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Safe Orthopaedics SA (ALSAF.PA)

Paris - Paris Delayed price. Currency in EUR
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0.4060-0.0055 (-1.34%)
At close: 5:35PM CEST
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  • Globe Newswire

    Safe Orthopaedics announces the Paris Court of Justice judgment in its favor in the infringement case against Neo Medical

    Condemnation of the companies Neo Medical SAS and Neo Medical SA for counterfeit Neo Medical prohibited from importing and marketing its Pedicle Screw Kits in France Destruction of the Inventories of Neo Medical SAS of Pedicle Screw Kit under control of bailiff. Éragny-sur-Oise, France, May 31st, 2021 at 8:35 a.m. CET – Safe Orthopaedics (FR0013467123 – ALSAF), a company specialised in the design, manufacture and marketing of ready-to-use technologies for back surgery, with a particular focus on the treatment of emergency vertebral fractures, announced the judgment of May 28, 2021 rendered by the 3rd Chamber of the Judicial Court of Paris in the infringement case against Neo Medical. Having discovered that the French and Swiss companies Neo Medical were importing and offering for sale on French territory products which, according to Safe Orthopaedics, reproduced the characteristics of the claims of one of its patents, Safe Orthopaedics sued the companies Neo Medical in front of the Paris Court of Justice for infringement and unfair competition. Excerpt from the judgment: "On May 28, 2021, the Judicial Court of Paris ruled publicly by judgment made available at the clerk's office, contradictory and in first instance and has: - Rejected the NEO MEDICAL companies' request for cancellation of the infringement seizure reports carried out on November 17, 2017 in the healthcare institutions - Rejected the request for cancellation of claims 1 to 13 of the SAFE ORTHOPAEDICS patent - Declared that the NEO MEDICAL companies, by importing, distributing and marketing in France products reproducing the characteristics of claims 1 to 5, 11 and 13 of the SAFE ORTHOPAEDICS patent, have committed acts of infringement to the detriment of SAFE ORTHOPAEDICS. As a consequence, the Paris Court of First Instance has: - Prohibited NEO MEDICAL from importing and marketing the PEDICLE SCREW KIT products on French territory under a fine - Ordered the destruction under penalty and under the control of a bailiff of the PEDICLE SCREW KIT products remaining in stock in the premises of NEO MEDICAL S.A.S, - ordered the NEO MEDICAL companies to communicate certain information enabling the exact amount of the damages suffered by SAFE ORTHOPAEDICS to be determined..." Pierre Dumouchel, Chairman and CEO of Safe Orthopaedics commented: "The Paris Court confirms the strength of our patents, as did the European Patent Office, and requires our competitor to withdraw its technologies that were found to be counterfeit. We are delighted with this decision, which defends our know-how and our distribution in the French market, estimated at around €100M. We will continue to protect our innovations, which are the result of the ideas of committed surgeons, and the financial interests of our shareholders who recognize our uniqueness and invest in our international expansion”. About Safe GroupThe Safe Group is a French medical technology group that brings together Safe Orthopaedics, a pioneer in ready-to-use technologies for spinal pathologies, and Safe Medical (formerly LCI Medical), a subcontractor of medical devices for orthopaedic surgery. The group employs approximately 150 people. Safe Orthopaedics develops and manufactures kits combining sterile implants and single-use instruments, available at all times to the surgeon. These technologies are part of a minimally invasive approach aimed at reducing the risk of contamination and infection, to the benefit of the patient and with a positive impact on hospitalisation times and costs. Protected by 18 patent families, SteriSpineTM kits are CE marked and FDA approved. Safe Orthopaedics is headquartered in the Paris region (95610 Eragny sur Oise - France) and has subsidiaries in the UK, Germany, the USA and the Lyon region where the manufacturing company is located.For more information: www.SafeOrthopaedics.com Safe Medical (formerly LCI Medical) produces implantable medical devices and ready-to-use instruments. It has an innovation centre and two production sites in France and Tunisia, offering numerous industrial services: design, industrialisation, machining, finishing and sterile packaging. Supported by the French recovery plan in 2020, the company is investing in additive printing and will be operational in 2022 with this new technology. For more information: www.safemedical.fr Contacts Safe Orthopaedics François-Henri Reynaud Chief Financial and Administrative Officer Tel: +33 (0)1 34 21 50 00 investors@safeorthopaedics.com Press RelationsUlysse CommunicationPierre-Louis Germain / +33 (0)6 64 79 97 61 / plgermain@ulysse-communication.comBruno Arabian / +33 (0)6 87 88 47 26 / barabian@ulysse-communication.com Attachment 20210528 - PR_Jugement Neo vDef[37]ARi

