MedAlliance announced today that it enrolled the first patient in an erectile dysfunction (ED) feasibility study with its drug-eluting balloon (DEB).
Nyon, Switzerland-based MedAlliance’s first patient was enrolled in the trial at the University of Rome Tor Vergata, Italy, under principal investigator Giuseppe Sangiorgi, a professor of cardiovascular interventional pathology.
According to a news release, the study will assess the feasibility and safety of angioplasty with a sirolimus-eluting balloon in patients with ED and distal internal pudendal and/or penile artery stenotic disease, using plain-old balloon (POB) angioplasty as a comparator. The study will enroll 10 patients, with a successful outcome set to lead to a larger ED study involving around 50 patients.
“We are very excited by the potential outcome of this study,” Sangiorgi said in the release. “There are a significant proportion of ED patients who don’t respond to conventional drug therapy, and initial studies have suggested that drug-eluting balloons could provide the solution. The balloon used in this study, providing a slow release of sirolimus, could be particularly suitable.”
MedAlliance’s Selution SLR DEB includes unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The micro-reservoirs provide a controlled and permanent release of the drug for up to 90 days, while MedAlliance’s CAT (cell-adherent technology) allows microdeposits to coat the balloons and adhere to the vessel lumen when delivered through an angioplasty balloon.
Selution SLR holds CE mark for treating peripheral artery disease and coronary arterial disease but is not currently licensed for treating ED. MedAlliance last week closed enrollment for a clinical trial evaluating Selution SLR to treat patients with disease below the knee.
“This is a very exciting study for us, as we believe it will indicate the potential of our sirolimus DEB to help significant numbers of ED sufferers who are unresponsive to other therapies,” added MedAlliance chairman & CEO Jeffrey B. Jump.