MedAlliance Acquires MDK Medical

February 2, 2022—MedAlliance, a Switzerland-based medical technology company, announced it has acquired its Japanese partner, MDK Medical, a vascular specialist company. MDK Medical has previously worked closely with MedAlliance in developing Japanese clinical studies for its Selution SLR sirolimus drug-eluting balloon in the treatment of peripheral arterial disease.

In September 2021, MedAlliance announced the completion of enrollment in the first clinical study of the Selution SLR in Japan, which was initiated in July 2020. The objective of the study, which enrolled 134 patients, is to assess the safety and efficacy of Selution SLR in the treatment of lesions of the superficial femoral arteries and/or popliteal arteries.

According to MedAlliance, the acquisition will facilitate expansion of the Japanese clinical trial program, which will include diseases of the inferior femoral artery, arteriovenous fistula (AVF) 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,” commented MedAlliance Chairman and Chief Executive Officer Jeffrey B. Jump in the company’s press release. “We will be focusing on gaining approval for Selution SLR in Japan, one of the world’s most important markets.”

MedAlliance noted that the Selution SLR device 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.

In the United States, the FDA has granted four Breakthrough Device designations for Selution SLR for the following indications: atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee artery disease; and AVF access.