DURHAM, N.C., August 20, 2015 — Micell Technologies, Inc. announced that its application for a manufacturing partner, Surgical Technologies, Inc. (STI), was approved by British Standards Institution (BSI) to begin full-scale manufacturing of Micell’s MiStent SES® Sirolimus Eluting Absorbable Polymer Coronary Stent System for commercial distribution in the European Union and other countries where the CE Mark is accepted. STI will be the primary contract manufacturer of MiStent SES, a new drug-eluting stent with a bioabsorbable coating designed to promote optimal healing in patients with coronary disease.
“We are excited to join the team that is bringing this new class of medical device to people suffering with coronary artery disease,” said Timothy M. Scanlan, President and Chief Executive Officer of STI and its parent company, Scanlan International. “As a pioneer in medical contracting, STI is well suited to partner with Micell to execute commercial-volume manufacturing. Micell’s uniquely efficient manufacturing process enables scalable, high-yield throughput within a small footprint.”
Arthur J. Benvenuto, Micell’s Chairman and Chief Executive Officer said, “With STI’s expertise and performance in full-service medical device contracting and Micell’s highly efficient manufacturing process, we are accommodating the controlled commercial launch of MiStent SES in CE Mark countries as well as supplying clinical trials currently being conducted in Europe and China. We also are prepared to support a commercial launch in China once granted regulatory approval.”
MiStent SES received a CE Mark in the European Union and is commercially available through Micell’s distribution partner, STENTYS. STENTYS introduced MiStent SES earlier this year in Western Europe via a controlled launch and will expand availability of MiStent SES in the second half of 2015 to selected countries within the Middle East, South-East Asia and Latin America. Micell is currently pursuing regulatory approval in China, Hong Kong and Macau. Upon completion, MiStent SES will be distributed exclusively by Hefei Life Science Technology Park Investment and Development Co., Ltd. (Hefei Life Science). MiStent SES is not approved for sale or use in the United States by the Food and Drug Administration (FDA).
About MiStent SES
MiStent SES® is designed to optimize healing in patients with coronary artery disease. The rapidly absorbable coating of MiStent SES, which contains crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for local drug delivery and limit the duration of polymer exposure. These characteristics potentially reduce the safety risks associated with currently commercially available drug-eluting stents.
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. MiStent SES leverages the benefits of a cobalt chromium coronary stent system — a state-of-the-art, thin-strut, bare-metal stent that has demonstrated excellent deliverability, conformability and flexibility.
The European Union’s approval of MiStent SES was supported by clinical data from two studies, DESSOLVE I and II. DESSOLVE II demonstrated superior in-stent late lumen loss rates and an excellent safety profile. Four-year DESSOLVE II data will be presented at TCT in October 2015. The three-year follow-up of the DESSOLVE clinical studies subjects was completed in 2014, and these patients continue to undergo long-term follow-up. In 2015, clinical sites in China began enrolling patients in DESSOLVE C, a prospective, single-blind, multi-center, randomized, controlled clinical trial to demonstrate MiStent SES’ efficacy and safety. DESSOLVE C, intended to support regulatory approval of MiStent SES in China, is being sponsored by Hefei Life Science in conjunction with Micell.
MiStent SES is not approved for sale or use in the United States by the FDA.
About Supercritical Fluid Technology and its Advantages
Micell’s supercritical fluid technology is designed to confer unique advantages in modifying and coating biomedical surfaces with advanced polymers and drugs. By combining electrostatic attraction with supercritical fluids, Micell hopes to create surface modifications for a broad range of medical devices with a variety of polymers and drugs. The supercritical fluid process is designed to allow the use of therapeutic agents that may be compromised by the elevated temperatures or solvents used in traditional processes. This technology has yielded not only the MiStent SES but also a proprietary manufacturing process that may confer competitive advantages by optimizing productivity while minimizing wasted resources.
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, China 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, China 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.
