Orchestra BioMed reported that it has secured over $111 million in financing through a series of transactions and offerings—supported by deals with Medtronic and Ligand Pharmaceuticals—as it looks to complete late-stage clinical studies.
That includes $40 million from a public offering announced last week, plus about $16 million in private placements of common stock to Medtronic and Ligand.
Medtronic also committed to deliver another $20 million by next May, in exchange for a promissory note that would convert to a prepaid revenue share—upon the FDA’s approval of Orchestra’s bioelectronic, pacemaker-like BackBeat therapy for lowering high blood pressure.
The proceeds are slated to fund the full enrollment of a global pivotal trial of BackBeat’s atrioventricular interval modulation approach, or AVIM, as well as support the study’s follow-up measures to evaluate its primary endpoints.
The BackBeat neuromodulation therapy, designed to integrate with existing cardiac rhythm implants, previously demonstrated a 10.3 mmHg reduction in 24-hour systolic blood pressure after six months, in a study of 14 patients.
Medtronic previously picked up an exclusive license and collaboration agreement with Orchestra for the development and commercialization of BackBeat. The companies said the collaboration has now been expanded to provide a path for developing AVIM-capable leadless pacemakers as well.
Ligand, meanwhile, committed $35 million in return for a tiered revenue interest in future royalties, tied to Orchestra’s BackBeat as well as its Virtue sirolimus-equipped balloon—with the latter program aiming to finish enrolling participants in a trial for treating in-stent restenosis of the coronary arteries.
Orchestra has been developing the Virtue angioplasty therapy—which delivers a precise dose through micropores in the balloon, as opposed to an outer drug coating—with Terumo Corporation, via a partnership launched in 2019.
“We are very proud to have secured significant long-term capital from strategic transactions with Medtronic and Ligand and the completion of our first underwritten public equity offering,” Orchestra CEO David Hochman said in a statement.
“With Ligand, an established royalty investor, joining us as a strategic capital partner and Medtronic, the global market leader in cardiac rhythm management, expanding their commitment to our existing collaboration, this new capital strongly positions us to advance our core technologies, AVIM therapy and Virtue SAB, toward fundamental clinical and regulatory milestones that have the potential to create significant value for all stakeholders,” Hochman added.