RegulatorySpine

Implanet and SeaSpine Announce FDA Clearance of the Mariner Cap System

October 19, 2020

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Euronext Growth: ALIMP, FR0013470168, eligible for PEA-PME equity savings plans) (Paris:ALIMP), a medical technology company specializing in vertebral and knee-surgery implants, and SeaSpine Holdings Corporation (NASDAQ: SPNE) today announce the clearance of the Mariner Cap System in the United States, which combines SeaSpine’s Mariner® pedicle screw system with Implanet’s unique JAZZ Cap® technology.

The ‘Mariner Cap System’ was developed in partnership to facilitate the treatment of adult degenerative disorders by offering novel stabilization of pedicle screws. This new implant was granted 510(k) clearance in August 2020 and enables commercial launch of the Mariner Cap System, which is anticipated to take place in the coming weeks in the United States, a market estimated to be worth 2.5 billion dollars1.

Ludovic Lastennet, CEO of IMPLANET, said: “The FDA clearance of the Mariner Cap System by SeaSpine is a major milestone in this partnership initiated 18 months ago, and reflects the clinical value of our proprietary JAZZ® technology. This implant, henceforth adapted to the SeaSpine Mariner system, will be deployed over the coming months and provides a direct response to the technological innovation requirements of the world’s largest market for the treatment of spinal disorders. This new system will enable SeaSpine to provide a distinctive and high-value-added offering in this market. The success of this collaboration with the materialization of the Mariner Cap System echoes that obtained by our JAZZ Cap® solution during the first surgeries performed in the United States in complex adult deformity indications.”

Keith ValentinePresident and CEO of SeaSpine Corporation, added: “TheMariner Cap System further strengthens our range of products dedicated totreating spinal disorders, and represents a proprietary alternative that we can offer our distributors, surgeons and their patients across the US. Combining our two technologies provides a unique solution for securing the stability of pedicle screw constructs. We look forward to continuing our innovative partnership with Implanet.

Implanet and SeaSpine have been in partnership since February 2019. SeaSpine, one of the most innovative technology companies specializing in the treatment of spinal disorders2, had obtained the distribution rights for the JAZZ® range under its own brand name in the United States.

Upcoming financial events:

– 2020 annual revenueon Tuesday January 19th, 20213 after market close

About Implanet
Founded in 2007, Implanet is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its activity revolves around two product ranges, the latest generation JAZZ® implant, designed to improve the treatment of spinal pathologies requiring vertebral fusion surgery, and the MADISON implant designed for first-line prosthetic knee surgery. Implanet’s tried-and-tested orthopedic platform is based on product traceability. Protected by four families of international patents, JAZZ® and MADISON have obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States, the CE mark as well as the ANVISA authorization in Brazil. Implanet employs 36 staff and recorded 2019 sales of €7.4 million. For further information, please visit www.implanet.com. Based near Bordeaux in France, Implanet established a US subsidiary in Boston in 2013. Implanet is listed on Euronext™ Growth market in Paris.

The Company would like to remind that the table for monitoring the equity line (OCA, OCAPI, BSA) and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

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 minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

1 Sources: i-Data 2010; D. K. Chin et al. Osteoporos Int (2007) 18:1219–1224; Company; 2015 Health Advances study
2 Source: Spine Market Group 2020
3 Subject to change without notice

Contacts

IMPLANET
Ludovic Lastennet, CEO
David Dieumegard, CFO
Tel.: +33(0)5 57 99 55 55
investors@Implanet.com

NewCap
Investor Relations
Sandrine Boussard-Gallien
Nicolas Fossiez
Tel.: +33 (0)1 44 71 94 94
implanet@newcap.eu

NewCap
Media Relations
Nicolas Merigeau
Tel.: +33 (0)1 44 71 94 94
implanet@newcap.eu

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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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