Cordis Completes Acquisition of MedAlliance in Deal Worth up to $1.135 Billion; SELUTION DeNovo Trial Could Have Big Implications for PCI Market
Cordis, a global leader in interventional cardiovascular and endovascular technologies, has completed its acquisition of MedAlliance, a Swiss medical technology company, in a deal worth up to $1.135 billion. The investment includes a $35 million infusion in 2022, a $200 million upfront closing payment in 2023, and potential milestone payments based on regulatory and commercial achievements through 2029.
MedAlliance is known for its sustained sirolimus drug-eluting balloon (DEB) program known as SELUTION SLR™ (Sustained Limus Release) that has been used to treat over 10,000 patients. This innovative technology offers a new approach to treating coronary and peripheral vascular disease by providing controlled and sustained drug release for up to 90 days via a balloon-based delivery system. SELUTION SLR received CE Mark Approval for treating peripheral artery disease in February 2020 and for coronary artery disease in May 2020. MedAlliance was the first drug-eluting balloon company to receive FDA Breakthrough Designation status. The FDA has also approved IDE (Investigational Device Exemption) studies involving SELUTION SLR for various indications, including peripheral artery disease, superficial femoral artery disease, coronary in-stent restenosis, and de novo coronary artery lesions.
MedAlliance is currently involved in a major study comparing its SELUTION SLR technology to drug-eluting stents. Drug eluting stents can cause an inflammatory response over time leading to neo-atherosclerosis and late stent thrombosis where the SELUTION SLR technology leaves nothing behind. The SELUTION DeNovo trial is an open-label, multi-center international randomized trial comparing a strategy of percutaneous coronary intervention with Medalliance’s drug-eluting balloon to drug eluting stents. The primary clinical outcome is total vein failure rates at one and five year follow up. The study is schedule to complete enrollment at the end of 2023 with over 3,000 patients randomized 1:1. Primary one year data should become available in early 2025 and five year data should be available in 2029. In the non-inferiority endpoint is met a superiority test will be performed. The study given its size and outcome measures could have significant implications for percutaneous coronary interventions if SELUTION SLR is shown to be superior to drug eluting stents. In the United States there are about 900,000 percutaneous coronary interventions performed annually.