Announcement • Nov 29
Neovasc Announces Progress on COSIRA-II Clinical Trial Neovasc Inc. announced an update on the COSIRA-II Clinical Trial (“Trial”) status. COSIRA-II is the U.S. Investigational Device Exemption (“IDE”) pivotal clinical trial the Company is executing for the Neovasc Reducer (“Reducer”) towards an approval decision for the device in the United States. The Trial will randomize approximately 380 patients at up to 50 sites in North America. To date, 55 patients have been enrolled at 17 active sites. The Company has undertaken several initiatives to further accelerate enrollment in the Trial, including machine learning technology, expanding the field clinical team, and initiating enrollments in Canada. Neovasc aims to complete randomization in the first half of 2024. To accelerate recruitment of patients into the Trial, Neovasc is leveraging predictive machine learning technology fromKomodo Health, to identify and engage healthcare practitioners (“HCP”) with screening-eligible patients at exactly the right moment in their care journey. Komodo’s clinical-alerting solution, Pulse, is built on the de-identified, longitudinal healthcare journeys of more than 330 million patients for real-time visibility into specific, complex patient populations. Komodo is deploying an algorithm into production that pinpoints HCPs who treat patients with refractory angina based on their use of a specific treatment and prescription history, empowering Neovasc’s clinical team to drive more efficient recruitment and accelerate Trial completion. Pharmaceutical companies have used the technology to accelerate clinical trial enrollment while maintaining Health Insurance Portability and Accountability Act (“HIPAA”) compliance. The Company continues to expand its Clinical Affairs team with the recent hire of a Site Engagement Manager. The new role is designed to accelerate enrollments in the Trial by partnering with key personnel at COSIRA–II Trial sites and driving patient identification with the sites. Reported Earnings • Nov 16
Third quarter 2022 earnings: EPS and revenues miss analyst expectations Third quarter 2022 results: US$3.00 loss per share (further deteriorated from US$2.79 loss in 3Q 2021). Net loss: US$8.23m (loss widened 9.2% from 3Q 2021). Revenue missed analyst estimates by 8.9%. Earnings per share (EPS) also missed analyst estimates by 10%. Revenue is forecast to grow 57% p.a. on average during the next 3 years, compared to a 58% growth forecast for the Medical Equipment industry in Canada. Over the last 3 years on average, earnings per share has increased by 77% per year but the company’s share price has fallen by 55% per year, which means it is significantly lagging earnings. 
