Clinical Trial Published in the Journal of Shoulder and Elbow Surgery Concludes That CollPlant's Vergenix™ STR Effectively Demonstrates Significant Clinical Improvements in Tennis Elbow
NESS ZIONA, Israel, December 10, 2018 /PRNewswire/ --
- 59% improvement in a key measure in patients with chronic tennis elbow at 6 months after treatment
- Vergenix™STR is currently sold in Europe; CollPlant plans to pursue FDA regulatory approval in U.S.
CollPlant (NASDAQ: CLGN), a regenerative medicine company utilizing its proprietary plant-based rhCollagen technology for tissue repair products, today announced a clinical trial published regarding its Vergenix™STR in the treatment of tennis elbow. The peer reviewed paper titled, "First clinical experience with a new injectable recombinant human collagen scaffold combined with autologous platelet-rich plasma for the treatment of lateral epicondylar tendinopathy (tennis elbow)" was published in the Journal of Shoulder and Elbow Surgery.
An estimated 1% to 3% of the population has lateral epicondylar tendinopathy, more commonly known as tennis elbow. The condition is characterized by micro tearing and degeneration of tendons. Current standard of care, which often does not alleviate the condition, includes steroids, physical therapy, needling, injecting platelet-rich plasma, ultrasound tenotomy, or surgery.
Vergenix™STR is an injectable gel comprised of cross-linked bioengineered recombinant human type I collagen combined with autologous platelet-rich plasma (PRP). Vergenix™STR forms a collagen-ﬁbrin matrix that serves as a scaffold for cell recruitment.
The clinical trial, which was concluded in August 2016, enrolled 40 patients and evaluated three key measures of tennis elbow at 6 months post-treatment. The mean Patient-Rated Tennis Elbow Evaluation score showed a 59% improvement (reduction) from baseline at 6 months. Grip strength increased by 28% from 28.8 kg at baseline to 36.8 kg at 6 months. In 68% of patients, improvements in sonographic tendon appearance were evident. No systemic or local severe adverse events were reported.
"Based on the very favorable data reported, this study concluded that Vergenix™STR demonstrated significant clinical improvements in patients with tennis elbow. Vergenix™STR offers a unique, and effective method to treat a wide range of tendinopathies with just a single application to initiate the healing process," stated Yehiel Tal, CollPlant's Chief Executive Officer. "In the U.S. market alone, there are estimated to be over 3 million procedures annually to treat tendinopathy. We look forward to advancing Vergenix™STR through the FDA approval process and into commercialization in the U.S."
Vergenix™STR has a CE mark and is currently sold in Europe. CollPlant plans to conduct a pre-submission meeting with the U.S. Food and Drug Administration in the coming weeks.
Vergenix™STR is primarily made of crosslinked recombinant human collagen (rhCollagen) and is intended to be combined with platelet-rich plasma (PRP), a concentrated blood plasma derived from the patient's own blood that contains high levels of platelets, which are critical to the healing process. Platelets contain growth factors which are responsible for stimulating tissue generation and repair, including soft tissue repair, bone regeneration, development of new blood vessels, and stimulation of the healing process. Upon administration, CollPlant's Vergenix™STR serves as a scaffold to support cell adhesion and proliferation involved in tendon healing, while maintaining growth factor-containing PRP in the vicinity of the injury. After injection into the affected area, the product forms a viscous gel matrix, holding the platelet concentrate in place. The formed matrix then has the ability to release growth factors in a controlled manner and with controlled biodegradation time, thereby enabling optimal healing.
CollPlant is a regenerative medicine company focused on 3D bioprinting of tissues and organs, and on developing and commercializing tissue repair products for orthobiologics, and advanced wound care markets. Our products are based on our rhCollagen (recombinant human collagen) that is produced with CollPlant's proprietary plant based genetic engineering technology.
Our products address indications for diverse fields of organ and tissue repair, and are ushering in a new era in regenerative medicine. Our flagship rhCollagen BioInk product line is ideal for 3D bioprinting of tissues and organs, and our unique Vergenix line of rhCollagen products includes a soft tissue repair matrix for treating tendinopathy and a wound repair matrix to promote a rapid optimal healing of acute and chronic wounds.
For more information about CollPlant, visit http://www.collplant.com
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Released December 10, 2018