Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its Virtue SAB.
The IDE enables the Virtue ISR-US pivotal study. It evaluates Virtue SAB, a novel AngioInfusion balloon for treating artery disease, in treating patients with coronary ISR.
New Hope, Pennslyvania-based Orchestra BioMed designed Virtue SAB to enable the protected delivery of SirolimusEFR to the artery. The device delivers the proprietary, investigational, extended-release formulation of sirolimus during balloon angioplasty. Its design doesn’t require balloon coating or a permanent implant.
Orchestra BioMed believes its Virtue SAB could address a significant unmet clinical need and improve outcomes, according to a news release.
“This IDE approval and forthcoming pivotal study reflect our commitment to accelerating innovation through our differentiated, partnership-enabled business model,” said Darren Sherman, president, COO and founder of Orchestra BioMed. “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.”
The company said its approval came on the heels of “encouraging” three-year follow-up from its pilot SABRE study. The European clinical trial evaluated coronary ISR patients.
Virtue ISR-US, a randomized, prospective, double-blind, multi-center, controlled study compares Virtue SAB against plain old balloon angioplasty (POBA). The study has a primary efficacy and safety endpoint of target lesion failure at 12 months.
Orchestra BioMed plans to randomize approximately 300 patients 2:1 to Virtue SAB or POBA. It also plans to enroll a non-randomized arm of approximately 100 patients with double-layer coronary ISR for treatment with Virtue SAB.