MedAlliance has been acquired by Cordis for a 2022 investment of US$35 million and a 2023 upfront closing payment of US$200 million, together with regulatory achievement milestones of up to US$125 million and commercial milestones of up to US$775 million through 2029, for a total consideration of up to US$1.135 billion.
Cordis is a developer and manufacturer of interventional cardiovascular and endovascular technologies. MedAlliance’s sustained sirolimus drug-eluting balloon (DEB) program, SELUTION SLR (Sustained Limus Release), has provided a flagship product family which complements Cordis’ existing product portfolio, together with their sales, marketing and distribution expertise, the companies said in a press release. Cordis customers will benefit from the extensive clinical study programme and publication plan that have been executed by MedAlliance to further Cordis’ heritage of bringing innovative products to patients, the press release states.
“The Cordis acquisition will accelerate access to this breakthrough technology for patients around the globe suffering from coronary and peripheral disease,” said Jeffrey B Jump, founder, chairman and CEO of MedAlliance. “I want to thank our entire MedAlliance team—including physicians, distributors and clinical patients—who have succeeded in disrupting the coronary and peripheral markets to provide a safe and effective new technology. The arsenal of SELUTION SLR DEB clinical data is designed to change medical practice and improve patient outcomes.”
“Nearly 20 years ago, Cordis introduced Cypher, the first drug-eluting stent, transforming cardiovascular treatment for patients around the world,” said Shar Matin, Cordis CEO. “As a newly independent company, we are beyond proud to further our legacy of innovation and market disruption with MedAlliance and the first MicroReservoir sirolimus drug-eluting balloon, Selution SLR.”
“We are excited to report on the positive Selution SLR data to date, with first-hand experience of the impressive clinical outcomes from patients treated with Selution SLR in Japan, India, Europe, and South America. We are now leading the effort to emulate these results in the USA. This technology has the distinct opportunity to change the treatment paradigm for patients suffering from cardiovascular and peripheral vascular disease,” commented George Adams (Cardiovascular and Peripheral Vascular Research, Rex Hospital, Raleigh, USA) Steering Committee member of both the US SELUTION4SFA and SELUTION4BTK IDE studies.
SELUTION SLR was awarded CE mark approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020. MedAlliance was the first drug-eluting balloon company to receive US Food Drug Administration (FDA) breakthrough designation status.
In addition to the below-the-knee (BTK) and superficial femoral artery (SFA) indications for which the company received FDA investigational device exemption (IDE) approval in May and August 2022 respectively, MedAlliance received coronary in-stent restenosis (ISR) IDE approval in October 2022 and de novo coronary artery lesions approval in January 2023.
Subsequent to achieving IDE Status, three FDA studies involving SELUTION SLR are currently enrolling with a fourth, involving patients with coronary de novo artery disease, planned to start in the next few weeks. The latter will complement the experience gained with the ground-breaking SELUTION DeNovo trial in Europe, which has now enrolled over 1,700 patients, halfway towards a planned 3,326 patients. SELUTION DeNovo compares the treatment strategy using SELUTION SLR versus any limus drug-eluting stent (DES).
MedAlliance’s DEB technology involves MicroReservoirs which contain a mixture of biodegradable polymer intermixed with the antirestenotic drug sirolimus applied as a coating on the surface of an angioplasty balloon. These MicroReservoirs provide controlled and sustained release of the drug for up to 90 days. MedAlliance’s proprietary Cell Adherent Technology (CAT) enables the MicroReservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon.
SELUTION SLR is commercially available in Europe, Asia, the Middle East, and the Americas (outside USA) and most other countries where the CE mark is recognised. Over 40,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical trials.