Regentis Biomaterials, a tissue repair company, has announced new clinical data demonstrating the efficacy and safety of its GelrinC implant, designed for the treatment of articular cartilage in injured knees.
The biodegradable hydrogel implant is inserted as a liquid to fill any form of cartilage defect and it is then converted into a solid after 90 seconds of exposure to ultra-violet light.
The GelrinC implant will be replaced with functional and durable cartilage following its natural degradation within 6-12 months.
According to study investigator Dr Ron Arbel, GelrinC works in combination with the microfracture procedure to greatly enhance the body’s ability to regenerate new cartilage so that patients can return to an active lifestyle.
There was a substantial improvement of the knee injury and osteoarthritis outcome score (KOOS) after two years of study.
KOOS is a patient-reported outcome measurement instrument designed to assess a patient’s opinion about their knee and associated problems.
The clinical results were found to be fruitful compared with existing standard procedures, such as micro fractures, which increase the flow of blood and bone marrow stem cells to the damaged area.
In addition, the MRI evaluations coupled with combined morphologic and biochemical assessment also supported the safety and effectiveness of GelrinC implant.
Regentis Biomaterials president and CEO Alastair Clemow said these results show that GelrinC is safe and that the treatment effectively regenerates high-quality cartilage.
"While recovery rates for knees treated with standard procedures plateau and even decrease over time, GelrinC patients showed constant improvement over the course of the study," Clemow said.
The clinical results were reported from a single-arm, multi-centre study that involved 23 patients in Europe and Israel.
The study reported limited adverse effects compared with those found in similar studies, with no serious adverse events related to the implant.
Currently, the study also enrolled an additional 30 patients at 12 new sites in Germany, Belgium, Poland, the Netherlands and Israel.
In March 2013, the company obtained CE mark approval for GelrinC biodegradable implant, which is currently an investigational device and not available for sale in the US and Israel.