MOUNTAIN VIEW, CA , May 18, 2016 (GLOBE NEWSWIRE) -- Amaranth Medical, a privately held medical device company, provided a clinical update on its ongoing RENASCENT-II study of its novel APTITUDE™ 120-micron sirolimus-eluting bioresorbable scaffold (BRS). This multi-center, international study is about to complete enrollment. Amaranth plans to use data generated from this study as part of the application process for a CE Mark. RENASCENT-II is being conducted in Italy and Colombia (South America), and is led by co-primary investigators Dr. Antonio Colombo (director of the Hemodynamics Division at Ospedale San Raffaele in Milan, Italy) and Dr. Juan F. Granada (executive director and chief innovation officer of the CRF-Skirball Center for Innovation). Interim study results are expected to be presented at the Transcatheter Cardiovascular Therapeutics (TCT) meeting this fall.
Commenting on the study, Dr. Colombo noted, “While we must wait to assess the 9-month follow-up results before drawing long-term conclusions, our co-investigators are highly encouraged by the acute performance of this new thin-strut scaffold. In this study, conventional angioplasty techniques have been used in the majority of the cases, departing from the notion that BRS implantation is a complex procedure. At the present time, no major peri-procedural complications have been recorded and we found the thinner APTITUDE scaffold to be highly deliverable when navigating in more complex anatomies.”
Dr. Granada added, “Long-term human data with the 150-micron FORTITUDE® BRS validated the safety and efficacy of the Amaranth BRS technology. The development of the 120-micron APTITUDE BRS is a significant technological advance, offering a truly thin-walled scaffold capable of treating real-world patients. I believe that following proper clinical validation, this technology has the potential to be disruptive and rapidly adopted by the interventional community."
“If we continue to see positive results in the RENASCENT-II patients during the follow-up period, we plan to apply for CE Mark approval this year and to be in a position to commercialize APTITUDE in 2017,” concluded Kamal Ramzipoor, president and CEO of Amaranth. “While this is an enormous milestone for Amaranth, and one that we’re eagerly awaiting, we continue to be aggressive in our development of scaffolds with even thinner struts. We have leveraged our innovative polymer technology to develop the 4th-generation MAGNITUDE™ scaffold, which has a strut thickness in the sub-100-micron range. We expect to initiate a study with this scaffold later this year, which would be the first time a scaffold of this type will be tested in a large-scale clinical trial. We look forward to providing updates as we continue to advance the APTITUDE and MAGNITUDE clinical programs.”
About Amaranth Medical
Amaranth Medical, Inc. is a medical device company which has created a novel technology platform for the development and manufacturing of fully bioresorbable scaffolds. The Company’s products include the 150-micron FORTITUDE®, 120-micron APTITUDE™, and sub-100-micron MAGNITUDE™ scaffolds. Each are designed to afford the strength of metal stents to assist the artery during the remodeling process following an interventional procedure, without leaving behind a permanent implant with inherent clinical limitations. Amaranth Medical is headquartered in Mountain View, California, and its research and manufacturing operations are located both in Singapore and at its Silicon Valley headquarters. Amaranth Medical is led by Kamal Ramzipoor, and its investors include Charter Life Sciences, Bio*One Capital, Philip Private Equity, DCP Management and Venstar Capital.