AROA Biosurgery Limited just revealed the details of its newest randomized controlled trial. This study focused on Symphony and its impact on diabetic foot ulcer healing. Preliminary results show that the trial successfully met its primary endpoint. It effectively combines multiple layers of AROA ECM™ with hyaluronic acid. Consequently, this design targets complex chronic wounds like diabetic foot ulcers.
The multi-center study evaluated safety and performance across several United States sites. Researchers compared Symphony against standard dressings over a twelve-week period. Specifically, the team recruited 150 patients for this robust clinical assessment. The primary goal measured how many ulcers healed within the timeframe. Naturally, Symphony performed better than the standard of care in this preliminary analysis. This outcome reinforces the company’s belief in its innovative product.
“This is a crucial step in building the clinical evidence base for Symphony and supporting clinical adoption in chronic, complex wounds,” said Brian Ward, Chief Executive Officer of AROA Biosurgery. “Randomised controlled trials are regarded as the most robust form of clinical evidence, and these results further validate Symphony’s clinical value. We are encouraged by the preliminary study read-out and look forward to publication of the full study results in the coming months.”
AROA expects these results to support future clinical adoption. Furthermore, the data will help meet strict future reimbursement requirements. The company plans to publish the final analysis in the coming months. Therefore, healthcare providers will soon see the full extent of this clinical success. This breakthrough marks a significant advancement for diabetic foot ulcer healing technology. It paves the way for better patient outcomes in the chronic wound care sector.
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News Source:PRNewswire.com
