Pseudarthrosis

At six months post-grafting surgery with NVDX3, x-rays demonstrate that 90% of patients have reached, or are steadily progressing towards, complete bone healing Derived from Novadip’s 3M 3 stem cell platform, NVDX3, a unique ‘off-the-shelf allogeneic matrix product to cure common but challenging orthopedic conditions, has potential to replace existing allogeneic bone substitutes to heal fractures MONT SAINT-GUIBERT, Belgium I October 17, 2024 I Novadip Biosciences, a clinical stage biotechnology company specializing in regenerative medicine, today announces positive interim results from its first-in-human clinical trial, NVDX3-CLN01, assessing the safety and efficacy of NVDX3 to heal distal radius fractures in adults. Originating from Novadip’s 3M 3 platform, NVDX3 is an allogeneic bone grafting material created from human osteogenic adipose tissue-derived mesenchymal stem cells (ASCs). It is formulated as a lyophilized powder intended to be used as an ‘off-the-shelf’ implant to induce bone formation between two bone segments in both orthotopic and heterotopic environments. NVDX3 is a new class of regenerative tissue products that accelerates bone healing in a single treatment for patients at high risk of nonunion due to co-morbidities (ageing, diabetes, obesity, smoking and other conditions) and medication use. NVDX3-CLN01 (NCT05987033) is a single-arm, open-label clinical trial designed to assess the safety and preliminary efficacy of NVDX3 in adults with distal radius fractures, involving the wrist joint with multiple bone fragments. Ten participants, aged 28 to 84 years old, were treated. Radiologically, 90% of patients have achieved, or are on-track to achieve, complete bone healing. All but one are progressing as expected clinically. There is no apparent impact of age or sex on the efficacy of NVDX3, despite the complexity of fractures treated. There have also been no safety concerns arising from this study. “The interim results of this first clinical trial mirror the safety and efficacy of NVDX3 demonstrated in our nonclinical program. NVDX3 is the first and only bone graft product following a Biologics License Application (BLA) pathway.Based on these preliminary data, NVDX3 has the potential to address the high unmet needs of patients with bone defects who, due to co-morbidity factors, experience delayed bone formation or nonunion,” said Denis Dufrane, MD, PhD, CEO of Novadip Biosciences. “We will share the results of this trauma study with the US FDA as part of our IND submission to support the further clinical development of NVDX3 as we explore its potential for the treatment of complex cervical spine fusion.” “We need more options to improve outcomes in bone healing, particularly for patients with co-morbidities like advanced age, diabetes and smoking,” said Philipp Leucht, MD, PhD, Vice Chair of Research, Department of Orthopedic Surgery at NYU Grossman School of Medicine. “These interim results suggest that NVDX3 may have the potential to address this unmet need.” The 12-month results of NVDX3-CLN01 are expected at the end of 2024. In parallel to NVDX3-CLN01, Novadip is investigating the safety and preliminary efficacy of NVDX3 as a bone graft to achieve spine fusion in the lumbar spine in trial NVDX3-CL02 (NCT05961956). One-year results from this trial are expected in March 2025. In addition to its allogeneic program with NVDX3, the clinical development of the company’s lead autologous program, NVD003, will soon be entering phase 3 for the treatment of congenital pseudarthrosis of the tibia, a rare pediatric disease that often leads to amputation. Planning for a pivotal phase 3 trial and BLA submission is underway. About Novadip’s 3M 3 platform The 3M 3 platform drives multiple classes of product candidates, with an initial focus on autologous cell therapies for critical size tissue reconstruction and allogeneic therapeutics in development for prevalent bone grafting procedures and solid tumors. The platform consists of a 3-dimensional, scaffold-free, extracellular matrix (ECM) utilizing differentiated adipose-derived stem cells (ASCs), to generate highly specific growth factors and miRNAs to restore the physiology of natural healing. The components of the 3M 3 include a matrix with ASCs to deliver growth factors/miRNA, the mature implant mimicking the physiology of natural healing. About Novadip Biosciences Novadip is a Belgium-based clinical stage biotech company aiming at advancing the standard of care in bone and tissue regenerative medicine. Based on the scientific discoveries of founder Prof. Dr. Denis Dufrane, MD, PhD, the company is developing its unique 3M³ tissue regeneration technology platform, which has the potential to generate an array of candidates that utilize adipose-derived stem cells to mimic the physiology of natural tissue healing, and hard and soft tissue reconstruction, for patients with limited or no treatment options. Novadip is a spin-off company from the Université Catholique de Louvain (UCLouvain) and St. Luc University Hospital. www.novadip.com SOURCE: Novadip Biosciences

