Companies

Orchestra BioMed Kept Its Revised Hypertension Trial Timetable

The Tip Desk · October 19, 2026 · 3 min read

Orchestra BioMed reported $32.4 million in first-half research and development spending while maintaining its revised enrollment target for its pivotal hypertension trial.

Orchestra BioMed Holdings, Inc. (OBIO), a biomedical technology developer, maintained its revised third-quarter enrollment target for its pivotal hypertension trial after an earlier shift from midyear. The timetable held through the latest quarter, while the company continued spending on two pivotal clinical programs and reported a wider first-half loss.

The company targets completion of BACKBEAT enrollment by the end of September. That was the same target announced in May, following the mid-2026 completion goal given in March. BACKBEAT tested AVIM Therapy, a treatment delivered through a pacemaker, in patients with uncontrolled hypertension who were indicated for a dual-chamber pacemaker. Orchestra BioMed had an exclusive development and commercialization collaboration with Medtronic for that population.

The study's patient descriptions did not represent another reduction in its enrollment requirements. The current target of 284 evaluable randomized patients matched the revised design described in May; the earlier total enrollment target of 316 included an allowance for potential loss to follow-up. The revised sample size followed an FDA-approved protocol amendment developed through collaboration with Medtronic and the agency.

The financial commitment to the programs continued. For the six months ended June 30, research and development expenses rose 18% to $32.4 million from $27.3 million a year earlier. The increase primarily reflected work advancing BACKBEAT and the Virtue trial. Personnel and consulting costs totaled $16.2 million, while clinical development costs were $8.5 million. Higher personnel and clinical costs were partly offset by lower non-clinical development spending.

For the same six-month period, the net loss widened to $44.4 million from $38.1 million. Selling, general and administrative expenses were $12.2 million. Orchestra BioMed expects research and development spending to increase as it develops products, supplies clinical studies and pursues regulatory approvals. Significant losses are also expected to continue for the foreseeable future.

First-half revenue consisted entirely of $198,000 in FreeHold surgical retractor sales. Partnership revenue was zero, against $1.4 million in the corresponding six months of 2025. Orchestra BioMed's former Terumo development and distribution agreement had ended in October 2025, eliminating its remaining performance obligations. Lower purchase volumes reduced FreeHold sales, while unit prices remained unchanged. No revenue had been recognized under the amended Medtronic collaboration through June.

Orchestra BioMed had $110.0 million in cash, cash equivalents and marketable securities at June 30. During May, it received a $20.0 million convertible loan from Medtronic and $15.0 million from Ligand under a royalty purchase arrangement. The company had funded operations principally through securities issuance, collaboration proceeds, borrowing and sales of future revenue, with product sales playing a smaller role.

The Medtronic financing linked repayment to the development program's outcome. The note carried an 11% simple annual interest rate, with no interest payments due before maturity in April 2031. Under its terms, FDA approval of a Medtronic device incorporating AVIM Therapy before maturity would automatically convert the outstanding balance into an obligation payable from Orchestra BioMed's collaboration revenue share. Those payments would continue until they totaled $40.0 million.

The company's other pivotal program, Virtue SAB, is expected to enroll 740 U.S. patients, with completion planned for 2027. That trial is comparing its sirolimus-delivery angioplasty system with Boston Scientific's AGENT drug-coated balloon for coronary in-stent restenosis. For BACKBEAT, Orchestra BioMed and Medtronic intend to submit primary endpoint data for a major cardiovascular conference presentation in the second quarter of 2027, assuming the endpoints are met, followed by marketing applications to U.S. and global regulators.