News | Drug-Eluting Balloons | June 13, 2019

Orchestra BioMed Partnering With Terumo Corp. for Development, Commercialization of Virtue Sirolimus-eluting Balloon

Virtue SEB is expected to become a flagship therapeutic product for Terumo and will strengthen its U.S. and global portfolio of interventional solutions

Orchestra BioMed Partnering With Terumo Corp. for Development, Commercialization of Virtue Sirolimus-eluting Balloon

June 13, 2019 — Orchestra BioMed Inc. announced it has formed a global strategic partnership with Terumo Corp. for development and commercialization of the Virtue Sirolimus-Eluting Balloon (SEB), one of Orchestra’s lead assets, in the percutaneous coronary and peripheral interventions field.

Virtue SEB is the first and only non-coated drug-eluting angioplasty balloon, according to Orchestra BioMed, that delivers a proprietary bioabsorbable, sustained-release formulation of sirolimus, the gold-standard drug for preventing restenosis following a percutaneous interventional procedure. In April, the U.S. Food and Drug Administration (FDA) granted Virtue SEB Breakthrough Device Designation for treatment of coronary in-stent restenosis (ISR), which provides prioritized regulatory review for this challenging cardiovascular condition that represents more than 10 percent of total interventional coronary procedures and for which available treatment options are limited. In a prospective study of very challenging ISR patients, Virtue SEB demonstrated excellent angiographic results at six months as well as outstanding clinical outcomes out to three years. Orchestra BioMed plans to conduct a near-term U.S. registrational trial for ISR.

Read the article "Orchestra BioMed Receives FDA Breakthrough Device Designation for Virtue Sirolimus-eluting Balloon"

Under the terms of the 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. Terumo will also make a strong commitment to finance and execute a global clinical program in collaboration with Orchestra BioMed to gain regulatory approval for commercial sale of Virtue SEB in multiple markets and indications.

Orchestra BioMed will share meaningfully in future commercial revenues of Virtue SEB through royalties and per unit payments as the exclusive supplier of the proprietary sustained-release sirolimus formulation used in Virtue SEB. Orchestra BioMed retains the rights to develop and license technology used in Virtue SEB for clinical applications outside of coronary and peripheral vascular interventions.

Virtue SEB strengthens the current cardiovascular product offering of Terumo Interventional Systems, Terumo Corp.’s largest division, which includes a complete, solution-based product portfolio used in advanced coronary and peripheral endovascular treatments, with solutions for vascular access, lesion access and intervention.

Orchestra BioMed and Terumo are seeking to make Virtue SEB the first drug-eluting balloon approved for coronary use in the U.S. 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.

Virtue SEB is currently not approved in any market, but Terumo and Orchestra BioMed plan to conduct trials to support global regulatory approvals in indications including ISR, 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.

For more information: www.orchestrabiomed.com

Related Content

Edwards Lifesciences Recalls IntraClude Intra-aortic Occlusion Device
News | Balloon Catheter | July 15, 2019
Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of balloon rupture during...
Gore Molding & Occlusion Balloon for Endovascular Aortic Repair Receives FDA Approval
Technology | Balloon Catheter | August 23, 2018
W. L. Gore & Associates Inc. (Gore) announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Gore...
Cardiovascular Systems Inc. and OrbusNeich Announce FDA Clearance  of Sapphire II Pro 1mm Coronary Balloon
Technology | Balloon Catheter | March 21, 2018
Cardiovascular Systems Inc. (CSI) recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k...
Cardiovascular Systems Expands Product Portfolio for Peripheral and Coronary Interventions
News | Balloon Catheter | January 24, 2018
Cardiovascular Systems Inc. recently announced two new partnerships broadening the company’s product portfolio. CSI is...
Abbott recalls its NC Balloon catheters
News | Balloon Catheter | May 22, 2017
May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports
Videos | Balloon Catheter | November 16, 2016
A discussion with Todd Brinton, M.D., about the newly FDA-cleared Shockwave Medical Lithoplasty System, at the Transc
NuCryo Vascular, Next Generation Cryoplasty Inflation Device, PolarCath Balloon Dilatation System

PolarCath Balloon Dilatation System image courtesy of NuCryo Vascular

Technology | Balloon Catheter | March 28, 2016
NuCryo Vascular LLC announced the launch of the Next Generation Cryoplasty Inflation device. The device received U.S....
NuCryo Vascular, FDA clearance, next-gen, PolarCath System, cryoplasty inflation device
Technology | Balloon Catheter | January 12, 2016
NuCryo Vascular LLC announced that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance on the...
Videos | Balloon Catheter | October 30, 2015
Todd Brinton, M.D., clinical associate professor and consulting associate professor of bioengineering at Stanford Uni
Overlay Init