Regentis receives FDA IDE approval for GelrinC trial: 3 thoughts

Regentis Biomaterials recently received FDA approval to begin a phase III clinical study of GelrinC, a treatment for focal cartilage defects in the knee.

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Here’s what you need to know.

 

1. The trial will be used to support a premarket approval application which will allow the GelrinC to be marketed in the U.S.

 

2. Focal defects of in the cartilage of the knee are caused by a result of trauma and can be painful to patients. They often require intervention.

 

The GelrinC is minimally invasive. It is administered as a liquid, and then is converted into a solid after being exposed to ultraviolet light. The implant degrades within six months to a year, and is replaced with functional and durable cartilage.

 

3. Rush University Medical Center’s Assistant Chairman and Professor in the department of Orthopedics Brian Cole, MD, said, “GelrinC is a potential game changer in the cartilage repair space, and can be an attractive and viable option for patients.”

 

More orthopedic device news:
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