FDA Grants QT Vascular Full IDE Approval to Begin Pivotal Trial of Drug-Coated Balloon

QT Vascular Ltd. is a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease. Further to the Company’s announcement on 19 September 2016 in relation to the Food and Drug Administration (“FDA”)’s grant of conditional Investigational Device Exemption (“IDE”) approval, the Company is pleased to announce that the FDA has granted the full IDE approval to begin enrolling patients in the pivotal study of its novel Chocolate Touch drug-coated balloon. The full IDE approval allows for enrollment up to 585 patients and up to 50 centers in the United States (“US”) while additional patients may be enrolled in selected centers outside the US. The co-Principal Investigators of the study are Dr. Mehdi Shishehbor of the Cleveland Clinic and Professor Thomas Zeller of the Heart Center in Bad Krozingen, Germany.
 
“FDA appropriately set a high bar for this type of drug device combination product,” stated Eitan Konstantino, PhD, CEO of QT Vascular. “We have worked hard to meet all conditions previously set by the FDA and are delighted to join a very small group of companies able to reach this point with a drug-coated balloon.”
 
The Chocolate Touch US pivotal study is a prospective randomized study in the US, Europe, and New Zealandthat will evaluate patients with disease in the superficial femoral and popliteal arteries in the legs. Patients will be randomized 1:1 to CR Bard’s Lutonix drug-coated balloon. The study will evaluate acute end points such as procedural successes and freedom from bail-out stenting, and long term endpoints such as patency and target lesion revascularization among others.
 
Chocolate Touch is the drug-coated version of the Company’s Chocolate PTA balloon which is already broadly available in hospitals across the United States. Chocolate PTA features a unique nitinol constraining structure that causes the balloon to open in a controlled uniform fashion, thus reducing acute trauma, dissections, and unplanned stenting compared to conventional PTA balloons¹. For Chocolate Touch, the Company has added a proprietary drug coating containing the drug paclitaxel to the Chocolate platform, in order to reduce the incidence of repeat procedures. This combination of an atraumatic balloon platform and a proven therapeutic agent is intended to allow patients to be treated while minimizing the need for a permanent implant.
 
Chocolate Touch received CE mark approval in July 2015. Commercial launch in selected accounts in countries that are accepting CE mark is underway. The Company has previously announced² strong acute and 6 month outcomes in its feasibility study for Chocolate Touch, ENDURE, with an incidence of bail-out stenting just 1.4%, a lumen loss of only 0.16mm, per-protocol primary patency of 90% and an incidence of clinically-driven target lesion revascularization of only 1.7%. The product is not approved for use in the US and CE mark does not constitute such approval.
 
Drug-coated PTA 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 to create a second generation of drug-coated balloons. 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 analyst estimates³, revenues for drug-coated balloons are expected to reach $1 billion by 2020.
 
References
¹Chocolate BAR interim results presented by Mustapha (AMP, August 2015)
²ENDURE interim results presented by Zeller (German Society of Angiology, September 2015)
³Morningstar (July 30, 2015)