SeaSpine Announces Limited Commercial Launch of WaveForm C 3D-Printed Interbody Implant System

Rhea-AI Summary

SeaSpine Holdings Corporation (NASDAQ: SPNE) announced the limited commercial launch of its WaveForm C Interbody Implant System on September 23, 2020. This implant, marking a year since the exclusive licensing agreement with restor3d, is the first of five 3D-printed interbody devices expected by mid-2021. WaveForm C features a highly porous structure designed to enhance surgical efficiency and patient outcomes in anterior cervical spine procedures. The launch expands SeaSpine's cervical portfolio, aligning with its Fusion Engineered philosophy and best-in-class allograft offerings.

Positive

• Launch of WaveForm C Interbody Implant System expands product portfolio.
• Implant features advanced 3D-printed design, increasing surgical efficiency.
• Aligns with the company’s Fusion Engineered philosophy to enhance patient outcomes.

Negative

• Limited commercial launch may indicate unproven product performance.
• Forward-looking statements carry risks regarding product efficacy and market acceptance.

CARLSBAD, Calif., Sept. 23, 2020 (GLOBE NEWSWIRE) -- 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 launch of its WaveForm C Interbody Implant System. WaveForm C represents the first of five 3D-printed interbody devices that the Company anticipates launching by mid-2021. This first limited launch marks the one-year anniversary of the SeaSpine and restor3d exclusive field-based licensing agreement.

“WaveForm technology represents a purpose-driven approach to maximizing patient outcomes in the anterior cervical spine,” said Dr. Erik Olsson, Southern Oregon Spine Care. “Every aspect of this interbody was designed to provide efficiency in the procedure for the surgeon and help achieve a successful fusion for the patient. WaveForm C, coupled with OsteoStrand^® fibers, offers a synergy that is unrivaled in the current interbody and orthobiologics market.”

The WaveForm C implant offers the next level of 3D-printed architectural innovation, balancing key geometric, manufacturing and clinical requirements. WaveForm C utilizes innovative WaveForm technology to deliver a highly porous and robust interbody solution. WaveForm C features targeted 65% porous endplates* and 75% porous architecture* within the body of the implant. This design is intended to balance subsidence resistance, implant stiffness, and orthobiologics packability, while maintaining radiographic visualization during intraoperative and postoperative imaging.

“Staying true to our Fusion Engineered™ philosophy, WaveForm C has been deliberately designed to help achieve fusion by working harmoniously with SeaSpine’s best-in-class allograft demineralized bone matrix offerings OsteoStrand and OsteoStrand Plus,” stated Shaeffer Bannigan, Senior Director of Product Development. “We could not be happier to add another material choice to our already successful Shoreline^® Anterior Cervical System and will continue to invest in the continued expansion of the cervical portfolio.”

WaveForm C is designed to be used in ACDF (anterior cervical discectomy fusion) procedures as part of the Company’s foundational Shoreline ACS System or in combination with its Cabo™ anterior cervical plate. The WaveForm C system includes multiple footprints and lordosis options, allowing surgeons the ability to intraoperatively address specific anatomical needs.

*Data on file

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 number of 3D-printed interbody devices that the Company anticipates launching by mid-2021; and the objectives of product design and the ability of the underlying products to achieve design objectives, including maximizing patient outcomes, providing efficiency for the surgeon and fusion for the patient, balancing key geometric, manufacturing and clinical requirements, and working with the Company’s allograft demineralized bone matrix offerings. 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 clinical validation of products in limited commercial (or “alpha”) launch; unexpected delay, including as a result of developing and supporting the launch of new products, including 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

FAQ

What is the WaveForm C Interbody Implant System launched by SeaSpine?

The WaveForm C Interbody Implant System is a new 3D-printed interbody device designed to improve surgical efficiency and patient outcomes in anterior cervical spine procedures.

When was the WaveForm C Interbody Implant System launched?

The WaveForm C Interbody Implant System was launched on September 23, 2020.

What are the features of WaveForm C implant?

WaveForm C features a highly porous structure with targeted 65% porous endplates and 75% porous architecture within the implant body to assist with surgical performance.

What is the significance of SeaSpine's licensing agreement with restor3d?

The licensing agreement with restor3d facilitated the development and exclusive launch of WaveForm C, marking significant collaboration in the spinal implant market.

What risks are associated with the launch of WaveForm C?

There are risks related to the unproven performance of newly launched products and their acceptance in the market, as indicated in SeaSpine's forward-looking statements.