Spineology Inc.  



Welcome! Check out our anatomy-conserving technologies!

Spineology proudly announces the De Novo grant for the OptiMesh® Expandable Interbody Fusion System!  OptiMesh is featured in the OptiLIF™ procedure, which provides enhanced recovery, proven outcomes, and exceptional efficiency, as demonstrated by the SCOUT (Spineology Clinical Outcomes Trial) Investigational Device Exemption (IDE) trial.

Twenty-four-month outcomes included:

  • Substantial improvement in back pain and function
  • 98 percent fusion
  • ~90 percent ‘excellent’ or ‘good’ patient satisfaction scores
  • Excellent safety record

At Spineology, we are dedicated to transforming spine surgery by providing innovative, anatomy-conserving technologies for surgeons and their patients. Our proprietary mesh technology is used in the OptiMesh and Duo implants, which expand in three dimensions to create large footprints and allow placement of anatomy-conforming interbody fusion devices through very small incisions. This technology preserves spinal anatomy, increases procedural efficiency, and accelerates patient recovery.


 Videos

OptiLIF with the OptiMesh Expandable Interbody Fusion System Animation
Duo™ Expandable Interbody Fusion System Animation
Elite™ Expandable Interbody Fusion System Animation

 Press Releases

  • Spineology® Announces FDA De Novo Grant of Minimally Invasive OptiMesh® Expandable Interbody Fusion System

    Novel OptiLIF™ Procedure Expected to Launch in Q1 2021

    ST. PAUL, Minn. (Sept. 21, 2020) – Spineology Inc., an innovator in anatomy-conserving surgery, is excited to announce the FDA grant of its proprietary Spineology Interbody Fusion System, now called the OptiMesh Expandable Interbody Fusion System. The grant follows the successful completion of the SCOUT (Spineology Clinical Outcomes Trial) Investigational Device Exemption (IDE) trial. OptiMesh is a unique mesh device that expands in three dimensions, enabling surgeons to perform interbody fusion procedures through the smallest access in the spine industry.

    The SCOUT IDE trial outcomes data was presented at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Meeting in November 2019, by the trial’s lead investigator, John Chi, M.D., M.P.H. Dr. Chi is Director of Neurosurgical Oncology at Brigham and Women’s Hospital in Boston, Massachusetts, and Associate Professor of Neurosurgery at Harvard Medical School. Dr. Chi and his co-authors reported:

    • Substantial improvements in low back pain and a reduction in functional limitations at six, 12, and 24 months
    • A 98 percent fusion rate at 24 months, as seen on CT scans assessed by two independent radiologists
    • ~ 90 percent “Excellent” or “Good” patient satisfaction scores at six, 12, and 24 months post-procedure
    • An excellent safety record with no serious, device-related, adverse events

    “We have found this innovative, minimally invasive device to be a safe and effective option for lumbar interbody fusion procedures,” said Dr. Chi. “The outcomes, including high fusion rates, improved function, reduced pain and high satisfaction rates, are very favorable. Additionally, the minimal exposure requirements yielded an exceptional safety profile.”

    Spineology is preparing for a Q1 2021 launch of the OptiLIF procedure utilizing the OptiMesh device. This procedure enables enhanced recovery and exceptional efficiency, and its outcomes are supported by prospective FDA IDE clinical data.

    “OptiLIF is the least invasive lumbar fusion procedure that I can do,” said Dr. Stephane Lavoie of DeLand, Florida, an investigator in the SCOUT study. “The unique OptiMesh implant can be inserted through a one-centimeter incision and then expanded to restore anatomy, which provides neural decompression and optimally conforms to a patient’s endplates. As a result, patients recover quickly, and the impact to procedure efficiency is significant. OptiLIF will have a major impact on the standard of care related to low back and leg pain.”

    The FDA De Novo grant of the OptiMesh Expandable Interbody Fusion System opens the door to commercialization of Spineology’s OptiLIF procedure, which supports Spineology’s anatomy-conserving product strategy.

    “I am pleased to announce the De Novo grant of our OptiMesh implants and instrumentation to support the OptiLIF procedure. Based on the strong SCOUT study results and experiences of our investigators, we are preparing for a full market launch in Q1 of 2021. I anticipate OptiLIF will help take surgery for low back and leg pain to the next level through its ability to provide excellent patient outcomes, enhanced recovery and exceptional efficiency,” said John Booth, Spineology’s CEO.

    About Spineology Inc.
    At Spineology, we are dedicated to transforming spine surgery by providing innovative, anatomy-conserving technologies for surgeons and their patients. Our proprietary mesh technology is used in the OptiMesh and Duo implants, which expand in three dimensions to create large footprints and allow placement of anatomy-conforming interbody fusion devices through very small incisions. This technology preserves spinal anatomy, increases procedural efficiency, and accelerates patient recovery. Learn more at spineology.com.

    Contacts

    John J. Booth, Chief Executive Officer
    651-256-8511
    jbooth@spineology.com

  • Spineology Completes Enrollment in Post-Market Study of Novel, Expandable Lateral Implant

    Duo™ System Demonstrates Reduced Operative Times, Shorter Hospital Stays, and Improved Clinical Outcomes Compared to Traditional Lateral Surgery

    ST. PAUL, Minn. (Oct. 5, 2020) – Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce full enrollment of its 200-patient Duo™ Expandable Interbody Fusion (IBF) System Post-Market Study, called RaDical. The RaDical Study is a prospective, Institutional Review Board (IRB)-approved, multi-center lateral interbody fusion study. It follows subjects for two years and measures intraoperative and postoperative metrics along with short- and long-term outcomes in a real-world patient population.

    The Duo Expandable IBF System offers a unique implant design that is placed through an 18 mm portal tube. This minimizes retraction of the neural structures and psoas muscle to reduce or eliminate the neurological deficits commonly associated with traditional lateral interbody fusion procedures. The Duo implant is then filled with bone graft in situ to expand the device in all directions, providing a large, endplate-conforming, load-sharing interbody construct.

    Data from the first 115 patients enrolled in the RaDical study demonstrated the Duo System’s benefits to the patient, surgeon and hospital when compared to traditional lateral interbody fusion systems, including:

    • Reduced neurological deficits following surgery1
    • 33 percent decrease in total operative time1
    • 37 percent shorter hospital stay1
    • Lower complication rate1

    “The RaDical Study is one of the most innovative lateral studies ever conducted,” said study investigator Dr. Pierce Nunley, Shreveport, Louisiana. “We’re measuring subjective and objective data and looking at anterior thigh pain and weakness as early as two weeks post-op, which, to my knowledge, has not been done before. We have seen exciting results with the Duo System, including a very low onset of new neurological events, reduced surgical times, and shorter hospital stays.” 

    “We are extremely pleased to complete enrollment in the RaDical Study and see the positive impact of the Duo System design,” said John Booth, CEO, Spineology Inc. “Based on the data compiled to date, patients are experiencing long-term, clinically meaningful improvements in pain and function; high fusion rates; and fewer neurological deficits and complications compared to traditional lateral interbody fusion surgery. The data also shows a very positive economic impact to hospitals with shorter operative times and hospital stays compared to traditional lateral interbody fusion surgery. We look forward to collecting complete data on all 200 patients enrolled in the study and expect to see continued favorable outcomes, which will provide further evidence of the system’s benefits to patients, surgeons and hospitals.”

    “My patients have had no neurologic issues post-operatively and far less pain,” added study investigator Dr. John Malloy, Coconut Creek, Florida. “This has resulted in shorter hospital stays and faster recovery.”

    1. Data on file

    About Spineology Inc.

    At Spineology, we are dedicated to transforming spine surgery by providing innovative, anatomy-conserving technologies for surgeons and their patients. Our proprietary mesh technology is used in the OptiMesh® and Duo implants, which expand in three dimensions to create a large footprint and allow placement of an anatomy-conforming interbody fusion device through a very small incision. This technology preserves spinal anatomy, accelerates patient recovery, and increases procedural efficiency. Learn more at spineology.com.

  • One-Year Outcomes Data from the OptiMesh® SCOUT (Spineology® Clinical Outcomes Trial) IDE (Investigational Device Exemption) to be Published in SPINE

    The OptiMesh® Expandable Interbody Fusion System demonstrates significant reduction in pain, improvement in back function, and high patient satisfaction scores

    ST. PAUL, Minn.--Spineology Inc., an innovator in anatomy-conserving surgery, is excited to announce that SPINE, the journal of the North American Spine Society, has accepted the manuscript, “One Year Outcomes from a Prospective Multicenter Investigation Device Trial of a Novel Conforming Mesh Interbody Fusion Device,” for publication. The outcomes data for this publication came from SCOUT, a prospective, multicenter investigation device trial of patients treated with the OptiMesh Expandable Interbody Implant. The unique OptiMesh device expands in three dimensions, enabling surgeons to perform interbody fusion procedures through an access smaller than any other fusion procedure. Publication is anticipated before the end of 2020.

    SCOUT demonstrated strong outcomes for the OptiMesh implant at one year including:

    • Significant reduction in back and leg pain1
    • Substantial improvement in functional status that occurred early and was sustained through 12 months1
    • 90 percent ‘excellent’ or ‘good’ patient satisfaction scores1
    • A 98 percent fusion rate1
    • An excellent safety record with no serious, device-related, adverse events1 

    “We have found this innovative, minimally invasive device to be a safe and effective option for lumbar interbody fusion procedures,” said John Chi, M.D., M.P.H., SCOUT’s lead investigator. Dr. Chi is the Director of Neurosurgical Oncology at Brigham and Women’s Hospital in Boston, Massachusetts and Associate Professor of Neurosurgery at Harvard Medical School, and the author of the SPINE article. “The outcomes, including high fusion rates, improved function, reduced pain, and high satisfaction rates, are very favorable. Additionally, the minimal exposure requirements yielded an exceptional safety profile.”

    “Spineology recently received an FDA De Novo Grant for the interbody placement of OptiMesh and is preparing for a Q1 2021 launch,” said John Booth, Spineology’s CEO.  “Publication of the SCOUT data is further testimony to the strength of the study. The results demonstrated by OptiMesh along with the experiences of our investigators will help take surgery for low back and leg pain to the next level by providing excellent patient outcomes, enhanced recovery, and exceptional efficiency.”

    In addition to the SPINE publication, the International Journal of Spine Surgery (IJSS) has accepted three manuscripts discussing Spineology’s proprietary mesh technology.  “Load-Share Mapping for Traditional PEEK versus Novel Hybrid PEEK with Expandable Porous Mesh Intervertebral Devices,” “Critical Evaluation of Biomechanical Principles of Radiographic Indicators for Fusion Assessment in a Novel Conformable Porous Mesh Implant,” and “Cell and Tissue Response to Polyethylene Terephthalate (PET) Mesh Containing Bone in Vitro and in Vivo.” IJSS will be publishing all three manuscripts in a special issue this fall.

    About Spineology Inc.
    At Spineology, we are dedicated to transforming spine surgery by providing innovative, anatomy-conserving technologies for surgeons and their patients. Our proprietary mesh technology is used in the OptiMesh and Duo implants, which expand in three dimensions to create large footprints and allow placement of anatomy-conforming interbody fusion devices through very small incisions. This technology preserves spinal anatomy, increases procedural efficiency, and accelerates patient recovery. Learn more at spineology.com

    Contacts

    John J. Booth, Chief Executive Officer
    651-256-8511
    jbooth@spineology.com

    1 Lu Y, Huang K, Lavoie S, Krag M, Nunley P, Bydon M. Preliminary 24-month Outcomes of a Prospective Investigation of a Novel Mesh Interbody Spacer in Single-Level Fusions. Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2019. Las Vegas, NV. 2019 Oct 31 - Nov 2.


 Featured Products

  • OptiMesh Expandable Interbody Fusion System
    The OptiLIF™ procedure employs Spineology’s proprietary OptiMesh® Expandable Interbody Fusion System to perform interbody fusion through an access smaller than any other fusion procedure....

  • The OptiLIF™ procedure employs Spineology’s proprietary OptiMesh® Expandable Interbody Fusion System to perform interbody fusion through an access smaller than any other fusion procedure. The procedure is performed using specialized, expandable instrumentation and implants that conserve bone and muscle, protect neural structures, and distract to indirectly decompress. Together, this provides enhanced recovery, proven outcomes backed by FDA IDE clinical trial data, and exceptional efficiency.
  • Duo Expandable Interbody Fusion System
    The Duo™ Expandable Interbody Fusion System represents the latest advancements in lateral interbody fusion surgery....

  • The Duo™ Expandable Interbody Fusion System represents the latest advancements in lateral interbody fusion surgery. The system is designed to minimize the amount and duration of retraction on the neural structures and surrounding soft tissues in order to reduce the neurological deficits commonly associated with the lateral transpsoas approach.
  • Elite Expandable Interbody Fusion System
    The Elite™ Expandable Interbody Fusion System represents the next generation of expandable technology....

  • The Elite™ Expandable Interbody Fusion System represents the next generation of expandable technology. Its unique design minimizes both neural retraction and insertion force, accommodates a larger graft channel than many competitive expandable cages, and provides controlled expansion to restore disc height, potentially providing indirect decompression. When paired with Incite Cortical Fibers, Elite’s clinical advantages promote fusion and quick recovery while conserving patient anatomy.

Send Email

Type your information and click "Send Email" to send an email to this exhibitor. To return to the previous screen without saving, click "Reset".