Financing Will Support Launch of Med Alliance's Selution DCB
May 22, 2018—Med Alliance announced that it has received $22 million in financing to be used to fund European commercialization, achieve United States regulatory approval, and support global clinical programs for the company's Selution drug-coated balloon (DCB). The investment round was led by a $20 million investment by Shenzhen Salubris Pharmaceuticals. The company has also received $15 million through nondilutive licensing agreements for Japan and China.
Med Alliance is developing and commercializing the sirolimus microreservoir Selution DCB to treat patients with peripheral artery disease, coronary artery disease, arteriovenous fistulas, and arteriovenous grafts for end-stage renal disease.
In January 2018, Med Alliance announced a strategic agreement with Kaneka Corporation, a leading provider of percutaneous transluminal coronary angioplasty balloons in Japan. The agreement involves technical collaboration, product licensing, manufacturing, and distribution for the Selution DCB, limited to the treatment of coronary arteries in Japan.
According to Med Alliance, the DCB's microreservoirs are made from a biodegradable polymer mixed with sirolimus, an antirestenotic drug. The microreservoirs provide controlled and sustained release of sirolimus. Med Alliance’s CAT cellular adhesive technology enables the microreservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.
Primary endpoint data from the first-in-human study of the Selution DCB were presented by Principal Investigator Professor Thomas Zeller, MD, at LINC 2018, the Leipzig Interventional Course held January 30 to February 2 in Leipzig, Germany. Late loss of the target lesion, as measured by quantitative vascular angiography at 6 months postindex procedure, was 0.19 mm. The rate of target lesion revascularization was 2.2%. There were no incidences of either death or the need for minor and/or major amputations.
Subgroup data presented by Prof. Zeller at CRT 2018, the Cardiovascular Research Technologies conference held March 3–6 in Washington, DC, indicated similar performance in patients with long lesions and with moderately severe and severe calcifications. The data were also presented at the 2018 Charing Cross International Symposium held April 24–27 in London, United Kingdom.