Med Alliance SA, a company developing and commercialising the first sirolimus micro-reservoir drug-coated balloon (SELUTION DCB) to treat patients suffering from peripheral artery disease (PAD), coronary artery disease (CAD), arteriovenous fistulas (AVF) and grafts (AVG) for end-stage renal disease, has raised US$37 million.
The US$37 million consists of US$22 million equity and US$15 million in non-dilutive licensing agreements for Japan and China. The Investment Round was led by a US$20 million investment by Shenzhen Salubris Pharmaceuticals.
Kevin Ye, chief executive officer of Salubris, highlighted the Med Alliance investment and distribution agreement: “Sirolimus’ combination of anti-restenotic and anti-inflammatory properties have been proven clearly superior to first generation paclitaxel drug coatings on stents, but technical challenges have precluded the transposition of this evolution in stents to the drug-coated balloons used in reperfusion procedures. Salubris is pleased to support Med Alliance progress through this strategic investment, and we look forward working together to commercialise the company’s technology for the benefit of many millions of patients with coronary and peripheral artery disease in China”.
The proceeds from the equity financing will be used to fund European commercialisation, US regulatory approval and support global clinical programs.
In January 2018, Med Alliance announced a strategic agreement with Kaneka Corporation, a leading provider of PTCA balloons in Japan. The agreement involves technical collaboration, product licensing, manufacturing and distribution for the Med Alliance DCB, limited to the treatment of coronary arteries in Japan.
“We are very pleased to have both Salubris and Kaneka as partners. These companies share our belief in providing clear patient benefit demonstrated by strong supporting clinical data”, said Jeffrey B Jump, chairman and CEO of Med Alliance. “The validation from these highly successful, international medical organisations represent a significant endorsement of both our technology and our team.”
The Med Alliance technology includes unique micro-reservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These micro-reservoirs provide controlled and sustained release of sirolimus. Extended release of sirolimus from stents has shown to be highly efficacious in both coronary and peripheral vasculatures. Med Alliance’s proprietary CAT (Cellular Adhesive Technology) enables the micro-reservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.
Encouraging primary endpoint data from the First-in-Man (FIM) study of the SELUTION DCB was presented at the Leipzig Interventional Course (LINC) in February 2018. Late Loss of the target lesion, as measured by Quantitative Vascular Angiography (QVA) at six months post-index procedure, was 0.19mm. The rate of Target Lesion Revascularisation (TLR) was 2.2%—one of the lowest ever reported in a drug-coated balloon FIM study at six months. There were no incidences of either death or the need for minor and/or major amputations.
Subgroup data presented at CRT and Charing Cross meetings indicated similar performance in patients with long lesions and with moderately severe and severe calcifications.
“We are very encouraged by the FIM data and investor enthusiasm for this novel sirolimus DCB technology”, concluded Jeffrey B Jump.