Embrace Active Site Care Patch Becomes First Medical Device Clinically Proven to Significantly Improve Lipohypertrophy (LH) in Insulin-Using Diabetes Patients
Findings from 16-week trial of novel compression patch will be shared for the first time at the 85th Scientific Sessions of the American Diabetes Association, beginning today
FREMONT, Calif., June 20, 2025 /PRNewswire/ -- Neodyne Biosciences announced that new clinical data demonstrate the company's embrace® Active Site Care compression patch promotes significant improvement in established lipohypertrophy (LH) among individuals with type 1 diabetes (T1DM). The data also establish injection-site care as a critical component of effective diabetes management. Neodyne will share the findings for the first time beginning tonight at the 85th Scientific Sessions of the American Diabetes Association (ADA) in Chicago (Poster #817-P).
"The findings from this trial show that the embrace patch promoted significant improvement in highly challenging, longstanding lipohypertrophy lesions," said Hans DeVries, MD, lead scientist at Profil Institute for Metabolic Research, who will present the data. "Taken together, the efficacy, safety and patient satisfaction results we will share at the ADA Scientific Sessions suggest that embrace could become the first treatment for this underappreciated issue that negatively impacts the majority of insulin users."
LH is caused by microtrauma from repeated insulin injections or pump insertion as well as the anabolic effects of insulin, which create a build-up of adipose (fat) and fibrotic scar tissue over time. Approximately 64 percent of insulin users develop LH at injection sites. In addition to being unpleasant for patients, LH lesions impact insulin absorption, leading to greater incidence of increased glycemic variability, intermittent, unexplained hypoglycemia, and elevated A1Cs. Other than rotating and/or avoiding injection sites, there is no available treatment for LH.
The data that will be shared at the ADA Scientific Sessions are from a 16-week clinical trial evaluating the efficacy and safety of the embrace Active Site Care patch in 29 individuals with at least two highly challenging, longstanding LH lesions (average age for both comparator and target lesions at baseline was >5 years). Trial participants self-applied embrace to one target LH lesion every ~10 days for 16 weeks. Investigators then compared the target, treated LH lesions to untreated (comparator) LH lesions, using ultrasound and biopsy to assess lesion volumes as well as to evaluate adipose tissue and fibrosis.
Key clinical findings from the trial show that treatment with the embrace Active Site Care patch:
- Led to a significant reduction in target LH lesion volume (~20% on average vs. comparator lesions) as measured by ultrasound, the gold standard for detection and evaluation of LH.
- Reduced adipocyte lipid (fat) content in LH lesions an average of 6.97-fold, as measured through histology analysis.
- Significantly reduced fibrosis: The architecture of treated LH tissue was significantly less fibrotic, based on connective tissue histology image analysis.
- Enabled 63% of trial participants to regain use of an exhausted injection site (self-reported).
Trial results also suggest that embrace is associated with high patient satisfaction: the majority of patients found embrace easy and comfortable to use, and the patch may have positively impacted both their experience with insulin therapy and treatment outcomes.
"This is a pivotal moment in diabetes care," said Kelley Lipman, president and CEO of Neodyne Biosciences. "For the first time, clinicians have access to a targeted, evidence-based solution that directly addresses LH, a commonly recognized barrier to effective diabetes care. Addressing lipohypertrophy isn't just about site health - it's about helping to improve insulin absorption, enhancing glycemic control, and empowering patients to manage their diabetes with greater precision and confidence."
The embrace poster, "A Weekly Tension Offloading Patch for Lipohypertrophy", will be available for viewing beginning tonight at 6:30 pm CT through June 23 in McCormick Place Convention Center, West Hall F1, Level 3 at the ADA Scientific Sessions. In addition, Dr. DeVries and Dr. Michael Longaker will deliver clinical presentations on the data at the Neodyne Biosciences ADA booth (#1324) on Saturday, June 21 at 11:00 am, 2:00 pm, and 3:00 pm CT, as well as Sunday, June 22 at 2:30 pm CT.
About Lipohypertrophy
Lipohypertrophy (LH) is a common complication that affects 64% of all insulin users worldwide. LH is the result of ongoing skin microtrauma caused by subcutaneous insulin infusion pumps as well as repeated injections. LH impairs insulin absorption and impedes effective diabetes management. Currently, there is no treatment for LH, other than rotating and/or avoiding injection sites.
About embrace® Active Site Care
embrace Active Site Care is a transparent compression patch that uses a proprietary state-of-the-art mechanism to offload tension on the skin. The embrace technology has proven ability to target multiple underlying mechanisms of LH (e.g., mechanically-driven inflammation, adipose tissue expansion, and fibrosis) to support remodeling and resolution of both adipose and fibrotic tissue in the context of LH lesions. Embrace is already 510(k) cleared for fibrosis and CE marked, and could be used immediately on former insulin pump/injection sites to minimize and treat fibrosis in LH.
About Neodyne Biosciences
Neodyne Biosciences was founded at Stanford University and is currently led by an experienced team of medical device industry executives. Neodyne's unique scar-prevention patch technology, embrace® Active Scar Defense, is considered a global standard of care for the prevention of scarring. Neodyne is located in the heart of Silicon Valley with access to a wealth of expertise in medical technology research and development and venture capital. More information is available at https://www.embracescartherapy.com/diabetes.
Media Contact:
Michele Parisi
925-864-5028
[email protected]
SOURCE Neodyne Biosciences
Share this article