  • Globe Newswire

    Safe Orthopaedics announces CE mark for new Hickory screw

    New screw in the SteriSpineTMPS next-generation rangeNew screw to improve bone anchorage in osteoporotic patientsLaunch of a study in Germany with Dr. Jens A.RicholtWorldwide commercialisation expected in 2022 Éragny-sur-Oise, France, May 27th, 2021 at 8:55 a.m. CET – Safe Orthopaedics (FR0013467123 – ALSAF), a company specialising in the design, manufacture and marketing of ready-to-use technologies for back surgery, with a particular focus on the safety of emergency vertebral fractures, announced today that it has obtained CE Mark approval for Hickory, a new treatment for the management of osteoporotic patients. Osteoporosis is a global clinical issue. This disease, which affects a growing number of people, mainly affects those over 50 years of age and has consequences for the treatment of spinal pathologies. Safe Orthopaedics, which recently announced the launch of Sycamore for the treatment of vertebral fractures, is now offering Hickory for the treatment of other pathologies requiring pedicle screw fixation. Developed with the help of Dr Jens A.Richolt, a renowned German spine surgeon and author of numerous studies on the subject, Hickory is a new pedicle screw in the SteriSpineTM PS range that improves bone anchorage in osteoporotic patients. Thanks to its new thread design, Hickory is more securely fixed into the vertebral pedicle and reduces the risk of instability due to the reduced bone quality of the osteoporotic subject. “The growing challenge of operating on osteoporotic patients has been defined by the inability to achieve an appropriate pedicle screw construct. That problem is not only seen in osteoporotic situations, but also cases with metastatic instabilities where the screw and rod system will not be supported by bony fusion over time. Having tried many screw designs for these indications, I have found that a variable-thread design provides improved haptic feedback as well as superior anchorage in the pedicle and in the vertebral body where fenestrations in the screw also allow for additional fixation by augmentation. In my experience, such a construct reduces the risk of screw loosening dramatically” comments Dr.med Jens A.Richolt, spine surgeon in Frankfurt, Germany: “ Concurrently, this fenestrated variable-thread screw design also has the potential to allow us to reduce the number of instrumented levels and thereby supports our pursuit of less invasive solutions. I’m delighted to be collaborating with Safe Orthopaedics on the design and evaluation of their variable-thread screw design and look forward to examining the results” Safe Orthopaedics, which has also just obtained the CE mark for Hickory, is launching a study of the technology in Germany, and expects it to be marketed worldwide by 2022. Designed by Safe Orthopaedics and manufactured by Safe Medical, Hickory is a 100% French technology. This new implant increases the number of indications for use of SteriSpineTM PS. "We thank Dr.med Jens A.Richolt for his support in this project and are proud to announce the CE marking of this new Hickory screw, to complete our SteriSpineTM PS product range in order to offer the maximum number of solutions to our customers" explains Pierre Dumouchel, President and CEO of Safe Group. "In accordance with the new European Medical Devices Regulation (MDR), we are launching a study in Germany and preparing the global launch of Hickory in 2022. Hickory is the second project after Sycamore from our Safe Group consolidation, designed by Safe Orthopaedics and produced by Safe Medical, and is part of our plan for accelerated innovation and double-digit commercial growth.” About Safe GroupThe Safe Group is a French medical technology group that brings together Safe Orthopaedics, a pioneer in ready-to-use technologies for spinal pathologies, and Safe Medical (formerly LCI Medical), a subcontractor of medical devices for orthopaedic surgery. The group employs approximately 150 people. Safe Orthopaedics develops and manufactures kits combining sterile implants and single-use instruments, available at all times to the surgeon. These technologies are part of a minimally invasive approach aimed at reducing the risk of contamination and infection, to the benefit of the patient and with a positive impact on hospitalisation times and costs. Protected by 18 patent families, SteriSpineTM kits are CE marked and FDA approved. Safe Orthopaedics is headquartered in the Paris region (95610 Eragny sur Oise - France) and has subsidiaries in the UK, Germany, the USA and the Lyon region where the manufacturing company is located.For more information: www.SafeOrthopaedics.com Safe Medical (formerly LCI Medical) produces implantable medical devices and ready-to-use instruments. It has an innovation centre and two production sites in France and Tunisia, offering numerous industrial services: design, industrialisation, machining, finishing and sterile packaging. Supported by the French recovery plan in 2020, the company is investing in additive printing and will be operational in 2022 with this new technology. For more information: www.safemedical.fr Contacts Safe Orthopaedics François-Henri Reynaud Chief Financial and Administrative Officer Tel: +33 (0)1 34 21 50 00 investors@safeorthopaedics.com Press RelationsUlysse CommunicationPierre-Louis Germain / +33 (0)6 64 79 97 61 / plgermain@ulysse-communication.com Bruno Arabian / +33 (0)6 87 88 47 26 / barabian@ulysse-communication.com Attachment PR 20212705

