August 31, 2020
Genesis MedTech Acquires Chocolate Touch DCB From TriReme/QT Vascular
August 31, 2020—Genesis MedTech International announced the completion of its acquisition of the Chocolate Touch drug-coated balloon (DCB) from TriReme Medical LLC, a wholly owned subsidiary of QT Vascular Ltd. The device is designed to treat disease of the peripheral vasculature, including the superficial femoral artery.
According to the company, the acquisition includes the intellectual property license for worldwide design, engineering, manufacturing, rights, claims, use, marketing, sale, and distribution for use in the treatment, prevention, diagnosis, or management of peripheral vascular diseases.
Through its subsidiary, G Vascular Pte Ltd, Genesis Medtech will aim to bring Chocolate Touch to the United States and various international markets by completing the United States investigational device exemption pivotal clinical study and obtaining premarket approval from the FDA.
Genesis MedTech advised that as of July 1, 2020, 333 patients have been enrolled in the Chocolate Touch pivotal study at 34 sites in the United States, Europe, and New Zealand. QT Vascular announced the commencement of study enrollment in August 2017.
In January 2019, QT Vascular advised that the FDA granted approval to include the use of atherectomy for lesion preparation in the pivotal study, which is evaluating patients with disease in the superficial femoral and popliteal arteries in the legs. The study is evaluating acute endpoints such as procedural successes and freedom from bail-out stenting and long-term endpoints such as patency and target lesion revascularization.
European CE Mark approval for the Chocolate Touch DCB has been received. In the United States, it can only be used in the investigational device exemption clinical study.
The Chocolate Touch device is the drug-coated version of the Chocolate percutaneous transluminal angioplasty balloon, which was acquired from QT Vascular by Medtronic in January 2018 and is commercially available in the United States.