FDA Grants Clearance to Gel4Med: Breakthroughs in Wound Management with G4Derm and G4Derm Plus
23 Oct 2023
Boston, Massachusetts – Gel4Med, an innovative biomaterials company, is proud to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its first biosynthetic matrix products, G4Derm and G4Derm Plus. This achievement reflects the relentless dedication of the Gel4Med team to design and develop transformative technology focused on advancing patient care.
Gel4Med’s novel biosynthetic matrix products, G4Derm and G4Derm Plus are designed to transform wound management. Current biomaterials for wound care use a top-down approach that often relies on bio-harvesting donor tissues (animal and human). This strategy often results in poor clinical outcomes due to the variable quality of donor tissue materials, donor availability, risk of disease transmission, extensive biochemical processing, and donor-host mismatch. In contrast, Gel4Med uses bottom-up design and bioinspired engineering approaches utilizing its Smart Materials Platform. The advanced polypeptide matrix in G4Derm family products forms a scaffold that facilitates wound healing while preventing bacterial penetration. The flowable form factor enables the contouring of irregularly shaped wounds and eliminating dead space. The product was designed with user-centric benefits, delivered as a prefilled, sterile, and ready-to-use syringe that can be stored at room temperature. The market clearance by the FDA supports the safety, effectiveness, and conformity to high-quality standards of G4Derm and G4Derm Plus. As the 2024 commercial launch approaches, Gel4Med is confident that the G4Derm and G4Derm Plus will establish a new standard in managing acute and chronic wounds.
“We are thrilled to introduce G4Derm and G4Derm Plus, a pivotal advancement in wound care,” said Dr. Manav Mehta, CEO of Gel4Med. “Using our synthetic peptide approach, our products were designed to closely resemble the extracellular matrix found in the host tissue. This formulation exerts a robust antibacterial barrier, addressing the challenge of multi-drug-resistant organisms and biofilms that are known to impede wound closure. The FDA clearance reaffirms our vision of purpose-driving biomaterial engineering and underscores our commitment to patient care.”
Exploring Partnerships for a Broader Patient Impact: Gel4Med invites those attending the Symposium on Advanced Wound Care (SAWC) Fall Conference in Las Vegas, November 2-5, 2023, to connect with the team to learn more about the Company’s portfolio and engineered biomaterials solutions. The company is actively engaging with strategic partners to amplify its reach in preparation for the G4Derm and G4Derm Plus commercial launch. If you want to partner with the Company, please contact the media contact below.
About Gel4Med: Originating from the Harvard Innovation Labs, Gel4Med stands at the forefront of biomaterials science. Leveraging its Smart Materials Platform, the company rapidly propels cutting-edge products through its development pipeline. This groundbreaking platform offers unparalleled customization capabilities, ushering in new horizons for therapeutic biomaterials across regenerative medicine, surgery, and both cell and drug delivery domains. Gel4Med's endeavors are supported by eminent backers, including Peter Thiel's Breakout Labs, the National Institutes of Health (NIH), the Department of Defense (DoD), the National Science Foundation (NSF), the Massachusetts Life Sciences Center (MLSC), and Mass Ventures.
For more information, please get in touch with Rebecca Salamone at rebecca@gelformed.com
Forward Looking Statements:
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward-looking statements.
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