Orchestra BioMed Reports Third Quarter 2026 Financial Results and Highlights Recent Business Updates
Key Highlights
- ➤BACKBEAT enrolled 349 patients across 92 sites in 15 countries
- ➤Primary endpoint data planned for late-breaking HRS 2027 presentation
- ➤Medtronic plans AVIM Therapy PMA supplement submission assuming positive trial results
- ➤Virtue Trial targets approximately 740 patients, with completion targeted by end of 2027
- ➤Public offering generated approximately $80.5 million in net proceeds
- ➤Haemonetics milestone payment added $6.1 million, bringing transaction proceeds to approximately $11 million
Expert Statements
David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed
“With the completion of enrollment of the BACKBEAT Trial, AVIM Therapy is nearing pivotal primary endpoint results. Alongside our collaborators at Medtronic, we now move to the completion of three-month follow-up in all patients, locking the primary endpoint database, and submitting a robustly powered data set for late-breaking presentation at HRS 2027 in May. We believe the results from the BACKBEAT Trial could set AVIM Therapy on a clear course to redefining the clinical impact of cardiac pacing and provide a powerful new therapeutic option for millions of higher-risk hypertensive patients who remain above blood pressure target despite medication.”
David Hochman, Chairman and Chief Executive Officer of Orchestra BioMed
“The third quarter also saw Virtue Sirolimus AngioInfusion™ Balloon advance in its own IDE pivotal, randomized trial. The Virtue(®) Trial is testing Virtue SAB’s fundamentally different approach to arterial drug delivery, liquid infusion of SirolimusEFR™ directly into the vessel wall without the need for a fragile balloon coating. We are also grateful to our new and existing shareholders that participated in the oversubscribed public equity offering we closed yesterday. The net proceeds from our public offering along with the over $100 million we had at the end of the quarter provide funding through 2028. We are in a strong position to deliver key value-creating milestones for both pivotal stage programs and support Medtronic as they drive toward potential global commercialization of AVIM Therapy. We look forward to showcasing both of our high-impact therapeutic device platforms at our investor R&D Day this Thursday, where leading physician investigators will join us to examine the clinical and commercial potential of AVIM Therapy and Virtue SAB.”
* BACKBEAT Global Pivotal Trial evaluating AVIM Therapy completed enrollment and exceeded enrollment target, with a total of 349 patients randomized. * BACKBEAT Trial primary endpoint data planned to be submitted for late-breaking presentation at the Heart Rhythm Society 2027 (“HRS 2027”). * Medtronic planning to submit AVIM Therapy Premarket Approval (“PMA”) supplement to the FDA following data presentation, assuming positive trial results.
* Site activation and patient enrollment accelerating in the Virtue Trial, the Company’s U.S. Investigational Device Exemption (“IDE”) pivotal trial comparing Virtue SAB head-to-head with the commercially available AGENT™ paclitaxel-coated balloon for coronary In-Stent Restenosis. * Raised approximately $80.5 million in net proceeds through an underwritten public offering of common stock, which closed on November 9, 2026, including proceeds from the underwriters’ full exercise of their option to purchase additional shares. * $101.9 million of cash and cash equivalents, and marketable securities as of September 30, 2026 and public offering proceeds provide projected cash runway through 2028.
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