Orchestra BioMed Granted FDA Approval Of IDE For U.S. Pivotal Study Of Virtue Sirolimus AngioInfusion Balloon In Patients With Coronary In-Stent Restenosis
Portfolio Pulse from Benzinga Newsdesk
Orchestra BioMed has received FDA approval for its Investigational Device Exemption (IDE) for a U.S. pivotal study of Virtue Sirolimus AngioInfusion Balloon in patients with coronary in-stent restenosis. The study is expected to start before the end of 2023. The company has a strategic partnership with Terumo Corporation for the global application of Virtue SAB.
August 08, 2023 | 12:36 pm
News sentiment analysis
Sort by:
Descending
POSITIVE IMPACT
Orchestra BioMed's FDA approval for its Virtue Sirolimus AngioInfusion Balloon study could potentially boost the company's profile and future revenues. The partnership with Terumo Corporation could also enhance its global reach.
FDA approval for Orchestra BioMed's Virtue Sirolimus AngioInfusion Balloon study is a significant milestone for the company. It not only validates the company's product but also opens up opportunities for future revenue generation. The strategic partnership with Terumo Corporation could further enhance Orchestra BioMed's global reach and market penetration.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100