Tissue repair company Regentis Biomaterials has reported positive results from a clinical safety study of hydrogel implant GelrinC, designed to treat articular cartilage in injured knees.
The CE mark-approved GelrinC hydrogel implant is administered as a liquid to fill any shape of cartilage defect and it is then converted into a solid following exposure to ultra-violet light for 90 seconds.
The implant will degrade in 6-12 months and will be replaced with functional and durable cartilage.
The clinical study results from a single-arm, multi-center study that involved 23 patients in Europe and Israel showed sustained knee function improvement over two years after implantation and significant pain reduction.
The results also showed limited adverse effects when compared to those reported in similar studies with no serious adverse events related to the implant.
Regentis Biomaterials president and CEO Alastair Clemow noted 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 added.
University of Vienna medical professor Dr Siegfried Trattnig noted MRI evaluations with combined morphologic and biochemical assessment allowed us to monitor patient progress made with GelrinC.
"We were able to understand using noninvasive magnetic resonance techniques how new tissue integrated with the host tissue, as well as the biochemistry behind the repair tissue," Dr Trattnig added.