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Press Release

SeaSpine Announces 510(k) Clearance from the FDA of Shoreline ACS System


Posted on: 27 Oct 16

CARLSBAD, Calif, Oct. 27, 2016 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Shoreline™ ACS Anterior Cervical Standalone System, featuring TruProfile™ technology. TruProfile offers a low profile plate designed to minimize cephalad-caudal encroachment onto the vertebral bodies and maximize the distance from adjacent disc spaces.  The Shoreline ACS anterior plate is 1.6mm thick, providing minimal profile on the anterior spine. 

The Shoreline ACS System is designed to maximize intraoperative flexibility by offering a full complement of zero and low-profile plating options, including two-, three- and four-hole variations, as well as 10 degree lordotic implants.  This complement of options provides surgeons the ability to address the variety of patient anatomical needs and surgical scenarios that may be encountered in the operating room. 

“SeaSpine set out to build a product platform that reflects the critical needs of its surgeon customers, and it shows,” stated James Bruffey, MD.  “The design of this system addresses common challenges, without sacrificing ease of use and technical reliability.  I believe Shoreline ACS will provide a safe and effective option for my cervical fusion surgery patients.”

The Shoreline ACS System incorporates proprietary NanoMetalene® surface technology.  NanoMetalene interbody implants are designed to provide the benefits of a titanium surface while retaining the benefits associated with traditional PEEK devices, such as biocompatibility, a modulus of elasticity similar to bone, and excellent radiographic visibility for post-operative imaging.  NanoMetalene describes a sub-micron layer of commercially pure titanium molecularly bonded to a PEEK-OPTIMA® polymer from INVIBIO®. It is applied in a proprietary, high-energy, low-temperature process that differs from other coating applications and maximizes implant surface area with titanium nanotopography.

“We are excited about the Shoreline ACS System because it provides advantageous intraoperative flexibility, while addressing key clinical challenges often encountered by surgeons,” stated Keith Valentine, Chief Executive Officer of SeaSpine.

SeaSpine will be conducting initial cases through a limited launch over the next few months and expects a full commercial launch in the first half of 2017. 

About SeaSpine
SeaSpine is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal hardware solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal fusion hardware product development helps SeaSpine to offer its surgeon customers a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the design benefits of TruProfile technology, the Shoreline ACS System and NanoMetalene; the ability of the Shoreline ACS System to address common or key clinical challenges in spine surgery without sacrificing ease of use and technical reliability, to provide advantageous intraoperative flexibility, and to make cervical fusion surgery safer and more effective; and the timing and success of both the limited and full commercial launch of its products and systems.  Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the fact that the Shoreline ACS System has not been validated clinically and may require substantial additional development activities, which could introduce unexpected expense and delay, including potentially requiring resubmission of one or more products to FDA for clearance, which clearance cannot be certain, whether on a timely basis or at all; surgeons’ willingness use the Shoreline ACS System; the risk that the Shoreline ACS System may not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support a full commercial launch; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law. 

GlobeNewswire
globenewswire.com

Last updated on: 28/10/2016

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