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Home/Biologics/CollPlant Awarded CE Mark for Plant-Based Human Collagen
Biologics

CollPlant Awarded CE Mark for Plant-Based Human Collagen

November 2, 2016 1 min read Premium comments

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CollPlant Awarded CE Mark for Plant-Based Human Collagen
Vergenix™STR / Courtesy of CollPlant
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CollPlant Ltd, a regenerative medicine company located in Israel, has received the CE Mark for its product Vergenix STR, a plant-based soft tissue repair matrix for the treatment of tendinopathy.

CollPlant Chief Executive Officer Yehiel Tal said, “The CE Mark for Vergenix STR denotes an additional and key milestone achieved by CollPlant. In the past few months, we have shown that treatment with our product provides for substantially superior results when compared to published steroid treatment results, the current standard of care for tendinopathy.”

This is the second CE Mark that the company has received this year. The first was granted at the beginning of 2016 for the company’s VergenixFG product, a treatment for chronic and surgical wounds.

These awards advance CollPlant’s strategic plan to position plant-based human collagen technology, and its medical byproducts, as the gold standard in regenerative medicine.

According to the press release, Vergenix STR is primarily made of cross linked rhCollagen which is intended to be combined with platelet-rich plasma (PRP), a concentrated blood plasma derived from the patient’s own blood.

This mixture contains high levels of platelets, which are critical to the healing process. The company claims that 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.

CollPlant’s Vergenix STR serves as a scaffold to support cell adhesion and proliferation involved in the tendon healing while, at the same time, 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 matrix formed has the ability to release growth factors in a controlled manner and with controlled biodegradation time, thereby enabling tissue repair. The matrix formed at that point has the ability to release growth factors in a controlled manner and with controlled biodegradation time, support and enable tissue repair, according to CollPlant officials.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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