Japanese medical device manufacturer Terumo entered into a strategic partnership with biomedical innovation firm Orchestra BioMed to develop and commercialise Virtue sirolimus-eluting balloon (SEB).


Image: Virtue sirolimus-eluting balloon. Photo: courtesy of Terumo Corporation.

Terumo has received exclusive global development and commercialization rights to Orchestra BioMed’s Virtue SEB for percutaneous coronary interventions.

Virtue SEB is claimed to be the first and only non-coated drug-eluting angioplasty balloon, which delivers bioabsorbable and sustained-release formulation of sirolimus, the gold standard drug for preventing restenosis following a percutaneous interventional procedure.

In April this year, Virtue SEB received breakthrough device designation from the US Food and Drug Administration (FDA) to treat coronary in-stent restenosis (ISR).

Virtue SEB showed better angiographic results at six months and advanced clinical outcomes at three years in a prospective study of challenging ISR patients. Orchestra also intends to carry out a near-term US registrational trial for ISR.

Terumo Medical CEO James Rushworth said: “We are excited to partner with Orchestra BioMed and secure global rights to Virtue SEB, which we intend to make a flagship therapeutic product that strongly compliments our broad US and global portfolio of interventional solutions.”

As per terms of the deal, Orchestra BioMed will secure a one-time and up-front payment of $30m and an equity commitment of $5m from Terumo.

Orchestra is also eligible to receive substantial future clinical and regulatory milestone payments from Terumo.

Terumo will also provide finance and conduct a global clinical program in collaboration with Orchestra BioMed to secure regulatory approval for commercial sale of Virtue SEB in multiple markets and indications.

Once commercialised, Orchestra will share in future commercial revenues of Virtue SEB through royalties and per unit payments as the exclusive supplier of its sustained-release formulation of sirolimus used in Virtue SEB.

Orchestra will hold the rights to develop and license technology used in Virtue SEB for clinical applications outside of coronary and peripheral vascular interventions.

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.”