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IMPLANET Receives FDA Clearance for Its SqualeTM Anterior Cervical Cage Range
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Rhea-AI Summary
IMPLANET, a medical technology company, has received FDA 510(k) clearance for its Squale anterior cervical cage, marking a significant step in its U.S. expansion strategy. The Squale cage, designed for optimal interbody fusion and suitable for vertebral anatomy, has already seen over 15,000 implants globally. This clearance follows earlier surgeries in the U.S. with the ORIGIN cervical plate in 2022. CEO Ludovic Lastennet emphasized that this development aligns with their goal to reinforce their presence in the estimated $1.35 billion U.S. spinal surgery market. The marketing launch is expected before summer 2023. IMPLANET will also release its 2023 First-Quarter Revenue on April 25, post-market close.
Positive
FDA 510(k) clearance for the Squale anterior cervical cage enhances product portfolio.
More than 15,000 Squale cages already implanted worldwide, indicating strong demand.
Expansion into the U.S. spinal surgery market valued at $1.35 billion.
Upcoming revenue release may provide insights into financial performance.
Negative
None.
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 implants and the distribution of technological medical equipment, today announced the Food and DrugAdministration (FDA) 510(k) clearance of its SqualeTM anterior cervical cage.
The SqualeTM anterior cervical cage, from the OSD product portfolio, features a wide range of implants a design adapted to vertebral anatomy and radiolucent for optimal radiographic confirmation of interbody fusion. To date, more than 15,000 SqualeTM cages have been implanted worldwide, confirming the clinical value of these vertebral fusion devices. The FDA clearance of this product follows the first surgeries in the United States in 2022 with the ORIGINTM cervical plate, which marked the first successful collaboration between Implanet and OSD.
Ludovic Lastennet, IMPLANET's Chief Executive Officer, stated: "This new clearance demonstrates once again the full potential of the synergies offered by the range of products in the OSD portfolio and is fully in line with our strategy to revitalize our presence in the United States. The Implanet America sales teams should be able to launch the marketing of this anterior cervical cage range before the summer of 2023. This is a new step for our development plan in the United States, aimed in particular at strengthening our offer in the field of spinal surgery in a market estimated at $1.35 billion1.“
Upcoming financial press release
2023 First-Quarter Revenue, on April 25, after market close
About IMPLANET Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery and distributing medical technology equipment. Its activity revolves around a comprehensive innovative solution for improving the treatment of spinal pathologies (JAZZ®) complemented by the product range offered by Orthopaedic & Spine Development (OSD), acquired in May 2021 (thoraco-lumbar screws, cages and cervical plates). Implanet’s tried-and-tested orthopedic platform is based on the traceability of its products. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States, the CE mark in Europe and ANVISA approval in Brazil. In 2022, IMPLANET entered into a commercial, technological and financial partnership with SANYOU MEDICAL, China's second largest medical device manufacturer. IMPLANET employs 43 staff and recorded a consolidated revenue of €8.0 million in 2022. Based near Bordeaux in France, IMPLANET opened a US subsidiary in Boston in 2013. IMPLANET is listed on the Euronext Growth market in Paris. For further information, please visit www.Implanet.com.
NewCap
Media Relations
Arthur Rouillé
Tél.: +33 (0)1 44 71 94 94
Implanet@newcap.eu
Source: IMPLANET
FAQ
What is the significance of the FDA clearance for IMPLANET's Squale anterior cervical cage?
The FDA 510(k) clearance allows IMPLANET to market its Squale anterior cervical cage in the U.S., enhancing its product offerings and expanding its market presence.
When will IMPLANET launch the Squale anterior cervical cage in the U.S.?
IMPLANET expects to launch marketing for the Squale anterior cervical cage before summer 2023.
What are the expected financial results for IMPLANET in Q1 2023?
IMPLANET will release its 2023 First-Quarter Revenue on April 25, after the market close.
How many Squale cages have been implanted globally?
Over 15,000 Squale cages have been implanted worldwide, showcasing their clinical value.
What is the estimated value of the U.S. spinal surgery market?
The U.S. spinal surgery market is estimated to be valued at $1.35 billion.
