Polyganics has received a Breakthrough Device Designation from the FDA for its biodegradable sealant patch for surgical wounds.
Polyganics, based in Groningen, the Netherlands, specializes in medical devices that use natural polymers to help regenerate injured tissue. The FDA granted a Breakthrough Device Designation for its Liver and Pancreas Sealant Patch. The patch uses Polyganics polymer technology to seal off surgically treated tissue and prevent fluid leakage from wounds after surgeries of the liver, pancreas and the bile tract.
“It’s applied like duct-tape on a tube,” CEO Rudy Mareel told me about the sealant patch. The device is applied during the operation in tandem with a liver resection or other abdominal surgical procedures.
The patch is made using Polyganics’ polymer technology, which can be fine-tuned for specific needs. For example, the biodegradability, strength and elasticity of the patch can all be adjusted through the polymers used.
Mareel elaborated, “What makes it so unique is that it is resistant to bile and pancreatic action.” This ensures that the patch maintains a tight seal after it has been applied, allowing surgical wounds to heal completely.
The FDA designation is not the first major stride for Polyganics. Last year, the company raised €1.2M to develop its dura sealant patch product, which reduces complications from brain surgery.
However, the Dutch company faces competition from Gecko Biomedical, a French biotech that also develops polymers for tissue reconstruction. In 2016, Gecko raised €22.5M to develop a bio-glue that can stop bleeding from sutured tissues.
The ease of applying Polyganics’ sealant patch may prove to be a key factor in differentiating the product from competitors.
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