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Fresh Hope For Chronic Wounds

FDA-approved wound management products include University of Delaware-developed biomaterials

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The U.S. Food and Drug Administration has approved two new wound management products that include patented hydrogels invented by UD material scientist Darrin Pochan and Joel Schneider, a former UD faculty member now at the National Cancer Institute.
The U.S. Food and Drug Administration has approved two new wound management products that include patented hydrogels invented by UD material scientist Darrin Pochan and Joel Schneider, a former UD faculty member now at the National Cancer Institute. Image for illustration purposes
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By  University of Delaware

Newswise — The U.S. Food and Drug Administration has approved two new wound management products that include patented hydrogels invented by University of Delaware material scientist Darrin Pochan and Joel Schneider, a former UD faculty member now at the National Cancer Institute. The unique hydrogel materials are made of peptides — the building blocks of proteins — that self-assemble to form a 3D matrix and are compatible with living cells. The consistency of jelly, the unique materials are useful for a variety of applications.

Gel4Med, a Harvard University-based biomaterials engineering company, licensed four patents related to the technology via UD’s Office of Economic Innovation and Partnerships (OEIP) in 2018. The company incorporated the UD-developed hydrogels into two products, G4Derm and G4Derm Plus, that have been intentionally designed to speed healing by combatting bacterial and fungal infection while simultaneously promoting tissue regrowth.

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Gel4Med is currently piloting the products in health care settings in the United States.

A new approach for wound care

According to Gel4Med CEO Manav Mehta, the needs in the clinic are vast and advances in biomaterials are needed. 

Antibiotic resistance is a huge problem. Wound closure also is a major issue. Traditionally, pharmaceutical companies and wound care companies approach these problems independently.

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“But a wound is a two-sided problem,” Mehta said. “You have an infection problem, which is managing the bioburden, but also a wound-closure problem.”

Current antimicrobials on the market are generally designed to sterilize everything they encounter. Placed on an open wound, this means that while killing bacteria, an antimicrobial also may exert a toxic effect on healthy cells that are participating in wound closure. 

This is where G4Derm and G4Derm Plus are different — and where UD’s technology shines. 

The UD-patented biomaterials included in the products are inherently antimicrobial and flow in such a way that allows the product to reach wounds with crevasses and uneven topography, often missed by traditional sheet form products. The product has the ability to remain in place over long time-periods, too, before gradually being absorbed by the body, creating a natural scaffold on which tissue can regenerate and grow.

“Having that type of localized activity that doesn’t dissipate into the bloodstream or body is incredibly powerful,” Mehta said. “I do not think anyone, even now, really is able to do that approach. We kind of own that space for now.”

Another feature that set the UD-developed biomaterials apart is that the hydrogel extrudes as a liquid and immediately regains its 3D structure at the molecular level after application.

“Being able to apply a liquid and have it immediately recover to its gel matrix form — that’s a big deal for wound healing, to be able to apply it to hard-to-access spaces and to start the healing process right away,” Mehta said. According to Mehta, other options in the market don’t offer this phase shifting and shear thinning property.

Mehta pointed to Pochan and Schneider’s approach and intellect around peptide design as critical to Gel4Med’s ability to advance such an industry-disrupting solution.

“It’s not just an innovation problem that they solved from a broad-spectrum antimicrobial perspective, but also other aspects from a commercialization standpoint, such as the ability to produce the hydrogels economically at-scale and the ability to build a simplified supply chain due to this innovative materials science approach,” Mehta said. 

Peptides and proteins typically degrade and break down under high heat, but the UD-developed peptides fold appropriately and are thermostable, allowing them to resist degradation at very high temperatures, an advantage over other materials in the marketplace. This allows them to be sterilized using steam as a final step in manufacturing, which enables a potentially safer and more environmentally friendly manufacturing approach, as well as the ability to use the product in various settings of care from operating rooms to the bedside.

Gel4Med is currently piloting the promising products in the U.S. hospital setting with the goal of demonstrating infection-free wound closure for conditions such as pressure ulcers, venous leg ulcers, diabetic foot ulcers and surgical wounds. The products are effective on both small and large wounds, including hard-to-access wounds, which are particularly challenging to heal. The company also is exploring the use of the UD-developed hydrogels in materials for the treatment of other conditions, including spinal cord injury, corneal diseases and other surgical applications.

The right timing 

Looking back, Pochan said he and Schneider recognized right away that the hydrogels they created had tremendous market potential. So much so that they formed a startup company shortly after filing the patents for their biomaterial’s discovery in the early 2000s, with OEIP’s help. They called the company Del-a-gel, but it never quite got off the ground. 

“In hindsight, it was way too early to do it. We explored some avenues, but it just didn’t go anywhere,” recalled Pochan. “Years later, when we had more papers published and a lot more evidence that these materials are viable for real biomaterials, that’s when Gel4Med came calling.”

In between, there were false starts, ongoing research, even a short-term, limited licensing opportunity that looked promising but went nowhere. That’s the nature of invention. 

OEIP Technology Transfer specialists, however, continued building relationships with companies that might want to take the technology forward, knowing that it takes the right idea but also the right combination of support and people to advance an invention through the commercialization pipeline.

Now, Gel4Med’s products offer an extremely original  approach for the advanced wound care space, one more example of UD discovery making its way beyond campus borders to positively impact society.

“It’s extremely gratifying to see Gel4Med and Manav take the fundamental ideas that we were very optimistic about and work hard over several years to get them approved,” Pochan said. “His success shows the work and the time needed to do it.”

New approaches in drug delivery for brain cancer

At UD, Pochan continues to explore new uses for the UD-developed biomaterials, from immunotherapy to tissue engineering. In one project, his research team is conducting fundamental studies exploring ways to use the patented hydrogels in drug delivery for medulloblastoma, a type of cancerous brain tumor in children. 

The NIH-supported work is collaborative with Sigrid Langhans, head of the cancer epigenetics laboratory at Nemours Children’s Health, which includes Nemours Children’s Hospital, Delaware. It’s a project that is close to the heart of Haozhe Zheng, a second-year doctoral student studying materials science and engineering at UD. 

“When I was in primary school, my grandfather died of brain cancer,” said Zheng. “He was a very kind person, and he suffered bad side effects from treatment. That’s the reason I want to study materials science, to help people find good therapies for disease.”

In the Pochan lab, located in the Ammon Pinizzotto Biopharmaceutical Innovation Center on UD’s Science, Technology and Advanced Research (STAR) Campus, Zheng’s daily work involves making and testing the novel biomaterials. The research team is investigating ways to encapsulate brain cancer cells in a three-dimensional hydrogel, then apply different drug combinations to better understand how drugs diffuse into the gel and interact with the cells. 

“It’s a way to discover drugs, drug doses or drug combinations that can impact chemotherapy by mimicking how the cells behave in the brain,” Pochan said.

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