GALWAY, Ireland & MILAN--(BUSINESS WIRE)--4Tech Inc., which is developing the world’s first transcatheter device, TriCinch™, for repair of the Tricuspid heart valve, today announced that its device has been used to successfully treat patients suffering from Tricuspid Regurgitation (TR), which afflicts more than three million patients in the U.S. and Europe, making the potential TR patient population approximately 2/3 the size of the MR (Mitral Regurgitation) patient population.
The ongoing feasibility study is being conducted at San Raffaele Hospital and in other sites in Italy and in Europe. The Cardiology Unit at San Raffaele Hospital is headed by Professor Ottavio Alfieri and is a leading institution for heart valve studies. The Interventional Cardiology Unit at San Raffaele Hospital is directed by Dr. Antonio Colombo and is a key center in Europe for treatment of coronary artery diseases and structural heart diseases. Dr. Colombo is also a Visiting Professor of Medicine at Columbia University Medical Center, New York. The investigators for the TriCinch feasibility study at San Raffaele Hospital include Dr. Azeem Latib, Senior Interventional Cardiologist; and, Dr. Paolo Denti, Hybrid Cardiovascular Surgeon.
“Today’s standard for treating Tricuspid Regurgitation leaves clinicians and patients with limited options,” said Carine Schorochoff, Co-Founder and CEO of 4Tech. “Along with San Raffaele Hospital and other leading interventional institutions, we are making great progress toward changing the outlook for this neglected disease.”
TR is a difficult-to-manage, age-related disease in which blood “backflows” into the right side of the heart. Today’s standard of care for TR is medical management. Surgical intervention is very high-risk. In-hospital death post-cardiac surgery for isolated TR can be as high as 37% (Source: McCarthy et al. Journal of Thoracic and Cardiovascular Surgery 2004). Unfortunately, TR patients tend to be non-compliant with their medications. Thus, TR and related complications induce substantial healthcare spending due to frequent re-hospitalizations. Furthermore, TR leads to chronic renal failure and end-stage dialysis. The combination of these negative outcomes results in a significant unmet need for an interventional cardiology solution to TR.
4Tech’s #TriCinch system is the world’s first transcatheter device developed to treat this unmet clinical need and is designed to allow clinicians to repair a diseased Tricuspid heart valve in a simple and reproducible interventional procedure. The 4Tech TriCinch device was invented by Professor Francesco Maisano, who was a senior surgeon at San Raffaele before being appointed as Chief of Cardiac Surgery at University Hospital in Zurich.
“We are enthusiastic about the growing trend toward transcatheter treatment of all heart valve disease,” said Dr. Latib. “From my clinical experiences to date, it appears that TriCinch has a chance to refashion the way in which Tricuspid heart valve disease is treated in the future, and we look forward to continuing our efforts to develop and validate the technology in more patients.”
“We must not forget that the patients who are benefitting from the TriCinch approach to treating TR had no other option left to them,” added Dr. Denti.
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About 4Tech Inc.
4Tech Inc. (www.4techtricuspid.com) is incorporated in Delaware, USA, with operations in Galway, Ireland (4Tech Cardio Ltd). 4Tech has developed a proprietary transcatheter solution for the treatment of TR. Because of its unique anchoring and tensioning mechanism, the 4Tech TriCinch™ System for Transcatheter Tricuspid Valve Repair (TTVR) allows a simple and reproducible percutaneous procedure, designed not only to reduce TR and restore patient quality of life, but also allow substantial potential cost-savings for healthcare systems. The Company was co-founded by Professor Francesco Maisano, M.D. (Zurich University Hospital, Switzerland); Hugo Vanermen, M.D. (OVL Hospital, Aalst, Belgium); Yossi Gross; and Carine Schorochoff.
Caution: The 4Tech TriCinch™ System for Transcatheter Tricuspid Valve Repair is in the early phase of development. It will not be available in the USA for clinical trials until further notice and is NOT available for sale.
Caution: This news release contains certain “forward-looking” statements under the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of 4Tech are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the protection of intellectual property, changes to governmental regulation of medical devices, the FDA’s approval of new products, the impact of competitive products, changes to the competitive environment, the acceptance of new products in the market, conditions of the interventional cardiology industry and the economy and other factors.