VANCOUVER and MINNEAPOLIS - (NewMediaWire) - November 09, 2021 - Neovasc, Inc.("Neovasc" or the "Company") (NASDAQ, TSX: NVCN) today reported financial results for the third quarter ended September 30, 2021.
Third Quarter Highlights
Strong progress...
VANCOUVER and MINNEAPOLIS - (NewMediaWire) - October 28, 2020 - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN) today announced that the United States Food and Drug Administration’s (FDA’s) Circulatory System Devices Advisory Panel voted 14 to 4 “in favor” that the Neovasc Reducer™ is safe when used as intended, and voted 1 to 17 "against" on the issue of a reasonable assurance of effectiveness. The third vote was 13 to 3 "against” (2 abstained) on whether the relative benefits outweighed the relative risks.“We would like to thank the FDA, the panel and members of the public that offered their insights during yesterday’s Circulatory System Devices Advisory Panel meeting,” said Fred Colen, President and Chief Executive Officer of Neovasc. “Clearly, we are disappointed with the meeting’s outcome, and we will provide further updates in the coming weeks.”The Reducer is currently under review by the agency for treatment of patients with refractory angina pectoris despite guideline directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention.About Neovasc Inc.Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. The Company is a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina. Its products include the Neovasc Reducer™, for the treatment of refractory angina, which is not currently commercially available in the United States (2 U.S. patients have been treated under Compassionate Use) 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. Click here for a link to the most recent corporate update.InvestorsMike CavanaughWestwicke/ICRPhone: +1.646.877.9641Mike.Cavanaugh@westwicke.comMediaSean LeousWestwicke/ICRPhone: +1.646.866.4012Sean.Leous@westwicke.comForward-Looking Statement DisclaimerCertain 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 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 could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described in the "Risk Factors" section of the Company's Annual Report on Form 20-F and in the Management's Discussion and Analysis for the three and six months ended June 30, 2019 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company's forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
VANCOUVER and MINNEAPOLIS - (NewMediaWire) - October 22, 2020 - Neovasc, Inc. (NASDAQ, TSX: NVCN) today announced that it will report financial results for the quarter ended September 30, 2020 after the market close on November 5, 2020. Neovasc President and Chief Executive Officer Fred Colen, and Chief Financial Officer Chris Clark will host a conference call to review the company’s results at 4:30 PM Eastern Time.Interested parties may access the conference call by dialing (800) 430-8332 or (856) 344-9206 (International). Participants wishing to join the call via webcast should use the link posted on the investor relations section of the Neovasc website at https://www.neovasc.com/investors/A replay of the webcast will be available approximately 30 minutes after the conclusion of the call using the link on the Neovasc website.About Neovasc Inc.Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. The Company is a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina. Its products include the Neovasc Reducer™, for the treatment of refractory angina, which is not currently commercially available in the United States (2 U.S. patients have been treated under Compassionate Use) 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. Click here for a link to the most recent corporate update.InvestorsMike CavanaughWestwicke/ICRPhone: +1.646.877.9641Mike.Cavanaugh@westwicke.comMediaSean LeousWestwicke/ICRPhone: +1.646.677.1839Sean.Leous@icrinc.comForward-Looking Statement DisclaimerCertain 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, expectations as to the future growth of the Company, the expansion of its product range 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 could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described in the "Risk Factors" section of the Company's Annual Report on Form 20-F and in the Management's Discussion and Analysis for the three and six months ended June 30, 2019 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company's forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
VANCOUVER and MINNEAPOLIS - (NewMediaWire) - October 13, 2020 - Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN) today announced that it will sponsor a symposiumentitled “Unmet Need in Treating Patients With Refractory Angina” at the 2020 TCT Connect Online Conference, taking place October 14-18, 2020.The training session will be available via the TCT Connect e-satellite for registered participants beginning Friday, October 16, at 7 AM EDT. The session will feature presentations by:· Prof. Tommaso Gori, MD, PhD, University Medical Center of Mainz, Germany.· Timothy D. Henry, MD, Lindner Family Distinguished Chair in Clinical Research and Medical Director of The Carl and Edyth Lindner Center for Research at The Christ Hospital, Cincinnati, OH.· Prof. Jonathan Michael Hill, Consultant Interventional Cardiologist at Royal Brompton & Harefield NHS Foundation Trust, London, U.K.· Gregg W. Stone, MD, Senior Faculty, Medicine, Cardiology, Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, and Director, Academic Affairs, Mount Sinai Heart, New York, N.Y.· Prof. Stefan Verheye, MD, PhD, Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium.About ReducerThe 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.11T. 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.About Neovasc Inc.Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. The Company is a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina. Its products include the Neovasc Reducer™, for the treatment of refractory angina, which is not currently commercially available in the United States (2 U.S. patients have been treated under Compassionate Use) 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. Click here for a link to the most recent corporate update.InvestorsMike CavanaughWestwicke/ICRPhone: +1.646.877.9641Mike.Cavanaugh@westwicke.comMediaSean ...
