Think Media Communications
FOR IMMEDIATE RELEASE
Angel Medical Systems, Inc. Receives Court Approval for its Chapter 11 Debt-For-Equity Reorganization
Paves the Way for Commercialization of the FDA Approved AngelMed Guardian® Implantable Cardiac Monitor and Alerting System
WILMINGTON, DELAWARE, FEBRUARY 14, 2019 – Angel Medical Systems, Inc., a medical device company, received court approval Monday for its Chapter 11 debt-for-equity reorganization, which paves the way to bring to market The AngelMed Guardian® System, the Company’s implantable cardiac monitor and patient alerting system.
Angel Medical Systems, Inc. received the court approval at a confirmation hearing in Wilmington, Delaware, before U.S. Bankruptcy Judge Kevin Gross. Company attorney Glenn Walter of Honigman LLP told the judge that Angel Medical Systems, Inc. is “poised and ready to launch” The AngelMed Guardianâ heart monitoring device, which received pre-market approval by the U.S. Food and Drug Administration in April 2018.
The Company commenced its Chapter 11 case on December 31, 2018, with support from senior creditors, to undertake a reorganization and eliminate all debt from its balance sheet to position the Company for long-term success. It has been business as usual for the Company throughout the process.
“This is an important step in our company’s nearly twenty years of effort to bring to market a better way to prompt patients having a heart attack or unstable angina to quickly get help whether they have symptoms or not,” said CEO Dr. David R. Fischell.
About The AngelMed Guardian® System
The AngelMed Guardian® System received pre-market approval by the U.S. Food and Drug Administration (FDA) in April 2018. It is an implantable cardiac monitor with patient alerting for patients who have had prior Acute Coronary Syndromes (ACS), including myocardial infarctions (heart attacks) or unstable angina and who remain at high risk for recurrent ACS events. The AngelMed 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.
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.
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, such as risks related to product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the Company’s products to patients, market and physician acceptance of the Company’s products, intellectual property protection and competitive product offerings, could cause actual events to differ from the expectations indicated in these forward-looking statements. You are cautioned not to put any undue reliance on any forward-looking statement. This press release is neither an offer to sell nor a solicitation of an offer to purchase any particular securities. Any such offer or solicitation will be made only pursuant to definitive legal agreements prepared specifically for such purpose. An investment in the Company’s securities entails significant risks and is suitable only for sophisticated investors who can afford a loss of their entire investment; no assurance can be given that investment objectives will be achieved. In considering the performance information contained herein, you should bear in mind that past performance is not necessarily indicative of future results; there can be no assurance that the Company will achieve comparable results or that any projected returns will be met. The Company does not assume any obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events, or otherwise.
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