November 27, 2018
MINNEAPOLIS–(BUSINESS WIRE)–Regentis Biomaterials today announced that Twin Cities-based TRIA Orthopedics is the first in Minnesota to perform a procedure using the GelrinC™ implant to treat damaged articular cartilage causing knee pain. GelrinC (pronounced “gel-rin-cee”) is an investigational device being evaluated as a treatment to help the body regrow cartilage in the knee. TRIA is the only site in Minnesota – and just one of 17 sites nationwide – enrolling patients with knee pain caused by damaged knee cartilage in the SAGE clinical trial.
Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. Damage to the cartilage layer can be extremely painful for patients and is generally associated with sudden trauma. Surgical intervention is often required because of the limited capacity for cartilage to repair itself. The current standard of care is a procedure called microfracture, which involves making tiny holes in the bone underneath the damaged cartilage to stimulate the growth of new cartilage. However, the cartilage is more like scar tissue than the original hyaline cartilage; as a result, microfracture often provides only short-term relief and may require repeat surgeries.
“There are limited options for patients who continue to experience knee pain caused by damage to their articular cartilage,” said Dr. Brad Nelson, orthopedic surgeon. “The hope is that GelrinC, which requires only a single minimally invasive procedure, will promote repair of the cartilage and alleviate pain.”
People 18-50 years old with pain in one knee caused by damaged articular cartilage can inquire about the study by visiting www.MyKneeStudy.com or by calling (833) 430-8686.
In the U.S., GelrinC™ from Regentis Biomaterials is an investigational device for patients with articular cartilage damage in their knee. GelrinC’s unique mode of action allows it to be implanted as a liquid so that it completely fills the cartilage defect in the knee, and then be cured into a gel that enables the body’s own stem cells to settle on its surface. Six to 12 months after surgery, the GelrinC is gradually resorbed by the body and replaced by new cartilage tissue. Preliminary clinical trials in Europe have indicated that this regenerated tissue provides excellent improvement in pain and function. To learn more about GelrinC, please visit www.GelrinC.com.
About the SAGE Clinical Trial
The SAGE study is a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study comparing GelrinC to microfracture, the current standard of care treatment for damaged knee cartilage. The multi-center Phase III pivotal study will enroll 120 patients. All patients who meet study requirements and agree to enter the trial are provided GelrinC as treatment.
About Regentis Biomaterials
With offices in Princeton, New Jersey, and Or Akiva, Israel, Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration. The technology was originally developed at the Technion-Israel Institute of Technology by Dr. Dror Seliktar. For more information, please visit www.regentis.co.il.
CAUTION Investigational device. Limited by United States law to investigational use.
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