Pending U.S. Food and Drug Administration (“FDA”) Humanitarian Use Device (“HUD”) Classification and Approval as a HUD, Company Expects to Begin Commercializing Reducer in U.S. by Early 2020
A potential HUD Reducer designation for Canadian Cardiovascular Society (“CCS”) Class IV would, by statute, allow the treatment of a limited number of patients per year, which has the potential to represent an estimated Total Annual Addressable Market of approximately US$80 Million
NASDAQ, TSX: NVCN
VANCOUVER, July 16, 2019 /PRNewswire/ – Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, today provided a further update on its Neovasc Reducer™ (the “Reducer”) program for the treatment of refractory angina.
As previously announced, following guidance recently received from the FDA, Neovasc intends to seek the FDA’s designation of the Reducer as a HUD for CCS Class IV refractory angina patients. If it is possible and if the FDA grants HUD designation for the Reducer for CCS Class IV patients, and if a subsequent HDE application is approved by the FDA as well, Neovasc expects to begin commercializing the Reducer in the U.S. by early 2020. The maximum total U.S. annual addressable market with a Reducer HDE under a CCS Class IV would be limited, by statute, to a maximum number of patients per year in the U.S. with the most severe refractory angina, and is therefore limited to an estimated US$80 million of potential revenue per year.
“Should the FDA grant the Class IV HUD designation to the Reducer, we expect to be in a position to offer treatment to those patients with CCS Class IV refractory angina in early 2020,” said Fred Colen, CEO of Neovasc. “We view this as a significant market opportunity for Neovasc. Concurrently, we will explore an alternate investigational device exemption clinical study design, in conjunction with our supportive U.S. cardiologists, with the intent of further expanding the patient population to CCS Class III patients and to seek full approval for the CCS Class IV patients over time.”
There can be no assurance that the HUD or HDE applications that Neovasc plans to file will be approved by the FDA, that the FDA will classify the Reducer for CCS Class IV refractory angina patients as a HUD, or that such applications will be approved on the timelines described above. In the event that the HUD and HDE applications are approved by the FDA, there can be no assurance that Neovasc will be successful in commencing commercialization of the Reducer in the U.S. on the timeline described above or at all, or of the total addressable market size for the Reducer.
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 in the heart’s circulatory system, thereby 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 U.S., the FDA granted Breakthrough Device designation to the Neovasc 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 for 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.1
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 the 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 the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada and Europe. For more information, visit: www.neovasc.com.
Forward-Looking Statement Disclaimer
This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws regarding the potential pathways and timelines to accessing the U.S. market with respect to the Reducer, including the Company’s ongoing discussions with the FDA, the Company’s intention to pursue HUD designation and a HDE for the Reducer with respect to CCC class IV refractory angina patients, FDA’s potential approval of a Reducer Class IV HUD designation, FDA’s potential approval of Neovasc’s HUD and HDE applications, and the Company’s intention to explore an alternate IDE study design with the intent to further expand the patient population and eliminate statutory restrictions over time, the potential addressable market for the Reducer in the U.S., the growing incidence of refractory angina and the rapidly growing cardiovascular marketplace. Words and phrases such as “continue”, “strategy”, “goal”, “would”, “may”, “could”, “should”, “expect” and “will”, and similar words or expressions, are intended to identify these forward-looking statements. 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, the substantial doubt about the Company’s ability to continue as a going concern; risks relating to the senior secured convertible notes (the “Notes”) issued pursuant to the November 2017 private placement (together, the “2017 Financing”), resulting in significant dilution to the Company’s shareholders; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to cashless exercise and adjustment provisions in the Notes issued pursuant to the 2017 Financing, which could make it more difficult and expensive for the Company to raise additional capital in the future and result in further dilution to investors; risks relating to the sale of a significant number of common shares of the Company; risks relating to the conversion of Notes issued pursuant to the 2017 Financing, which may encourage short sales by third parties; risks relating to the possibility that the Company’s common shares may be delisted from the Nasdaq Capital Market or the Toronto Stock Exchange, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did not have effective internal control over financial reporting as at December 31, 2018; risks relating to the Company’s common share price being volatile; risks relating to the influence of significant shareholders of the Company over the Company’s business operations and share price; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to claims by third parties alleging infringement of their intellectual property rights; 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; 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 of the Company’s 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; 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 associated with the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks associated with post-market regulation of the Company’s products; health and safety risks associated with the Company’s products and industry; risks associated with 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; risk 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 breaches of anti-bribery laws by the Company’s employees or agents; risks associated with 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; 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 associated with 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 the Company’s ability to successfully enter into fundamental transactions as defined in the Notes issued pursuant to the 2017 Financing; 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; and risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers. 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 and in Management’s Discussion and Analysis for the three months ended March 31, 2019 (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.
1T. J. Povsic, S. Broderick, K. J. Anstrom et al., “Predictors of long-term clinical endpoints in patients with refractory angina,” Journal of the American Heart Association, vol. 4, no. 2, article e001287, 2015.
SOURCE Neovasc Inc.
