FIRST CLINICAL EVIDENCE PUBLISHED ON AROA's ENIVO™ SYSTEM FOR SURGICAL DEAD SPACE MANAGEMENT.

AUCKLAND, New Zealand, Aug. 27, 2025 /PRNewswire/ -- AROA is pleased to announce the findings of the first in human study involving its new ENIVO platform technology. The study is the subject of a peer-reviewed publication entitled Prospective, First-in-Human Clinical Evaluation of a Novel Tissue Apposition Device (ENIVO™) Following Simple Unilateral Mastectomy, which was published in the well-respected journal, Plastic and Reconstructive Surgery, Global Open.

The ENIVO platform is designed for the management of 'dead space,' which is an open cavity created by surgical separation or excision of soft tissue. Dead spaces commonly fill with seroma, which can lead to secondary complications, increase the risk of infection, and lengthen hospital stays for patients.

AROA's novel ENIVO system is comprised of a wearable vacuum pump connected to a tube and an Aroa ECM sleeve which is implanted within the patient's body. It delivers suction to the surgical site and allows the tissue surfaces at the surgical site to be held closely together, aiming to eliminate the dead space, remove fluid, and improve the speed and quality of healing. The multi-center study, which involved ten patients who had undergone simple unilateral mastectomy where all tissue from one breast is removed, was conducted in New Zealand and led by Associate Professor Michelle B. Locke, MBChB MD.

The ENIVO system was used as an alternative to a surgical drain, which is the current standard of care. The shortcomings of drains are well-known - they can fail due to blockages and often lead to seroma formation. Seromas (a collection of fluid that accumulates in a surgical cavity) are one of the most common complications following mastectomy, with reported incidence rates as high as 22-43%.[1] Seromas are associated with delayed wound healing, increased risk of infection and unsatisfactory aesthetic results.

The study monitored the patients for a period of three months postoperatively and found that the ENIVO device performed as designed and all patients healed well, with only one clinically relevant seroma recorded.

AROA CEO Brian Ward says: "We're pleased to see this first ENIVO clinical study published. The results are promising, and it's pleasing to see the device has functioned exceptionally well in a procedure where complications have serious consequences for the patient's care. While further research is required, the findings of this first study support our belief that ENIVO could pave the way for a new standard of care in a wide range of surgeries where managing dead space is challenging. ENIVO has the potential to significantly reduce complications, positively impact patient outcomes, and reduce treatment costs".

Associate Professor Locke says: "It was rewarding to collaborate with AROA and the New Zealand based surgical teams to lead this first human study of the ENIVO system. The device functioned well, the study results were encouraging, and I am optimistic that this innovation could significantly improve patient outcomes following surgery."

AROA estimates the market opportunity for ENIVO to be in excess of US$1B[2], and is actively pursuing commercialisation, with two out of three of the components already having received US FDA clearance.

The study is available online, here^[1]

*ENIVO is a device in development and is not currently cleared for use in the tested configuration within the United States.

Authorised on behalf of the Aroa Biosurgery Board of Directors by Brian Ward, CEO.

About Aroa Biosurgery:

Aroa Biosurgery is a soft-tissue regeneration company committed to 'unlocking regenerative healing for everybody'. We develop, manufacture, sell and distribute medical and surgical products to improve healing in complex wounds and soft tissue reconstruction. Our products are developed from a proprietary AROA ECM™ technology platform, a novel extracellular matrix biomaterial derived from ovine forestomach. AROA has commercialised four product families based on its AROA ECM technology, targeting chronic wounds, hernia, soft tissue, and breast reconstruction. Over 7 million AROA products have been used globally in a range of procedures to date, with distribution into our key market of the United States via our direct sales force and our partner TELA Bio. AROA has regulatory approvals in more than 50 countries. Founded in 2008, AROA is headquartered in Auckland, New Zealand and is listed on the Australian Securities Exchange (ASX: ARX). www.aroa.com/^[2] 

References

1. ^{^} here (journals.lww.com)
2. ^{^} www.aroa.com/ (www.aroa.com)