Welcome to our dedicated page for Orchestra BioMed Holdings news (Ticker: OBIO), a resource for investors and traders seeking the latest updates and insights on Orchestra BioMed Holdings stock.
Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) generates news primarily around its cardiovascular device programs, strategic partnerships and capital markets activity. The company describes itself as a biomedical innovation platform that advances high-impact technologies to patients through collaborations and risk-reward sharing agreements with global medical device companies, which often leads to announcements of new agreements, trial milestones and financial transactions.
News coverage for Orchestra BioMed frequently highlights progress in its two flagship product candidates: Atrioventricular Interval Modulation (AVIM) Therapy for hypertension and the Virtue Sirolimus AngioInfusion Balloon (Virtue SAB) for atherosclerotic artery disease. Investors can expect updates on pivotal clinical trials such as the BACKBEAT global study for AVIM Therapy and the Virtue Trial, a U.S. IDE pivotal trial comparing Virtue SAB to a commercially available paclitaxel-coated balloon in coronary in-stent restenosis.
The company’s releases also detail strategic collaborations and rights agreements, including its partnership with Medtronic for AVIM Therapy and a right of first refusal arrangement with Terumo related to Virtue SAB for coronary artery disease. Additional news items describe revenue participation and financing agreements with partners such as Ligand Pharmaceuticals, as well as public offerings, private placements and preferred stock issuances that support its clinical programs.
On this OBIO news page, readers can review company press releases, third-party announcements referencing Orchestra BioMed and regulatory-related communications. Topics typically include clinical data presentations, conference participation, updates on FDA Breakthrough Device Designation status for AVIM Therapy and Virtue SAB, and disclosures of material agreements filed via Form 8-K. Investors and researchers who follow developments in device-based hypertension therapy and drug-delivery balloons for coronary and peripheral artery disease may find this news feed particularly relevant.
Orchestra BioMed (NASDAQ: OBIO) expects to receive up to $21 million in cash proceeds from the sale of its strategic holding Vivasure to Haemonetics, which closed on January 9, 2026. Orchestra expects $11 million in 2026 (approximately $5 million upfront and ~$6 million milestone) with the remainder payable via future revenue earnouts tied to milestones. Vivasure’s PerQseal Elite is CE marked for arterial and venous indications, has a PMA filed with the FDA in 2025, and reported 0% major complications at 30 days in the ELITE arterial study.
Vivasure Medical was acquired by Haemonetics (NYSE: HAE) in a transaction valued up to €185M (~$215M) payable on completion of certain milestones. Vivasure, based in Galway, develops fully absorbable polymer implants and delivery systems for minimally invasive arterial and venous vessel closure. Vivasure previously received an expanded CE mark for PerQseal Elite covering large-bore venous closure and has submitted a PMA application to the FDA for PerQseal Elite for arterial procedures. Haemonetics made a strategic investment in Vivasure in 2022 that included an acquisition option. PerQseal products are not currently available for sale in the United States.
Orchestra BioMed (Nasdaq: OBIO) announced three presentations at the 2025 Innovation in Cardiology Intervention (ICI) meeting in Tel Aviv on December 8–9, 2025. Two talks cover AVIM Therapy—highlighting the strategic collaboration with Medtronic and clinical potential for hypertensive heart disease—and one covers the Virtue Sirolimus AngioInfusion (Virtue SAB) balloon and the Virtue IDE trial for coronary in-stent restenosis.
Speakers and times: David Hochman and Robert Kowal on the Orchestra–Medtronic partnership (Dec 9, 14:00 IST / 07:00 AM EST); Avi Fischer on AVIM Therapy (Dec 8, 15:12 IST / 08:12 AM EST); Bill Little on Virtue SAB and the Virtue Trial (Dec 8, 14:00 JST / 07:00 AM EST).
Orchestra BioMed (Nasdaq: OBIO) announced that on November 24, 2025 its Compensation Committee granted stock options to purchase an aggregate of 151,250 shares of common stock to 12 newly hired employees under the company’s 2025 New Hire Inducement Plan, pursuant to Nasdaq Listing Rule 5635(c)(4).
Per the awards, 25% of each grantee’s options vest on the first anniversary of employment, with the remainder vesting ratably each quarter over the following three years. The company provided these details to comply with Nasdaq disclosure requirements.
