Neodyne Biosciences has revealed new clinical data demonstrating that its embrace Active Site Care compression patch significantly improved established lipohypertrophy (LH) in individuals with type 1 diabetes (T1DM).
According to the company, the findings highlight the importance of injection-site care as a component of diabetes management. These results will be presented at the 85th Scientific Sessions of the American Diabetes Association (ADA) in Chicago.
Neodyne Biosciences president and CEO Kelley Lipman said: “For the first time, clinicians have access to a targeted, evidence-based solution that directly addresses LH, a commonly recognised barrier to effective diabetes care.
“Addressing lipohypertrophy isn’t just about site health – it’s about helping to improve insulin absorption, enhancing glycaemic control, and empowering patients to manage their diabetes with greater precision and confidence.”
Lipohypertrophy results from microtrauma caused by repeated insulin injections or pump insertions, and the anabolic effects of insulin leading to a build-up of adipose and fibrotic tissue.
Approximately 64% of insulin users develop LH, which can impact insulin absorption and contribute to glycemic variability, unexplained hypoglycaemia, and elevated A1Cs, said Neodyne Biosciences. Currently, rotating or avoiding injection sites are the primary strategies for managing LH.
The research being presented comes from a 16-week clinical trial involving 29 individuals with persistent LH lesions. Participants applied the embrace Active Site Care patch to one targeted lesion every ten days over the trial period.
The study compared treated LH lesions with untreated ones using ultrasound and biopsy to evaluate lesion volumes, adipose tissue, and fibrosis.
Findings indicate that the embrace Active Site Care patch led to an approximate 20% reduction in target LH lesion volume compared to untreated lesions. Histology analysis revealed a significant decrease in adipocyte lipid content and reduced fibrosis within treated tissue.
Furthermore, 63% of participants reported regaining use of previously exhausted injection sites.
Patient satisfaction data suggests that the embrace patch is user-friendly, potentially enhancing patient experiences with insulin therapy. The transparent patch employs a proprietary mechanism to alleviate skin tension, targeting inflammation, adipose expansion, and fibrosis associated with LH lesions.
The technology is 510(k) cleared by the US Food and Drug Administration (FDA) for fibrosis and CE marked.
