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AI brief of an SEC Form 8-K · Orchestra BioMed Holdings, Inc. (OBIO)

Orchestra BioMed Enrolls 330 Patients in BACKBEAT Trial, Exceeding 316 Target

Neutral Impact 3 of 5 other Written later

Orchestra BioMed said that as of September 30, 2026, 330 patients had been randomized in the BACKBEAT pivotal trial of its AVIM Therapy, above the previously announced target of 316. The company reiterated that primary endpoint data are expected to be submitted for a late-breaking presentation at a major cardiovascular conference in the second quarter of 2027, with Medtronic planning marketing applications if results are positive. The filing contains no financial results, so the update is a clinical development milestone rather than a change in reported financial performance.

Key points

  • 330 patients randomized as of September 30, 2026, versus a target of 316 to account for potential loss to follow-up
  • Trial protocol specifies 284 evaluable randomized subjects for the primary endpoint analysis
  • Trial conducted at 81 sites across 13 countries with Medtronic plc as strategic collaborator
  • Primary endpoint results to be submitted for a late-breaking presentation in Q2 2027

The filing

CompanyOrchestra BioMed Holdings, Inc. (OBIO)
Form8-K, current report
Filed with the SECOct 1, 2026, 8:14 AM ET
Accession number0001104659-26-112586

Items reported: 7.01 Regulation FD Disclosure8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 01, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.