Boston, Massachusetts – Gel4Med, a commercial-stage biomaterials company, today announced the publication of a real-world evidence (RWE) case series evaluating G4Derm™ Plus, its FDA-cleared biomimetic matrix (referred to as BMM™), in the treatment of chronic diabetic foot ulcers (DFUs) unresponsive to standard and advanced wound therapies. The study, conducted at Massachusetts General Hospital (MGH) and affiliated with Harvard Medical School, was published in the peer-reviewed Journal of Clinical and Translational Research as part of a special issue on Innovations in Wound Healing.
Real-World Results in Complex Clinical Settings
Unlike randomized controlled trials (RCTs), which often exclude the most challenging patients, this investigator-led study reflects real-world clinical performance of G4Derm™ Plus in hard-to-heal wounds. The diabetic foot ulcers (DFUs) included in the study had persisted for an average of 21.5 months despite aggressive and advanced wound care including treatment with biologics. The patients evaluated in the study had multiple comorbidities, such as venous stasis, Charcot neuroarthropathy, osteomyelitis, obesity, and prior foot amputations.
“We are proud to see G4Derm™ Plus recognized by the clinical community for its transformative potential in chronic wound management,” said Dr. Manav Mehta, CEO of Gel4Med. “Our peptide-based matrix was designed to closely mimic the native tissue’s extracellular matrix while providing a broad-spectrum antibacterial barrier protection. This dual functionality enables rapid wound healing progression while addressing bioburden—two essential factors for treating hard-to-heal wounds.”
This study marks an important milestone as the first published manuscript evaluating G4Derm™ Plus in DFUs that failed to respond to previous treatments, including advanced biologics. The primary objective of this real-world evidence study was to assess wound healing progression through granulation tissue formation, a critical endpoint in operating room (OR)-based settings.
Key Findings from the Real-World Evidence Study:
- Rapid Response in Difficult Cases: All patients showed formation of healthy granulation tissue and progression toward healing within 1–2 applications of BMM™, despite prior treatment failures with advanced therapies.
- Accelerated Wound Reduction: An average of 63.6% wound area reduction in 6 weeks using BMM™, versus ~48% in 12 weeks with biologics (Cochrane meta-analysis).
- Superior Results in Larger Wounds: BMM™ achieved higher reduction rates in larger wounds (mean size: 7.5 cm²) in half the time required by other products.
- Compelling Clinical Outcomes:
- A Wagner 3 DFU with exposed calcaneus regranulated fully after 3 applications.
- One patient achieved 100% wound closure in just 6 weeks with a single BMM™ application.
- Improved Wound Quality: Reductions in odor, drainage, and inflammation were observed. No adverse events were reported.
The rapid formation of granulation tissue supports earlier opportunities for skin grafting—an important outcome for inpatient settings.
Positioning Real-World Evidence as Clinical Strength
This case series demonstrates the value of G4Derm™ Plus in treating real-world, hard-to-heal wounds, offering external validity and practical insights often absent from RCTs. The study, authored by Dr. Sara Rose-Sauld, Dr. Jennifer Skolnikat, and Dr. Adam Landsman, highlights the matrix’s ability to support tissue regrowth and manage bioburden in a patient population with few remaining options.
The full publication is available at doi:10.36922/jctr.24.00063.
About G4Derm™ Plus (BMM™)
G4Derm™ Plus is an FDA-cleared, flowable, self-assembling peptide matrix developed to mimic the body’s native extracellular matrix while providing protection against bacteria, including multidrug-resistant organisms. The multifunctional matrix supports tissue revascularization and regrowth, while managing bioburden and mitigating antibiotic resistance. Built using Gel4Med’s proprietary Smart Materials Platform™, BMM™ is engineered to treat complex, non-healing wounds across settings of care.
G4Derm™ Plus is now commercially available in the United States, as a solution to supporting hospitals and clinicians seeking effective tools for managing chronic wounds. To learn more about integrating G4Derm™ Plus into your clinical practice, please get in touch with our team at info@gelformed.com
About Gel4Med
Founded out of Harvard Innovation Labs/Harvard University, Gel4Med is a commercial-stage materials science company dedicated to pioneering innovative treatments for unmet clinical needs. Utilizing our patent-protected Smart Materials Platform™, which uses synthetic biology and peptides, we design and engineer therapeutic materials with unparalleled customization. Esteemed investors, including Peter Thiel/Breakout Labs, National Institutes of Health (NIH), Department of Defense (DoD), National Science Foundation (NSF), Massachusetts Life Science Center (MLSC), and Mass Ventures, have recognized and funded our potential. Our robust product pipeline addresses various unmet clinical needs across applications such as surgery, cell delivery, drug delivery, and immunomodulation.
Media Contact:
For media inquiries, please contact Rebecca Salamone at rebecca.salamone@gelformed.com