VANCOUVER and MINNEAPOLIS - (NewMediaWire) - September 08, 2020 - Neovasc, Inc. ("Neovasc" or the "Company") (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina, today announced that its management team will be participating in the 22nd Annual H.C. Wainwright Global Investment Conference on September 14-16, 2020. Fred Colen, Neovasc’s President and CEO, will present on September 15 at 3:30 pm EDT. A link to the live webcast of Mr. Colen’s presentation will be available online through the investor relations section of the Neovasc website at https://www.neovasc.com/investors/. Following the event, a replay of the presentation will be archived on the Neovasc website for approximately 90 days.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.InvestorsMike CavanaughWestwicke/ICRPhone: +1.646.877.9641Mike.Cavanaugh@westwicke.comMediaSean LeousWestwicke/ICRPhone: +1.646.677.1839Sean.Leous@icrinc.comForward-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, expectations as to the future growth of the Company, the expansion of its product range 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 could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including those described in the "Risk Factors" section of the Company's Annual Report on Form 20-F and in the Management's Discussion and Analysis for the three and six months ended June 30, 2019 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company's forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Vancouver, BC, Canada - (NewMediaWire) - September 3, 2020 - Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) is pleased to announce the results of the votes on matters considered at its Annual General Meeting of Shareholders held on September 3, 2020 in Vancouver, B.C. (the “Meeting”).At the Meeting, the shareholders of the Company (the “Shareholders”) re-elected board members Steven Rubin, Paul Geyer, Doug Janzen, Norman Radow, Alexei Marko and Fred Colen to serve in office until the next annual meeting or until their successors are duly elected or appointed. Detailed results of the voting in respect of the election of directors are as follows:NomineeVotes For% Votes ForVotes Withheld% Votes WithheldSteven Rubin5,744,65680.531,388,97219.47Paul Geyer6,632,05592.97501,5737.03Doug Janzen6,702,43893.96431,1906.04Norman Radow6,693,98493.84439,6446.16Alexei Marko6,497,33691.08636,2928.92Fred Colen6,613,03892.70520,5907.30At the Meeting, the Shareholders also approved the Company’s share unit plan (78.00% of votes cast in favour), the Company’s previous grants of share units (77.78% of votes cast in favour) and re-appointed Grant Thornton LLP, Chartered Accountants as auditors of the Company.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.InvestorsMike CavanaughWestwicke/ICRPhone: +1.646.877.9641Mike.Cavanaugh@westwicke.comMediaSean LeousWestwicke/ICRPhone: +1.646.677.1839Sean.Leous@icrinc.comForward-Looking Statement DisclaimerCertain 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, expectations as to 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 could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by the forward looking statements, including those described in the "Risk Factors" section of the Company's Annual Report on Form 20-F and in the Management's Discussion and Analysis for the three months ended June 30, 2020 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on the Company's forward-looking statements. The Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
VANCOUVER and MINNEAPOLIS, – August 17, 2020 – Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) announced today that Strul Medical Group LLC (“SMG”) exercised 501,000 of the remaining 1,149,910 common share purchase warrants (the “May...
Vancouver, Canada, August 12, 2020 – Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ: NVCN / TSX: NVCN) announced today that it has closed its previously announced registered direct offering (the “Offering”) priced at-the-market under the Nasdaq rules...
VANCOUVER and MINNEAPOLIS, August 6, 2020 – Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the...
