MedAlliance has acquired its partner MDK Medical, a Japanese vascular specialist company. MDK Medical has previously worked closely with MedAlliance in developing Japanese clinical studies for its novel sirolimus drug-eluting balloon (DEB) Selution SLR in the treatment of peripheral arterial disease (PAD).
The first Selution SLR study was initiated in July 2020 and involved 134 patients. Enrolment was completed in September 2021. Its objective is to assess the safety and efficacy of Selution SLR in the treatment of lesions of superficial femoral arteries and/or popliteal arteries. The acquisition will facilitate expansion of the Japanese clinical trial programme, which will include diseases of the inferior femoral artery, arteriovenous (AV) fistula access used for kidney dialysis and a drug eluting balloon for the treatment of erectile dysfunction.
“We are very excited to have acquired MDK Medical, as we now have direct access to the Japanese market”, said MedAlliance chairman and CEO Jeffrey B Jump. “We will be focusing on gaining approval for Selution SLR in Japan, one of the world’s most important markets”.
Selution SLR was awarded CE mark approval for the treatment of PAD in February 2020 and for the treatment of coronary arterial disease in May 2020. The US Food and Drug Administration (FDA) has awarded Selution SLR with four breakthrough designations: for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and AV fistula indications.
In August 2021, the first of over 3,000 patients was enrolled in a coronary randomised controlled study comparing Selution SLR with limus drug-eluting stents (DESs). According to MedAlliance, this is the largest DEB study ever initiated and has the potential to change medical practice.