Client Need
ReGelTec, a medical device company focused on minimally invasive solutions of chronic low back pain from degenerative disc disease, engaged with MCRA for assistance to bring HYDRAFIL to market.
ReGelTec obtained IDE approval from the FDA for their study design after working with MCRA’s regulatory and biocompatibility teams.
MCRA Approach
Over the course of several years, MCRA’s regulatory and biocompatibility teams worked closely with ReGelTec to navigate FDA’s strict biocompatibility requirements to design novel test methods suitable for the novel HYDRAFIL device and indication. MCRA’s regulatory team also assisted the company with breakthrough, clinical study design, and IDE development.
MCRA THERAPY: Spine
MCRA SERVICES: US Regulatory, Biocompatibility
Outcome
MCRA assisted ReGelTec with obtaining IDE approval for a study designed with primary endpoint evaluated at 1 year.
"We initially started working with MCRA based on their reputation and experience in regulatory consulting with spine technologies, but it was their team of biocompatibility experts who ultimately helped us address FDA questions and secure IDE approval. We are thrilled to initiate our clinical investigation of our breakthrough device, HYDRAFIL, in the United States.”
