March 19, 2019
BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:
IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans), a medical technology company specializing in vertebral and knee surgery implants, has announced that it has received 510(k) authorization from the Food and Drug Administration (FDA) for its JAZZ Cap® System, designed to meet the constraints of vertebral fusion indications in adult patients. This is the 10th 510(k) authorization from FDA for the JAZZ® product range.
This approval follows the award of CE marking last November2. Developed primarily to facilitate the treatment of degenerative conditions in adult patients, JAZZ Cap® is a unique and complete proprietary solution for securing screws in poor quality bone – a factor in 10% to 30% of vertebral fusion cases in adult patients3.
This clearance is a key component in the Private Label Distribution Agreement signed with SeaSpine Holdings Corporation (NASDAQ; SPNE) announced in February4. JAZZ Cap® technology is suitable for use with specific SeaSpine screw systems and will strengthen the company’s product offering by providing a unique solution for securing pedicle screws.
Ludovic Lastennet, Implanet’s Chief Executive Officer, commented: “In an increasingly restrictive regulatory climate, the speed with which we received this clearance represents a significant step for the development of our company, opening a unique opportunity in the US degenerative spine market. Alongside the marketing of this solution by our Implanet America team, the combination of JAZZ Cap® technology with the SeaSpine posterior fixation system will enable us to offer a unique solution and cost effective solution with broad access to the world’s biggest market.”
Founded in 2007, Implanet is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the Jazz® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. 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 and the CE mark. Implanet employs 38 staff and recorded 2018 sales of €6.7 million. For further information, please visit www.implanet.com. Based near Bordeaux in France, Implanet established a US subsidiary in Boston in 2013.
This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 16, 2018 under number D.18-0337 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.
1 Sources: i-Data 2010; D. K. Chin et al. Osteoporos Int (2007) 18:1219–1224; Company; 2015 Health Advances study
2 See press release of 20 November 2018: CE mark clearance for the Jazz Cap System®, a screw securing solution for vertebral fusion
3 Source: 2015 Health Advances study
4 See press release of 21 February 2019: Strategic partnership between SeaSpine and Implanet in the United States
Ludovic Lastennet, CEO
David Dieumegard, CFO
Tel.: +33(0)5 57 99 55 55
Valentine Brouchot / Pierre Laurent
Tel.: +33 (0)1 44 71 94 94
Tel.: +33 (0)1 44 71 94 94