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SOURCE QT Vascular Ltd.
Chocolate® PTCA FDA clearance opens large new market opportunity
SINGAPORE, June 5, 2014 /PRNewswire/ -- QT Vascular Ltd. (QT Vascular) is pleased to announce that on 4 June 2014, its wholly owned US subsidiary, TriReme Medical LLC, received notification from the United States Food and Drug Administration (FDA) of 510(K) clearance to market the Chocolate® PTCA Balloon Catheter (Chocolate PTCA) in the United States, for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
"Chocolate PTCA is an exciting new product for interventional cardiologists," said Dr. Martin Leon of Columbia University Center for Interventional Vascular Therapy. "It leverages the strong clinical outcomes and low rates of dissections of the Chocolate PTA Balloon Catheter (Chocolate PTA) while providing an important new tool that could be now used in coronary arteries."
Currently, the Chocolate PTA is used for the treatment of patients with vascular disease in their legs, known as peripheral arterial disease. The Chocolate PTA has demonstrated low rates of dissections and bail-out stenting in clinical studies (1). The Chocolate PTCA was designed with similar engineering principles and is aimed to provide predictable and uniform dilatation of the coronary vasculature. There is no clinical data available for the Chocolate PTCA at this point in time.
Coronary artery disease, also known as coronary heart disease (CHD), is the most common form of cardiovascular disease and the number one cause of death in the United States and Europe. According to the American Heart Association, an estimated 15.4 million Americans over 20 years of age suffer from coronary heart disease. CHD was an underlying cause of death in approximately 1 of every 6 deaths in the United States in 2010 (2).
"The coronary business is an important element of our 2015 growth. This new product approval demonstrates the team's ability to effectively execute on our milestones," said Dr. Eitan Konstantino, Chief Executive Officer of QT Vascular. "We look forward to working closely with physicians to generate clinical data and serve a larger patient population."
About Coronary Artery Disease
Coronary artery disease occurs when the coronary arteries (the arteries surrounding the heart) become narrowed by a buildup of plaque, including cholesterol, fatty deposits, calcium, and other substances. As plaque accumulates over time, the diameter of the arterial lumen, or inner channel, narrows, resulting in reduced or stopped blood flow. When this occurs in arteries supplying blood to the heart, it can cause chest pain, a heart attack, or even death.
About QT Vascular
QT Vascular Ltd. (QT Vascular) is an emerging leader in the development and commercialization of next generation minimally invasive products for the treatment of complex vascular disease. The Company works closely with leading physicians and scientists from around the world to create differentiated devices that improve procedural and clinical outcomes. QT Vascular is based in Singapore with a US subsidiary, TriReme Medical LLC, in Pleasanton, California. The Company was listed on the Catalist Board of the Singapore Exchange Securities Trading Limited on 29 April 2014.
(1) Das T for Mustapha J. Chocolate® Bar, Leipzig Interventional Course, 28-31 January, 2014.
(2) Heart disease and stroke statistics-2014 update: a report from the American Heart Association. Circulation. 2014;129:e28–e292.
Cautionary Note on Forward-Looking Statements
All statements other than statements of historical facts included in this announcement are or may be forward-looking statements. Forward-looking statements include but are not limited to those using words such as "expect", "anticipate", "believe", "estimate", "intend", "project", "plan", "strategy", "forecast" and similar expressions or future or conditional verbs such as "if", "will", "would", "should", "could", "may" and "might". These statements reflect the Company's current expectations, beliefs, hopes, intentions or strategies regarding the future and assumptions in light of currently available information. Such forward-looking statements are not guarantees of future performance or events and involve known and unknown risks and uncertainties. Accordingly, actual results may differ materially from those described in such forward-looking statements. Shareholders should not place undue reliance on such forward-looking statements, and the Company undertakes any obligation to update publicly or revise any forward-looking statements, subject to compliance with all applicable laws and regulations and/or the rules of the SGX-ST and/or any other regulatory or supervisory body or agency.
The Company was listed on Catalist board of the Singapore Exchange Securities Trading Limited (the "SGX-ST") on 29 April 2014. The initial public offering of the Company was sponsored by PrimePartners Corporate Finance Pte. Ltd. (the "Sponsor").
This press release has been prepared by the Company and its contents have been reviewed by the Sponsor for compliance with the relevant rules of the SGX-ST. The Sponsor has not independently verified the contents of this press release.
This press release has not been examined or approved by the SGX-ST and the SGX-ST assumes no responsibility for the contents of this press release including the correctness of any of the statements or opinions made or reports contained in this press release.
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