Orchestra BioMed (OBIO) received approval from the US Food and Drug Administration to initiate an updated clinical trial for its Virtue Sirolimus AngioInfusion Balloon, a drug-delivery device for heart patients.
The trial will compare Virtue SAB to Boston Scientific's (BSX) AGENT, a paclitaxel-coated balloon, in the treatment of coronary in-stent restenosis, a condition where arteries narrow again after stent placement, the company said.
Virtue SAB uses a non-coated, microporous balloon technology to deliver liquid sirolimus, ensuring protected delivery and extended release of the drug during the critical 30-day healing period.
The new 12-month trial, expected to start in H2, will enroll 740 patients at up to 75 locations across the US.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.