  • Globe Newswire

    Safe Orthopaedics announces CE mark for Sycamore

    Novel treatment for osteoporotic fractures Very dynamic market segment Launch of a multi-centric study in France and Germany Worldwide commercialization expected in 2022 Éragny-sur-Oise, France, On May 24, 2021 à 8:35 CET – Safe Orthopaedics (FR0013467123 – ALSAF), a holding of the Safe Group (composed of Safe Orthopaedics, a company specializing in the design, manufacturing and marketing of single-use technologies for spinal surgeries, and Safe Medical (Ex-LCI medical), integrated subcontractor for orthopedic medical devices, today announces the CE mark for Sycamore, a new treatment for the management of patients with one or more osteoporotic fractures. Osteoporotic fracture is a global clinical issue. Driven by the aging population and the dynamic lifestyle of those 50 years and older, the number of vertebral fractures has increased significantly over the past two decades. Developed with the help of a dozen European surgeons, Sycamore is a minimally invasive, ready-to-use technology that improves the first treatment of one or more fractures and reduces the risk of recurrence in osteoporotic patients. In the laboratory, Safe Orthopaedics has demonstrated the potential clinical benefit of this new technology on human vertebrae, increasing the strength of a cementoplasty-reconstructed vertebra by more than 30%, reducing the risk of post-operative vertebral collapse and thus the patient's re-operation.Prof. Jean-Charles Le Huec, surgeon at the polyclinic Bordeaux Nord Aquitaine and former professor at the Bordeaux University Hospital, France comments: “Studies have shown that 25% of patients over 50 years of age have a risk of vertebral fracture and 20% of women may suffer an adjacent level fracture within 12 months. With an ageing global population, the treatment of these pathologies is a real challenge over the coming years. In collaboration with Safe Orthopaedics, we have designed and tested in human vertebrae at the biomechanical lab a new solution. The Sycamore implant is based on a new mechanical concept that has shown it can significantly reinforce a fractured vertebra and has the potential to reduce long-term risk of loss of correction commonly seen with some devices. I’m delighted to see the CE mark of the technology and will participate in the evaluation of Sycamore in clinical practice”. Dr. Ardeshir Ardeshiri, surgeon at the Itzehoe Clinic, Germany adds: “Like many surgeons, I continuously look to improve the treatment and outcomes for the increasing number of fracture surgeries that I operate on, seeking options that are minimally invasive, reproducible and efficient. Along with the other evaluation centers, I am proud to participate in the evaluation of the Sycamore implant with Safe Orthopaedics to demonstrate the clinical benefits of the device. Like all Safe Orthopaedics products that I have used, the ready-to-use instrumentation of Sycamore, and the implant design, has the potential to help streamline the surgical process for the entire operating room team whilst also bringing tangible benefits to my patients”. Safe Orthopaedics, which recently obtained CE Mark approval for Sycamore, is launching a multi-centric study of the technology in France and Germany and expects Sycamore to be marketed worldwide by 2022. Designed by Safe Orthopaedics and manufactured by Safe Medical, Sycamore is a 100% French technology, which comes in a ready-to-use kit including minimally invasive instrumentation and sterile implants. “Motivated by the clinical challenges expressed by surgeons, our research team is committed to finding simple and effective solutions. We are proud to announce the launch of this new technology called Sycamore and to complete our range of SteriSpineTMVA products for the management of patients with vertebral fractures” explains Pierre Dumouchel, Chairman and CEO of Safe Group. "In accordance with the new European Medical Devices Regulation (MDR), we are launching a multi-center study in several French and German centers and preparing for the global launch of Sycamore in 2022. Sycamore is the first project resulting from the consolidation of our Safe Group, designed by Safe Orthopaedics and produced by Safe Medical and is part of our plan to accelerate innovation and double-digit commercial growth”. About Safe Group Safe Group is a French medical technology company, composed of Safe Orthopaedics, pioneer of ready-to-use technologies for spinal diseases and Safe Medical (ex-LCI medical), subcontractor of medical devices for orthopaedics surgery. The Group employs around 150 employees. Safe Orthopaedics develops and manufactures kits combining sterile implants and single-use instruments, available at any time for the surgeon. These technologies enable minimally invasive approach, reducing the risk of cross contamination and infection, in the interest of the patient with a positive impact on hospitalization durations and costs. Protected by 17 patent families, the SteriSpineTM PS are CE marked and FDA approved. Safe Orthopaedics has its headquarters close to Paris (95610 Eragny-sur-Oise - France) and subsidiaries in the UK, Germany, United States and in the Lyon area where the manufacturing company is located. For more information: www.SafeOrthopaedics.com Safe Medical (formerly LCI Medical) produces implantable medical devices and ready-to-use instruments. It has an innovation center and two production sites in France and Tunisia, offering a wide range of industrial services: design, manufacturing, machining, finishing and sterile packaging. Supported by the French stimulus plan in 2020, the company is investing in additive printing and will be operational in 2022 on this new technology.For more information: www.safemedical.fr Contacts Safe Orthopaedics François-Henri Reynaud Chief Financial and Administrative Officer Tél. : +33 (0)1 34 21 50 00 investors@safeorthopaedics.com Press RelationsUlysse CommunicationPierre-Louis Germain / +33 (0)6 64 79 97 61 / plgermain@ulysse-communication.com Bruno Arabian / +33 (0)6 87 88 47 26 / barabian@ulysse-communication.com Attachment PR 20210524