Orchestra BioMed (Nasdaq: OBIO) said company management will participate in multiple institutional investor conferences in late 2025. The company will hold one-on-one investor meetings at the 2025 Jefferies London Healthcare Conference on Nov 17-20, 2025, with meetings on Nov 18. Management will also appear at the Piper 37th Annual Healthcare Conference on Dec 2-4, 2025, including a live fireside chat on Dec 3 at 11:00am ET and additional one-on-one meetings.
The Piper presentation will be available via live webcast and replay on Orchestra BioMed’s Investor Relations website for investors and interested parties.
Orchestra BioMed (Nasdaq: OBIO) reported Q3 2025 results and secured $147.6 million in gross proceeds and committed capital from strategic transactions and equity offerings to fund pivotal programs. Cash and marketable securities were $95.8 million as of Sept 30, 2025, with additional $30.0 million received Nov 7, 2025 and commitments of $35.0 million from Ligand and Medtronic by May 1, 2026. Company extended runway into Q4 2027 to support BACKBEAT and the Virtue SAB pivotal trial.
Clinical progress includes initiated enrollment in the Virtue SAB randomized IDE pivotal trial and BACKBEAT protocol enhancements; Q3 operating cash use was $14.9M and net loss was $20.8M (Q3 2025).
Orchestra BioMed (Nasdaq: OBIO) will host a business update call on Wednesday, November 12, 2025 at 8:00 AM ET. The company said the call will cover recent clinical, strategic and financing developments, including an additional strategic investment and collaboration expansion with Medtronic, a new strategic capital relationship with Ligand, a right of first refusal agreement with Terumo, acceleration of enrollment in the BACKBEAT pivotal study of AVIM Therapy, and initiation of patient enrollment in the Virtue SAB US pivotal IDE coronary trial.
Conference details: Toll Free 877-407-9039; International 201-689-8470; Conference ID 13756518; webcast available at https://viavid.webcasts.com/starthere.jsp?ei=1738644&tp_key=c80bc7995c.
Orchestra BioMed (Nasdaq: OBIO) entered into a termination and right of first refusal agreement with Terumo on Oct 28, 2025 for Virtue Sirolimus AngioInfusion Balloon (Virtue SAB) for coronary artery disease.
Key terms: Terumo pays an upfront $10 million for ROFR and will invest an additional $20 million via non‑voting preferred stock convertible into common at a minimum of $12 per share, for total proceeds of $30 million. The ROFR supersedes the prior distribution agreement and gives Terumo first review rights on third‑party offers in the global coronary market. Orchestra BioMed retains development and distribution rights in all indications. Orchestra has initiated patient enrollment in the U.S. pivotal IDE Virtue Trial for coronary in‑stent restenosis. Transactions are expected to close no later than Nov 7, 2025.
Orchestra BioMed (NASDAQ: OBIO) announced first patient enrollments in the U.S. pivotal IDE Virtue Trial for the Virtue Sirolimus AngioInfusion Balloon (Virtue SAB), a non-coated sirolimus delivery system. The randomized head-to-head study will compare Virtue SAB to the AGENT paclitaxel-coated balloon for coronary in-stent restenosis (ISR).
The trial plans to randomize 740 patients across up to 75 U.S. centers with enrollment completion currently planned for mid-2027. Virtue SAB holds FDA Breakthrough Device Designation for coronary ISR, small vessel disease and below-the-knee PAD. Prior SABRE pilot results cited: 12-month TLF 2.8%, zero TLR from 12–36 months, and 6-month late lumen loss 0.12mm. Orchestra BioMed estimates a >$10 billion global DCB market opportunity.
Orchestra BioMed (NASDAQ: OBIO) will present AVIM Therapy clinical data in a keynote on October 10, 2025 at the Georgia Innovation Summit.
The presentation highlights a strategic collaboration with Medtronic, FDA Breakthrough Device designation for uncontrolled hypertension, an estimated U.S. population of 7.7 million, and a pacemaker-indicated global population of > 750,000 annually.
Key clinical results cited: MODERATO I 24-hour aSBP −11.6 mmHg (1 day) and −10.1 mmHg (3 months); MODERATO II 24-hour aSBP −15.6 mmHg (1 day) and −11.1 mmHg (6 months) with office systolic −17.5 mmHg at 24 months. Reports note improved diastolic measures, favorable hemodynamics, sustained BP reduction, and reversible effect on deactivation.
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