Degenerative disc disease

ZygoFix Receives FDA Clearance for its zLOCK Lumbar Facet Fixation System

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星期一, 五月 6, 2024

FDA, Orthopedic surgery, Certification, ASC, Surgeon, Spinal fusion, Degenerative disc disease, Joint, Spinal stenosis, Patient, Health, CE

MISGAV, Israel, May 6, 2024 /PRNewswire/ -- ZygoFix Ltd. a portfolio company of The Trendlines Group Ltd. ("Trendlines") announced that it received regulatory clearance from the United States Food and Drug Administration (FDA clearance) for its zLOCK Lumbar Facet Fixation System.

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MISGAV, Israel, May 6, 2024 /PRNewswire/ -- ZygoFix Ltd. a portfolio company of The Trendlines Group Ltd. ("Trendlines") announced that it received regulatory clearance from the United States Food and Drug Administration (FDA clearance) for its zLOCK Lumbar Facet Fixation System.
ZygoFix's revolutionary zLOCK system harnesses the spine's innate bone structure to securely lock its connecting joints.
With CE certification and six years of clinical utilization yielding long-term pain reduction and bone growth, ZygoFix's zLOCK Lumbar Facet Fixation System is positioned to revolutionize spinal fusion surgery.
ZygoFix CEO Ofer Levy remarked, "Receiving FDA clearance for our zLOCK Lumbar Stabilization System is an exciting milestone, and I am very proud of the team that has worked hard to achieve this goal.

FibroBiologics Plans to Collaborate with Charles River to Manufacture Fibroblast-based Spheroids

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星期四, 四月 25, 2024

HOUSTON, April 25, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics") and Charles River Laboratories (“Charles River”), a highly respected, global provider of drug discovery, development, and manufacturing solutions, today announced the signing of a letter of intent allowing for the transfer, testing and validation of FibroBiologics’ technology.

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HOUSTON, April 25, 2024 (GLOBE NEWSWIRE) -- FibroBiologics, Inc., (Nasdaq: FBLG) ("FibroBiologics") and Charles River Laboratories (“Charles River”), a highly respected, global provider of drug discovery, development, and manufacturing solutions, today announced the signing of a letter of intent allowing for the transfer, testing and validation of FibroBiologics’ technology.
To help advance FibroBiologics’ fibroblast-based therapies into the clinic, Charles River will conduct feasibility studies on FibroBiologics' cell manufacturing processes within its facility.
Additionally, contingent upon entering into a master services agreement, Charles River would serve as the contract development and manufacturing organization (CDMO) responsible for producing drug products for certain FibroBiologics’ clinical trials.
Combined with its legacy testing capabilities, Charles River offers a premier “concept-to-cure” advanced therapies solution.

Aurora Spine Corporation Celebrates Second Anniversary of Initial Implantation of the World’s First Bone Density Matched DEXA-C Cervical Interbody Fusion Device

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星期三, 三月 20, 2024

ASG, ACDF, Institutional review board, MRI, Patent, Patient, United, Degenerative disc disease, DEXA, DDD, Neurosurgery, Bone density, Spine, Trial of the century, IRB

The DEXA-C implants, a line of cervical cages for anterior cervical discectomy with fusion (ACDF) procedures, are the first of its kind in the world offering an implant based upon a patient's bone density.

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The DEXA-C implants, a line of cervical cages for anterior cervical discectomy with fusion (ACDF) procedures, are the first of its kind in the world offering an implant based upon a patient's bone density.
I am able to confidently offer multilevel anterior fusions to patients who likely could not have benefitted from other existing implants because of their bone density.
In June 2023, Aurora announced that the first patient has been enrolled for its multicenter study of DEXA-CTM Cervical Interbody System.
Preliminarily, we have seen both in radiographs and surgical exploration that patients have incipient bone fusion by 90 days after surgery.

