NASDAQ, TSX: NVCN
VANCOUVER, June 15, 2017 /PRNewswire/ - Neovasc Inc. ("Neovasc" or the "Company")(NASDAQ, TSX: NVCN) today announced its Tiara™ technology, developed to treat severe Mitral Regurgitation (MR), is being featured in a video recorded procedure to be presented at the 10th Annual Transcatheter Valve Therapies (TVT) Conference. TVT is
The video recording is being presented by Dr. Shmuel Banai, Director of Interventional Cardiology in the Cardiology Department at the Tel Aviv Medical Center and Neovasc's Medical Director.
The case presented was completed in Lugano, Switzerland, where a 35mm Tiara™ transcatheter mitral valve was successfully implanted in a 79-year-old male with a complex cardiovascular history, which included ischemic cardiomyopathy, poor left ventricular function, calcified mitral ring, with severe mitral valve regurgitation, chronic atrial fibrillation, previous mechanical aortic surgical valve placement, CABG, aortic aneurysm, and a biventricular pacemaker and defibrillator implantation. The Tiara™ implantation was successfully completed in 30 minutes. Implantation of the Tiara™ valve resulted in the complete resolution of the patient's MR. At 7-week follow up the patient is at home and is doing well. Of note, prior to the Tiara™ procedure, several alternative treatments were considered, including MitraClip, redo surgery and other implantable devices currently under investigation, however due to the anatomical challenges and poor cardiac function of this patient and the presence of a mechanical aortic valve, they were not considered to be viable options.
"This case highlights two critical aspects of the Tiara. One, it clearly demonstrates the Tiara's medical role in very damaged and sick heart that simply are not candidates for conventional surgery, a patient pool that is unfortunately already large and growing," said Alexei Marko, CEO of Neovasc. "Two, the audience witnessed the elegant simplicity of this implantation procedure. Combined, these two themes underscore the Tiara's potential for the medical community and patients suffering from mitral regurgitation."
The Tiara™ has now been used to treat 30 patients under early feasibility, compassionate use and clinical study protocols across North America and Europe. Results using the device continue to be encouraging with good technical success, and positive patient outcomes. One of the first patients treated with the Tiara™ is now over three years post implant. The Company has begun enrolling patients into its European CE Mark trial, with an initial case performed in Italy and additional cases anticipated in Germany and Italy over the coming months. Implantation is completed through a short trans-apical procedure and typically results in complete resolution of the patient's MR without significant residual leaks or obstruction of the ventricular outflow tract.
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 Neovasc Reducer™, for the treatment of refractory angina which is not currently available in the United States and has been available in Europe since 2015 and the Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under investigation in the United States, Canada and Europe. The Company also sells a line of advanced biological tissue products that are used as key components in third-party medical products including transcatheter heart valves. For more information, visit: www.neovasc.com.
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 Company's plans and expectations concerning its business, and other matters, including the Company's expectations on the number of patients that will not be candidates for conventional surgery, and the Company's intentions and expectations with regard to patient enrollment and additional cases to be performed in the TIARA II CE Mark study. Words and phrases such as "growing", "begun" and "anticipated", 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, risks relating to the Company's litigation with CardiAQ, including the Company's ability to successfully appeal the validity of the awards as well as the ruling on inventorship, which create material uncertainty and which cast substantial doubt on the Company's ability to continue as a going concern; the substantial doubt about the Company's ability to continue as a going concern; risks relating to the Company's need for significant additional future capital and the Company's ability to raise additional funding; risks relating to claims by third parties alleging infringement of their intellectual property rights; 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 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 the Company's 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 the Company's 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 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; the Company's dependence upon key personnel to achieve the Company's 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; the Company's ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; 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; 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 the influence of significant shareholders of the Company over the Company's business operations and share price. 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 Company's Management's Discussion and Analysis of Financial Condition and Results of Operations (copies of which filings may be obtained at www.sedar.com or www.sec.gov, each of which are included in the Company's Annual Report on Form 40-F). 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, except as required by law.
SOURCE Neovasc Inc.
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