Orchestra BioMed (Nasdaq:OBIO) announced today that it entered into a termination and right of first refusal agreement with Terumo. The agreement relates to the New Hope, Pennsylvania–based company's Virtue Sirolimus AngioInfusion Balloon (SAB). It supersedes and terminates a prior distribution agreement between the companies and grants Terumo a … [Read more...] about Orchestra BioMed, Terumo terminate drug-eluting balloon distro deal in $30M agreement
Orchestra BioMed
Orchestra BioMed enrolls first patient in Sirolumus AngioInfusion balloon trial
Orchestra BioMed (Nasdaq:OBIO) today announced the first patient enrollments in a study of its Virtue Sirolimus AngioInfusion Balloon (SAB). The FDA investigational device exemption (IDE) trial compares the Virtue SAB to the Boston Scientific Agent paclitaxel-coated balloon. Agent is currently the only FDA-approved drug-coated balloon (DCB) for … [Read more...] about Orchestra BioMed enrolls first patient in Sirolumus AngioInfusion balloon trial
Orchestra BioMed wins FDA IDE for sirolimus-angioballoon
Orchestra BioMed (Nasdaq:OBIO) announced today that it received FDA investigational device exemption (IDE) for its Virtue drug-coated balloon. It marks the second major regulatory milestone for Orchestra BioMed in just a week. The company last week picked up FDA breakthrough device designation for its atrioventricular interval modulation (AVIM) … [Read more...] about Orchestra BioMed wins FDA IDE for sirolimus-angioballoon
Orchestra BioMed wins FDA IDE for drug-coated balloon study
Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its Virtue SAB. The IDE enables the Virtue ISR-US pivotal study. It evaluates Virtue SAB, a novel AngioInfusion balloon for treating artery disease, in treating patients with coronary ISR. New Hope, Pennslyvania-based Orchestra … [Read more...] about Orchestra BioMed wins FDA IDE for drug-coated balloon study
