SeaSpine Announces Limited Commercial Launch of the WaveForm® TO (TLIF Oblique) 3D-Printed Interbody System

Rhea-AI Summary

SeaSpine Holdings Corporation (NASDAQ: SPNE) has announced the limited commercial launch of its 3D-printed WaveForm TO Interbody System designed for lumbar interbody fusion procedures. This innovative system supports both PLIF and TLIF techniques, enhancing surgical versatility with its comprehensive instrumentation compatible with the existing Reef TO system. The WaveForm TO features a unique porous design aimed at optimizing fusion and improving surgical outcomes. SeaSpine plans additional launches in the 3D-printed interbody space within the year, further advancing its product offerings.

Positive

• Limited commercial launch of WaveForm TO Interbody System enhances product portfolio.
• Versatile design suitable for both PLIF and TLIF procedures improves surgical efficiency.
• WaveForm technology offers innovative features like subsidence resistance and optimal packability.

Negative

• Limited clinical validation due to alpha launch may raise performance concerns.
• Potential delays in regulatory clearances could impact product rollout.

CARLSBAD, Calif., April 19, 2021 (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 3D-printed WaveForm TO (TLIF Oblique) Interbody System.

WaveForm TO was designed for both PLIF (posterior lumbar interbody fusion) and TLIF (transforaminal lumbar interbody fusion) procedures. The system accommodates both direct impact insertion and insert-and-rotate techniques. With a comprehensive set of decompression, disc preparation, and implant insertion instruments that are compatible with the NanoMetalene-based Reef TO system, WaveForm TO provides a versatile lumbar interbody solution for surgeons.

“With the launch of WaveForm TO, SeaSpine is once again raising the industry standard,” said Dr. Erik Westerlund of Jackson Hughston Memorial Hospital in Alabama. “This 3D-printed interbody system demonstrates the philosophy that every implant should be designed to biologically optimize and support the progress to fusion. The unique, porous gyroid architecture is a perfect example of refined and thoughtful next-generation innovation.  Spine surgeons now have a titanium TLIF interbody solution that truly delivers on the amazing potential of 3D printing.”

WaveForm interbody devices offer the next level of 3D-printed architectural innovation, balancing key geometric and manufacturing advancements without compromising clinical requirements. WaveForm TO utilizes innovative WaveForm technology to deliver a highly porous and robust interbody solution, with a design intended to balance subsidence resistance, implant stiffness, and orthobiologics packability, while maintaining radiographic visualization during intraoperative and postoperative imaging.

“WaveForm TO is our third entry into the 3D-printed interbody space, with two more launches planned before the end of this year,” said Dennis Cirino, Senior Vice President of Global Spinal Systems.  “This new system builds upon our foundational WaveForm architecture. Designed for strength, radiolucency, and an unparalleled ability to pack orthobiologics due to its innovative design, WaveForm TO is a comprehensive, intuitive, and reliable system capable of addressing multiple patient pathologies, while offering efficiency by utilizing the same instrumentation as our NanoMetalene-based Reef TO system.”

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.

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 additional launches the Company plans before the end of this year in the 3D-printed interbody space; the design of WaveForm TO and its ability to provide a versatile lumbar interbody solution for surgeons; the ability of WaveForm TO to balance key geometric and manufacturing advancements without compromising clinical utility; the ability of WaveForm technology to deliver a highly porous and robust interbody solution and appropriately balance subsidence resistance, implant stiffness, and orthobiologics packability, while maintaining radiographic visualization during intraoperative and postoperative imaging. 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: unexpected expense and delay, including as a result of developing and supporting the launch of new products, such as Waveform TO, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of delay in timely obtaining regulatory clearances; the ability of newly launched products, such as WaveForm TO, 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; 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
Source: SeaSpine Holdings Corporation

FAQ

What is the WaveForm TO Interbody System launched by SeaSpine?

The WaveForm TO Interbody System is a 3D-printed spinal implant designed for PLIF and TLIF procedures, enhancing surgical versatility.

How does the WaveForm TO Interbody System benefit surgeons?

It offers a unique porous design that optimizes fusion, supports various surgical techniques, and improves efficiency.

What future product launches does SeaSpine plan for 2021?

SeaSpine plans to launch two more products in the 3D-printed interbody space by the end of 2021.

What should investors know about the clinical validation of WaveForm TO?

The WaveForm TO is in its alpha launch phase, meaning limited clinical validation could affect its perceived effectiveness.

What risks are associated with SeaSpine's new product launches?

Risks include potential delays in regulatory approvals and the need for further development of newly launched products.