Orchestra BioMed has entered a deal providing exclusive worldwide development and commercialisation rights for its Virtue Sirolimus-Eluting Balloon (SEB) to Japanese medical devices maker Terumo.
Designed for percutaneous coronary and peripheral interventions, the Virtue SEB is a non-coated drug-eluting angioplasty balloon delivering a bioabsorbable, sustained-release formulation of sirolimus.
Sirolimus is intended for the prevention of restenosis after a percutaneous interventional procedure.
The SEB obtained breakthrough device designation from the US Food and Drug Administration (FDA) in April for coronary in-stent restenosis (ISR).
Terumo expects the device to boost its Intervention Systems division, which comprises advanced coronary and peripheral endovascular treatment solutions.
Orchestra BioMed chairman and CEO David Hochman said: “Terumo has a proven global distribution and operations infrastructure with the sales and marketing expertise necessary to make Virtue SEB broadly accessible to physicians and patients worldwide, pending regulatory approvals.”
As part of the licensing agreement, Orchestra BioMed will receive a one-time upfront payment of $30m, along with a $5m equity investment. Terumo will also pay clinical and regulatory milestones in the future.
Terumo has committed to work with Orchestra BioMed to finance and execute a global clinical programme for obtaining regulatory approval for Virtue SEB in various markets and indications, including ISR, small coronary vessels and peripheral artery disease below-the-knee.
Orchestra BioMed intends to conduct a registrational trial for ISR under an Investigational Device Exemption (IDE) from the FDA within the next year.
Furthermore, Orchestra BioMed will receive royalties and per unit payments for the exclusive use of its sustained-release sirolimus formulation used in the device.
The company retains the rights to develop and license Virtue SE’s technology for clinical applications in areas other than coronary and peripheral vascular interventions.