OFFICIAL LAUNCH OF THE NATIONAL UNIVERSITY SPINE INSTITUTE (NUSI): LEADING SPINE CARE INTO THE FUTURE

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星期六, 三月 30, 2024

SINGAPORE, March 30, 2024 /PRNewswire/ -- The National University Spine Institute (NUSI) is a new dedicated specialist spine institute under the National University Health System (NUHS) that provides multidisciplinary care for patients with spinal diseases and deformities.

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SINGAPORE, March 30, 2024 /PRNewswire/ -- The National University Spine Institute (NUSI) is a new dedicated specialist spine institute under the National University Health System (NUHS) that provides multidisciplinary care for patients with spinal diseases and deformities.
Under the leadership of Associate Professor Gabriel Liu, NUSI aims to set new standards in spine care through a patient-centric approach.
A/Prof Liu said: "NUSI differentiates itself by providing dedicated sub-specialties within the spine practice, standardising work processes and providing value-driven patient care across the cluster to address spinal problems.
NUSI is dedicated to developing community care programmes for patients, with cases expected to rise in the coming years partly due to an ageing population."

Mesoblast Reports Financial Results and Operational Update for Half-Year Ended December 31, 2023

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星期三, 二月 28, 2024

NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.

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NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023.
Reduction in net cash usage for operating activities:
For the three months ended December 31, 2023, net cash usage was US$12.3 million, a 25% reduction versus the comparative quarter in FY2023.
For the six months ended December 31, 2023, net cash usage was US$26.6 million, a 14% reduction versus the comparative period in FY2023.
Manufacturing reduced by 47% for the six months ended December 31, 2023, from US$12.8 million to US$6.7 million.

Bone Biologics Reports Progress With NB1 Clinical Program

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星期五, 三月 1, 2024

Health, Stem Cells, Other Science, Clinical Trials, Research, Science, Biotechnology, Division, Spinal fusion, Degenerative disc disease, Safety, NB1, Patient, DDD, Pharmaceutical industry

Bone Biologics Corporation (NASDAQ: BBLG), a developer of orthobiologic products for spine fusion markets, reports progress with advancing its product candidate NB1 into human clinical testing for spinal fusion.

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Bone Biologics Corporation (NASDAQ: BBLG), a developer of orthobiologic products for spine fusion markets, reports progress with advancing its product candidate NB1 into human clinical testing for spinal fusion.
Following Human Research Ethics Committee (HREC) approval last year in Australia for the multicenter, prospective, randomized pilot clinical trial, the Company reports that three hospital sites have been engaged to participate in the pilot clinical trial.
This pilot clinical trial will evaluate the safety and effectiveness of NB1 in 30 adult subjects who undergo transforaminal lumbar interbody fusion (TLIF) to treat degenerative disc disease (DDD).
The study design was previously reviewed and agreed upon by the Division of Orthopedic Devices in a Pre-submission to support progression to a pivotal clinical trial in the United States.

SPINEART COMPLETES ENROLLMENT IN THE BAGUERA®C IDE TRIAL FOR SINGLE-LEVEL CERVICAL DISC REPLACEMENT

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星期四, 二月 29, 2024

Degenerative disc disease, Freedom, Spine, C3, MD, Surgeon, IDE, Decompression, Patient, Federal, C7, Birth control

GENEVA, Feb. 29, 2024 /PRNewswire/ -- Spineart SA, manufacturer of the BAGUERA®C Cervical Disc Prosthesis, is delighted to announce completion of enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with single-level cervical disc disease between C3 to C7 compared to a commercially marketed cervical disc implant.

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GENEVA, Feb. 29, 2024 /PRNewswire/ -- Spineart SA, manufacturer of the BAGUERA®C Cervical Disc Prosthesis, is delighted to announce completion of enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with single-level cervical disc disease between C3 to C7 compared to a commercially marketed cervical disc implant.
"We are committed to advancing spine arthroplasty worldwide and establishing BAGUERA®C as a leading motion preserving technology for US surgeons and their patients."
The BAGUERA®C Cervical Disc Prosthesis has been commercially available in selected European and worldwide markets since 2008 with over 60,000 implants sold.
The BAGUERA®C Cervical Disc Prosthesis, developed by Spineart SA (Geneva, Switzerland), is an investigational device designed to maintain or restore segmental motion and disc height in the cervical region of the spine following single- or two-level discectomy for symptomatic cervical disc disease.