KING OF PRUSSIA, Pa.--( BUSINESS WIRE )-- Camber Spine , a leading innovator in spine and medical technologies, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its SPIRA-A Integrated technology. Part of the SPIRA product platform, the SPIRA-A Integrated Fixation System is an anterior lumbar interbody fusion device that has an open matrix design to permit packing with autogenous and/or allogenous graft material to facilitate fusion, as well as additional fixation options to secure the implant in the disc space. “The FDA’s 510(k) clearance of our SPIRA-A Integrated technology ushers in the next evolution in our innovative SPIRA platform and marks another major step forward in our company’s development,” said Camber Spine CEO Brooks McAdam. “It also helps bring more innovation-based solutions and options to the surgical community and a solution for surgeons engaging or wanting to engage in the ALIF market. We believe SPIRA Technology, which encompasses the structure, surface, and science behind our 3D-printing process, is the archetypal design for modern spine implants and exemplifies the true benefits of additive manufacturing.” SPIRA-A Integrated offers a complete solution to the ALIF procedure, with integrated fixation deployed in a traditional ALIF cage and approach, as well as a windswept cage geometry for accessing L5-S1 with difficult vascular anatomy, and each implant offers up to 40 points of endplate contact. The superior and inferior surfaces of the SPIRA-A Integrated device have a rough surface to help prevent movement of the device while fusion takes place, and structural arches to help distribute load across the joint space. The device contains three holes to insert bone screws or anchors for integrated fixation, as well as blocking screws to prevent fixation back-out. SPIRA-A’s screws and anchors have been designed to complement the performance of the cage, increase fixation in the cortical endplate, and provide first-of-their-kind 3D-printed anchors with a SPIRA Surface, designed to increase potential for osseointegration and resist pull-out. The robust inserter attachment, multiple technique possibilities, and a wide variety of screw prep options are designed to facilitate clear visualization of, and easy access to, the surgical site once the approach is complete. The FDA’s action means that SPIRA-A Integrated is now indicated for use at one or more levels, from L1-S1 as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy) spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis and failed previous fusion (pseudarthrosis). Camber’s SPIRA implants are 3D printed. This specialized manufacturing technology allows Camber to create unique patented structures featuring open arched matrices and proprietary surfaces designed to enhance fusion and promote bone growth. All of Camber Spine’s products are developed and manufactured in the United States. Innovative spine and medical technology company Camber Spine Technologies is dedicated to creating surgeon-designed solutions in MIS and minimally disruptive access for the treatment of complex spinal pathology. Incorporating state-of-the-art manufacturing, 3-D printing, and an acute sensitivity to patient anatomy, Camber Spine is making quantum leaps in the spinal fusion market. Learn more at CamberMedtech.com .

PLEASANTON, Calif., June 13, 2024 /PRNewswire/ -- Providence Medical Technology, Inc., an innovator in solutions for spinal surgery, announces that the U.S. Food and Drug Administration (FDA) has cleared the use of the CORUS™ Navigation Access System for use with the CORUS Spinal System during spinal surgery. The CORUS Navigation Access System is specifically designed for use with Medtronic's StealthStation™ System for posterior spinal fusion procedures. This FDA clearance strengthens Providence Medical Technology's portfolio and underscores its commitment to advancing spinal surgery for high-risk spinal fusion patients. Continue Reading The CORUS™ Navigation Access System assists spine surgeons in locating and preparing facet joints in open and minimally invasive spinal surgery procedures and is designed for use with the Medtronic StealthStation™ System. The CORUS™ Navigation Access System is intended to assist surgeons in locating, accessing, and preparing facet joints for posterior fusion procedures. It enables surgeons to utilize surgical navigation to perform procedures with its novel CORUS Spinal System. Surgical guidance and navigation have become increasingly utilized in spinal surgical procedures, particularly for less invasive surgical techniques. The potential benefits of utilizing the CORUS™ Navigation Access System to perform a navigated CORUS fusion include: Enhanced accuracy and precision with surgical instruments and spinal implants, e.g., CAVUX FFS-LX. Improved visualization of the facet joints and other anatomical structures during procedures. Reduced risk of complications and shorter operative time. Bryan Lee, MD, a neurosurgeon at Barrow Neurological Institute, commented, "The newly released CORUS navigation system offers simplicity and accuracy for placement of CAVUX® FFS-LX implants and provides the surgeon with a truly minimally invasive approach for posterior fusion, with a wide array of indications, including advanced disc degeneration and adjacent segment disease." "We are thrilled to integrate our CORUS™ Spinal System with the leading surgical navigation platform and allow for incredible precision and safety in posterior fusion surgeries," said Jeff Smith, CEO of Providence Medical Technology. "This clearance signifies another leap forward in our mission to improve clinical outcomes for high-risk patients and prevent surgical failures of the spine." For more information about the CORUS™ Navigation Access System please visit providencemt.com. As with all medical devices, there are risks and considerations to device use. Please refer to the device labeling for a full discussion of potential risks, contraindications, warnings, precautions, and instructions for use. Rx only. View product safety information: providencemt.com/safety About Providence Medical Technology, Inc. Providence Medical Technology, Inc. is a leading medical device company focused on advancing spine surgery technologies. Its commitment to improving clinical outcomes and reducing failures in high-risk spinal surgery has led PMT to develop a range of innovative solutions like CORUS™ Spinal Systems, CAVUX® Facet Fixation Systems, and ALLY® Bone Screws and Facet Screws. Indications for use: The CORUS™ Navigation Access System for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open or minimally invasive procedures. The CORUS™ Navigation Access System is specifically designed for use with the Medtronic StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. CORUS™ Spinal System-X is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease. CORUS™ Spinal System-LX is a set of instruments indicated to be used to perform posterior lumbar fusion in patients with lumbar degenerative disc disease. CAVUX® Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft. CAVUX Facet Fixation System, Lumbar (CAVUX FFS-LX) is an integrated construct comprised of a CAVUX Cage and an ALLY Bone Screw. CAVUX FFS-LX is placed bilaterally through a posterior surgical approach and spans the facet interspace with points of fixation at each end of the construct. CAVUX FFS-LX is intended to provide temporary stabilization as an adjunct to a 1 or 2 level interbody lumbar fusion with autogenous and/or allogenic bone graft and must be accompanied with an FDA-cleared intervertebral body fusion device implanted at the same spinal level(s), and may be used with a pedicle screw and rod system implanted at the same spinal level(s). CAVUX FFS-LX is indicated for the treatment of patients with lumbar degenerative disc disease (DDD) from L4 to S1 in skeletally mature patients who have failed conservative care. SOURCE Providence Medical Technology, Inc.