Empirical Spine
SCOPE
Restart production of the LimiFlex Dynamic Sagittal Tether – a previously CE marked spinal implant – in preparation for launch in the United States. The LimiFlex device provides an alternative to spinal fusion. It was a successful product in the European market prior to moving to the U.S., but due to the favorable market potential and reimbursement structure in America, Empirical Spine decided to reincorporate to pursue FDA approval and ultimately U.S. and commercialization.
OUTCOME
PDV MedTech was contracted to restart their manufacturing line, which has been successfully completed. Empirical Spine is preparing to ramp up commercial manufacturing pending FDA approval.
