Orchestra BioMed raises $111mln, achieves multiple FDA milestones.

• Orchestra BioMed raises $111mln in proceeds and committed capital. • Led by $71mln from Medtronic and Ligand. • Achieved FDA Breakthrough Device Designation for AVIM therapy. • FDA approves expanded BACKBEAT study enrollment criteria. • IDE approval for US pivotal Virtue SAB trial. • Versus commercially available paclitaxel-coated balloon.

Orchestra BioMed (NASDAQ: OBIO) has secured $111.2 million in proceeds and committed capital, extending its cash runway into the second half of 2027. The funding, led by $71 million from Medtronic and Ligand, will support the company's clinical development strategy for its atrioventricular interval modulation (AVIM) therapy and Virtue Sirolimus AngioInfusion Balloon (SAB) programs [2].

The company achieved several significant regulatory milestones in the second quarter of 2025. The FDA granted Breakthrough Device Designation for AVIM therapy, which addresses an unmet need in patients with uncontrolled hypertension and increased cardiovascular risk [1]. This designation provides Orchestra with prioritized review processes, more interactive communication with the FDA, and potentially accelerated approval pathways. Additionally, the FDA approved an important update to the BACKBEAT study protocol, expanding eligibility criteria and increasing the potential patient pool by 24-fold. This amendment aims to support the company's enrollment completion objectives for mid-2026 [1].

Orchestra BioMed also received IDE approval for the US pivotal trial of Virtue SAB, positioning it for a direct comparison against an established paclitaxel-coated balloon (AGENT DCB) [2]. This comparative trial design is expected to provide stronger evidence for regulatory approval and subsequent market adoption than trials against placebo or standard care.

Orchestra BioMed's strategic collaboration with Medtronic and Terumo, global leaders in medical technology, will drive successful global commercialization of its products. The company's expanded intellectual property portfolio, now comprising 137 issued patents worldwide, further strengthens its market position and potential partnership opportunities in both hypertension and heart failure therapeutic areas [2].

References:
[1] https://www.massdevice.com/fda-approves-expansion-orchestra-pacemaker-trial/
[2] https://www.stocktitan.net/news/OBIO/orchestra-bio-med-reports-second-quarter-2025-financial-results-and-nfbz912klbk7.html