TYRX: Is This the Model for Drug/Device Convergence?
Executive SummaryTYRX has a novel device - an antibiotic-impregnated envelope designed to prevent infections in CRM implants - that could create signifcant opportunities, not just for itself, but also for large CRM companies looking to differentiate their devices in a flat, crowded market. Convergence has fallen on hard times recently, but TYRX hopes to succeed where others have failed by stripping risk out of drug/device convergence.
You may also be interested in...
TYRX Inc. has received FDA clearance for a fully-resorbable version of its antibacterial envelope, used to prevent surgical site infections in patients who receive implantable devices such as ICDs. The resorbable device has important advantages over the previous durable envelope and could substantially boost physician adoption of the company’s technology.
US FDA usually recommends using overall survival for pancreatic cancer drugs, but AstraZeneca choose progression-free survival; now ODAC will weigh in on whether the PARP inhibitor olaparib demonstrated a clinically meaningful impact. The firm cites enrollment and design challenges in the gBRCAm population as reasons for using PFS.