November 1, 2016

Pinnacle Spine Group Announces Launch of InFill® V2 Lateral Interbody Device for Lumbar Spinal Fusion Surgeries

V2 Lateral Interbody Fusion Device is compatible with Patented InFill Graft Delivery System

Dallas, Texas – October 25, 2016 — Pinnacle Spine Group, LLC, a developer of innovative spinal fusion solutions engineered to deliver optimal bone graft volume and graft-to-endplate contact, today announced the launch of its InFill® V2 Lateral Interbody Device. The innovative InFill V2 Lateral Interbody Fusion device features a larger, single graft chamber and a large load-bearing surface area, which helps restore and maintain disc height and facilitates the formation of a robust fusion column.

The V2 Lateral implants, the most recent update to Pinnacle’s patented flagship line of InFill Interbody Fusion Systems, features an expanded size matrix and wide range of lordotic options.

“Science has shown that in many unilateral posterior lumbar interbody fusion procedures, less than 50 percent of the disc area is actually grafted,” said Zach Sowell, President of Pinnacle Spine Group. “Creating a greater opportunity to fill the biologic void is exactly why we developed the only patented Interbody Fusion System designed to deliver optimized graft-to-endplate contact. We are excited to add the V2 Lateral device to our growing line of patented fusion systems.”

Features of the V2 Lateral device include:

  • Unique access port to secure the implant to the inserter, ensuring controlled device placement and allowing in situ delivery of optimal bone graft volume
  • A larger graft chamber to allow greater volume of bone graft material, promoting a more robust fusion column
  • A larger load-bearing surface area to help maintain disc height and reduce chances of subsidence
  • Bulleted nose to ease insertion and ensure precise placement for challenging disc conditions
  • Implant size matrix to address unique patient anatomy with lengths ranging from 30mm to 60mm, heights ranging from 8mm to 14mm, widths of 18mm, 21mm and 24mm, and lordotic angles of 0°, 7°, 10° and 13°
  • Comprehensive instrumentation, including angled instruments and a variety of handles
  • Multiple retractor options

Pinnacle Spine Group has pioneered the novel concept for filling the biologic void by placing bone graft material into an implanted device in situ for optimal bone graft volume and contact with vertebral endplates – a critical element for a successful spine fusion outcome.

Pinnacle Spine’s InFill Fusion Systems include a full line of innovative interbody fusion devices engineered for easier insertion, reduced subsidence through maximum contact with the apophyseal ring, a generous bone grafting chamber and compatibility with the InFill® Graft Delivery System. The backbone of the technology is based on controlled and precise in situ placement of bone graft material.

Pinnacle recently announced its first international patent, a Chinese patent, which followed receipt of three U.S. patents on the InFill Fusion System. For more information on Pinnacle Spine Group’s unparalleled innovation, please visit PinnacleSpineGroup.com.

About Pinnacle Spine Group, LLC

Pinnacle Spine Group was founded with the focused goal of developing innovative medical devices, conceived in the operating room, for surgical procedures of the spine. The objective for every device and instrument we develop is a better outcome for the patient, and a better experience for the surgeon and operating room staff. Backed by the pioneering private equity firm Sowell & Co., Pinnacle is dedicated to developing advanced technologies that offer greater opportunities for positive patient outcomes. The team applies innovative thinking to deliver implants and instrumentation that simplify and enhance the surgical procedure.

 

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June 7, 2016

Pinnacle Spine Group and Xtant Medical Announce Distribution Agreement

DALLAS, TEXAS, and BELGRADE, MT, June 7, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT: XTNT), a leader in the development of regenerative medicine products and medical devices and Pinnacle Spine Group, LLC, a developer of innovative spinal fusion solutions, today announced a joint agreement to expand distribution of Pinnacle’s InFill® Lateral Lumbar Interbody Fusion System. Through this agreement, Xtant enters the lateral lumbar interbody fusion market, expanding its spinal hardware portfolio.

The foundation of Pinnacle Spine Group’s complete InFill fusion systems is its patented ability to deliver bone graft material to the fusion device in situ. The unique features of the InFill Lateral Fusion device combined with the InFill Graft Delivery System provide the opportunity for a more robust fusion column and maximized bone graft-to-endplate contact. The InFill Lateral Lumbar Interbody Fusion system is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1.

“We are excited to partner with Xtant Medical, a recognized industry leader, to bring new and innovative solutions to spine surgeons,” said Zach Sowell, President of Pinnacle Spine Group. “Our patented innovative technology offers a terrific platform for Xtant and Pinnacle to grow their core competencies and expand their scope in the spinal fusion segment.”

“It is a very exciting time for Xtant Medical as we continue to broaden our portfolio. This system will allow Xtant Medical to meet the needs of orthopedic and neuro spine surgeons who currently practice minimally invasive spine surgery or looking to expand their procedural options,” stated Dr. David Kirschman, Executive Vice President and Chief Scientific Officer.

