Neovasc Inc. announced positive clinical data at the Transcatheter Cardiovascular Therapeutics Conference (TCT) held September 16, 2022 to September 19, 2022 in Boston. Prof. Shmuel Banai, MD, Neovasc Medical Director and Head of Interventional Cardiology at the Tel Aviv Medical Center, Israel, presented new interim clinical data on the use of the Neovasc Reducer™ in patients who have angina with non-obstructive coronary artery disease, so-called ANOCA patients, most often caused by underlying microvascular disease. The condition, which is more prevalent in women, is a vexing challenge for clinicians and there are no interventional treatment options available that have proven effective at treating the debilitating symptoms associated with it.

ANOCA patients with microvascular disease have refractory angina while their coronary arteries are not amenable to stenting procedures or bypass surgery. Prof. Banai presented interim data from the first 11 patients in a clinical trial in Israel aimed at evaluating the impact of the Reducer in patients with microvascular disease. The study aims to enroll 30 patients in total.

67% of patients enrolled in the study thus far are female. Importantly, in addition to evaluating the impact of the Reducer on symptoms of angina, the study is using objective measures of blood flow in the heart before, and 4 months after, Reducer implantation.  The interim results suggest improvements in objective measures of blood flow in the microvascular system of the heart (the small vessels that are not amenable to stenting or bypass surgery). After invasive physiological assessment the following observations were made: Coronary microvascular flow parameters (including the Index of Microvascular Resistance and Coronary Flow Reserve) improved; Symptoms of angina improved; Functional capacity (6 Minute Walk Test) improved; Quality of Life (all 5 domains of the Seattle Angina Questionnaire) improved.

In addition to the study in Tel Aviv, there are multiple other clinical trials evaluating the Reducer in ANOCA patients including an FDA approved IDE study at the Mayo Clinic, Rochester, Minnesota and an additional trial at Imperial College, London. Neovasc provides update on mitral valve program: After careful analysis and given the emerging opportunities for the Reducer in the ANOCA patient population, the Company has decided to put further development and the European CE-Marking regulatory approval process for the Tiara-TA on hold and focus the organization on Reducer therapy and the ongoing COSIRA-II clinical trial. Strategically, the Company believes this is the best use of its financial and workforce resources.

The increased complexity, cost, and ever-increasing regulatory hurdles developed over the last several years with respect to standards and requirements, and in the new European MDR regulations, were meaningful factors in the company's analysis.  The Company will continue work on its mitral and tricuspid valve intellectual property portfolio and remains committed to Tiara patient surveillance and clinical trial follow-up.