CollPlant reported positive final clinical trial results for Vergenix STR.
Here are five highlights:
1. Vergenix STR is a device intended for the treatment of a range of tendon injuries, including tendinopathy.
2. The Vergenix STR Technical File was submitted in December 2015 in anticipation of CE mark approval in Europe in Q2 2016.
3. The objective of the company's trial was to demonstrated the safety and performance of Vergenix STR in 20 patients suffering from inflammation of the elbow tendon. All patients were followed for a total of six months after initial treatment.
4. At three months, Vergenix STR patients reported an average Patient Related Tennis Elbow Evaluation questionnaire score improvement of 55.8 percent. At six-month follow-up, Vergenix STR patients reported a mean PRTEE score improvement of 58.1 percent.
5. CollPlant is a clinical-stage regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products.