BOTTOM-UP ENGINEERING SOLUTIONS
The Gel4Med approach is focused on nano-engineering the extracellular matrix to guide cell and tissue fate.
Unlike using top down approaches with current biomaterials that rely on harvesting from natural resources that often result in poor clinical outcomes due to variable quality of donor materials, donor availability, risk of disease transmission, extensive biochemical processing, donor-host mismatch, Gel4Med uses bottom up design and engineering approaches by employing its Smart Materials Platform with unique capabilities in synthetic biology to customize therapeutic biomaterials for regenerative medicine.
URGENT CLINICAL NEED
Wound infections are on the rise affecting Millions of Americans and costing Billions in healthcare expenditure
According to the Centers for Disease Control and Prevention Report, antibiotic-resistant bacteria will cause serious infections in millions of Americans each year, resulting in patient deaths, morbidity, serious complications, and huge economic losses. Bacterial colonization is common in wounds (surgical, burn, combat, and chronic) causing impaired tissue regeneration. Every year, complications associated with wound infections result in approximately 500,000 surgical site infections, 100,000 amputations and 99,000 deaths, with a health care burden of 3.7 million excess hospital days, over $428 million hospital re-admission penalties, and over $10 billion in health care expenditure. Patients surviving MRSA (multidrug-resistant Staphylococcus aureus) often spend months in the hospital and endure repeated surgeries to remove the infected tissue. Current treatments include systemic antibiotics, and/or applications of antimicrobial dressings, which are becoming less effective in prevention and treatment of antibiotic-resistant infections, and cause tissue toxicity in regenerating tissue. New prophylactic treatments are needed to prevent bacterial pathogens from wounds through mechanisms against which bacterial resistance will be unlikely to develop, and simultaneously accelerate wound closure.
Wound infections are preventable, Gel4Med has a solution: In order to address the problem of impaired tissue regeneration due to emerging antibiotic resistance associated with wound infections, Gel4Med has developed a new prophylactic technology that prevents bacterial pathogens from wounds through a mechanism of action that makes bacterial resistance unlikely to develop.
Our first product is a flowable extracellular matrix that promotes infection free tissue regeneration in surgical, chronic, and combat wounds without the use of any exogenous added drugs or biologics.
Gel4Med's tissue regeneration technology is an innovative patent protected nanofiber composition that has been molecularly engineered for maximum effectiveness. The nanofibers self-assemble in wounds to form a macromolecular hydrogel that functions as an extracellular scaffolding matrix for tissue regeneration. Wound regeneration is further enhanced by antimicrobial shielding properties of the matrix against bacteria. The product improves tissue regeneration and decreases the need for concomitant antibiotics. The product components are non-toxic, do not rely on plant or animal products for manufacturing (and thus are free of endotoxins), are biodegradable by hydrolysis and protease break down, are easy to manufacture and scale up using outsourcing, and are shown to offer flexible bio-design for a variety of applications to serve additional unmet medical needs in regenerative medicine market and bio-surgery.
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