BORDEAUX, France & BOSTON--(BUSINESS WIRE)--Regulatory News:
IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext Growth: ALIMP, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces the first presentation of JAZZ® clinical US study data in adult spinal deformity surgery at the NASS Annual Meeting on October 26th, 2017.
Technical advances have enabled spinal deformity surgeons to correct severe spinal mal-alignment. However, proximal adjacent segment pathology, such as proximal junctional kyphosis (PJK) and proximal junctional failure (PJF) remain serious issues. About 65% of surgeons use a PJK prevention strategy in over 40% of patients1. The diversity of strategies employed by surgeons to prevent PJK/PJF illustrates i) the desire to address the problem, and ii) the lack of effective options available to surgeons.
Dr. H. Francis Farhadi, The Ohio State University Wexner Medical Center, will present findings from his prospective study at the NASS Annual Meeting, on Thursday October 26th in Orlando. ‘Prospective Assessment of Early Clinical and Radiologic Outcomes Following Sublaminar Band Placement for Proximal Junctional Kyphosis Prophylaxis in Adult Spinal Deformity Surgery.’ The presentation P114 will take place as part of Poster Grand Rounds, The Learning Place, Exhibition Hall Entrance, Green Theater, Thursday, October 26th at 3:10PM.
Dr. Farhadi commented: “We have seen encouraging results so far at one-year follow-up. Proximal junctional sublaminar banding appears safe and does not increase proximal junctional kyphosis following long-segment adult spinal deformity surgeries. We have not seen any cases of proximal junctional failure to date in over 60 patients enrolled. Longer term follow-up in a larger cohort of patients will be needed before we can make any definite conclusions on prevention of proximal junctional kyphosis.”
Ludovic Lastennet, CEO of Implanet, adds: “Implanet is a clinical solutions driven company, developing novel technology JAZZ® for the spine surgery community. This is an important first step in addressing with JAZZ® an unmet clinical need in complex spine surgery, aUS $200 Million market2. We are actively recruiting patients in multiple prospective studies to both strengthen and document the clinical evidence for the JAZZ platform as the option in the prevention of PJK.”
About The Ohio State University Wexner Medical Center and Dr H.F. Farhadi
Ohio State University Wexner Medical Center is one of America's top-ranked academic medical centers, with more than 900 beds. Their mission is to improve people’s lives in Ohio and across the world through innovation in research, education and patient care.
Dr H. Francis Farhadi, MD, PhD, FRCSC is Chief of the Degenerative and Deformity Spine Division, Director of the Spinal Surgery Fellowship Program, Department of Neurological Surgery.
About the North American Spine Society (NASS)
The North American Spine Society (NASS) is a medical society for health care professionals who specialize in spine care. Founded in 1985, it is the largest society in America. The organization's goal is the promotion of evidence-based and ethical spine care. NASS does this with policies and actions aimed at promoting education, research and advocacy in health care fields related to the spine. NASS membership consists of about 8,000 health care professionals; such as orthopedic surgeons, neurosurgeons, physiatrists, anesthesiologists, researchers and other related practitioners. NASS publishes two major publications, the Spine Journal and SpineLine. The Spine Journal is the official peer-reviewed journal of the North American Spine Society, and was launched in 2001. SpineLine is a bimonthly clinical and news publication for spine care professionals; it is published both in print and in digital editions.
About IMPLANET
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 48 staff and recorded 2016 sales of €7.8 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.
Disclaimer
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 26, 2016 under number
R.16-035 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 Results of the 2014 SRS survey on PJK/PJF give valuable
insight into PJK/PJF management (SPINE Volume 40, Number 11, pp 829 –
840).
2 Health Advance study & company data.
