Neovasc Inc Stock Price, News & Analysis

Neovasc Inc. (NVCN) reported Q4 2022 revenue of $1.45 million, marking a 91% increase year-over-year. Full-year revenue reached $3.8 million, up 49% from 2021. The company confirmed a gross margin of 80% for 2022, slightly improved from 78% in 2021. However, total expenses rose to $37.18 million, leading to a comprehensive loss of $41.42 million for the year, with a loss per share of $15.07. The company is in the process of being acquired by Shockwave Medical, expected to close in Q2 2023, following a favorable court ruling related to class action litigation.

Neovasc Inc. (NASDAQ: NVCN) has announced that shareholders approved the acquisition of the Company by Shockwave Medical, Inc. during a special meeting. The acquisition received overwhelming support with 97.36% of votes cast in favor. The arrangement awaits final approval from the Supreme Court of British Columbia, with a court hearing scheduled for March 9, 2023. Upon completion, Neovasc's shares will be delisted from the TSX and Nasdaq, and the Company will cease to be a reporting issuer. The management information circular dated February 3, 2023, outlines further details about the acquisition.

Neovasc has received NUB Status 1 designation for its Reducer device from the German Institute for the Hospital Remuneration System. This status enables 329 German hospitals to negotiate full reimbursement for using the Reducer in treating refractory angina, a condition affecting millions globally. The NUB designation, valid for one year, highlights the increasing recognition of the Reducer in Germany, with more hospitals applying than last year. Currently, the Reducer is CE-marked in Europe but is still under clinical investigation in the U.S. The company aims to expand patient access to this innovative therapy.

Neovasc (NVCN) announced a binding agreement with Shockwave Medical for an acquisition valued at approximately US$100 million. Shareholders will receive US$27.25 per share in cash, representing a premium of 27% over the closing price on January 13, 2023. In addition, there are potential deferred payments of up to US$47 million based on future FDA regulatory milestones related to the Neovasc Reducer device. The transaction requires approval from at least 66 2/3% of shareholders and court approval, expected to complete in the first half of 2023. The deal includes provisions for potential rival offers and a termination fee of US$3.824 million for Neovasc.

Neovasc Inc. (NVCN) has provided an update on its COSIRA-II Clinical Trial for the Neovasc Reducer, targeting refractory angina. The trial aims to enroll 380 patients across 50 North American sites, with 55 participants currently enrolled at 17 sites. Neovasc is implementing machine learning technology to enhance patient recruitment and has expanded its clinical team. Additionally, the trial has received Investigational Testing Authorization (ITA) from Health Canada, allowing for the inclusion of Canadian sites, which may expedite enrollment. The Reducer is already CE-marked in Europe.

Neovasc Inc. has announced the publication of a case report in the European Heart Journal detailing the successful implantation of the Neovasc Reducer for a patient suffering from refractory angina due to coronary microvascular dysfunction. The procedure led to significant improvements in blood flow and patient symptoms, highlighting the Reducer's potential in treating this condition. Although CE-marked in Europe, the Reducer is still under investigation in the U.S. with Breakthrough Device designation from the FDA. Neovasc continues to focus on the growing cardiovascular market.

Neovasc Inc. (NVCN) reported third-quarter 2022 revenues of $923,000, marking a 31% year-over-year increase. The company saw strong acceptance of its Reducer product in the UK and France, with France being the largest market. Enrollment in the COSIRA II pivotal trial is on track for completion in the first half of 2024. The company received US outpatient reimbursement effective January 1, 2023. Despite a COVID surge and currency fluctuations, Neovasc maintained a gross margin of 76% but reported a net loss of $6.7 million. Cash reserves stood at $31.3 million.

Neovasc announced that the Centers for Medicare and Medicaid Services has assigned a new outpatient reimbursement code for the Neovasc Reducer implant procedure, effective January 1, 2023. This code will allow U.S. hospitals to receive reimbursement for the Reducer, enhancing its adoption during the COSIRA-II clinical trial and potential commercialization. Neovasc's President highlighted this as a significant step towards securing payment for both inpatient and outpatient procedures, indicating progress in their reimbursement strategy since 2019.

Neovasc Inc. (NVCN) will report its financial results for the quarter ending September 30, 2022, on November 10, 2022. CEO Fred Colen and CFO Chris Clark will host a conference call at 4:30 PM ET on the same day to review the results. Interested parties can join via a provided phone line or through the investor relations section of the Neovasc website. Neovasc focuses on the cardiovascular market, developing devices like the Neovasc Reducer™ and Tiara™, the latter of which is currently under clinical investigation. Further information is available on their website.