Highlights
• AROA has received U.S. FDA 510K clearance for its Enivo™ pump and catheter,
• U.S. FDA 510K clearance simplifies the process for initiating future clinical studies and early commercialization activities.
• AROA’s management estimates the total addressable U.S. market for the Enivo Tissue Apposition platform to be greater than $1B.
Aroa Biosurgery Limited (ASX: ARX, ‘AROA or the ‘Company’) is pleased to announce that it has received U.S. Food and Drug Administration (‘FDA’) 510K clearance for its Enivo pump and catheter which are key components of the Company’s new Enivo Tissue Apposition Platform.
The device applies negative pressure to a surgical site, helping to reduce fluid accumulation following surgery. It has been cleared for use in the removal of surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed. Currently, surgeons use surgical drains, adhesives, and quilting sutures to manage dead-space and prevent fluid accumulation, but these techniques are unreliable.
AROA plans to pursue approval for the AROA ECM™ sleeve, the third component of this system, including a DeNovo application to support use and expand future claims.
AROA CEO Dr Brian Ward said that the clearance simplifies the process for initiating future clinical studies and early commercialization activities.
“Gaining FDA clearance is a key milestone in establishing our second technology platform.
We expect to develop a portfolio of products based on this technology platform for a range of soft tissue reconstruction procedures.
This is the culmination of several years’ development across a number of teams. The Enivo system complements our AROA ECM based products and we expect that these technology platforms will be synergistic when used concurrently.”
The total addressable market for the Enivo Tissue Apposition Platform in the U.S. is estimated by AROA’s management to be in excess of $1B.
