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Neovasc, a leader in minimally invasive transcatheter mitral valve replacement technologies, has filed for CE Mark approval for its Tiara TA system designed to treat mitral valve disease. The procedure is less invasive than traditional surgery, potentially benefiting millions of patients. Following a recent extension of the Medical Device Directive, Neovasc confirmed that its Tiara application review will continue under the MDD, providing a clearer regulatory pathway. The Tiara valve is currently not commercially available and is under investigation in clinical trials across the U.S. and Europe.
Neovasc, a leader in transcatheter mitral valve replacement technologies, announced progress towards its value creation strategies. The company reported a return to elective procedures in Germany, with Reducer implant rates nearing pre-COVID-19 levels. Neovasc is collaborating with NICE in the UK to establish Reducer therapy's value. The FDA Pre-Market Approval milestones for Reducer have progressed, and a CE Mark application for Tiara TA is under review. A recent financing of approximately $5M aims to improve capital structure and support upcoming milestones.
Neovasc announced an offering of convertible notes and warrants to Strul Medical Group for gross proceeds of up to US$5 million. The company fully repaid or converted all 2017 Notes and settled with holders by issuing warrants. Strategic actions aim to strengthen Neovasc's capital structure and improve its share capital, now totaling 12,306,270 common shares. The proceeds will further the development of the Neovasc Reducer™ and Tiara™ products. These transactions are expected to complete by early June 2020, subject to approval.