January 22, 2017 3:41 PM ET

Healthcare Equipment and Supplies

Company Overview of Amaranth Medical, Inc.

Company Overview

Amaranth Medical, Inc., a medical device company, develops and manufactures bioresorbable scaffolds for vascular and nonvascular applications. It offers FORTITUDE, a bioresorbable coronary scaffold that assists the artery during the remodeling process following an interventional procedure. The company was incorporated in 2005 and is based in Mountain View, California. It has research and manufacturing operations in Singapore; and Silicon Valley, California.

1145 Terra Bella Avenue

Mountain View, CA 94043

United States

Founded in 2005

Phone:

650-965-3830

Fax:

650-965-3831

Key Executives for Amaranth Medical, Inc.

Chief Executive Officer, President and Director
Executive Chair
Vice President of Operations
Senior Vice President of Regulatory, Clinical and Quality
Vice President of Research and Development
Compensation as of Fiscal Year 2016.

Amaranth Medical, Inc. Key Developments

Amaranth Medical Announces 9-Months Clinical and Imaging Results of the FORTITUDE Sirolimus-Eluting Bioresorbable Scaffold

Amaranth Medical announced that a presentation of the 9-month clinical and imaging results from the company’s FORTITUDE® sirolimus-eluting bioresorbable scaffold (BRS) took place during the First Report Investigations session at the Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium on October 31st. Dr. Antonio Colombo, co-principal investigator and director of the Hemodynamics Division at Ospedale San Raffaele in Milan, Italy presented the main clinical and imaging findings from the 62 patients who received the FORTITUDE scaffold. In addition to FORTITUDE, Amaranth has developed the thinner-strut APTITUDE™ 115-micron sirolimus-eluting BRS. APTITUDE is being tested in the RENASCENT-II study, which completed enrollment in May 2016. Short-term results showed the device to be highly deliverable in more complex anatomies, while retaining a high radial strength. In the patients who have completed their nine-month imaging follow-up, the APTITUDE scaffold continues to show comparable clinical results and mechanical stability compared to the validated FORTITUDE scaffold. The company anticipates initiating an application for a CE Mark this quarter for APTITUDE, with an expectation that the CE Mark could be granted by the end of 2017.

Amaranth Medical Reports Findings from Two FORTITUDE Bioresorbable Scaffold Studies

Amaranth Medical announced clinical results from the company's ongoing trial of its second-generation FORTITUDE sirolimus-eluting bioresorbable scaffold (BRS). The FORTITUDE sirolimus-eluting BRS is being evaluated in two multi-center, international trials, both of which are designed to support a planned application for CE Mark. In this clinical program, a total 49 patients have been treated in centers in Colombia, South America (MEND-II trial) and Italy (RENASCENT trial). Early preliminary results from these studies demonstrate the scaffold's capabilities to navigate through complex anatomies with a balance of deliverability and biomechanical performance. No peri-procedural complications have been reported to date. The MEND-II and RENASCENT trials are built upon the successful results from the first-in-human clinical study of Amaranth's bare FORTITUDE BRS, MEND-I, which was conducted in Colombia, South America. This study met its primary endpoint at six months. Patients who had been enrolled in MEND-I continue to show excellent clinical performance two years after implant. Further, angiographic and OCT follow-up demonstrate late lumen gain in treated vessels at two years, relative to six months.

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