FDA Grants Breakthrough Device Designation to ORTHOSON's Bio-Structural Gel

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星期三, 二月 7, 2024

Biotechnology, FDA, Pharmaceutical, Health, Breakthrough, Intervertebral disc, Patient, I Am the Moon, Food, Degenerative disc disease, Back pain, Biomedical engineering, University, Doctor of Philosophy, Sheffield Hallam University, Medical device

ORTHOSON , a medtech innovator developing a portfolio of novel treatments for back pain, today announced that its Bio-Structural Gel product has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).

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ORTHOSON , a medtech innovator developing a portfolio of novel treatments for back pain, today announced that its Bio-Structural Gel product has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
ORTHOSON's Bio-Structural Gel follows the natural fissures of degeneration in the nucleus pulposus of the intervertebral disc, before gelling in-situ to form a highly-hydrated biology-supporting structure.
“Gaining Breakthrough Device Designation is a significant achievement that will prioritize our work with the FDA as we go through the regulatory process,” said Ken Reali, chair of ORTHOSON.
“We believe the Breakthrough Device Designation for our Bio-Structural Gel is a testament to our team's spirit of innovation and dedication.

U.S. FDA GRANTS THERADAPTIVE IDE APPROVAL FOR PHASE I/II CLINICAL TRIALS

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星期四, 二月 1, 2024

FREDERICK, Md., Feb. 1, 2024 /PRNewswire/ -- Theradaptive, the market leader in targeted regenerative therapeutics, has gained approval from the U.S. Food and Drug Administration (FDA) for their Investigational Device Exemption (IDE) submission to begin enrolling patients into OASIS, their global Phase I/II Feasibility study in spine fusion.

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IDE approval from the FDA serves as a key milestone for this platform and will generate its first human clinical data, thus opening a new chapter in Theradaptive's growth into a clinical-stage company.
Theradaptive's path to FDA IDE approval has been aided by their unprecedented three Breakthrough Medical Device Designations which provide them with priority review and interactive communication regarding device development and clinical trial protocols.
John Greenbaum, SVP of Regulatory & Clinical Affairs at Theradaptive, said: "The FDA created Breakthrough Device Designations to accelerate the clinical trials and approval processes for devices that promise to improve on current treatments for life-threatening and debilitating conditions.
Based on the safety profile of OsteoAdapt, we will be allowed to combine Phase I and II trials.

Providence Medical Technology Announces FDA Clearance of CAVUX® FFS-LX Lumbar Facet Fixation System for 1- and 2-Level Lumbar Spinal Fusion

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星期三, 一月 10, 2024

Patient, MD, Nicotine, Food, Safety, FFS, FDA, Pain, DDD, PMT, Motion, Degenerative disc disease, Trial of the century

PLEASANTON, Calif., Jan. 10, 2024 /PRNewswire/ -- Providence Medical Technology, Inc. (PMT), a medical device innovator focused on improving surgical outcomes for high-risk spine surgery patients, announced that the U.S. Food and Drug Administration (FDA) has cleared its CAVUX® FFS-LX: Lumbar Facet Fixation System for use in lumbar spinal fusion surgery.

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CAVUX® FFS-LX is a novel integrated cage and screw system that is implanted bilaterally in the facet joints to treat lumbar degenerative disc disease (DDD).
The implant spans the facet interspace with points of fixation at each end of the construct to offer additional stabilization for 1- or 2-level lumbar interbody fusion.
CAVUX® FFS-LX may be used with or without pedicle screws and rods and is implanted using the company's CORUS™ Spinal System-LX tissue-sparing access and spinal fusion system.
Patients who fail to fuse after a lumbar spine fusion surgery face a substantial risk of added complications, suffering, and costly revision procedures.