LEXINGTON, Ky.--(BUSINESS WIRE)--Intralink-Spine, Inc. (ILS) announces that it has received unanimous approval from the Data Safety Monitoring Board (DSMB) to proceed with the Réjuve® clinical safety study (GEM-SE) for chronic low back pain (CLBP). As a result, ILS will be adding new sites to broaden Principal Investigator (PI) and participant representation in Australia.
“After careful review of the patient data, the DSMB has unanimously decided to approve the continuation of the GEM-SE study,” states Dr. Harwant Singh, Orthopaedic Surgeon at Pantai Hospital and DSMB Chairman.
“This is a great way to begin the new year,” states Lyle Hawkins, CEO of Intralink-Spine, Inc. “The DSMB has reviewed the study participant data and unanimously recommended that the study continues. This is another important step for ILS, as we continue to move forward to commercialization of Réjuve.”
According to Tom Hedman, Ph.D., Founder and CSO of Intralink-Spine, Inc., “The unique ability of Réjuve to address the core issues contributing to CLBP and progressive and debilitating tissue degradation is even more important in view of the current opioid addiction crisis, where prescription of opioids following back surgery or as part of a treatment regimen for CLBP has played a role in this epidemic.”
About Intralink-Spine, Inc. (ILS)
ILS was formed to manufacture and exclusively sell the Réjuve® medical device to treat Degenerative Disc Disease (DDD), low back pain, and related spinal diseases such as spondylolisthesis. In anticipation of forthcoming commercialization under the CE mark, ILS is conducting an active fundraising round for accredited investors; contact LHawkins@IntralinkSpine for more details.