Neovasc Seeks to Accelerate Enrollment in COSIRA-II Clinical Trial

November 28, 2022—Neovasc Inc. announced an update on the status of the COSIRA-II clinical trial, which is the company’s investigational device exemption (IDE) pivotal clinical trial for the Neovasc Reducer toward seeking regulatory approval for the device in the United States.

The transvenous Reducer device provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle.

The COSIRA-II IDE trial will randomize approximately 380 patients at up to 50 sites in North America. To date, 55 patients have been enrolled at 17 sites. Neovasc aims to complete randomization in the first half of 2024.

According to Neovasc, the company has undertaken several initiatives to further accelerate enrollment in the trial, including initiating enrollments in Canada, incorporating machine learning technology, and expanding the field clinical team.

COSIRA-II has received Investigational Testing Authorization approval from Health Canada. A limited number of investigational sites in Canada will join in the COSIRA-II trial. Three initial sites have been approved by Health Canada. An additional five sites will be added with up to 75 Canadian patients approved.

The company expects the Canadian approval to accelerate enrollment and randomizations. Although a majority of patients will be from the United States, the Canadian site additions will allow for Canadian patients to participate in the study.

To accelerate recruitment of patients into the trial, Neovasc is leveraging predictive machine learning technology from Komodo Health, to identify and engage health care practitioners with screening-eligible patients at exactly the right moment in their care journey.

The company stated that Komodo’s Pulse clinical-alerting solution is built on the deidentified, longitudinal health care journey of more than 330 million patients for real-time visibility into specific, complex patient populations.

Komodo is deploying an algorithm into production that pinpoints health care practitioners who treat patients with refractory angina based on their use of a specific treatment and prescription history, allowing Neovasc’s clinical team to drive more efficient recruitment and accelerate trial completion.

The Clinical Affairs team was expanded with the recent hire of a Site Engagement Manager to accelerate enrollments in the trial by partnering with key personnel at COSIRA–II trial sites and driving patient identification with the sites.

The company recently announced that the Reducer implant procedure now has adequate coding, coverage, and payment in the United States from the Centers for Medicare & Medicaid Services, for both the randomized arms of the trial and the recently approved single arm. The single arm will enroll specific subsets of patients including those with angina and nonobstructive coronary artery disease.