Orchestra BioMed Granted FDA Approval of IDE for U.S. Pivotal Study of Virtue Sirolimus AngioInfusion Balloon in Patients with Coronary In-Stent Restenosis

• Virtue Sirolimus AngioInfusion Balloon (“SAB”) is the only non-coated angioplasty system providing protected delivery of extended release sirolimus under clinical investigation worldwide
• Virtue ISR-US pivotal study focused on coronary in-stent restenosis (“ISR”), a difficult-to-treat and serious complication of coronary stenting, currently expected to start before the end of 2023
• Strategic partnership with Terumo Corporation (“Terumo”) targets coronary ISR and multiple additional vascular indications for Virtue SAB globally
  

NEW HOPE, Pa., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced the U.S. Food and Drug Administration (the “FDA”) granted investigational device exemption (“IDE”) approval with conditions to initiate the Virtue ISR-US pivotal study evaluating the efficacy and safety of Virtue 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, a proprietary, investigational, extended release formulation of sirolimus, to the artery during balloon angioplasty without the need for balloon coating or a permanent implant.

“We believe that Virtue SAB has the potential to address a significant unmet clinical need and improve outcomes for a patient population with suboptimal treatment options. In a field currently dominated by paclitaxel-coated balloons, Virtue SAB is the only device that provides protected delivery of extended release sirolimus, the class of drugs used on all currently marketed coronary drug-eluting stents, to the treated artery during angioplasty without the need for a coating or a permanent implant,” commented Darren R. Sherman, President, Chief Operating Officer and Founder of Orchestra BioMed. “This IDE approval and forthcoming pivotal study reflect our commitment to accelerating innovation through our differentiated, partnership-enabled business model. We look forward to continued collaboration with our partners at Terumo, as well as with the FDA as we work to deliver this highly differentiated, leave-nothing-behind therapy to patients.”