First Clinical Evidence Unveiled for AROA's ENIVO™ System in Surgical Recovery Management

First Clinical Evidence on AROA's ENIVO™ System

The medical field is constantly evolving, and AROA Biosurgery is at the forefront with its innovative ENIVO™ system, aimed at enhancing surgical recovery. Recently, the company published promising findings from its inaugural human study, an endeavor that could redefine postoperative care in surgical procedures.

The research, titled "Prospective, First-in-Human Clinical Evaluation of a Novel Tissue Apposition Device (ENIVO™) Following Simple Unilateral Mastectomy," appeared in the esteemed journal Plastic and Reconstructive Surgery, Global Open. This marks a pivotal contribution to the medical literature dedicated to surgical techniques and postoperative outcomes. The ENIVO system methodically addresses a critical challenge in surgeries—the management of 'dead space.' These are cavities formed post-surgery, often filled with seroma fluid, leading to complications like infection and longer recovery times.

The ENIVO system consists of a wearable vacuum device connected to a tube, paired with an Aroa ECM sleeve implanted within the patient's body. The device applies suction at the surgical site, facilitating the close apposition of tissue surfaces to minimize dead space and clear excess fluid. By doing so, it aims to advance both healing speed and quality. The multi-center study involved ten patients recovering from simple unilateral mastectomies, overseen by Associate Professor Michelle B. Locke, MBChB MD, in New Zealand.

Traditionally, surgeons have relied on drains as the standard post-operative care for managing dead space. However, drains have their pitfalls—blockages can result in failure and they are often linked with seroma formation. Seromas are collections of fluid in surgical cavities and are a prevalent complication after mastectomies, with rates reported between 22% and 43%. They can impede wound healing, increase the likelihood of infections, and compromise aesthetic results.

The study monitored participants for three months following their surgeries. Results indicated that the ENIVO device operated as intended, with remarkable outcomes: among the ten patients, only a single clinically significant seroma was documented. This is a substantial improvement compared to the usual post-operative forecasting for drainage systems.

Brian Ward, CEO of AROA, expressed his enthusiasm about the study's publication, emphasizing that the ENIVO device performed impressively in an area where complications could severely compromise patient care. He highlighted that while further studies are required, initial results support the potential for ENIVO to revolutionize standard care practices in a variety of surgeries requiring dead space management. "It could significantly lessen complications, enhance patient outcomes, and lead to reduced healthcare costs," asserted Ward.

Associate Professor Locke shared her gratification in collaborating with AROA and New Zealand surgical teams for this groundbreaking study. She remarked, “The device functioned well and the results are encouraging. I am optimistic that this innovation can notably improve surgery outcomes for patients.”

Notably, AROA is eyeing commercial opportunities, estimating a market potential exceeding $1 billion for ENIVO. The company is actively pursuing this goal, having already secured FDA clearance for two-thirds of the system’s components. Though the ENIVO device is still in development and not yet cleared for use in its tested configuration within the United States, it's a significant step toward realizing its potential.

Aroa Biosurgery is dedicated to advancing healing in complex wounds and soft tissue reconstruction. Their extensive range of products is built upon the proprietary AROA ECM™ technology platform, derived from ovine forestomach. Since its founding in 2008, AROA has achieved regulatory approval in over 50 countries, with seven million AROA products utilized globally. Their commitment to regeneration and improved patient outcomes is reflected in their continued innovation and dedication to surgical excellence.

For a deeper insight into this study and its findings, the publication is available online. As the medical community welcomes these findings, all eyes are on AROA as it navigates toward a potentially groundbreaking advancement in surgical care.