A Switzerland company has developed a potentially transformative drug-eluting balloon, and Cordis wants it bad enough to shell out $1.135 billion.
Miami Lakes, FL-based Cordis said the acquisition of MedAlliance would position the company for market leadership in drug-eluting balloon technology with the Selution SLR (sustained limus release). The total addressable market for the Selution SLR is estimated to reach 2 million patients globally by 2027.
The Selution SLR could be just the differentiated device Cordis has been needing in its portfolio for years. Cordis was originally a Johnson & Johnson company, but J&J sold the business to Cardinal Health for $2 billion in 2015. Cardinal Health ended up selling Cordis last year for $1 billion to Hellman and Friedman, a private equity firm.
The agreement includes an initial investment of $35 million plus $200 million when the deal closes in 2023. Cordis also agreed to tack on up to $125 million in regulatory achievement milestones and another $775 million in commercial milestones through 2029. Cordis said it will immediately begin co-promotion of MedAlliance's Selution SLR drug-eluting balloon in markets where the device is commercially available.
The Selution platform leverages spherical MicroReservoirs made from biodegradable polymer mixed with the drug to control the sustained release of sirolimus. The continuous manufacturing process produces millions of precisely formed, miniature drug-delivery systems. According to the company, Selution SLR is the only drug-eluting balloon using MicroReservoirs and is designed to provide the longest and most effective pharmacokinetics release profile of any device on the market. Cordis emphasized that the technology is "truly differentiated from all other sirolimus-coated balloons" and is uniquely positioned to deliver therapeutic effect.
"I have had the privilege to meet with clinical experts around the world and review hundreds of angiograms demonstrating the impact of Selution SLR in both cardiovascular and peripheral vascular patients," said George Adams, MD, chief medical officer for Cordis. "The clinical outcomes are remarkable, to say the least – especially for patients with few if any other treatment options."
Selution SLR received a CE mark for the treatment of peripheral artery disease in February 2020, and for the treatment of coronary artery disease in May 2020. MedAlliance also has investigational device exemptions (IDEs) for peripheral below the knee and superficial femoral artery interventions through FDA. Two IDE studies are already underway.
"Nearly twenty years ago, Cordis introduced Cypher, the first drug-eluting stent, transforming cardiovascular treatment for patients around the world," said Cordis CEO Shar Matin. "Today, we are furthering that legacy of innovation and market disruption with MedAlliance and the first MicroReservoir sirolimus drug-eluting balloon, Selution SLR."
Duke Rohlen, executive chairman at Cordis, noted that the acquisition illustrates the company's vision of maximizing patient impact by pairing highly innovative growth drivers with Cordis' brand and global commercial capabilities.
"Our sirolimus drug-eluting balloon program provides a flagship product that complements Cordis' existing portfolio and will benefit greatly from its deep marketing and distribution expertise," said Jeffrey Jump, chairman and CEO at MedAlliance.
MedAlliance estimates that its Selution SLR drug-eluting balloon has benefited about 10,000 patients, including 9,200 commercial units and more than 2,000 clinical trial patients.
Cordis is strategically putting cash to work
Cordis appears to be making some strategic investments this year. In June Cordis-X kicked in $11.5 million for Adient Medical's series F round. Cordis-X is an independent innovation accelerator based in Menlo Park, CA affiliated with Cordis.
Adient is developing an absorbable inferior vena cava (IVC) filter. The device is designed to avoid risks of perforation, migration, fracture, and thrombosis currently associated with IVC filters. Such safety issues have been the focus of the FDA-mandated PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study of IVC filters from six manufacturers.