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August 01, 2015 1:48 AM ET

Healthcare Equipment and Supplies

Company Overview of Amaranth Medical, Inc.

Company Overview

Amaranth Medical, Inc. operates as a medical device company that develops and manufactures fully bioresorbable scaffolds. The company was incorporated in 2005 and is based in Mountain View, California with its research and manufacturing operations in Singapore and California.

1145 Terra Bella Avenue

Suite A

Mountain View, CA 94043

United States

Founded in 2005

Phone:

650-965-3830

Fax:

650-325-4762

Key Executives for Amaranth Medical, Inc.

President and Chief Executive Officer
Vice President of Operations
Senior Vice President of Regulatory, Clinical, and Quality
Vice President of Research and Development
Compensation as of Fiscal Year 2015.

Amaranth Medical, Inc. Key Developments

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.

Amaranth Medical Reports Positive Safety and Feasibility Findings for the FORTITUDE(TM) Bioresorbable Scaffold

Amaranth Medical presented positive six-month angiographic results from its first-in-human study including patients undergoing percutaneous coronary intervention (PCI) with single coronary lesions. The FORTITUDE(TM) non-drug eluting bioresorbable scaffold was successfully delivered in 12 patients within the target lesion. Post-deployment angiographic and IVUS analysis indicated that the FORTITUDE scaffold maintained its mechanical integrity, showing no indication of vessel recoil or other structural failures. At the time of the presentation, 10 patients had completed six-month angiographic follow up and six patients had available independent angiographic analysis indicating 0% binary restenosis. The data was presented at the "Next generation DES and bioabsorbable scaffolds" session at the Transcatheter Cardiovascular Therapeutics (TCT) meeting on October 27, 2013 in San Francisco, CA. Six-month angiographic follow-up data is available on 10 of the 13 patients enrolled in the first cohort and demonstrate excellent biomechanics and biocompatibility of the scaffolds. An independent core laboratory has reviewed findings on the first six patients, and affirmed that late lumen loss is similar to that observed with bare metal stents. Intravascular ultrasound and optical coherent tomography (OCT) images indicate that the scaffolds are fully opposed to the vessel walls with no indication of recoil or other compromise to their mechanical integrity.

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