QT Vascular Announces CE Mark Clearance Of Chocolate® Touch By LRQA 0088


- CE Mark clearance opens large new opportunity in a rapidly growing market segment

- Chocolate® Touch offers a differentiated platform compared to currently available drug-coated balloons

- Initial clinical results of Chocolate® Touch study (the Endure study) will be presented by Prof. Thomas Zeller in late September

Sep 08, 2015, 13:47 ET from QT Vascular Ltd.

SINGAPORE, Sept. 7, 2015 /PRNewswire/ -- QT Vascular Ltd., together with its subsidiaries (the "Company" or "QT Vascular", and together with its subsidiaries, the "Group"), a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced today that has received CE mark clearance for its unique peripheral drug-coated balloon, Chocolate® Touch.  The CE mark was granted by Lloyds Register Quality Assurance Notified Body Number 0088 ("LRQA 0088").

Drug-coated balloons represent a new category of device that combines the mechanical dilatation of a balloon catheter with the biological effect of a drug to treat occluded arteries. These devices have been available for several years in Europe and were recently approved in the United States. Since their approval in the U.S., adoption has been increasing and CMS (Centers for Medicare and Medicaid Services) has granted additional reimbursement for these devices. According to some analysts' estimates1, revenues for drug-coated balloons are expected to reach $1 billion by 2020.

"Chocolate® Touch combines the low trauma Chocolate® platform with the proven drug paclitaxel", stated Professor Thomas Zeller of the Heart Center in Bad Krozingen, Germany and Principal Investigator of the ENDURE study (First-in-human EvaluatioN of the DrUg-coated Chocolate balloon for percutaneous transluminal REvascularization of infrainguinal arterial disease). "In my personal experience, the Chocolate® Touch has produced excellent acute clinical outcomes. I look forward to presenting the first ENDURE results at the meeting of the German Society of Angiology conference in late September."

"Currently available first generation drug-coated balloons provide significant benefits to patients suffering from blockages in their legs, but they have limitations", stated Dr Eitan Konstantino, PhD, Chief Executive Officer of QT Vascular. "We believe that the Chocolate® platform with its demonstrated low rates of dissections and unplanned stenting(2) and the addition of paclitaxel, make sense and will continue to produce clinical data to prove its benefits."

Commercial launch of Chocolate® Touch in countries that are accepting CE mark is expected to commence later this year. The product is not approved for use in the United States and CE mark does not constitute such approval.  The Group also applied for CE marking approval with respect to the Chocolate® Heart, its drug-coated coronary balloon.

1. Morningstar, July 30, 2015
2. Tony Das on behalf of the Chocolate BAR investigators, LINC 2014

About QT Vascular Ltd. (SGX Stock code: 5I0)

QT Vascular Ltd. together with its subsidiaries ("QT Vascular" or the "Group"), is an emerging leader in the development and commercialization of next generation minimally invasive products for the treatment of complex vascular disease. QT Vascular 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 ("TriReme Medical"), based in Pleasanton, California. TriReme Medical's range of percutaneous transluminal angioplasty ("PTA") and percutaneous transluminal coronary angioplasty ("PTCA") products include (i) Chocolate® PTA Balloon Catheter, (ii) Chocolate® PTCA Balloon Catheter, (iii) GliderXtremeTM PTA Balloon Catheter, (iv) GliderfleX® PTA Balloon Catheter and (v) GliderTM PTCA Balloon Catheter, all of which have the CE Mark that allows them to be sold in Europe, and FDA clearance to be sold in the United States. Additionally, the GliderXtremeTM PTA Balloon Catheter has the regulatory clearance in China and Japan, while the GliderTM PTCA Balloon Catheter has the regulatory clearance in Japan. These products are sold through its main distributors: (i) Cordis Corporation (a wholly-owned subsidiary of Johnson & Johnson), (ii) Shandong Weigao Group Medical Polymer Co Ltd and (iii) Century Medical, Inc.

For more information, please visit the company website at www.qtvascular.com


SOURCE QT Vascular Ltd.