIRA-II sub-studies provide to study the Reducer in women with non-obstructive disease, the anticipated procedures and timelines of the COSIRA-II study and the growing cardiovascular marketplace. Forward-looking statements are based on estimates and assumptions made by the Company in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that the Company believes are appropriate in the circumstances. 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, risks around the Company's ability to continue as a going concern; risks around the Company's history of losses and significant accumulated deficit; risks related to the 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 may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; 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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; 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risks relating to conflicts of interests among the Company's officers and directors as a result of their involvement with other issuers; risks relating to future issuances of equity securities by the Company, or sales of common shares or conversions of convertible notes, and exercise of warrants, options and restricted stock units by our existing security holders, causing the price of the Company's securities to fall; 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 Report on Form 20-F for the year ended December 31, 2021 and the Company’s Management Discussion and Analysis for the three months ended March 31, 2022 (a copy of which may be obtained at 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 (copies of which may be obtained at www.sedar.com or www.sec.gov), whether because of new information, future events or otherwise, except as required by law.