According to iData Research, it is estimated that the US market for lateral lumber interbody fusion in 2015 was nearly $254M and is expected to be close to $309M in 2020.

About Xtant Medical Holdings

Xtant Medical Holdings, Inc. (NYSE MKT:XTNT) develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

About Pinnacle Spine Group, LLC

Pinnacle Spine Group was founded with the focused goal of developing innovative medical devices, conceived in the operating room, for surgical procedures of the spine. The objective for every device and instrument we develop is a better outcome for the patient, and a better experience for the surgeon and operating room staff. Backed by the pioneering private equity firm Sowell & Co., Pinnacle is dedicated to developing advanced technologies that offer greater opportunities for positive patient outcomes. The team applies innovative thinking to deliver implants and instrumentation that simplify and enhance the surgical procedure.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

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June 1, 2016

Pinnacle Spine Group Lanches InFill ALIF

Dallas, Texas – June 1, 2016 — Pinnacle Spine Group, LLC, a developer of innovative spinal fusion solutions engineered to deliver optimal bone graft volume and graft-to-endplate contact, today announced the launch of its InFill® Anterior Lumbar Interbody Fusion (ALIF) Interbody Device. This device is designed to maximize wall thickness and graft chamber volume, ensuring optimal contact with the vertebral endplates by both the interbody device and bone graft material.

The InFill ALIF device is compatible with Pinnacle’s InFill Graft Delivery System, which allows surgeons to deliver the optimal volume of graft material to the implant in situ without disrupting the interbody device’s placement, providing an opportunity to achieve maximum bone graft-to-endplate contact.

“Anterior lumbar spinal fusion is a common spine fusion technique, but often must be combined with an additional posterior approach to provide immediate stabilization. Science shows that in many unilateral posterior lumbar interbody fusion procedures, less than 50 percent of the disc area is actually grafted,” said Zach Sowell, President of Pinnacle Spine Group. “Pinnacle is committed to innovation that offers surgeons and patients options which address significant challenges in spinal fusion and enable more effective spinal fusion surgeries. We are excited to add the InFill ALIF device to our growing line of patented fusion systems.”

Features of the ALIF device include:

  • Optimization for use in the L5/S1 disc space
  • A gently bulleted nose for ease of insertion
  • The option for in situ delivery of bone graft material to ensure a more complete fill
  • A large graft chamber which facilitates formation of a robust fusion column
  • An aggressive tooth design to prevent displacement of the device
  • A large surface area which provides maximum contact with the apophyseal ring, helping to restore and maintain disc space and height
  • Tantalum rod markers which provide excellent radiographic visualization of interbody device orientation and placement
  • Pinnacle Spine Group has pioneered the novel concept of placing bone graft material in situ into an implanted device in order to allow optimal bone graft material volume and maximized contact with vertebral endplates – a critical element for a successful spine fusion outcome. Pinnacle Spine’s InFill Fusion Systems include a full line of innovative interbody fusion devices engineered for easier insertion, reduced subsidence through maximum contact with the apophyseal ring, a generous bone grafting chamber and compatibility with the InFill® Graft Delivery System. The backbone of the technology is based on controlled and precise in situ placement of bone graft material.

Pinnacle recently announced its first international patent, a Chinese patent, which followed receipt of three U.S. patents on the InFill Fusion System. For more information on Pinnacle Spine Group’s unparalleled innovation, please visit PinnacleSpineGroup.com.

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April 21, 2016

Pinnacle Spine Group Granted Chinese Patent for Innovative Spinal Fusion Technology

First international patent, following three US patents for innovative InFill® fusion technology

Dallas, TX, April 21, 2016 – Pinnacle Spine Group, LLC, a developer of innovative spinal fusion solutions to address unmet surgical needs and improve outcomes, today announced that the Chinese Patent Office is in the process of issuing Chinese Patent Application No. 201180020517.1 titled Intervertebral Implants and Graft Delivery Systems and Methods as an enforceable patent. This patent will be the first international patent, following the receipt of three U.S. patents covering Pinnacle Spine’s innovative InFill® fusion technology. The company owns other non-U.S. applications, including applications in Australia, Canada and Europe.

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December 22, 2015

Pinnacle Spine Announces Third Patent for InFill®

Dallas, TX, December 22, 2015 – Pinnacle Spine Group, LLC, a developer of innovative spinal fusion systems, today announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 9,216,096 titled Intervertebral Implants and Related Tools. This patent is the third issued in the U.S. covering Pinnacle Spine’s innovative InFill® fusion technology.

