AUCKLAND, New Zealand, May 2, 2025 /PRNewswire/ — Soft tissue regeneration company, Aroa Biosurgery, is pleased to announce a milestone in clinical evidence.
There are now over 100 peer-reviewed studies describing the efficacy of the company’s proprietary AROA ECM technology.
AROA’s most recent publication was a large retrospective analysis of real-world evidence (RWE) from wound care centers in the US, assessing the efficacy of the company’s Endoform NaturalTM product in treating venous leg ulcers (VLUs), in comparison to a leading reconstituted collagen dressing.
VLU’s are open sores that are hard-to-heal because of impaired blood flow and can be very debilitating and painful. These types of wounds are difficult for clinicians to treat successfully. For example, only ~40% of VLUs can be healed after 3 months of treatment and there is a relatively high chance that these wounds will recur[1].
The peer-reviewed study, entitled “Clinical Efficacy of Ovine Forestomach Matrix and Collagen/Oxidized Regenerated Cellulose for the Treatment of Venous Leg Ulcers: A Retrospective Comparative Real-World Evidence Study” was published in the open access journal ‘International Wound Journal in April 2025.
The study compared 470 VLU’s that had been treated with Endoform Natural to 360 VLU’s that had been treated with a reconstituted collagen product. The study used existing data from 223 wound care centers with minimal inclusion or exclusion criteria so that ‘real-world’ use of both products could be compared.
“There is a growing awareness of RWE studies to validate clinical performance” says Chief Scientific Officer, Dr. Barnaby May. “These types of studies enable much larger patient numbers to be compared versus traditional randomized controlled trials. Given that RWE studies use data from ‘real-world’ use of a treatment, the results can be more meaningful, especially in wound care where there is a high degree of variability in how wounds are cared for and patient factors.”
The study found that VLUs treated with Endoform Natural healed up to ~ 8 weeks faster versus the comparator group, and the chances of the wound healing were significantly improved when Endoform Natural was used as part of treatment.
The striking difference in the healing outcomes demonstrate the potential for considerable cost reductions and improvements in patient quality of life, due to the significant improvements seen when VLUs were treated using Endoform Natural.
Dr. Gregory Bohn MD was part of the research team. “I was first introduced to Endoform in 2012 and started using the product to treat my own patients with VLUs. This new data validates what I have seen in my own practice managing VLUs with Endoform.”
This is the second large retrospective RWE comparing Endoform Natural to a leading reconstituted collagen dressing. A previous study included the analysis of over 2,200 diabetic foot ulcers (DFUs) and also demonstrated significantly faster healing of DFUs using Endoform Natural[2].
The study is available online here.
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[1] Kolluri R, Lugli M, Villalba L, Varcoe R, Maleti O, Gallardo F, et al. An estimate of the economic burden of venous leg ulcers associated with deep venous disease. Vasc Med. 2022;27(1):63-72. |
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[2] Bosque BA, Frampton C, Chaffin AE, Bohn GA, Woo K, DeLeonardis C, Lepow BD, Melin MM, Madu T, Dowling SG, May BCH. Retrospective real-world comparative effectiveness of ovine forestomach matrix and collagen/ORC in the treatment of diabetic foot ulcers. Int Wound J. 2022 May;19(4):741-753. |
