Source: Neovasc.
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  • Expansion Driven by NICE Guidelines and Enhanced Reimbursement for the Neovasc Reducer
  • Excellent foundational efforts supporting the early growth of Reducer
  • Neovasc is a specialty medical device company that develops and markets products for the rapidly growing cardiovascular marketplace
  • Neovasc Inc. (TSX:NVCN) opened trading at C$5.76.

Neovasc (NVCN) has expanded its direct sales operations in Europe to include the United Kingdom, effective July 1, 2022.

The company has hired its first two direct employees in England and plans future growth in the sales team as the commercial requirements increase.

The decision to move to a direct sales operation in the U.K. was driven by the Neovasc Reducer being granted national reimbursement in England following inclusion in the most recent High-Cost Tariff Excluded Devices (HCTED) national catalogue. Hospitals can order the Reducer and bill the cost of the device directly to NHS England.

Fred Colen, Neovasc President and Chief Executive Officer, commented on the news.

“We are pleased to expand our direct presence into the United Kingdom and want to thank our partners at Healthcare 21 for their excellent foundational efforts supporting the early growth of Reducer. We are now poised to provide even deeper support with a full-time dedicated team in the U.K. and intend to continue to invest in clinical research and field personnel to support patients, physicians, and hospitals.”

Additionally, last year the United Kingdom’s Interventional Procedures Programme at the National Institute for Health and Care Excellence (NICE) issued guidance supporting the implantation of the Reducer in appropriate patients suffering from refractory angina. According to the guidance document, “Coronary sinus narrowing device implantation is indicated for people in whom [1] other treatment options (medical or surgical) have failed, or [2] are not possible. The aim is to reduce symptoms and to improve quality of life.”

Prof. Jonathan Hill, MD, Consultant Interventional Cardiologist at Royal Brompton & Harefield NHS Foundation Trust, London, U.K, an early pioneer in the development of Reducer therapy, said:

“An important next step in the widespread use of the therapy is a robust program of training and proctoring. We are looking forward to the support of Neovasc’s direct operation in the UK in training new operators and centers and allowing them to offer the Reducer therapy for all their indicated patients.”

The Reducer is CE-marked in the European Union for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate blood supply to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. Reducer is investigational in the United States in the COSIRA-II clinical trial. Refractory angina, resulting in persistent symptoms despite maximal medical treatment and without revascularization options, affects millions of patients worldwide, who typically lead severely restricted lives because of their disabling symptoms. The Reducer is designed to alter blood flow within the myocardium of the heart and increase the perfusion of oxygenated blood to ischemic areas of the heart muscle, which may provide relief of angina symptoms.

Neovasc is a specialty medical device company that develops and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel, and Europe. 

Neovasc Inc. (TSX:NVCN) opened trading at C$5.76.

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