Micell Technologies said today that it began its Dessolve J randomized, double-blind study comparing its MiStent SES sirolimus eluting absorbable polymer coronary stent to the Xience V everolimus eluting coronary stent in patients with coronary artery disease.
The Durham, N.C.-based company touts its device as a bare-metal stent coated in crystalline drug, sirolimus, and an absorbable polymer, with the goal of providing local drug delivery.
The study’s primary endpoint will compare target lesion failure in the 12-month clinical outcomes of patients in both arms. Enrollment will take place at 10 sites throughout Japan, the company reported.
“We are pleased to enroll the first patient in this important study,” principal investigator Dr. Shigeru Saito said in prepared remarks. “This study is a historic one for Japan. It will provide us with valuable insights into the potential benefits of MiStent’s unique pharmacokinetic profile, with a rapidly absorbing polymer and extended elution of crystalline sirolimus.”
MiStent has won CE mark approval in the European Union, supported by clinical data from Dessolve I and II. Micell also completed enrollment of 1,400 patients for Dessolve III in December last year. Dessolve J will provide Japan-specific data to support a pre-market application with Japan’s Pharmaceuticals and Medical Devices Agency, which the company will file after the study is complete.
“Cardiovascular disease poses a significant health risk in Japan and even with recent improvements in coronary artery disease treatment, additional advances in drug-eluting stents are still needed,” Micell chairman & CEO Arthur Benvenuto said. “Studies of MiStent to date have demonstrated a desirable lack of late lumen loss over 18 months, a characteristic that makes MiStent a clinically meaningful improvement that could provide clinicians and patients worldwide with enhanced treatment options.”
Earlier this month, Micell raised $25.8 million in a new round of equity and debt financing, according to an SEC filing.