Micell Technologies Announces Plans for MiStent SES® Commercial Launch
— Distribution Agreement Secured with STENTYS —
DURHAM, N.C., November 3, 2014 — Micell Technologies, Inc. today announced commercialization plans for its MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®). In support of this strategy, the company has entered into a five-year agreement with STENTYS (Princeton, NJ and Paris, France) as an exclusive worldwide distributor of the MiStent SES, except in the United States, Canada, China, South Korea and Japan. STENTYS plans to launch MiStent in the first half of 2015 in Europe, followed by many other geographies where they have built a commercial network.
Arthur J. Benvenuto, Micell’s Chairman and Chief Executive Officer, said, “This is an exciting time as we further expand treatment options for patients with the introduction of MiStent – a highly differentiated bioabsorbable drug-eluting stent. STENTYS has an ongoing commitment to pursuing meaningful innovation for interventional cardiology, and their products and global reach are most important in this significant partnership.”
Dennis Donohoe, M.D., Micell’s Chief Medical Advisor, added, “We hear from physicians that they need the innovation MiStent SES offers as the only bioabsorbable coated DES to sustain local drug delivery beyond the presence of the polymer. MiStent provides therapeutic drug levels of sirolimus in the tissue surrounding the stent for up to nine months. The polymer is eliminated by three months without the loss of anti-restenotic drug effects, which differentiates MiStent from any other DES formulation.”
In addition to the distribution partnership, Micell will work closely with STENTYS to perform a post-market study, DESSOLVE III. This study will be a prospective, multi-center, balanced randomized controlled study enrolling approximately 1,400 subjects at up to 20 study centers. Subjects will be followed for a total of three years with a primary endpoint of Target Lesion Failure (TLF) at 12 months follow up. There will also be an OCT sub-study that will evaluate the progression of neointimal volume over 2 years follow up.
About the MiStent SES
The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) is designed to optimize healing in patients with coronary artery disease. The rapidly absorbable coating of the MiStent SES is intended to precisely and consistently control drug elution and limit the duration of polymer exposure, thereby potentially reducing the safety risks associated with current commercially available drug-eluting stent technologies. The innovative MiStent SES system includes a proprietary stent coating that contains crystalline drug (sirolimus) and an absorbable polymer. The coating provides controlled and sustained release of therapeutic levels of drug as the polymer softens and disperses from the stent into the adjacent tissue. These properties are intended to enhance safety as compared to conventional permanent polymer DES.
Using an approved drug (sirolimus) and polymer (PLGA), Micell’s patented supercritical fluid technology allows a rigorously controlled drug/polymer coating to be applied to a bare-metal stent. The MiStent SES leverages the benefits of a cobalt chromium coronary stent system, a state-of-the-art thin-strut bare-metal stent, which has demonstrated excellent deliverability, conformability and flexibility.
Results of animal studies have determined that the coating is cleared from the stent in 45 to 60 days leaving a bare-metal stent, and the polymer is completely absorbed into the surrounding tissue within 90 days to promote long-term patency and compatibility with the artery.
Micell was granted CE (Conformité Européenne) Mark approval for MiStent SES for the European Economic Union but is not approved in the United States or any other country. The three-year follow-up of DESSOLVE I and II clinical studies subjects was completed in 2014 and these patients continue to undergo long-term follow up.
About DESSOLVE I and DESSOLVE II Studies
The DESSOLVE I trial, the first clinical assessment of safety and efficacy of the MiStent SES®, treated thirty patients with de novo lesions in coronary arteries ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 23 mm length stent. Subjects were enrolled across five study centers in New Zealand, Australia and Belgium. Three independent subgroups of 10 patients each were evaluated using angiography, IVUS and OCT at three time points: four, six and eight months. The primary efficacy endpoint was in-stent late lumen loss. Safety was assessed by incidence of MACE and presence of strut coverage with tissue within the treated artery at each time point. William Wijns, M.D., Ph.D., Cardiovascular Center, Aalst, Belgium and John Ormiston, M.B.Ch.B., Mercy Angiography Unit, Auckland, New Zealand are co-principal investigators for this trial. Imaging results demonstrated no progression of late lumen loss beyond 6/8 months and at three years, MACE was 6.9% due to two non-target vessel MI, TLF was 0.0% and TLR was 0.0%.
The DESSOLVE II CE (Conformité Européenne) Mark trial is a randomized, multi-center study of patients with documented stable or unstable angina pectoris. The primary endpoint is superiority of the MiStent SES in minimizing in-stent late lumen loss at nine months, compared to Medtronic’s Endeavor® Sprint DES, as measured by an independent angiography core laboratory in de novo coronary lesions in vessels ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 30 mm length stent. The DESSOLVE II study completed enrollment of 184 patients in July 2011. Data analysis confirms that DESSOLVE II met all study objectives, demonstrated a competitive in-stent late lumen loss and achieved a strong signal of safety. At three years, MACE was 8.3%, TLF was 5.8% and TLR was 2.5%.
STENTYS is developing and commercializing innovative solutions for the treatment of patients with complex coronary artery disease. STENTYS’ Self-Apposing® Stents are designed to adapt to vessels with ambiguous or fluctuating diameters in order to prevent the malapposition problems associated with conventional stents. STENTYS has built a fast-growing commercial network in Europe and in many countries in the Middle East, Asia and Latin America. More information is available at www.stentys.com.
About Micell Technologies Inc.
Micell Technologies is a biomedical company that is enhancing the performance of cardiovascular medical devices with innovative drug-delivery systems. Its unique surface and polymer modification technologies enable Micell to precisely and consistently control drug elution and polymer exposure duration, creating the potential for a therapeutic solution to coronary artery disease without the long-term safety concerns of currently available drug-eluting stents. Micell is also developing a drug-coated balloon for vascular interventions. Visit us at www.www.micell.com.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements that can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements include words such as “anticipates,” “estimates,” “expects,” “projects,” “intends,” “plans,” “believes” and words and terms of similar substance in connection with the results of a post-marketing clinical program and the commercialization and sale of the MiStent SES® in Europe and other markets. We caution readers that the forward-looking statements contained in this press release are predictions based on our current analysis of and expectations about future events and speak only as of the date of this press release. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, including, but not limited to the following: the results of any further clinical trials and studies; our ability to obtain regulatory approval of the MiStent SES in other jurisdictions; the successful development and commercialization of the MiStent SES in Europe and other markets; the ability of the MiStent SES to effectively and successfully compete with current commercially available drug-eluting stent technologies in Europe and other markets; and our ability to maintain and protect our proprietary stent coating technology. Actual results, performance or achievements could differ materially and adversely from those expressed or implied by any forward-looking statement contained in this press release.
Micell, Micell Technologies, the Micell Logo, MiStent and MiStent SES are among the trademarks of Micell Technologies, Inc.
Contact for Micell Technologies
Arthur J. Benvenuto, Chairman CEO