Orchestra BioMed Holdings, Inc. announced the U.S. Food and Drug Administration granted investigational device exemption approval with conditions to initiate the Virtue ISR-US pivotal study evaluating the efficacy and safety of Virtue(R) SAB for the treatment of patients with coronary ISR. Virtue SAB is a novel AngioInfusion balloon for the treatment of artery disease that is designed to enable protected delivery of SirolimusEFR(TM), a proprietary, investigational, extended release formulation of sirolimus, to the artery during balloon angioplasty without the need for balloon coating or a permanent implant. The Virtue SAB IDE approval was supported by encouraging three-year follow-up results from the pilot SABRE Study, a European multi-center, prospective, independent core lab-adjudicated clinical trial in coronary ISR patients. The Virtue SAB pivotal study is a randomized, prospective, double-blind, multi-center, controlled study of Virtue SAB vs.

Plain Old Balloon Angioplasty ("POBA") in the treatment of single-layer coronary ISR. In parallel to the randomized arm of the study, Orchestra BioMed plans to enroll a non-randomized arm consisting of approximately 100 participants with double-layer coronary ISR for treatment with Virtue SAB. Dean J. Kereiakes, M.D., FACC, MSCAI, President of The Christ Hospital Heart & Vascular Institute, Medical Director of The Christ Hospital Research Institute, Professor of Clinical Medicine at The Ohio State University, and the Principal Investigator for the Virtue ISR-US study commented, "Virtue SAB's differentiated design, as well as the encouraging three-year clinical results from the pilot SAB RE study make it a potentially compelling treatment option for coronary ISR disease indications. The Company is permitted to begin enrollment upon completion of standard clinical trial initiation activities including clinical center Institutional Review Board approvals.

The conditional approval also requires the Company to submit additional information to the FDA. The only device treatments currently approved by the FDA for use in coronary ISR lesions are balloon angioplasty and intravascular radiation therapy known as brachytherapy. Virtue SAB has been granted Breakthrough Device designation by the FDA for specific indications relating to coronary ISR, coronary small vessel disease and peripheral artery disease below-the-knee.

Orchestra BioMed's partnership-enabled business model focuses on forging strategic collaborations with leading medical device companies to drive successful partnerships with leading medical device companies to deliver successful clinical studies.