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IMPLANET Announces the First Surgical Procedures in the United States with JAZZ™ PF
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Rhea-AI Summary
IMPLANET has announced the launch of JAZZ™ PF, a new spinal implant designed to minimize the risk of proximal junctional kyphosis (PJK) following surgery. This innovation addresses a significant market need, with an addressable annual market of almost $350 million in the United States. JAZZ™ PF has received CE marking in Europe and 510(k) clearance from the FDA. The product aims to improve surgical outcomes, with initial procedures yielding encouraging results. CEO Ludovic Lastennet stated that the device could quickly become essential for spine surgeons in treating adult spinal deformities.
Positive
Launch of JAZZ™ PF, addressing a significant market need with a potential worth of $348 million annually in the U.S.
Received CE marking in Europe and 510(k) regulatory clearance from the FDA.
Initial surgical results have been encouraging, bolstering confidence in the product's effectiveness.
Negative
None.
JAZZ™ PF: a simple, innovative and proprietary addition to the JAZZ® range
Addressable annual market of almost $350 million in the United States1
BORDEAUX, France & BOSTON--(BUSINESS WIRE)--
Regulatory News:
IMPLANET (Paris:ALIMP) (Euronext Growth: ALIMP, FR0013470168, eligible for PEA-PME equity savings plans), a medical technology company specialized in vertebral implants, today announces the first surgeries in the United States with JAZZ™ PF, the latest innovation from its JAZZ® range.
A unique concept on the market, JAZZ™ PF allows surgeons to create a soft landing of posterior spinal constructs to prevent proximal junctional kyphosis (PJK). This syndrome is a relatively common and serious complication following adult spinal deformity surgery. Studies show that up to 40% of patients who have undergone spinal deformity surgery develop PJK and may need to be reoperated2.
Use of JAZZ™ PF creates a stiffness gradient, between the upper instrumented vertebrae and the tethered proximal segmental level.
Having obtained CE marking in Europe and 510(k) regulatory clearance from FDA in the United States, this solution is quick and easy to use and requires no specific instrumentation.
William Barrick, MD of Orthopedic Associates of Dutchess County, said: “I have been using Implanet’s Jazz Band for some time, with excellent results in complex adult spinal deformity indications. The addition of JAZZTM PF to Implanet’s range is a major breakthrough in the protection of the adjacent level. This new implant has been easy to use during the first surgical procedures and has supplied encouraging early post-operative clinical results. We will monitor these patients to confirm these results over the longer term. I believe that JAZZTM PF will rapidly become an essential tool for spine surgeons.”
Ludovic Lastennet, CEO of IMPLANET, added: “JAZZTM PF provides a response both to the issues surgeons face in degenerative disorders and more importantly to the budgetary requirements placed on American healthcare facilities during this post-pandemic period. This new implant was launched in Europe last September, and the marketing of this unique solution on the US market by our Implanet America team began during the final quarter of 2021. This concept has rapidly generated considerable interest from spine surgeons specializing in the treatment of large deformities in adults,the first step in positioning ourselves in this large-scale market estimated at 37,000 surgical procedures and to be worth $348 million a year. For the first time, we have a universal solution that can be used in 25 to 30% of procedures.”
About proximal junctional kyphosis
Proximal junctional kyphosis (PJK) can lead to proximal junctional failure (PJF), a progressive complication of adult spine surgery that regularly requires revision surgery. 66% of PJK cases generally occur within 3 months of surgery3 and up to 40% of adult patients having undergone spinal deformity surgery develop PJK2. Risk factors include overcorrection, undercorrection, excessive ligament dissection and osteoporosis4.
About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. 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. IMPLANET employs 29 staff and recorded a consolidated revenue of €7.7 million in 2021. 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.
The Company would like to remind readers that the table for monitoring the equity line (OCA, BSA) and the number of shares outstanding is available on its website: http://www.implanet-invest.com/suivi-des-actions-80
1 Source Global Market 2018
2 Lau D, Clark AJ, Scheer JK, Daubs MD, Coe JD, Paonessa KJ, LaGrone MO, Kasten MD, Amaral RA, Trobisch PD, Lee JH, Fabris-Monterumici D, Anand N, Cree AK, Hart RA, Hey LA, Ames CP; SRS Adult Spinal Deformity Committee. Proximal junctional kyphosis and failure after spinal deformity surgery: a systematic review of the literature as a background to classification development. Spine 2014 Dec 1;39(25):2093-2102.
3 Yagi M, Rahm M, Gaines R, Maziad A, Ross T, Kim HJ, Kebaish K, Boachie-Adjei O; Complex Spine Study Group. Characterization and surgical outcomes of proximal junctional failure in surgically treated patients with adult spinal deformity. Spine 2014 May 1;39(10):E607-614.
4 Liu FY, Wang T, Yang SD, Wang H, Yang DL, Ding WY. Incidence and risk factors for proximal junctional kyphosis: a meta-analysis. Eur Spine J. 2016 Aug;25(8):2376-2383
NewCap
Media Relations
Arthur Rouillé
Tel.: +33 (0)1 44 71 00 15
implanet@newcap.eu
Source: IMPLANET
FAQ
What is the JAZZ™ PF implant by IMPLANET?
JAZZ™ PF is a spinal implant designed to reduce the risk of proximal junctional kyphosis (PJK) after spinal surgery, with a focus on improving patient outcomes.
What is the annual market size for JAZZ™ PF in the U.S.?
The addressable annual market for JAZZ™ PF in the United States is estimated to be nearly $350 million.
When did IMPLANET receive FDA clearance for JAZZ™ PF?
IMPLANET received 510(k) regulatory clearance from the FDA for JAZZ™ PF prior to its market launch.
How does JAZZ™ PF benefit spine surgeons?
JAZZ™ PF provides a solution to prevent PJK, a common complication in adult spinal surgeries, and is designed for ease of use during procedures.
What are the early results of using JAZZ™ PF in surgeries?
Initial procedures using JAZZ™ PF have shown encouraging early post-operative clinical results, indicating its potential effectiveness.
