Neovasc Inc. (NASDAQ:NVCN) Q3 2019 Earnings Conference Call - Final Transcript
Nov 07, 2019 • 04:30 pm ET
start our discussion about the Company, I would like to take a moment to welcome our new Chief Operating Officer, Bill Little, formerly the Global Head of Customer and New Market Insights at Abbott St. Jude Medical, to Neovasc. We are very excited to have Bill join the team and it is a testament to the products, personnel and the progress we have made so far that we are able to attract Bill. Bill is extremely excited from his side as well. He is a true believer in the great potential of the Reducer as well as of the Tiara Valve. He will be a great addition to our already strong leadership team, and we look forward to him deploying his considerable expertise in both interventional cardiology and structural heart to bringing our value creation strategies to fruition.
The third quarter of 2019 was another one of significant progress for the Company as we build a clinical data around Tiara and expand our commercial presence for Reducer. On Reducer, we continued to add to our sales team and reached an important milestone with close to 200 patients being implanted in Germany with Reducer just after the end of the quarter.
Additionally, we have taken concrete steps on the path to approval in the US market. To that end, we decided to submit a full PMA application to the FDA before the year is out. We believe that the totality of clinical data available now from the COSIRA study, new and additional data from the REDUCER-I European post-market study, with interim analysis of over 200 from 400 patients enrolled, with up to two-year follow-up as well as multiple independent published studies should provide reasonable assurance of safety and effectiveness to support a PMA.
We believe that taking this more rigorous path demonstrates the confidence we have in the size of the market opportunity and in the
safety and efficacy of Reducer. However, any pathway to US market approval by the FDA carries considerable risk, and there can be no assurance that the PMA will be approved by the FDA in a timely manner or at all.
We continue to focus on the commercialization of this product in the European market and to obtain approval in the US market. As of November 5, 2019, the REDUCER-I post-market observational study has enrolled 224 of 400 patients across Europe at 23 active centers. Additional new clinical data from this study, the original randomized sham-controlled COSIRA study as well as published data from several physician initiated studies continues to demonstrate the very positive safety profile as well as the effectiveness for the treatment of a patient's refractory angina, therefore improving the patient's quality of life following Reducer implantation.
We believe that these clinical trial results, along with an expanded sales force in Europe, will continue to raise awareness of Reducer with healthcare providers. It is important to note here that there are currently no devices on the market that compete with Reducer, a key advantage