Aroa Biosurgery Limited (ASX: ARX) has secured clearance from the US Food and Drug Administration (FDA) for its Enivo pump and catheter, part of the Enivo Tissue Apposition Platform. The device applies negative pressure to a surgical site, helping to reduce fluid accumulation after 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.
Surgeons currently use surgical drains, adhesives, and quilting sutures to manage dead-space and prevent fluid accumulation, but these techniques are unreliable. AROA plans to seek approval for the AROA ECM sleeve, the third component of this system. AROA CEO Dr Brian Ward said that the clearance simplifies the process for initiating future clinical studies and early commercialization activities. The total addressable market for the Enivo Tissue Apposition Platform in the US is estimated by AROA’s management to be in excess of AU$1 billion.
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