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Neovasc Inc. (NASDAQ, TSX: NVCN) will announce its financial results for the quarter and full year ended December 31, 2021, on March 10, 2022. The conference call will feature CEO Fred Colen and CFO Chris Clark at 4:30 PM EDT. Interested participants can join by phone or webcast. Neovasc specializes in medical devices for cardiovascular treatment, including the Reducer for refractory angina and Tiara™ for mitral valve disease, both currently under clinical investigation in multiple regions.
Neovasc announced that the German Institute for the Hospital Remuneration System has awarded the Neovasc Reducer™ NUB Status 1 designation for 2022, signifying the highest priority for reimbursement negotiations. The Reducer is a medical device for treating refractory angina, with 500 patients now treated in Germany. The NUB process allows hospitals to negotiate reimbursement before full approval, enhancing accessibility to this therapy. CEO Fred Colen emphasized the importance of reimbursement coverage for patient access, underscoring recent successes in Germany and other countries.
Neovasc, with stock symbol NVCN, recently announced positive findings from cost-effectiveness studies for its Neovasc Reducer™ therapy, aimed at treating refractory angina. Conducted by ALTEMS in Italy, the analyses showed that the Reducer therapy not only increases patient quality of life but is also cost-effective, potentially saving the National Health Service substantial costs starting in year four. The therapy addresses a growing patient demographic with limited treatment options, which may further solidify Neovasc's position in the cardiovascular market.
Neovasc, Inc. (NVCN) announced the publication of a meta-analysis assessing the effectiveness of the CS Reducer for treating refractory angina in the Canadian Journal of Cardiology. The study, involving 846 patients, showed a 76% improvement in angina severity, with a 98% procedural success rate. This underscores the Reducer's safety and efficacy, supporting its market expansion. While CE-marked in the EU, the device is not yet available in the U.S., though it has received FDA Breakthrough Device designation.
Neovasc Inc. (NASDAQ, TSX: NVCN) announced the publication of a case series revealing successful results from the compassionate use of its Neovasc Reducer™ device in the treatment of refractory angina. The case series, involving two patients treated at Henry Ford Hospital, showed significant improvement in symptoms after using the Reducer. The company is also excited to start the COSIRA-II Trial, which aims to evaluate the safety and effectiveness of the Reducer in approximately 380 patients in the U.S. and Canada, indicating a strong potential for addressing this debilitating condition.
Neovasc announced its participation in the 2022 H.C. Wainwright BIOCONNECT Virtual Conference, taking place from January 10-13, 2022. CEO Fred Colen will present a recorded session available from January 10 at 7:00 am EST on the conference website, archived for 90 days. Neovasc specializes in medical devices for cardiovascular treatments, focusing on minimally invasive technologies. Notable products include the Neovasc Reducer for refractory angina and the Tiara for mitral valve disease, currently in clinical trials across multiple countries.
Neovasc Inc. has enrolled the first patient in the COSIRA-II clinical trial, designed to study the Neovasc Reducer™ for patients with refractory angina. This pivotal trial aims to complement existing data and support a pre-market approval application to the FDA. Approximately 380 patients will be enrolled across 50 sites in the U.S. and Canada. The trial's primary endpoint is exercise tolerance improvement over six months. The Reducer is CE-marked in Europe, and the company has received FDA Breakthrough Device designation for the U.S. market.
Neovasc Inc. (NASDAQ, TSX: NVCN) will participate in the Sidoti December Virtual Microcap Conference on December 8-9, 2021. CEO Fred Colen is set to present on December 8 at 3:15 PM EST. The live webcast will be accessible through the Investor Relations section of Neovasc's website, with a recording available for 90 days post-event. Neovasc is recognized for its innovative cardiovascular devices, including the Neovasc Reducer™ and Tiara™, aimed at treating refractory angina and mitral valve disease, respectively.
Neovasc Inc. has received the Prise en Charge Transitoire (PECT) reimbursement designation in France for its Neovasc Reducer™ therapy, which is aimed at patients with refractory angina. The Reducer is the first therapy approved under this new reimbursement process and offers potential relief for patients with limited treatment options. This authorization, valid for one year, may be renewed. The decision follows recent reimbursement expansions in the UK and a new CPT code in the US, enhancing Neovasc's market presence.
Neovasc Inc. (NVCN) has received a Nasdaq notice granting an additional 180 days to comply with the $1.00 bid price requirement, extending the deadline to May 23, 2022. This extension allows the company to regain compliance by having its common shares close at or above $1.00 for at least 10 consecutive business days. Currently, Neovasc remains listed on the Nasdaq Capital Market. The company specializes in medical devices for cardiovascular treatment, particularly its Reducer™ and Tiara™ products.
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