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Neovasc announced the feature of its Neovasc Reducer™ in a supplement of Frankfurter Allgemeine Zeitung, targeting nearly 500,000 readers in Germany. The Reducer addresses refractory angina when conventional therapies fail. Leading cardiac experts highlighted that 75% of patients treated report symptom relief. Neovasc aims to educate the public on this therapy's potential benefits. The Reducer has been recognized in European guidelines as a treatment option for refractory angina, solidifying its role in the cardiovascular landscape.
Neovasc announced the exercise of 1,424,049 out of 2,573,959 common share purchase warrants by Strul Medical Group, generating proceeds of approximately US$3.75 million. These funds will be used to prepay a portion of an existing convertible debenture of US$11.5 million, resulting in reduced annual interest charges of around US$360,000 without increasing the fully diluted share count. Following this transaction, the outstanding shares total 17,613,355 with no change to the fully diluted share count of 29,207,819.
Neovasc announced that the U.S. FDA will review its premarket approval application for the Neovasc Reducer device on October 27, 2020. This device aims to treat patients with refractory angina pectoris who cannot undergo coronary artery bypass grafting or percutaneous coronary intervention. The Reducer has received Breakthrough Device designation from the FDA. Currently CE-marked in Europe, it may significantly alleviate symptoms for 600,000 to 1.8 million Americans affected by this debilitating condition. CEO Fred Colen highlights the importance of this milestone for Neovasc.
Neovasc, Inc. (NASDAQ: NVCN) reported preliminary revenue of approximately $295,000 for Q2 2020, down due to reduced Reducer procedures caused by COVID-19. However, there was a notable recovery in June with record implants, indicating strong underlying demand. CEO Fred Colen expressed optimism about continued growth in Q3, contingent on the pandemic's impact. The company plans to disclose full financial results on August 6, 2020, during a conference call at 4:30 PM ET, highlighting its focus on the cardiovascular marketplace.
Neovasc announced participation in two major conferences showcasing its technologies, the Neovasc Reducer™ and Tiara™. The Tiara Mitral Valve Replacement program presented positive clinical outcomes, including 0% procedural mortality and a 92.4% procedural success rate, alongside significant symptom improvement. The Reducer study revealed that 70% of patients with refractory angina reported symptom relief, with nearly 91% reduction in emergency department visits post-treatment. Neovasc aims to expand global regulatory approvals to increase patient access to these innovative treatments.
Neovasc announced positive interim results from the REDUCER-I study, focusing on treatment for refractory angina. Presented at the PCR E-Course, data from 241 patients showed significant symptom improvements, with 70% experiencing at least a 1 CCS Class reduction maintained over three years. Emergency department visits decreased by 91%. The Reducer is CE-marked in the EU, and while not yet approved in the US, it has FDA Breakthrough Device designation. The study highlights the Reducer's potential to safely relieve symptoms in a challenging patient population.
Neovasc Inc. (NVCN) announced on June 25, 2020, that it has regained compliance with Nasdaq's minimum market value requirement, confirming its market value exceeded US$35 million for ten consecutive business days from May 29 to June 11, 2020. The notification follows a previous compliance issue reported in October 2019. CEO Fred Colen expressed satisfaction, stating this compliance allows the firm to focus on growth strategies. Neovasc is also compliant with the Toronto Stock Exchange, ensuring stability in its listings.
Neovasc has completed its registered direct offering, raising approximately US$11.5 million through the sale of 3,883,036 units at US$2.97375 per unit. Each unit includes one common share and three-quarters of a warrant exercisable at US$2.88 until June 16, 2025. The net proceeds of about US$10.4 million will be allocated to the development of the Neovasc Reducer™ and Tiara™, as well as for general corporate purposes. The offering was facilitated by H.C. Wainwright & Co. and complies with regulations under the SEC.
Neovasc has announced a definitive agreement for a registered direct offering of 3,883,036 common shares at $2.97375 per share, aiming for gross proceeds of approximately $11.5 million. The offering is set to close around June 16, 2020, with net proceeds intended for the development of the Neovasc Reducer and Tiara devices and general corporate purposes. Each share comes with 0.75 warrants exercisable at $2.88 for five years. The securities will not be offered to Canadian purchasers and are subject to customary closing conditions, including listing requirements.
Neovasc announced the resumption of elective interventional procedures in Germany, particularly featuring its Neovasc Reducer™ device for refractory angina, highlighted on the public television program NDR Visite. The program showcased a patient whose quality of life improved significantly after undergoing Reducer therapy, coinciding with a rebound in procedure volumes to pre-COVID-19 levels. CEO Fred Colen expressed satisfaction with the strong recovery in the German market, which is crucial for the company. The Reducer is CE-marked in the EU and is undergoing PMA review in the US.
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