Empirical Spine, Inc. news

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 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