IMPLANET Announces CFDA Approval for Its Innovative JAZZ Range in China

15 Jul 2025 18:00 CEST

Regulatory News:

IMPLANET (Euronext Growth: ALIMP, FR0013470168, PEA-PME eligible), a medical technology company specializing in implants for orthopedic surgery and the distribution of advanced medical equipment, today announced that its innovative JAZZ range has been approved by the CFDA in China.

As part of a distribution partnership signed in November 2022, IMPLANET and Sanyou Medical have successfully registered the JAZZ range, dedicated to tape fixation in the treatment of spinal pathologies, on the Chinese market, the world's largest potential market in terms of volume.

This is a major milestone in the strategic partnership with Sanyou Medical. The JAZZ system can be used in combination with the full range of spinal fixation systems already developed by Sanyou Medical, offering Chinese surgeons a complete hybrid surgical solution that is unique in this market.

Ludovic Lastennet, CEO of IMPLANET, said: "Obtaining the registration certificates for our JAZZ range from the CFDA, the Chinese health authority, marks a major new turning point for Implanet, and once again attests to the high clinical value of our JAZZ^® technology. Penetration of the Chinese market, through our alliance with SanYou Medical, has been at the heart of our strategy since 2022. SanYou Medical's marketing and commercial strength in China should rapidly provide Implanet with new resources to accelerate its development in one of the world's most important markets. This partnership also demonstrates our ability to develop disruptive technologies that meet the need for innovation in new markets. It is fully in line with our medium-term strategic development plan, based both on the deployment of our direct sales model in France, the United States and high-potential European markets, and on the development of strategic partnerships with major players. We are now working on the commercial launch, which should take place early in the fourth quarter of this year".

Strategy and Outlook for 2025

• Finalize the registration of existing products under the European Medical Device Regulation (MDR) and the FDA’s 510(k).
• Continue to expand the Company’s presence in the United States:
  • Reinforce resources and commercial capabilities for the historical team;
  • Expand the Company’s direct approach by enlarging the scientific team of key opinion leaders;
• Enhance market momentum and expand the product offering:
  • Deploy the commercial and technological partnership with Sanyou Medical for the joint development of a new, innovative European range of hybrid posterior fixation systems;
  • Launch distribution of the JAZZ^® platform in China, the world's largest spine market by volume, in collaboration with Sanyou Medical;
  • Distribute advanced medical technology equipment in Europe, including the ultrasonic surgical scalpel from SMTP Technology Co.
  • Position Implanet as a partner for surgeons and healthcare institutions in terms of Artificial Intelligence and robotics adapted to our implants.

Upcoming Financial Communications

• First Half 2025 results – September 16^th, 2025, after market close

About IMPLANET

IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery and distributes medical technology equipment. Its activities focus on an innovative solution to improve the treatment of spinal pathologies (JAZZ^®), complemented by the product range of thoraco-lumbar screws, cages, and cervical plates, acquired through Orthopaedic & Spine Development (OSD) in May 2021. In 2022, the Company entered into a commercial, technological, and financial partnership with Sanyou Medical, China’s second-largest medical device manufacturer. As part of this strategic agreement, IMPLANET developed in 2024 the Jazz Spinal System™ hybrid fixation system, a unique new range featuring a comprehensive pedicle screw solution, combined with the market’s most advanced braided implant technology, JAZZ^®. IMPLANET’s orthopedic platform is built on the traceability of its products. Protected by four families of international patents, JAZZ^® has received 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA), CE marking in Europe, and ANVISA approval in Brazil. IMPLANET employs 46 people and generated €9.4 million in consolidated revenue in 2024. Based near Bordeaux, France, IMPLANET has operated a U.S. subsidiary in Boston since 2013. IMPLANET is listed on the Euronext Growth market in Paris. For more information, visit www.Implanet.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250715553561/en/

IMPLANET
Ludovic Lastennet, CEO
David Dieumegard, CFO
Tel. : 05 57 99 55 55
investors@implanet.com

NEWCAP
Investor Relations
Mathilde Bohin
Tel. : 01 44 71 94 94
implanet@newcap.eu

NEWCAP
Media Relations
Arthur Rouillé
Tel. : 01 44 71 94 94
implanet@newcap.eu