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Neovasc has received positive guidance from NICE in the UK, supporting the use of the Neovasc Reducer for patients with refractory angina. This is the first therapeutic intervention recommended for stable angina patients who have not responded to other treatments. The recommendation emphasizes the need for informed consent and patient selection by specialized teams. Neovasc's CEO expressed optimism about expanding access to this therapy, which is already CE-marked in the EU, and has the potential to alleviate symptoms for millions affected by refractory angina.
Neovasc reported third-quarter 2021 revenue of $703,000, a 12% increase from the previous year. The company is advancing its strategies for the Neovasc Reducer, including securing reimbursement across multiple countries. Cost-cutting measures resulted in a 32% reduction in total expenses, extending its cash runway into 2024. Despite challenges, including a breach of Nasdaq's $1 minimum bid price, the company is eligible for an additional grace period. Net losses decreased significantly, with a basic loss per share of $0.11, compared to $0.51 in Q3 2020.
Neovasc Inc. (NASDAQ: NVCN, TSX: NVCN) will report its financial results for the quarter ending September 30, 2021, on November 9, 2021, at 4:30 PM EDT. The announcement will be led by President and CEO Fred Colen, along with CFO Chris Clark, during a conference call. Participants can access the call by phone or via a webcast on Neovasc's investor relations page. Neovasc specializes in medical devices for cardiovascular treatment, with products like the Neovasc Reducer™ and Tiara™, currently under clinical investigation.
Neovasc announced the publication of a study on its Neovasc Reducer™ in the Polish Heart Journal, focusing on patients with chronic total occlusions (CTOs) of the right coronary artery. The study shows a significant improvement in angina severity among 22 patients treated with the Reducer, comparable to improvements seen in left-sided ischemia patients. The Reducer is CE-marked in Europe and under investigation in the U.S. for refractory angina, which affects up to 1.8 million Americans annually. Positive results may expand treatment options for patients with right-sided ischemia.
Neovasc Inc. announced the publication of interim results from the REDUCER-I study in the September 2021 issue of EuroIntervention. This multicenter study involved 228 patients with refractory angina, demonstrating a procedural success rate of 99% and significant improvement in angina symptoms. At two years, 82% of patients experienced symptom relief, with mean CCS class improving from 2.8 to 1.8. Despite the positive clinical outcomes, the Reducer is still under investigation in the U.S. and not yet commercially available. The growing incidence of refractory angina highlights the potential market for the Reducer device.
Neovasc announced its participation in the 2021 Benzinga Healthcare Small Cap Conference on September 29-30, 2021. Bill Little, the Chief Operating Officer, will present on September 29 at 4:00 pm EDT. A live webcast link will be available on the Neovasc website, with the presentation archived for 90 days. Neovasc is focused on minimally invasive technologies for cardiovascular conditions, including the Neovasc Reducer™ for refractory angina, and Tiara™ for mitral valve disease, currently in clinical investigation.
Neovasc Inc. (NVCN) announced FDA approval for the Investigational Device Exemption (IDE) for its COSIRA-II clinical trial, set to begin late this year. This randomized, sham-controlled study will evaluate the safety and effectiveness of the Neovasc Reducer™ for patients with refractory angina. The trial aims to enroll approximately 380 patients across up to 50 U.S. sites and some locations outside the U.S., focusing on improving exercise tolerance. Approval marks a significant milestone, following discussions with the FDA, and reflects Neovasc's commitment to addressing refractory angina.
Neovasc, a leader in cardiovascular medical devices, announced its participation in the 23rd Annual H.C. Wainwright Global Investment Conference from September 13-15, 2021. Management will present via a pre-recorded session available starting at 7:00 am EDT on September 13. The presentation can be accessed through the conference website and Neovasc's investor relations page, with an archive available for 90 days. Neovasc specializes in minimally invasive heart technologies, including the Neovasc Reducer and Tiara.
Neovasc Inc. (NASDAQ: NVCN, TSX: NVCN) announced the filing of a supplement to the COSIRA-II Investigational Device Exemption Study with the FDA. This trial focuses on the Neovasc Reducer for patients with refractory angina, aiming to enroll approximately 380 patients across 50 sites in the U.S. The study will assess the device's effectiveness by measuring changes in exercise tolerance over six months. The Reducer, CE-marked in the EU, is designed to alleviate symptoms of refractory angina, affecting an estimated 600,000 to 1.8 million Americans.
Neovasc, Inc. (NVCN) reported a revenue of approximately $633,000 for Q2 2021, marking a 123% increase year-over-year and a 40% sequential rise from Q1. The company is focusing on its Reducer and Tiara TA strategies, suspending Tiara TF development, and reducing its workforce by 40% to extend its cash runway into 2024. Total expenses increased to $9.6 million, with a gross margin of 83%. Neovasc reported operating losses of $9.1 million, which is a slight increase from $8.7 million in the previous year.
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