Drug Eluting Stent System*
Elixir is developing a strong pipeline of drug eluting stent platforms utilizing durable polymers, biodegradable polymers and release technologies.
USA | International Clinical Studies
Novolimus
Novolimus™ is a novel mTOR inhibitor macrocyclic lactone with anti-proliferative and anti-inflammatory properties developed by Elixir for drug eluting stents. The macrocyclic lactone drugs represent the most widely utilized drug family for drug eluting stent applications and have an established safety and efficacy profile. Elixir observed positive results from evaluating the safety and effectiveness of Novolimus for the prevention of restenosis through extensive pre-clinical testing including in vivo animal studies and in vitro testing conducted over the past several years.
EXCELLA First-in-Man Clinical Studies
Elixir has completed two separate first-in-man clinical studies evaluating the therapeutic effectiveness of the company's Novolimus eluting coronary stent systems. These studies used the company's proprietary stent platform and three proprietary polymer technologies.
In the first study, EXCELLA I, the stent platform incorporates a proprietary durable polymer coating with an established safety profile designed to have a low polymer load and drug dose. Four and eight month angiographic late loss and IVUS analysis at follow-up were completed. In addition, twelve month clinical follow up has also been successfully completed. In the second FIM study, the stent platform incorporates a proprietary biodegradable polymer coating designed to biodegrade within six to nine months. This study is currently ongoing.
EXCELLA II
EXCELLA II is a multi-center randomized clinical trial with a single arm registry.
The study will enroll 210 patients in Europe, South America and Asia Pacific.
Data from EXCELLA II will be submitted for future CE mark approval of the
Novolimus eluting coronary stent system.
*Exclusively for Clinical Investigations. For Export Only.
Myolimus
Myolimus™, a novel mTOR inhibitor macrocyclic lactone has demonstrated impressive versatility, stability, and a broad therapeutic index. The macrocyclic lactone drugs represent the most widely utilized drug family for drug eluting stent applications and have an established safety and efficacy profile. Myolimus can be used in a broad range of site–specific drug delivery therapeutic applications including a fully biodegradable stent program.
Elixir observed positive results from evaluating the safety and effectiveness of Myolimus for the prevention of restenosis through extensive pre-clinical testing including in vivo animal studies and in vitro testing conducted over the past several years.
Myolimus First-in-Man Clinical Trials:
Elixir has completed three separate first-in-man clinical studies evaluating the therapeutic effectiveness of the company’s Myolimus-eluting coronary stent systems. These studies used the company’s proprietary stent platform and three proprietary polymer technologies. In the first study, the stent platform incorporates a proprietary durable polymer coating with an established safety profile designed to have a minimal polymer load and the lowest known "olimus" drug dose. In the second study, the stent platform incorporates a proprietary biodegradable polymer coating designed to biodegrade within three to six months. In the third study, the stent platform incorporates a different proprietary biodegradable polymer coating designed to biodegrade within six to nine months.