SeaSpine® Announces Limited Commercial Launches of NorthStar™ OCT and Cervical Facet Fusion™ Systems

SeaSpine Announces Limited Commercial Launches of NorthStar™ OCT and
Cervical Facet Fusion™ Systems

 

CARLSBAD, CA (June 22, 2020) – SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the limited commercial launches and completion of initial surgeries of both its NorthStar OCT and Cervical Facet Fusion systems, which significantly expand its procedural offerings for posterior cervical fusion.

The NorthStar OCT system brings to market an innovative and elegant posterior cervical fixation solution that has been designed to offer both clinical and economic efficiencies. The system’s novel, anatomically designed implants connect seamlessly with the versatile instrumentation platform allowing spine surgeons and hospitals to more efficiently address today’s wide variety of pathologies. NorthStar’s innovation is showcased by multipurpose instruments that help reduce steps in the procedure to save OR time and implants meticulously designed to address any anatomical challenges that may occur.

“NorthStar OCT is impressive,” said Dr. Jay Turner from Barrow Neurological Institute. “The system manages to expand versatility with fewer instruments–I’m able to do more with less.”

“We are extremely excited about the alpha release of NorthStar OCT,” said Dennis Cirino, Senior Vice President, Global Spinal Systems.  “This system includes novel instrumentation that minimizes the need for additional hands while streamlining steps to drive efficiency and reduce OR time.  It also includes thoughtfully designed screw technology with market-leading angulation of up to 90 degrees conically, without the need of a favored-angle tulip design.  Moreover, the novel occipital plate offers angled holes (shingles) that facilitate a new cranial to caudal trajectory into the occipital keel. This new trajectory should facilitate easier implant placement and additional screw purchase during an occipital fusion procedure, and we could not be more excited to see this come to market.”

The Cervical Facet Fusion system was designed to be a simple and complementary graft delivery solution to posterior cervical fusions. With a streamlined set of tools, surgeons can access the facet joint, prepare a defined fusion bed, and deliver OsteoStrand MIS demineralized bone fibers. This system can be used in conjunction with SeaSpine’s posterior cervical fixation systems, including the NorthStar OCT system, which may further provide clinical value to patients and surgeons.

“The launch of the Cervical Facet Fusion system highlights the evolution that we’ve taken in the development of new Orthobiologics products, by not only developing best-in-class DBM products, but also integrating them into new and improved fusion procedures,” said Frank Vizesi, Ph.D., Vice President, Orthobiologics Research & Development and Clinical Affairs.

The launches of both the NorthStar OCT and Cervical Facet Fusion systems reflect SeaSpine’s desire to provide comprehensive procedural solutions to the global spine market and its surgeon customers. These procedural offerings not only reflect current market standards, but also offer advancements to the longstanding posterior cervical fusion procedure.

 

 

About SeaSpine

SeaSpine (www.seaspine.com) 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 implants 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 implants portfolio consists of an extensive line of products to facilitate spinal fusion in degenerative, minimally invasive surgery (MIS), and complex spinal deformity procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in approximately 30 countries worldwide through a committed network of increasingly exclusive distribution partners.

 

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 innovation and elegance of the NorthStar OCT system and its ability to offer both clinical and economic efficiencies; the novelty of the NorthStar OCT system’s implants and their ability to connect seamlessly with instrumentation and allow surgeons and hospitals to more efficiently address a wide variety of pathologies; the ability of the NorthStar OCT system to reduce procedural steps and/or save time and address anatomical challenges; the design of the Cervical Facet Fusion system to be a simple and complementary graft delivery solution to posterior cervical fusions and, alone or in when used in conjunction with the NorthStar OCT system, to provide clinical value to patients and surgeons; and that either or both the NorthStar OCT and Cervical Facet Fusion systems reflect current market standards and an advancement to longstanding PCF procedures.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of substantial clinical validation of products following limited commercial (or “alpha”) launch; unexpected delay, including as a result of developing and supporting the launch of new products, including the fact that newly launched products may require substantial additional development activities, which could introduce further delay, or as a result of obtaining regulatory clearances; and other risks and uncertainties more fully described in the Company’s 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.

 

 

Investor Relations Contact   

Leigh Salvo

(415) 937-5402

ir@seaspine.com


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