Imola IBF System Patent Announcement

West Chester, PA- June 23, 2017 – Altus Spine, a leader in the development and innovation of medical devices used in spinal correction surgery, announces the issuance of its United States Patent No. 9,408,598 entitled “Systems and Methods for Accessing an Intervertebral Disc Space in a Body of a Patient.”  The patent covers surgical site access technology that supports the market release of the Imola Lateral IBF System.  The Imola IBF System is comprised of the patented retractor access system used in establishing surgical access, a variety of lumbar spacer implants, and the supporting instrumentation used in implantation procedures.

“The Imola System represents a unique advance in lateral access surgery with a one step retractor-to-frame set up,” notes Charles Goodwin MD, Associate Attending Surgeon at Hospital for Special Surgery.  “This saves time and eliminates repeated retractor insertions that can cause irritation to surrounding muscles and nerves.  The patented system includes biconvex implant options that fit anatomically with the biconcave vertebral bodies.”

Gary Fantini MD, Associate Attending Surgeon at Hospital for Special Surgery, states “The Imola IBF System constitutes the next generation in lateral lumbar interbody fusion.  Proprietary frame-to-blade technology permits rapid and safe localization of the target disc under direct vision, limiting operative time, and reducing neurologic sequelae and cost.”

“We are very proud of our accomplishments with Imola,” says Michael Fitzgerald, CEO of Altus Spine and co-inventor.  “We knew that we would need to reassess every stage of lateral access to best accommodate this new approach, so Altus engineers coordinated with nationally recognized surgeons; the result of this collaboration is the Imola IBF System.”

The Imola IBF System was developed to address the flexibility needed by surgeons in lumbar fusion procedures.  Imola’s “all in one” design aids in reducing excess tools, and keeps the OR clear and uncluttered.  Imola’s patented retractor system is a one-of-a-kind approach that strives to minimize patient trauma while allowing for optimized surgical access.

Indications

The Altus Spine Imola Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The Altus Spine Imola Interbody Fusion System is to be combined with cleared supplemental fixation systems, such as the Altus Spine Pedicle Screw System.

Altus Spine

Based in West Chester, PA, Altus Spine is dedicated to creating the next generation of medical devices.  Altus strives to improve patient care by designing and developing products to meet the highest standards in an ever changing and evolving field.  Implemented and used by over 100 hospitals across the United States, Altus is among the fastest growing spinal implant companies in the world.  For additional information and distribution opportunities, please visit  www.altus-spine.com

Forward Looking Statements

All statements made in the above press release, with the exception of historical fact, may be forward-looking statements that include risk, uncertainty, and assumptions.  These factors could cause Altus Spine’s results to differ from those predicted if they do not occur as expected.  These uncertain factors include, but are not limited to; acceptance and clearance of the company’s surgical products and procedures, development of new products and procedures, innovations and alterations to existing products and procedures, clinical and statistical verification of the success using Altus Spine’s products, company’s ability to maintain and monitor inventory as it releases new products, its ability to hire and retain personnel, and any other risks stated in prior or subsequent news releases.  All risks and potential complications can be found in our most recent 510k report from the Food and Drug Administration (FDA).  Given the constantly changing market, readers are encouraged to not place undue reliance on forward looking statements.  Altus Spine assumes no obligation to update forward-looking statements as these changes occur, or as events and circumstances are altered, after the date they are posted.