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 Rejuve(R)
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 Rejuve.”According to Tom
Hedman, Ph.D., Founder and CSO of Intralink-Spine, Inc., “The unique
ability of Rejuve 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 Rejuve(R) 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.
LEXINGTON, Ky.–(BUSINESS WIRE)– #backpain–Intralink-Spine, Inc. (ILS) announces that it has received unanimous approval from the Data Safety Monitoring Board (DSMB) to proceed with the Rejuve(R) 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,