PLEASANTON, Calif., July 14, 2015 /PRNewswire/ -- QT Vascular Ltd., together with its subsidiaries ("QT Vascular" or 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 the United States Patent and Trademark Office ("USPTO") has issued allowance letters of four (4) fundamental patents critical to its unique portfolio of specialty balloons for the treatment of vascular disease in coronary and peripheral vessels. Three of the patents cover the Group's flagship platform, Chocolate®, while the fourth patent covers the Group's Glider™ family of products.
"To receive four key patents allowances within a short span of time is truly an exceptional experience for a start-up company," stated Dr. Eitan Konstantino, PhD, Chief Executive Officer of QT Vascular. "We remain focused on the execution of our operational milestones and especially the Drug Coating program."
Chocolate® – A Unique Platform
The Chocolate® balloon has a unique mechanism of action that reduces acute trauma, minimizes flow-limiting dissections and thus reduces the need for unplanned stenting in the peripheral arteries as compared to conventional balloons(1). It is precisely this unique mechanism of action that was recognized by the United States ("US") patent authorities in three separate patents titled: "Device and Methods for Compartmental Vessel Treatment," "Constraining Structure with Non-Linear Axial Elements," and "System and Method for Treating Biological Vessels." The Chocolate® PTA Balloon Catheter was the first interventional product from Singapore to receive the US FDA clearance. It is commercially available in the US, various countries in Europe, and approval in Japan is expected later this year. The Chocolate® is also available in a version specifically tailored to treat coronary arteries.
The Chocolate® balloon is the underlining platform for the Group's entry into the rapidly growing drug-coated balloon ("DCB") market through its next generation product, Chocolate Touch™. With the addition of a proven anti-proliferative drug paclitaxel to the Chocolate® balloon platform, Chocolate Touch™ could offer the potential to achieve improved acute outcomes (less trauma, lower rates of unplanned stenting) that may hold up over time (less tissue growth at the treated area). This additional long-term effect is due to the paclitaxel drug's ability to reduce the body's natural response to vascular intervention, which may otherwise lead to the need for repeat interventions. The Chocolate Touch™ is not yet approved for commercial sales and its potential benefits are being studied in early clinical studies.
With two DCBs by other companies approved by the FDA and a third in the regulatory process, the Group is optimistic that its highly differentiated Chocolate Touch™ may be the fourth DCB to be approved in the US. The initial clinical trial for Chocolate Touch™ (ENDURE study) is on track to release six months follow up data this summer. Companies that do not yet have a DCB to offer may look to fill this product gap through strategic partnerships or acquisitions. As such, the Group believes that Chocolate Touch™ is well positioned.
DCBs are creating a significant new market space. In Q4 2014, when C.R. Bard first launched its DCB in the US, it reached approximately US$18 million in global sales, compared with an analyst's estimate of US$11 million(2). In Europe and the US, DCBs are rapidly becoming the standard of care for certain peripheral interventions as they provide robust long-term outcomes. By some estimates, the DCB market in the US may be worth US$100 million in 2015 and US$600 million in 2018(3)(4). This is a positive development for the market, as it creates greater awareness for DCBs and the US Centers for Medicare and Medicaid Services also recently established supplemental reimbursement to hospitals to support hospitals using these products.
(1) Dr. Tony Das, et al. "Chocolate® BAR: Chocolate® PTA in a broad range of patients with PAD, a prospective post-marketing study", LINC 2014
(2) Mike Matson, Needham & Company, LLC. Analyst report on C.R. Bard, Inc., 30 January 2015.
(3) StarTribune. "Boston Scientific jumps into the market with a drug-eluting balloon", 10 February 2015.
(4) FierceMedicalDevices. "Medtronic readies for 2015 drug-eluting balloon FDA approval", 11 June 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) GliderXtreme™ PTA Balloon Catheter, (iv) GliderfleX® PTA Balloon Catheter and (v) Glider™ 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 GliderXtreme™ PTA Balloon Catheter has the regulatory clearance in China and Japan, while the Glider™ 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.
The Group is also applying for CE marking approval with respect to the Chocolate Touch™, its advanced drug-coated peripheral balloon.
In October 2014, the Group acquired a novel technology platform called Java, and all its associated intellectual property. The Group believes the Java technology is a strong fit with QT Vascular's core expertise in minimally invasive angioplasty.
For more information, please visit the company website at www.qtvascular.com
SOURCE QT Vascular Ltd.