Orchestra BioMed has formed a global strategic partnership with Japanese medical device powerhouse Terumo to develop and commercialize its lead product, the Virtue sirolimus-eluting balloon, in the field of percutaneous coronary and peripheral artery surgical interventions.
Located in the picturesque town of New Hope, Pennsylvania along the Delaware River, the biomedical company is focused on developing innovative tools for surgical interventions, working with physicians to address their unmet needs and fit seamlessly within current clinical practice and workflow. Twenty people strong and growing, it was set up in 2018 by absorbing some companies for product development with the strategy to partner with larger companies for shared risk and reward in order to speed innovation in medical devices.
The Virtue SEB system for interventional cardiology is an angioplasty balloon that delivers a bioabsorbable, sustained release formulation of sirolimus, the gold standard drug for preventing restenosis following a percutaneous interventional procedure. Restenosis, the narrowing of the arterial wall after a coronary artery is unblocked by angioplasty or a stent, occurs in more than 10 percent of interventional procedures within three to 12 months. Available treatment options are limited. In a prospective study of patients with restenosis following surgery, the Virtue SEB system demonstrated positive clinical outcomes out to three years. In April, the U.S. Food and Drug Administration granted the system Breakthrough Device Designation, which prioritizes regulatory review.
Under the terms of the partnership agreement, Terumo will make a one-time, up-front payment of $30 million and an equity commitment of $5 million to Orchestra BioMed. Terumo will also make substantial future clinical and regulatory milestone payments to Orchestra BioMed, and also a strong commitment to a global clinical program, as well as meaningful revenue sharing through royalty and exclusive drug formulation supply payments. Orchestra BioMed retains the rights to develop and license technology used in Virtue SEB for clinical applications outside of coronary and peripheral vascular interventions.
“This strategic partnership is a major milestone for Orchestra BioMed. It validates our differentiated strategy to focus on the development of high-impact therapies while leveraging alliances with established market leaders, like Terumo, to drive global commercialization of our products,” said David Hochman, chairman and CEO of Orchestra BioMed.
Terumo intends to make Virtue SEB a flagship therapeutic product of its cardiovascular product offerings in its Interventional Systems division, its largest. “The unique design of Virtue SEB demonstrates Orchestra BioMed’s deep knowledge of the needs of interventional cardiologists and its capability to deliver innovative solutions that have the potential to improve patient outcome,” said James Rushworth, CEO of Terumo North America.
The partners want to make Virtue SEB the first drug-eluting balloon approved for coronary use in the United States. To that end, Orchestra BioMed expects to initiate a U.S. registrational trial for Virtue SEB in ISR under an Investigational Device Exemption (IDE) from the FDA within the next year. The partners also plan to conduct trials to support global regulatory approvals in small coronary vessels, peripheral artery disease below-the-knee and other indications. Terumo and Orchestra BioMed’s objective is to commercialize Virtue SEB in the U. S., Japan, China, and other markets.