UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): September 19, 2023

ORCHESTRA BIOMED HOLDINGS, INC.
(Exact name of registrant as specified in its charter)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

On September 19, 2023, Orchestra BioMed Holdings, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration granted the Company investigational device exemption approval to initiate the Company’s planned BACKBEAT pivotal study of the Company’s BackBeat Cardiac Neuromodulation Therapy product candidate, also known as Atrioventricular Interval Modulation (AVIM) therapy, to treat hypertension in patients indicated for a pacemaker. The BACKBEAT name of the study is an acronym for the full study title which is the BradycArdia paCemaKer with atrioventricular interval modulation for Blood prEssure treAtmenT pivotal study.

A copy of the press release and a copy of the slide presentation that the Company uses at investor and industry conferences and presentations are each attached to this Current Report on Form 8-K (“Current Report”) as Exhibit 99.1 and Exhibit 99.2, respectively, and are each incorporated herein solely for purposes of this Item 7.01 disclosure. Additionally, the Company has posted the press release and slide presentation on its website at https://investors.orchestrabiomed.com under the Investor Relations section.

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.

(d) Exhibits.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.