Spinal Fusion News
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Wenzel Spine Announces Publication of Case Series Detailing Endoscopic Transforaminal Decompression and Fusion Technique with VariLift-LX
Wenzel Spine, Inc., a medical technology company focused on providing minimally invasive solutions for the treatment of spinal disorders, today announced a 24 Consecutive Patient Case Series detailing an endoscopic, stand-alone TLIF surgical technique used with the VariLift-LX System has been published in the Journal of Spine, Volume 7, Issue 2. The Case Series, authored by Kai-Uwe ...
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Empirical Spine Receives FDA Breakthrough Device Designation for the LimiFlex Device Targeting Degenerative Spondylolisthesis
Empirical Spine, Inc., a company developing advanced solutions for the surgical treatment of spinal disorders, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its LimiFlex™ Paraspinous Tension Band. In doing so, the FDA has determined that LimiFlex™ holds the potential to offer significant advantages over ...
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Empirical Spine Initiates PMA Submission Process for FDA Approval of Limiflex for Degenerative Spondylolisthesis
Empirical Spine, Inc., maker of the LimiFlex™ Paraspinous Tension Band, today announced initiation of the PMA process for FDA review and approval of the use of the LimiFlex with a decompression for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis. The Pivotal Trial supporting the PMA compares outcomes of patients who receive either LimiFlex or ...
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FDA Accepts & Closes Empirical Spine`s Limiflex PMA Module II as a Motion-Preserving Alternative to Lumbar Fusion
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently had its Premarket Approval (PMA) Module II accepted and closed by the US Food & Drug Administration (FDA), an important milestone in the commercial approval process for its ...
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Isto Biologics Launches Influx™ Fibrant, a New Line of Advanced Allograft
Isto Biologics, a leader in surgical-based, orthobiologic regeneration technologies and cell-based therapies, announced today the launch of Influx™ Fibrant, an unprecedented line of functional constructs derived from 100% cortical allograft. The cutting-edge line consisting of five new products includes Fibrant Anchor, Boat, Bullet, Pak and Wrap. The Fibrant launch features the patented ...
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Bone Therapeutics signs definitive subscription agreement for a maximum of EUR 5M convertible bonds facility with ABO
BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics, today announces that it has signed the definitive subscription agreement for a maximum EUR 5 million convertible bonds (CBs) facility arranged by ABO Securities, through its affiliated entity Global Tech Opportunities 15. The proceeds of the financing will contribute to ...
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Bone Therapeutics enters into exclusive reverse merger discussions with Medsenic
BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces it has entered into a non-binding term sheet and exclusive discussions for a period of three months with the shareholders of Medsenic, a privately held, clinical stage biopharmaceutical company incorporated in France and specialized in ...
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Bone Therapeutics to host Annual General Meeting and Extraordinary General Meeting on 8 June 2022
BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics, invites its shareholders and the holders of registered subscription rights and registered convertible bonds of the Company to the Annual General Meeting to be held on Wednesday 8 June 2022 as from 4:00 pm CEST, at Rue Granbonpré 11, Building H, 1435 ...
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Empirical Spine Submits PMA Module II for Limiflex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, recently submitted Premarket Approval (PMA) Module II in the US Food & Drug Administration (FDA) approval process for its LimiFlex™ Dynamic Sagittal Tether™ (DST). LimiFlex is ...
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Ad-hoc announcement pursuant to Article 53 of the SIX listing rules Kuros Biosciences’s MagnetOs Flex Matrix Cleared by FDA for Spinal Indications
Schlieren (Zurich), Switzerland, April 21, 2022 – Kuros Biosciences (“Kuros” or the “Company”), a leader in next generation bone graft technologies, announced today that its MagnetOs Flex Matrix has been cleared by the U.S. Food and Drug Administration (FDA) as a bone void filler for use in the posterolateral spine. MagnetOs Flex Matrix is a new open matrix bone ...
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Transparency notification received from Nyenburgh Holding NV
BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces that it has received a transparency notification dated 16 March 2022 indicating that the shareholdings held by Nyenburgh Holding NV have crossed below the minimum threshold of 5%. The notification dated 16 March 2022 contains the ...
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Surgentec releases whitepaper featuring A Novel Decortication and Graft Delivery Technique for Minimally Invasive Spine Fusion Surgery
Minimally invasive (MIS) lumbar fusion has become a popular alternative to traditional methods of lumbar decompression and fusion. When compared with the open technique, the minimally invasive approach can result in decreased pain and blood loss as well as a shorter length of hospitalization. However, the narrower working channel in the MIS technique increases the difficulty of decortication and ...
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Cerapedics Completes Enrollment of Pivotal U.S. FDA IDE Study for its P-15L Bone Graft
Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, announced today the completion of enrollment of the ASPIRE study, a pivotal U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study, to evaluate the safety and efficacy of P-15L Bone Graft for use in transforaminal lumbar interbody fusion (TLIF) surgery in patients with ...
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Empirical Spine Advances LimiFlex as a New Motion-Preserving, Minimally Invasive Standard in Spine Surgery
Empirical Spine, Inc., a medical device company creating a new class of spinal implant that works in parallel with the natural structures of the spine to restore functionality and optimize quality of life, achieved several clinical, reimbursement and regulatory milestones in the past 12 months that are moving its LimiFlex™ Dynamic Sagittal Tether™ (DST) closer to market in the US. The ...
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Bone Therapeutics announces closing of private placement
BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces the closing of the private placement announced on 3 December 2021, with existing and new institutional investors having purchased 4,832,352 new shares at an issue price of EUR 0.68 per share resulting in gross proceeds of approximately ...
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Bone Therapeutics and Link Health sign a non-binding term sheet for the global rights of ALLOB
BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, and Link Health Pharma Co., Ltd (“Link Health”), today announce the signing of a non-binding term sheet for the global rights for ALLOB, Bone Therapeutics’ allogeneic bone cell therapy. Subject to the fulfillment of customary ...
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Empirical Spine Presents Data from Study of the LimiFlex Tension Band at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2021
Empirical Spine, Inc., a Silicon-Valley based medical technology company, announced today that data from the IDE study of the company’s LimiFlex Tension Band for patients suffering from degenerative spondylolisthesis with lumbar spinal stenosis, was presented at the Society for Minimally Invasive Spine Surgery (SMISS) Annual Forum 2021. The SMISS Annual Forum took place from October 28 ...
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Carlsmed Announces aprevo Launch and NTAP Reimbursement
CARLSBAD, Calif.--(BUSINESS WIRE)--Carlsmed, Inc., announced today the U.S. launch of the aprevo® patient-specific spine technology and the New Technology Add-On Payment (NTAP) reimbursement. “We are grateful for our surgeon partners that worked with the company early on to develop a truly personalized solution for patients and to collect the clinical data for improved outcomes,” ...
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Carlsmed aprevo Wins Spine Technology Award
CARLSBAD, Calif.--(BUSINESS WIRE)--Carlsmed announced today that aprevo® has been recognized by Orthopedics This Week with the prestigious Spine Technology Award. This award was presented at a ceremony today at the North American Spine Society (NASS) meeting in Boston. The award is given annually to exemplary and innovative spine surgery products that improve spine care, as judged by a panel ...
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SeaSpine Announces CE Mark Certification of 7D Surgical Cranial Module and Percutaneous Spine Module for Minimally Invasive Spine Surgery
CARLSBAD, Calif., Sept. 27, 2021 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ: SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced it received simultaneous CE Mark certification for its Cranial Module and Percutaneous Spine Module for the 7D FLASH™ Navigation System. This achievement expands the ...
By 7D Surgical
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