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May 6, 2014

Pinnacle Spine Group, LLC Announces CE Mark Approval for its Entire Line of InFill® Interbody Devices and its Patented Infill Graft Delivery System

Dallas, TX, May 6, 2014 – Pinnacle Spine Group has announced the CE (Conformité Européenne) Mark approval for its entire line of InFill Interbody Devices, as well as its patented InFill Graft Delivery System.

Pinnacle’s line of interbody devices includes the InFill Direct Lateral system, the InFill Lordotic Oblique TLIF, the InFill Convex Oblique TLIF, the InFill Contour Oblique TLIF, the InFill ALIF, and the InFill Cervical Lordotic, and InFill Anatomic interbody devices.

Pinnacle also received CE Mark approval for its novel InFill Graft Delivery System, which initial studies have shown can place up to 94% more biologic between the vertebral bodies using the lateral approach than traditional prepacking of the implant

“We are very pleased that we are now able to expand our operations into the European market. We believe that our novel approach to fusion, which includes the ability to deliver graft directly into the disc space, will resonate as well with the European spinal community as it has here in the USA. We look forward to developing a strong presence in CE Mark countries within Europe,” says Zach Sowell, Vice President of Marketing for Pinnacle Spine.

About Pinnacle Spine Group, LLC

Pinnacle Spine Group is committed to developing spinal fusion systems that improve the results for the patient, surgeon and hospital. Based around the concept of delivering a more complete fill of the disc space with graft material, the company believes it can enhance outcomes for all parties.

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May 6, 2014

Pinnacle Spine Group, LLC announces FDA 510(k) clearance for two new models of the InFill® TLIF Interbody series, the InFill® ALIF Interbody Device and two InFill® Cervical Interbody Devices

The InFill TLIF line and the InFill ALIF can both take advantage of The InFill Graft Delivery System.

Dallas, TX, May 6, 2014 – Pinnacle Spine Group has announced the FDA 510(k) clearance of two new InFill TLIF interbody devices, the Convex Oblique and the Contour Oblique models. These two additions complement the InFill Lordotic TLIF product offering, giving surgeons a range of options to choose from depending on surgeon preference, the vertebrae in need of attention, and patient anatomy. All three TLIF interbody devices can be used in conjunction with the InFill Graft Delivery System to provide for a controlled fill, for contact between bone graft material and the vertebral endplates.

Pinnacle also received FDA 510(k) clearance on its InFill ALIF interbody device, with a design optimized for the L5 – S1 space. This device can also take advantage of the InFill Graft Delivery System, offering the surgeon and patient a controlled fill of the disc space with the bone graft material required to initiate fusion.

Finally, the Company received FDA 510(k) clearance for two InFill Cervical interbody fusion devices. The Cervical Lordotic product offers a form factor that emphasizes lordotic angle, while the Cervical Anatomic product is designed for endplate preservation.

Taken together with the current direct lateral and TLIF products, these clearances give the Company a far broader range of solutions for surgeons.

“We are excited to announce that we have greatly expanded our product portfolio and extended the ability to capitalize on our patented InFill Graft Delivery system. We believe that creating contact with the graft material and the vertebral endplate creates a robust fusion column. The InFill system is the first to achieve it easily and practically,” says Zach Sowell, Vice President of Marketing. “Remember, fusion is a contact sport!”

About Pinnacle Spine Group, LLC

Pinnacle Spine Group is committed to developing spinal fusion systems that improve the results for the patient, surgeon and hospital. Based around the concept of delivering a more complete fill of the disc space with graft material, the company believes it can enhance outcomes for all parties.

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November 13, 2012

Independent Study Confirms Effectiveness of InFill Graft Delivery System

Dallas, TX, November 13, 2012 – Pinnacle Spine Group, LLC, (“Pinnacle”) a Dallas, Texas-based company that designs, develops, manufactures and markets spinal implants and instruments, is pleased to announce the results of a new study, completed by an independent surgeon. Pinnacle received FDA clearance for the system in September 2012, and now has completed its first formal study proving the efficacy of the InFill Graft Delivery System.

The study was designed to evaluate the efficacy of a novel graft filling technique for maximizing interbody space and implant filling and optimizing endplate surface contact with the graft.

The results of the study demonstrate successful increase in interbody space and cage filling, with greatly enhanced endplate surface contact. Volumetric analysis 3-D CT scanning confirmed that up to 94% more graft material can be placed and contained between the vertebrae, including endplate surface contour filling and contact, when compared to traditional prepacking methods.

The study was conducted by Dr. Burak M. Ozgur MD FAANS and Erin Gleckman PA-C, in Newport Beach, CA. Dr. Ozgur has authored 25 studies in this field, contributed to more than 20 publications, and is a member of multiple associations.

The InFill Graft Delivery System was designed around the concept of placing autogenous graft material into the graft chamber of the implant in situ. It can be used to bulk up a pre-packed implant, or for a complete fill of the implant to maximize contact with the vertebral endplates.

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