Empirical Spine


Empirical Spine is dedicated to providing innovative, minimally invasive, motion-preserving solutions for spinal conditions such as degenerative spondylolisthesis and lumbar spinal stenosis. Their flagship product, the LimiFlex™ Dynamic Sagittal Tether, offers an alternative to traditional spinal fusion, aiming to restore natural motion and stability while reducing surgical invasiveness and associated risks.

Industries

health-care
medical
medical-device

Nr. of Employees

small (1-50)

Empirical Spine

San Carlos, California, United States, North America


Patents

Surgical tether apparatus and methods of use

US-12167874-B2

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Methods and apparatus for coupling a prosthesis to a spinal segment

US-10864022-B2

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Surgical tether apparatus and methods of use

US-10314623-B2

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Methods and apparatus for coupling a prosthesis to a spinal segment

US-10092331-B2

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Methods and systems for laterally stabilized constraint of spinous processes

US-9295499-B2

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Surgical tether apparatus and methods of use

US-9107706-B2

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Products

Dynamic sagittal tether implant (motion-preserving posterior tension band)

An implantable device intended to augment the posterior tension band after lumbar decompression to provide elastic resistance to flexion, maintain lordosis, encourage facet engagement, and preserve segmental motion as an alternative to rigid fusion for selected patients.

LimiFlex™ Dynamic Sagittal Tether™

A dynamic sagittal tether device conceived in the Biodesign program at Stanford University, developed for spinal applications.

LimiFlex 4 Dynamic Sagittal Tether

LimiFlex is intended to provide segmental stabilization following decompression for Grade 1 lumbar degenerative spondylolisthesis with spinal stenosis. It is implanted through a dorsal approach, typically through the same incision used for surgical decompression. The device uses ultrahigh molecular weight polyethylene bands looping around the spinous processes and dynamic titanium rods designed to increase segmental stiffness and reduce flexion range of motion.

LimiFlex Dynamic Sagittal Tether (DST)

A first-of-its-kind surgical implant designed to maintain motion and stability after spinal decompression for grade 1 lumbar degenerative spondylolisthesis patients with spinal stenosis, without using screws or bone grafts.

LimiFlex Paraspinous Tension Band

The LimiFlex™ Paraspinous Tension Band is a new potential alternative to spinal fusion for patients receiving surgical decompression for grade 1 lumbar degenerative spondylolisthesis with spinal stenosis. It is made of two titanium spring couplers attached by strong textile straps, forming a loop around two spinous processes to stabilize the spine when bending forward, restoring anatomic stability to the lumbar spine.


Services

Management and enrollment of a pivotal IDE clinical study for a motion-preserving posterior tension-band spinal implant; includes investigational-arm management and data presentation.

Preparation and submission of PMA documentation and interaction with regulatory authorities for implantable spinal devices.

Expertise Areas

  • Motion-preserving spinal implant development
  • Minimally invasive spine surgery
  • Pivotal IDE clinical trial management
  • FDA PMA regulatory strategy and Breakthrough Device interactions
  • Show More (3)

Key Technologies

  • Dynamic tension-band implant mechanics
  • Motion-preserving spinal implants
  • Minimally invasive posterior implantation techniques
  • Posterior tension-band augmentation
  • Show More (2)

News & Updates

Empirical Spine receives FDA breakthrough device designation for the Limiflex device targeting degenerative spondylolisthesis

Empirical Spine presents data from study of the Limiflex tension band at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2021

Empirical Spine completes full premarket approval (PMA) submission to FDA for Limiflex Dynamic Sagittal Tether

Empirical Spine completes enrollment in pivotal IDE clinical trial studying Limiflex in degenerative spondylolisthesis

Empirical Spine submits PMA module II for Limiflex as a new motion-preserving minimally invasive standard in spine surgery

Empirical Spine closes $10 million Series B financing

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