The United States Patent and Trademark Office (USPTO) has issued allowance letters of four fundamental patents critical to QT Vascular Ltd's unique portfolio of specialty balloons for the treatment of vascular disease in coronary and peripheral vessels.
Three of the patents cover the QT Vascular's flagship platform, Chocolate, while the fourth patent covers its 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 programme."
The Chocolate balloon has a unique mechanism of action that reduces acute trauma, minimises flow-limiting dissections and thus reduces the need for unplanned stenting in the peripheral arteries as compared to conventional balloons. It is precisely this unique mechanism of action that was recognized by the United States 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 company'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
With two DCBs by other companies approved by the FDA and a third in the regulatory process, the company 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 company 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. 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. 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.
QT Vascular is a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease.