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2018

Spineology Rampart One™ Standard ALIF Interbody Fusion System Gains FDA Clearance for Stand-Alone Use

-Spineology Inc., announces FDA clearance of its Rampart One™ Standard ALIF device allowing it to be used with or without supplemental fixation. “Following the success of our beta launch, this stand-alone clearance will provide additional momentum as we prepare for the full market release of the Rampart One ALIF Interbody Fusion System,” said John Booth, CEO of Spineology. The Rampart One ALIF Interbody Fusion System is another anatomy-conserving technology from Spineology. The system includes both standard and oblique interbody devices, each with integrated fixation screws and is designed to minimize vascular retraction and exposure to maximize safety. Additionally, Rampart One...

Spineology Completes First Lateral Post-Market Study Cases Using Novel Implant Design

Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce the completion of the first post-market study cases using its recently FDA-cleared Duo™ Lumbar Interbody Fusion System. In October, the company announced the initiation of this prospective, post-market lateral interbody fusion study designed to evaluate patient outcomes. To date, study cases have been completed by Dr. Craig Kuhns, Austin, Texas; Dr. Sandeep Kunwar, Fremont, California; and Dr. Jason Huffman, Napa, California. The Duo System implant is the first to combine PEEK, titanium and graft containment mesh elements. This design dramatically reduces the access required to implant a device...

Spineology Completes Enrollment in IDE Trial for Mesh Fusion Implant

Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that enrollment is now complete in the Company’s SCOUT clinical trial. The SCOUT (Spineology Clinical Outcomes Trial) IDE, conducted under an FDA-approved protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented lumbar interbody fusion procedures for the treatment of degenerative disc disease (DDD). Spineology’s deployable graft containment mesh implant is a uniquely porous device that deploys within the disc space as it is filled, permitting the contained bone graft to conform to the prepared vertebral body endplates. The system’s...

Spineology Receives a Notice of Allowance for a New US Patent on its Duo™ Lumbar Interbody Fusion Implant

Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application No. 15/476,911, “Mesh Spacer Hybrid.” The allowed claims include three independent device claims covering Spineology’s Duo implant, a novel proprietary intervertebral implant that includes PEEK intervertebral spacer elements and an expandable mesh graft containment element. Spineology expects the patent to be issued within the next several weeks. “We always strive to attain protection for strategic intellectual property,” said John Booth, Chief Executive Officer of Spineology. “This Notice of Allowance...

Spineology U.S. Clinical Trial for Interbody Fusion - Interim 12-Month Outcomes Data Presented by Dr. John Chi

Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that John Chi, M.D., M.P.H, Associate Professor of Neurosurgery at Harvard Medical School and the Director of Neurosurgical Spinal Oncology at Brigham and Women’s Hospital in Boston MA, has presented the first 12-month outcomes data from Spineology’s SCOUT clinical trial. The results were presented at the recent annual meeting of the International Society for the Advancement of Spine Surgery (ISASS) in Toronto, Canada. The SCOUT study (Spineology Clinical Outcomes Trial), conducted under an FDA-approved IDE protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety...

Two Data Presentations Highlight the Unique Potential of Spineology's Duo™ Implant

Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that two laboratory studies relating to the Spineology Duo™ Lumbar Interbody Fusion System were presented at the recent annual meeting of the International Society for the Advancement of Spine Surgery (ISASS) in Toronto, Canada. The Duo implant is the first to combine PEEK, titanium, and graft containment mesh elements. The unique hybrid design includes lateral PEEK supports integrated with an expandable porous mesh that serves to contain bone graft. The Duo implant, filled with bone graft after it is placed in the disc space, provides a large, endplate-conforming...

Spineology U.S. Clinical Trial for Interbody Fusion - Twelve-Month Outcomes Data Presented by Dr. John Chi

ST. PAUL, Minn.--( BUSINESS WIRE )--Spineology Inc., an innovator in anatomy-conserving spine surgery, is excited to announce that John Chi, M.D., M.P.H., Associate Professor of Neurosurgery at Harvard Medical School and the Director of Neurosurgical Spinal Oncology at Brigham and Women’s Hospital in Boston, Massachusetts, presented 12-month outcomes data from Spineology’s SCOUT clinical trial at the recent annual meeting of the North American Spine Society (NASS) in Los Angeles, California. The SCOUT study (Spineology Clinical Outcomes Trial), conducted under an FDA-approved IDE protocol, is a prospective multicenter non-randomized performance goal investigation, designed to evaluate safety and effectiveness outcomes in instrumented...

Spineology Inc. Announces New Board Members

Spineology Inc., the innovator in anatomy-conserving spine surgery, announced today the appointment of two new members to its Board of Directors, Bob Paulson and Phil Soran. Mr. Soran is a successful serial entrepreneur who has founded several technology companies and was inducted into the Minnesota Business Hall of Fame in 2016. He was co-founder, President, and CEO of XIOtech Corp., which sold to Seagate Technology for $360 million in 2000. Later, he served as President and CEO of Compellent Technologies, which went public in 2007 and was subsequently acquired by Dell Inc. for $960 million. Most recently, he co-founded Flipgrid,...