Empirical Spine, Inc.


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, Inc.

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.


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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