Research

Description:

Orange County Heart Institute & Research Center Announces FDA Approval

of World’s First and Only Implantable Cardiac Monitor and Patient Alerting System for Acute Coronary Syndromes (ACS) after its

Participation in the ALERTS Clinical Study

The ‘AngelMed Guardian System’ Designed to Warn

High Risk Patients of Potential ACS (MI or Unstable Angina)

ORANGE COUNTY HEART INSTITUTE & RESEARCH CENTER, ORANGE CA, May 11, 2018 - Dr. Kelly Tucker of Orange County Heart Institute & Research Center announces that the ‘AngelMed Guardian® System’. has received U.S. Food and Drug Administration (FDA) premarket approval (PMA).

The AngelMed Guardian System is an implantable cardiac monitor with patient alerting capability and an additional external alarm device. It is indicated for use in patients who have had prior ACS events including myocardial infarctions (heart attacks) or unstable angina and who remain at high risk for recurrent ACS events. The Guardian System is an adjunct to patient recognized symptoms by detecting potential ongoing ACS events, characterized by sustained ST segment changes, and alerting the patient to seek medical attention for those events.

Approval of the ‘AngelMed Guardian System’ by the U.S. FDA was based on preclinical and clinical data, including data derived from the ALERTS Clinical Study that began in 2009. Orange County Heart Institute & Research Center was among the one hundred centers across the U.S. that participated in the ALERTS Clinical Study, with 910 patients implanted. The ALERTS Clinical Study concluded in 2015 after accumulating 3,450 implant years of follow-up data.

"The AngelMed system represents a huge move forward in medical technology and allows physicians now for the first time to detect silent events. This is going to save hundreds of thousands of lives each year. It's a wonderful device." said Orange County Heart Institute & Research Center Electrophysiologist, Dr. Kelly J. Tucker.

“We are so thankful to Dr. Kelly J. Tucker, Principle Investigator and Karena De La Mora, Research Coordinator at Orange County Heart Institute & Research Center for all of their efforts during the ALERTS Clinical Study. Without their dedication and hard work, we would never have reached approval. We will also be forever thankful to the patients who participated in our clinical study. We have worked tirelessly to bring this device to market to fill this unmet need that addresses a life-threatening condition and may improve their quality of life." said Angel Medical System’s Chief Executive Officer, Dr. David R. Fischell.

The national principal investigator for the ALERTS pivotal clinical study, Dr. C. Michael Gibson of Harvard Medical School, states: "Patients who have had a recent acute coronary syndrome often remain at a high risk of a recurrent event. The AngelMed Guardian System has shown it can identify true heart problems better than patients' symptoms alone as well as in those patients who have no symptoms."

"Helping our patients was always foremost in our minds and hearts." said Angel Medical System’s Chief Operating Officer, David Keenan.

The Guardian System is implanted like a pacemaker, typically in less than an hour under a local anesthetic. This well-studied implantation technique demonstrated an adverse event rate that was also very similar to the rate seen for pacemaker implants. The types of adverse events seen were also similar to those seen with pacemaker implants.

About Coronary Heart Disease and Heart Attacks

According to the American Heart Association, one of every five deaths in the U.S. is attributable to coronary heart disease, making heart attacks the number 1 killer nationwide. Early detection of heart attacks and prompt intervention has been shown to improve clinical outcomes.Despite efforts to educate the public over the past decade, the time from heart attack (MI) symptom onset to arrival at a hospital for treatment has not changed.

In the ALERTS Clinical Study, the median time from symptom onset to arrival at the hospital for a heart attack was one hour.

About Angel Medical Systems, Inc.

Angel Medical Systems, Inc. was founded in 2001 by Drs. Robert, Tim and David Fischell, active serial entrepreneurs and inventors of medical devices. In 1999, the company filed its first of more than 50 issued US patents relating to detecting cardiac events and patient alerting, with the company’s first human implant occurring in 2005.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans, regulatory approvals and product performance and impact. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements.

These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.