QT Vascular Announces Interim Clinical Trial Results Of Chocolate Touch

Highlights:

- Interim clinical results of the Chocolate Touch study (ENDURE) were presented by Prof. Thomas Zeller on September 29, 2015 at the annual meeting of the German Society of Angiology in Freiburg, Germany

- Independent core lab adjudication revealed positive outcomes, including low rate of bail out stenting, low late lumen loss and a low rate of re-intervention at six months

- Chocolate Touch was used as a primary technology and without a requirement for pre-dilatation that is indicated for other Drug Coated Balloons in the US

Oct 05, 2015, 19:20 ET from QT Vascular Ltd.

SINGAPORE, Oct. 5, 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 the release of the interim results from ENDURE, the first study of its unique peripheral drug-coated balloon, Chocolate Touch.

Presenting at the annual meeting of the German Society of Angiology (DGA) in Freiburg, Germany, Professor Thomas Zeller of the Heart Center in Bad Krozingen, Germany and Co- Principal Investigator of the ENDURE study described the study findings in patients with above the knee disease at 6 months. The presentation included:

Study Parameters

Interim Outcomes

Technical success: ability to deliver & inflate Chocolate Touch at the intended location

100% (70/70)

Device success: <50% residual diameter stenosis without a flow limiting dissection after treatment with Chocolate Touch

98.6% (68/69)

Procedural Success: <50% residual diameter stenosis without a flow limiting dissection at the end of the study procedure

100% (70/70)

Adjudicated bail-out stenting

1.4% (1/69)

Average improvement in Rutherford class at 6 months

2.5 classes

Clinically-driven target lesion revascularization at 6 months

1.7% (1/60)

Primary patency (per protocol)

90.0% (45/50)

Average late lumen loss at 6 months

0.16mm

ENDURE is a prospective, core lab adjudicated study of the Chocolate Touch Paclitaxel drug- coated PTA balloon conducted at multiple sites in Germany and New Zealand. The study enrolled 67 patients (70 lesions) with above-the-knee disease and assessed outcomes at 30 days and 6 months. There will also be a clinical and duplex ultrasound assessment of patients at 12 months. Unlike most other studies of drug-coated balloons, pre-dilatation was not required for Chocolate Touch and was left to the operator's discretion. Angiographic results were adjudicated by the core lab at Yale University. Duplex ultrasound results were assessed by VASCORE.

"The patients enrolled in ENDURE represented similar demographics and lesions characteristics to the patients I treat in my everyday clinical practice. ENDURE results confirm that the Chocolate® PTA platform induces very few flow-limiting dissections which leads to a very low rate of bail-out stenting", stated Professor Thomas Zeller. "With the evidence of a very low rate of lumen loss and very few re-interventions at 6 months, we now have a drug-coated balloon that offers excellent acute and mid-term results in interventional treatment of TASC(1) II femoro- popliteal lesions."

Dr. Steven Kum, Vascular and Endovascular Surgeon at Mount Elizabeth Novena Hospital in Singapore added: "The mid-term results of the ENDURE trial are encouraging news for the Endovascular community. Re-narrowing after successful balloon angioplasty is a significant problem for us. Drug Eluting technology to reduce re-narrowing, in combination with the Chocolate® Balloon, could usher a new "non–stent" paradigm in the way we treat patients. The Chocolate Touch can potentially be applied to a wide range of lesions and we await the long term results and it's availability in Singapore."

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 United States, adoption has been increasing and CMS (Centers for Medicare and Medicaid Services) has granted additional reimbursement for these devices. According to some analysts' estimates(2), revenues for drug-coated balloons are expected to reach $1 billion by 2020.

"These results from ENDURE echo our experience in the Chocolate BAR registry which demonstrated low rates of dissections and unplanned stenting(3)", stated Dr. Eitan Konstantino, PhD, Chief Executive Officer of QT Vascular. "With this new and exciting evidence of low late lumen loss and very few re-interventions, we believe that the Chocolate Touch represents a significant step towards our vision of keeping more arteries open without a stent."

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 has also applied for CE marking approval with respect to the Chocolate Heart, its drug-coated coronary balloon.

1. Trans-Atlantic Inter-Society Consensus Document of Management of Peripheral Arterial Disease
2. Morningstar, July 30, 2015
3. 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 mainly 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.



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