Neovasc provides investor update
Neovasc seeks to provide an update for investors, including a recap of recent corporate activity and a look ahead into 2020 in advance of the J.P. Morgan Investor Conference this week. "We closed 2019 by doing what we said we would do, when we said we would do it," said Fred Colen, President and CEO of Neovasc. "We filed the PMA application for the Neovasc Reducer with the FDA by the end of 2019 as intended. We opened 2020 by raising $10M in an at-the-market financing under Nasdaq rules, increasing our cash balance to approximately $14M, sufficient to provide operating cash into Q3 2020. We are excited for the opportunities in all four of our value creation strategies, and look forward to moving both of our products forward throughout the year. We sincerely thank the investors who have stayed with us, and we are working diligently to continue the turnaround at Neovasc." On December 30, 2019, Neovasc submitted a premarket approval application to the FDA for the Reducer device. Reducer is in the commercial stage in Europe and the company is seeking to enter the US market by 2021. Thus far approximately 1,300 patients have received the device and results have been encouraging, demonstrating effectiveness in treating refractory angina with a strong safety profile. We are also pleased with the European Society of Cardiology including Reducer in the 2019 ESC Guidelines for the management of chronic coronary syndromes as a "New Major Recommendation for 2019". The new Guideline, coupled with the Society's new emphasis on the diagnosis of patients with angina and microvascular dysfunction, will support broader treatment populations with the Reducer device. Patients with angina and non-obstructive coronary artery disease (ANOCA) who have evidence of reversible ischemia represent a challenging population in whom medications to treat chest pain have failed and whom have few other treatment options. Reducer may be a treatment option for these patients and we are looking forward to working with clinicians to build the evidence base in the ANOCA population. To help capitalize on our momentum with the Reducer device, we have increased the sales force in Germany to three representatives. As a result of the increased field presence in Germany, coupled with our positive NUB status 1 reimbursement in Germany and the impact of the Guidelines, we expect an initial ramping period to be followed by a marked increase in the volume of Reducer devices being implanted in Europe. Neovasc completed a $10M financing in early January and post-closing we have cash on hand of approximately $14M, which Neovasc believes is sufficient to fund operations into Q3 2020. Following the most recent financing, the issued and outstanding share count is 10,518,319 and the market cap on the Nasdaq as of the close of trading on Friday, January 10, 2020 was $33.1 million. The Company has until February 17, 2020 to cure the Nasdaq minimum market value deficiency. To regain compliance, the Company's market value must exceed US$35 million for a minimum of 10 consecutive business days. In addition, the Company confirms that the only instruments outstanding from the highly dilutive 2017 Financing are $3.9 million of the 2017 Notes that mature on May 17, 2020. The Company is actively working to amend certain variable pricing mechanisms and anti-dilution protections within these notes to help fix the Company's capital structure, subject to agreement with the noteholders.