NVCN - NVCN STOCK NEWS

Neovasc Inc. (NVCN) has made significant progress in its strategy to expand global reimbursement for its Neovasc Reducer™. The company aims to enhance market adoption by obtaining adequate reimbursement across various countries. In the U.S., Neovasc supports the MCIT executive order, which could facilitate reimbursement for breakthrough medical devices. The company is also working with the American Medical Association and CMS to establish new procedural codes for the Reducer. Additionally, Neovasc is pursuing reimbursement strategy developments in the U.K., France, and Germany.

Neovasc Inc. (NASDAQ: NVCN, TSX: NVCN) is set to report its financial results for Q1 2021 on May 6, 2021, at 4:30 pm EST. The conference call will feature CEO Fred Colen and CFO Chris Clark, who will discuss the company’s performance during the quarter. Neovasc is focused on the cardiovascular market, known for its development of minimally invasive transcatheter mitral valve replacement technologies and the Neovasc Reducer™, which addresses refractory angina. The Reducer is available in Europe but not yet in the U.S., while Tiara™ is under clinical investigation globally.

Neovasc, Inc. (NVCN) announced the publication of a significant study in EuroIntervention demonstrating that the Neovasc Reducer™ improves exercise capacity and oxygen kinetics in patients with refractory angina. In a multicenter study involving 37 patients, results showed a 11.3% increase in VO2 max and a 34% increase in workload post-treatment. Angina severity improved in 86.5% of patients. The Reducer is CE-marked in the EU but not yet approved for commercial use in the U.S., where it holds FDA Breakthrough Device designation.

Neovasc announced that its Tiara Transapical system will not receive a CE mark before the Medical Device Directive ends on May 26, 2021. The company has collaborated with its Notified Body for over a year, but cannot provide the necessary testing data in time. The transition to the Medical Device Regulation (MDR) will not impact the Tiara Transfemoral program, which is expected to be assessed under MDR. Neovasc CEO Fred Colen expressed disappointment over the delay and emphasized the device's promising safety and efficacy profile as seen in clinical trials.

Neovasc (NVCN) reported fourth-quarter 2020 revenues of $514,000, totaling $1.96 million for the year, reflecting a 6% decline from 2019 due to COVID-19 impacts on elective procedures. Notably, the company completed its first Reducer implants in France and raised $6.1 million from a direct share offering in December. Total expenses increased by 16% to $36.68 million, mainly due to higher legal costs and salaries. Operating losses were $35.17 million, translating to a loss per share of $1.72. Neovasc is advancing CE mark submission for Tiara and plans a first-in-human implant in H2 2021.

Neovasc Inc. (NVCN) will release its fourth quarter and fiscal year 2020 results on March 11, 2021, after market close. CEO Fred Colen and CFO Chris Clark will host a conference call at 4:30 PM EST to discuss the results. The company specializes in cardiovascular medical devices, including the Neovasc Reducer™ for refractory angina and Tiara™ for mitral valve disease treatment, currently under investigation. The Reducer has been available in Europe since 2015 but is not commercially available in the U.S. Interested investors can join the call via a dial-in number or webcast.

Neovasc Inc. (NASDAQ: NVCN, TSX: NVCN) announced participation in the 2021 H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. Bill Little, Chief Operating Officer, will present a recorded session available from 7:00 am EST on March 9. Management will also hold one-on-one investor meetings, which can be requested through H.C. Wainwright. Neovasc specializes in cardiovascular medical devices, focusing on minimally invasive technologies, including the Neovasc Reducer™ for refractory angina and the Tiara™ for mitral valve disease.

Neovasc announced the publication of a multicenter study in Clinical Cardiology highlighting long-term outcomes for 99 patients who underwent coronary sinus reducer implantation. The study revealed significant improvements in angina severity, with a reduction in the mean Canadian Cardiovascular Society (CCS) angina class from 3.1 to 1.66 at one year, and maintained low levels over the following years. The Reducer therapy is CE-marked in Europe but not yet FDA-approved in the U.S., though it holds Breakthrough Device designation. This therapy addresses refractory angina, impacting a significant patient population.

Neovasc Inc. (NVCN) has announced that it has regained compliance with Nasdaq’s minimum market value requirement. Following a notification from Nasdaq in December 2020 regarding non-compliance, Neovasc has since exceeded the required market value of US$35 million for 14 consecutive business days from February 2 to February 22, 2021. The company is now in compliance with all previously reported breaches of Nasdaq Listing Rules. Neovasc focuses on the development of innovative cardiovascular medical devices.