Empirical Spine, Inc. news
Empirical Spine, Inc., maker of the LimiFlex™ Paraspinous Tension Band, today announced initiation of the PMA process for FDA review and approval of the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The Pivotal Trial supporting the PMA compares outcomes of patients who rece
Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in its U.S. IDE trial studying the use of LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar interbody fusion (TLIF) after
Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced completion of enrollment in the investigational arm of its U.S. IDE trial studying the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The trial compares outcomes of patients who receive either LimiFlex or transforaminal lumbar
Empirical Spine, Inc., a company developing advanced solutions for the surgical treatment of spinal disorders, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its LimiFlex™ Paraspinous Tension Band.
In doing so, the FDA has determined that LimiFlex™ holds the potential to offer significant advantages over existing approved or cleared treatment alternatives. Key potential
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently had its Premarket Approval (PMA) Module II accepted and closed by the US Food & Drug Administration (FDA), an important milestone in the commercial approval process for its LimiFlex Dynamic Sagittal Tether (DST).
The LimiFlex DST
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently submitted Premarket Approval (PMA) Module II in the US Food & Drug Administration (FDA) approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST).
LimiFlex is an investigational device targeting grade 1 lumbar degenerative spondylolisthesis patients
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, achieved several clinical, reimbursement and regulatory milestones in the past 12 months that are moving its LimiFlex™ Dynamic Sagittal Tether™ (DST) closer to market in the US. The company also recently initiated several key pre-commercial/market readiness projects.
Lim
Empirical Spine, Inc., a Silicon-Valley based medical technology company, announced today that data from the IDE study of the company’s LimiFlex Tension Band for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis, was presented at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2021. The SMISS Annual Forum took place from October 28 – 30, 2021 in Las Vegas, Nevada.
On Friday, October 29, Dr. Hyun Bae, LimiFlex Principal
Empirical Spine, Inc., maker of the LimiFlex Paraspinous Tension Band, today announced the closing of a Series B financing of $10 million. SHD (Scientific Health Development) led the round, with additional investment from GP&G (Green Park & Golf) and other syndicate members. The funds will be used to advance the product on its path to market, including completing the ongoing pivotal trial and submitting all components of the PMA filing to the FDA.
"We are gratified by the conf