Amaranth Medical initiates clinical trial of the second-generation FORTITUDE bioresorbable drug-eluting scaffold

Amaranth Medical, a privately held medical device company, announced the initiation of patient enrollment in multiple centers in Colombia, South America in MEND-II, a clinical trial to assess safety and feasibility of the Company's FORTITUDE(R) Sirolimus-Eluting Bioresorbable Scaffold in patients with symptomatic coronary artery disease. As seen with the first generation scaffold, preliminary patient results using optical coherence tomography (OCT) following implantation show that the scaffolds were fully apposed to the vessel wall achieving optimal acute lumen gain. Additional details of Amaranth's bioresorbable scaffold program will be presented at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) Meeting during the didactic symposium: Bioresorbable Vascular Scaffolds: The 4th Revolution?

"The FORTITUDE Sirolimus-Eluting Bioresorbable Scaffold is designed to have comparable mechanical strength and durability to our bare bioresorbable scaffold, while also providing the controlled release of sirolimus to reduce the risk of restenosis." said Kamal Ramzipoor, chief executive officer of Amaranth. "We look forward to advancing FORTITUDE through this clinical trial and initiating a study next year in Europe, both of which will support our planned application for CE Mark."

Complete 12-month clinical follow-up results on the 13 patients enrolled in MEND-I, Amaranth's clinical study of the bare FORTITUDE(TM) bioresorbable scaffold, will also be presented in the aforementioned didactic symposium at TCT. All patients enrolled in MEND-I have completed their one-year follow-up visits. This study met its primary endpoint of six-month incidence of target vessel failure with no incidents of stent thrombosis or mechanical failure. Importantly, late lumen loss, as confirmed by an independent core lab, was shown to be comparable to that of bare metal stents.

Juan F. Granada, M.D., executive director and chief innovation officer of the CRF-Skirball Center for Innovation (SCI) and primary investigator of the Amaranth clinical program, added, "We are encouraged by the positive results from MEND-I, especially in terms of the biocompatibility profile of the polymer. It is notable that FORTITUDE appears equivalent in its biological response to metal stents, which represents a significant leap forward in the advancement of the science and processing technology of these polymers. Further, while the FORTITUDE Sirolimus-Eluting Bioresorbable Scaffold is still in early stages of enrollment, it appears to have similar mechanical behavior but enhanced deliverability compared to the first-generation bare scaffold."

Details of Amaranth's clinical findings will be provided by Dr. Granada in a presentation titled: "BRS with Clinical Data III - Amaranth: Differentiating Features and Clinical Update," which takes place at 4:04pm ET on Tuesday, September 16th within the didactic symposium: Bioresorbable Vascular Scaffolds: The 4th Revolution?

About the FORTITUDE Studies

The Amaranth MEND-I and MEND-II studies are prospective, non-randomized, investigational studies to assess the safety and feasibility of the FORTITUDE(TM) Bioresorbable Scaffold and the second-generation FORTITUDE(R) Bioresorbable Drug-Eluting Scaffold. The studies will enroll patients in multiple centers in Colombia who have symptomatic coronary artery disease who are undergoing percutaneous coronary intervention (PCI) with single coronary lesions. MEND-I and MEND-II study participants will be evaluated at six and nine months, respectively; participants in both studies will also be assessed at two years following implantation.

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 lead product is the FORTITUDE(TM) scaffold, which is 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.