Common stock, par value $0.0001 per share
- Symbol
- OBIO
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 8.01, 9.01 · 8-K
Orchestra BioMed Holdings, Inc.
OBIONASDAQEQUITYCurrent
Regulation FD Disclosure · Other Events
Item 7.01. Regulation FD Disclosure. On October 1, 2026, Orchestra BioMed Holdings, Inc. (the “Company”) issued a press release titled “Orchestra BioMed Exceeds Enrollment Target in the BACKBEAT Global Pivotal Trial of AVIM Therapy.” A copy of the press release is attached to this Current Report on Form 8-K (“Current Report”) as Exhibit 99.1 and is incorporated herein solely for purposes of this I…
Company context
Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates, Atrioventricular Interval Modulation (AVIM) Therapy and Virtue Sirolimus AngioInfusion Balloon (Virtue SAB), are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic, one of the largest medical device companies in the world and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has FDA Breakthrough Device Designations for these patients, as well as an estimated 7.7 million total patients in the U.S. with uncontrolled hypertension despite medical therapy and increased cardiovascular risk. Virtue SAB is a highly differentiated, first-of-its-kind non-coated drug delivery angioplasty balloon system designed to deliver a large liquid dose of proprietary extended-release formulation of si
Current securities
Historical securities (1)
Registered securities in this filing
ORCHESTRA BIOMED HOLDINGS, INC. · 8-K · Filed 2026-10-01
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.
On October 1, 2026, Orchestra
BioMed Holdings, Inc. (the “Company”) issued a press release titled “Orchestra BioMed Exceeds Enrollment Target in the
BACKBEAT Global Pivotal Trial of AVIM Therapy.” A copy of the press release is attached to this Current Report on Form 8-K (“Current
Report”) as Exhibit 99.1 and is incorporated herein solely for purposes of this Item 7.01 disclosure.
The information in Item
7.01 of this Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the
liabilities of such section. The information in Item 7.01 of this Current Report, including Exhibit 99.1, shall not be incorporated by
reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any incorporation by reference
language in any such filing.
Item 8.01Item 8.01 - Other Events
Item 8.01. Other Events.
On October 1, 2026, the
Company announced that, as of September 30, 2026, 330 patients had been randomized in the BACKBEAT
Global Pivotal Trial (“BACKBEAT Trial”), exceeding its previously announced target of 316 randomized patients. The BACKBEAT
Trial is evaluating Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) in pacemaker-indicated patients with uncontrolled
hypertension despite the use of medication. The BACKBEAT Trial is being conducted with Medtronic plc (NYSE: MDT), the Company’s
strategic collaborator for the BACKBEAT Trial and, subject to regulatory approval, for the commercialization of AVIM Therapy in pacemaker-indicated
patients with uncontrolled hypertension despite the use of medication. The 330 patients enrolled in the BACKBEAT Trial have been randomized
at 81 sites across 13 countries. The BACKBEAT Trial’s protocol, approved by the U.S. Food and Drug Administration, specifies 284
evaluable randomized subjects for the primary endpoint analysis, with a total enrollment target of 316 patients to account for potential
loss to follow-up.
Filed exhibits (1)
Exhibit 99.1 Orchestra BioMed Exceeds Full Enrollment Target in the BACKBEAT Global Pivotal Trial of AVIM Therapy 330 patients randomized as of September 30, 2026, surpassing full trial enrollment target Company reiterates prior guidance: primary endpoint data to be submitted for late-breaking presentation consideration at a major cardiovascular conference in Q2 2027 ───────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────── Data expected to support future marketing application submissions by Medtronic to the FDA and other global regulatory agencies NEW HOPE, Pa., Oct. 1, 2026 (GLOBE NEWSWIRE) - Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO) (“Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through strategic partnerships with market-leading medical device companies, today announced that it has surpassed full enrollment in the BACKBEAT Global Pivotal Trial (“BACKBEAT Trial”), exceeding its previously announced target of 316 randomized patients. The BACKBEAT Trial is evaluating Atrioventricular Interval Mo…
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