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February 11, 2016 8:21 AM ET

Healthcare Equipment and Supplies

Company Overview of Angel Medical Systems, Inc.

Company Overview

Angel Medical Systems, Inc. develops cardiac medical devices for patients in Brazil. It offers AngelMed Guardian system, an implantable cardiac monitoring and alerting system, which detects and warns patients of acute episodes of cardiac ischemia related to the progression of coronary artery disease and thrombotic coronary occlusion caused by vulnerable plaque ruptures. The company’s AngelMed Guardian System components include an internal implantable device that is designed to detect, analyze, and record crucial heart signal data; vibrate to alert patients of cardiac events; and track ST deviations vs. heart rate for up to six months. Its AngelMed Guardian System components also include an e...

1163 Shrewsbury Avenue

Suite E

Shrewsbury, NJ 07702

United States

Founded in 2001

Phone:

732-542-5551

Fax:

732-542-5560

Key Executives for Angel Medical Systems, Inc.

Chief Executive Officer
Founder and Chairman of the Board
Age: 86
Chief Financial Officer
Chief Operating Officer
Vice President of Research & Development
Compensation as of Fiscal Year 2015.

Angel Medical Systems, Inc. Key Developments

Angel Medical Systems Announces FDA Advisory Committee Meeting for Review of the AngelMed Guardian System

Angel Medical Systems Inc. has announced that the Circulatory System Devices Panel (CSDP) of the U.S. Food and Drug Administration will review the company's Premarket Approval application for the AngelMed Guardian System at a meeting on March 16, 2016. The AngelMed Guardian system is an implantable cardiac monitor, designed to detect rapid changes in the heart's electrical signal caused by a coronary artery occlusion, the precursor to a heart attack. Once an occlusion is detected, the system alerts patients to seek medical care by delivering a series of vibratory, auditory, and visual warnings. The Advisory Committee will review data submitted in the PMA from the pivotal study of the Guardian System called ALERTS. This trial was a randomized, prospective study of 907 high-risk subjects who had experienced a previous heart attack or acute coronary syndrome event. All subjects were implanted with the Guardian System and assigned to have the alerting feature of the device either turned on or off for a 6-month period to assess whether Guardian System alerts reduced the composite incidence of death, new Q-wave myocardial infarction, or late presentation for thrombotic coronary occlusion events. In conjunction with the scheduling of the CSDP meeting, Angel Medical also received the final $10 million tranche of a milestone-based $40 million convertible note financing that had its initial closing in 2012.

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