AUCKLAND, New Zealand, Jan. 17, 2025 /PRNewswire/ -- New Zealand headquartered soft tissue regeneration company Aroa Biosurgery recently announced the publication of further strong clinical evidence reinforcing both efficacy and cost benefits of its AROA ECM™ technology when used in high-risk limb salvage surgery.
Conducted between May 2022 and April 2023, the single site prospective clinical study included a total of 130 complex lower limb defects from 120 patients.
A staggering 95% of patients enrolled in the study had at least one risk factor for lower limb amputation, and 55% had 3 or more predictive risk factors for amputation.
Lower limb amputation has the potential to severely impact quality of life, with the 5-year mortality rate for patients receiving a lower limb amputation being as high as ~50%[1].
Published in the December issue of highly respected peer-reviewed journal, Plastic and Reconstructive Surgery – Global Open, the real-world study, titled "Limb Salvage via Surgical Soft Tissue Reconstruction with Ovine Forestomach Matrix Graft: A prospective study", is the largest prospective study of its kind targeting inpatient reconstruction of lower extremity defects with a dermal matrix. The study is the first publication to emerge from the company's ongoing prospective study, Myriad Augmented Soft Tissue Reconstruction Registry (MASTRR).
The study found that AROA's Myriad Matrix™ and Myriad Morcells™ achieved successful tissue coverage and fill in 30 days, after just one product application with no infections or complications reported.
In addition to further validating the use of Myriad products in these challenging lower extremity reconstructions[2], the study highlights the potential for significant cost benefits. Findings showed an estimated cost difference of up to 195%, compared to other commercially available dermal matrices, when used for inpatient lower extremity reconstruction.
Founder and CEO of the ASX-listed company, Brian Ward says: "We are very pleased to see the first clinical evidence emerge from our large prospective MASTRR study. The evidence from this study further validates both the efficacy of, and potential cost benefits associated with Myriad use in lower limb reconstruction procedures. With a total addressable market of $225 million USD[3], for lower limb procedures alone, this represents a considerable opportunity for AROA."
The study's lead Investigator Dr. John Lawlor is an experienced Foot and Ankle Surgeon based in Florida. "I've been using AROA's Myriad products for several years now and have seen the difference Myriad can make in my own patient population. It's very encouraging to see this large study published, quantifying the significant positive impact to patients, as well the overall cost benefit associated with using Myriad to manage this complex patient group. I'm excited with the opportunity to share our positive outcomes data with my fellow surgeons". says Dr. Lawlor.
[1] Armstrong, D.G., et al, Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer. Journal of Foot and Ankle Research, 2020. 13(1): p. 16.
[2] Bosque, B.A., et al, Ovine Forestomach Matrix in the Surgical Management of Complex Lower-Extremity Soft-Tissue Defects.** Journal of American Podiatric Medical Association, 2023. 113(3).
[3] AROA Management estimates