Angel Medical Systems, Inc., manufacturer of an implantable cardiac monitor designed to alert patients to potential recurrent acute coronary syndrome events, announced that it has filed for Chapter 11 bankruptcy.
The Eatontown, N.J.-based company said in news release on Monday, Dec. 31, 2018, that the bankruptcy filing and resulting restructuring of its balance sheet “best position the Company to bring to market Angel Medical Systems’ The Guardian® implantable cardiac monitor and alerting system.”
“Operations will remain ongoing during the reorganization process, and manufacturing efforts will continue to move forward to successfully commercialize The Guardian®,” Dr. David R. Fischell, Angel Medical Systems’ CEO, said in the release. “With a stronger balance sheet and greater financial flexibility to grow, we look forward to serving patients around the world.”
The Guardian® System received pre-market approval from the U.S. Food and Drug Administration (FDA) in April 2018. It is an implantable cardiac monitor with an alert system for patients who have had prior acute coronary syndromes (ACS), including myocardial infarctions 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.
In a letter sent to investigators of the ALERTS trial, the results of which led to FDA’s pre-market approval of The Guardian, Fischell and David Keenan, Angel Medical’s chief operating officer, reiterated the company’s plan to commercialize the device in 2019.
“This is a temporary step and is being done with the assistance of our legal and business consultants in order to resolve issues associated with what has become (over the past 16 years of development and clinical trials) a very complicated balance sheet,” Fischell and Keenan wrote. “The positive news is that this restructuring has been helpful in attracting new funding which will enable a strong commercial launch when we exit the reorganization. Our goal is to ship new, FDA approved Guardian® systems with a 6-year battery, in the 4th quarter of 2019!”