secwatch.observer — SEC 8-K summary
======================================

Issuer:     Orchestra BioMed Holdings, Inc. (OBIO)
CIK:        0001814114
Form:       8-K
Filed at:   2025-10-28T23:59:59+00:00
Accession:  0001104659-25-102862
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 1.01, 1.02, 3.02, 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Orchestra BioMed restructures Terumo deal: $30M total, retains Virtue SAB rights, starts pivotal trial
--------------------------------------------------------------------------------

- Terumo pays $10M for ROFR on Virtue SAB coronary rights globally; $20M equity investment via Series A convertible preferred at $100/share.
- Prior $30M non-refundable payment and $5M common stock investment unchanged; Terumo total commitment now $65M.
- Orchestra BioMed retains full rights for below-the-knee peripheral artery disease and other non-coronary indications.
- First patients enrolled in Virtue Trial (U.S. pivotal IDE for coronary ISR, 740 patients, enrollment mid-2027).
- Virtue SAB has FDA Breakthrough Device Designation; pilot data showed 12-month TLF 2.8% and zero TLR from 12–36 months.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1814114/000110465925102862/0001104659-25-102862-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1814114/000110465925102862/tm2529597d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-102862

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer