DCRC launches a leading medical device study with several hospitals in Michigan
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03-11-2013: Farmington Hills, Michigan.

Botsford Hospital and the Detroit Clinical Research Center investigates heart attack early-detection device.

First AngelMed Guardian System implanted in Farmington Hills as part of new study.

Botsford Hospital and cardiologist Robert Grodman, D.O., the principal investigator of the ALERTS Pivotal Study at Botsford, today announce their first implant of the AngelMed Guardian Cardiac Monitor and Alert System. The system is designed to reduce the time it takes patients to get to the emergency room during an impending heart attack. Majid Qazi, D.O., performed this implant in the Farmington Hills hospital and is among the very first physicians across the United States to implant the experimental device.

The AngelMed Guardian System is designed to track significant changes in the heart's electrical signal and then alert patients to seek medical attention. The objective of the ALERTS Pivotal Study is to provide an assessment of the safety and effectiveness of the AngelMed Guardian System.

Robert Gabler of Applegate, Michigan, is among the first patients in Michigan enrolled in the ALERTS Study to receive the AngelMed Guardian System. He suffers from unstable angina and has had previous myocardial infarctions. His most recent event was last December. Gabler is also diabetic and has a high TIMI score. He was worried about future cardiac events and believed this device would be a great fit for him. Gabler was successfully implanted with the device on February 12, 2013, by Dr. Qazi at Botsford Hospital.

Dr. Grodman states, “This study provides an excellent opportunity for some of our patients who are at high-risk of having another heart attack. The device is designed to measure changes in the electrical signal of the heart and alert the patient at the earliest onset of a heart attack so that he or she can get treatment as soon as possible.”

According to the American Heart Association, one of every five deaths in the US is attributable to coronary heart disease. Further, 50 percent of heart-attack fatalities occur within one hour of symptom onset and occur before the patient even reaches the hospital.

The AngelMed Guardian System is comprised of an internal implantable device about the size of a standard pacemaker with a lead into the heart, an external telemetry device, and a programmer that aids physicians in evaluating heart signals.

Botsford Hospital, in conjunction with the Detroit Clinical Research Center, is among the first medical facilities to participate in the AngelMed Guardian System trial. To participate in the ALERTS Study, patients must meet various inclusion criteria. For more information on the AngelMed Guardian System or the ALERTS Study protocol, contact Candice Shallal at (248) 716-7010 or candice.shallal@dcrc.us .

Forward Looking Statements: Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits are forward-looking statements. A number of risks and uncertainties could cause actual events to adversely differ from the expectations indicated in these forward looking statements. These would include risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of AngelMed’s products to patients, market and physician acceptance of the products, intellectual property protection, and competitive product offerings.

Media Contacts:

Lynn Anderson, Director of Marketing & Public Relations, or Beth Montalvo, Coordinator, Publications and & Media Relations

Botsford Hospital 28050 Grand River Ave. Farmington Hills, MI 48335 (248) 442-7986