Earnings release
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Neovasc Announces First Quarter 2021 Financial Results Vancouver , British Columbia and Minneapolis , Minnesota -- ( Newsfile Corp. - May 6 , 2021 ) - Neovasc , Inc. ( NASDAQ : NVCN ) ( TSX : NVCN ) ( " Neovasc " or the " Company " ) , today reported financial results for the first quarter ended March 31 , 2021 . First Quarter Highlights • • • Generated revenue of $ 451,794 in the quarter as Neovasc Reducer TM implants rebounded after being suppressed for much of 2020 due to the COVID - 19 pandemic . Continued to advance our program to expand reimbursement for Reducer in the EU and the US , and received a CPT Category III code from the American Medical Association for transcatheter implantation of a coronary sinus reduction device . Completed a registered direct share offering in February , raising gross proceeds of $ 72 million . Subsequent Highlights • • • Held initial discussions with the U.S. Food and Drug Administration ( FDA ) regarding the initiation of COSIRA II , a proposed study of the Reducer device in the US . Received ICD - 10 procedural Code for Reducer device implantation . Assigned to MS - DRGs 228-229 for in - patient Reducer procedures in the United States . Enrolled the 300th Reducer patient in the Reducer - 1 post - market clinical study . " Neovasc realized better - than - expected Reducer implants in the first quarter , as we continued to advance our efforts to commercialize the Reducer and further develop the Tiara devices , aided tremendously by a significant event for Neovasc ; the completion of a $ 72 million private placement in February 2021. This transaction solidifies the Company's finances and importantly provides a clear operational pathway for the next 18 months as we seek to realize value for our two devices , " said Fred Colen , President and Chief Executive Officer of Neovasc . " We are advancing the development of our IDE Clinical trial for Reducer with the FDA , in the form of an amended COSIRA II IDE Study and continue to pursue expanded reimbursement status for this unique device in Europe and the US . Our reimbursement progress in the U.S. has been noteworthy , as we have gained CPT , ICD - 10 and MS DRG codes in the past several weeks . We also continued to enlarge the Reducer's footprint in Europe , and we are excited about the opportunities in that market . We remain engaged with our notified body in Europe as we are evaluating options to potentially pursue Tiara TA approval under the Medical Device Regulation . Separately , we are continuing to develop the next - generation Tiara TF device , with the goal of a first - in - human implant towards the end of 2021. We look forward to forging ahead in 2021 with our value creation strategies based on our two devices . "