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The FDA Panel to Decide on Reducer Commercialization in the US

FDA Meeting is Scheduled for October

Neovasc Removes Financing Overhang

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Healthcare

Medical Devices & Instruments

Neovasc Inc.

Investment Appraisal
Neovasc&#8217;s Reducer is commercially available in Europe. Reducer is a medical device used for the treatment of refractory angina, a debilitating disease characterized by chronic chest pain. In 2019, the Reducer was added to the European Society of Cardiology (ESC) Practice Guidelines as the recommended treatment for patients suffering from angina, refractory to medical and interventional therapies. The Reducer device is not yet approved in the US. The company submitted a premarket approval application (PMA) for the Reducer device in December 2019. In&nbsp;October 2018, the Reducer was granted Breakthrough Device Designation for the treatment of refractory angina by the U.S. Food and Drug Administration&nbsp;(FDA). The company submitted a PMA for the Reducer device in December 2019 seeking approval for Reducer in the U.S. for the treatment of patients suffering from refractory angina pectoris despite guideline-directed medical therapy, who are unsuitable for revascularization by coronary artery bypass grafting (CABG) or by percutaneous coronary intervention (PCI). The FDA&#8217;s Circulatory System Devices Panel of the Medical Devices Advisory Committee will review the PMA for the Neovasc Reduce device on October 27, 2020.
Refractory angina is a debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite standard of care treatment with revascularization or cardiac drug therapies. In clinical trials (REDUCER-1 and COSIRA), treatment with the Reducer resulted in a statistically significant and clinically relevant benefit to patients suffering from refractory angina. The COSIRA trial Reducer met its primary efficacy end point (Exhibit 1) and demonstrated that 35% of treated patients showed a reduction of two or more CCS angina classes compared to only 15% of patients in the control group. The &#8220;Canadian Cardiovascular Society&#8221; (CCS) angina class I/II corresponds to mild disease, whereas Class III/IV represents a more serious condition. In patients treated with the Reducer, the mean &#8220;Canadian Cardiovascular Society (CCS) angina class&#8221; was reduced from 3.2 at baseline (before treatment) to 2.1 at six months post-treatment compared to a reduction from 3.1 to 2.6 for the control group (data was statistically significant with P value of 0.001; a P value of less than 0.05 is deemed significant). Treatment with the Reducer was found to not only alleviate clinical symptoms (improving CCS angina class) but also reduce ischemic burden in treated patients, improves left ventricular functions including contractility and ejection fraction, ameliorates oxygen kinetics of heart muscle, improves microvasculature functions, which are all very important attributes of an effective treatment for patients suffering from refractory angina.
 
Exhibit 1. Results from COSIRA clinical trial: Significant reduction in the Canadian Cardiovascular Society (CCS) angina class patients treated with Reducer device
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/nvcn.10.21.20.png" />
Source: Company SEC filings
We believe the decision from the FDA&#8217;s panel is likely to be positive. In our view, Reducer represents a strong favorable case based on i) the clinical benefit demonstrated in patients in the clinical trials, ii) the post market studies demonstrating similar results to the clinical studies, ii) the approval obtained in the EU, and addition to the ESC guidelines, and iv) the strong unmet need in the refractory angina landscape. The potential approval is anticipated in H1 2021 following the panel. In our view, it is a good entry point for the investors as the approval decision would act as a major value generating catalyst for the company. We guide investors to also keep an eye on the Tiara program for the treatment of mitral valve regurgitation, we expect additional upside in the next year via material developments. With the company now progressing towards US commercialization for Reducer, we reiterate our Buy rating and $15 price target.

Neovasc Inc. (NVCN:CA)

The FDA Panel to Decide on Reducer Commercialization in the US

Fundamental Analysis:

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Complied with Nasdaq Minimum Bid Price Requirement (NVCN:CA)

The FDA Panel to Decide on Reducer Commercialization in the US (NVCN:CA)

FDA Meeting is Scheduled for October (NVCN:CA)

Neovasc Removes Financing Overhang (NVCN:CA)

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