bone grafting News
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Cerapedics Announces FDA Breakthrough Device Designation Granted for P-15L Bone Graft for the Treatment of Degenerative Disc Disease
Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its investigational P-15L Bone Graft for the treatment of degenerative disc disease (DDD). The FDA’s Breakthrough Device designation is designed to expedite the development and review ...
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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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Kuros Biosciences continues strong commercial roll-out of MagnetOs bone graft
Schlieren (Zurich), Switzerland, April 27, 2022 – Kuros Biosciences (SIX: KURN), a leader in next generation bone graft technologies, today provided a first-quarter business update, showing a significant acceleration in product sales of its Medical devices segment. Medical devices sales increased 102% in Q1 2022 compared to Q1 2021. The U.S. Food and Drug Administration (FDA) cleared ...
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Kuros Biosciences continues strong commercial roll-out of MagnetOs bone graft
Schlieren (Zurich), Switzerland, April 27, 2022 – Kuros Biosciences (SIX: KURN), a leader in next generation bone graft technologies, today provided a first-quarter business update, showing a significant acceleration in product sales of its Medical devices segment. Medical devices sales increased 102% in Q1 2022 compared to Q1 2021. The U.S. Food and Drug Administration (FDA) cleared ...
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Kuros Biosciences continues strong commercial roll-out of MagnetOs bone graft
Schlieren (Zurich), Switzerland, April 27, 2022 – Kuros Biosciences (SIX: KURN), a leader in next generation bone graft technologies, today provided a first-quarter business update, showing a significant acceleration in product sales of its Medical devices segment. Medical devices sales increased 102% in Q1 2022 compared to Q1 2021. The U.S. Food and Drug Administration (FDA) cleared ...
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Cerapedics Announces FDA approval of an IDE supplement
Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) supplement, reducing the enrollment requirement for the on-going clinical trial, ASPIRE, for P-15L Bone Graft in a single level transforaminal lumbar interbody fusion (TLIF) surgery. “We are pleased to announce ...
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Synergy Biomedical Launches BIOSPHERE® MIS II, Next Generation Minimally Invasive Bone Graft Delivery System
Synergy Biomedical, LLC, a developer of innovative biomaterial products, today announced the launching of BIOSPHERE® MIS II, Next Generation Minimally Invasive Bone Graft Delivery System. Synergy continues to add solutions for surgeons with new innovative biomaterial products to an already successful portfolio. Leveraging off the proven success of the first-generation design, BIOSPHERE® ...
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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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Cerapedics Announces FDA Approval of PMA Supplement Based on Two-Year Clinical Data
Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Premarket Approval (PMA) supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Cerapedics requested approval for an updated package insert that ...
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Synergy Biomedical Announces FDA Clearance of BIOSPHERE FLEX
Synergy Biomedical, LLC, a developer of innovative biomaterial products, announced today that it has received FDA 510(k) clearance of BIOSPHERE® FLEX and is targeting a launch in the 4th quarter of 2018. Based on Synergy’s BioSphere® Technology, BIOSPHERE® FLEX is composed of porous, bioactive glass granules combined with a porous collagen and sodium hyaluronate scaffold. The ...
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Synergy Biomedical Announces Publication of Core Scientific Study on Its BioSphere® Bone Graft Technology
Synergy Biomedical, LLC, a developer of innovative bone graft products for spine and orthopedic surgery, announced the publication of a basic science study describing the findings and scientific strategies of controlling the bone formation response of bioactive glass. This study was conducted by Synergy’s founder, Mark Borden Ph.D. and a team of clinical and basic science collaborators, and ...
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Cerapedics Announces Canadian Approval of its next-generation bone graft
Cerapedics, a private ortho-biologics company, today announced the Health Canada approval of the company’s next-generation bone graft called i-FACTOR+ Matrix, making it the first market to approve the commercial launch of this product. “We are excited to announce Canadian regulatory approval of our next-generation product, based on P15 osteogenic cell-binding peptide , i-FACTOR+ ...
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Clinical Launch of SurGenTec® GraftGun® System Prefilled with ViBone® a Resounding Success
BOCA RATON, Fla.–(BUSINESS WIRE)–SurGenTec announced today the successful completion of the initial clinical launch of its new GraftGun bone graft delivery system combined with ViBone Viable Bone Matrix prefilled tubes. This early evaluation of the combined products was focused in the Minimally Invasive Spine (MIS) surgery ...
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Cerapedics Announces Results from Clinical Trial of i-FACTOR Peptide Enhanced Bone Graft in Lumbar Fusion Surgery
Cerapedics, a private ortho-biologics company, today announced that results from a clinical trial evaluating i-FACTOR Peptide Enhanced Bone Graft in non-instrumented lumbar fusion surgery has been published in the May 2020, Volume 20, Issue 5 print of The Spine Journal as the lead article. The data demonstrate that elderly patients in Denmark treated with i-FACTOR bone graft plus local bone had a ...
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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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Synergy Biomedical Launches BIOSPHERE® Flex SP Extremities, Synthetic Bioactive Bone Graft.
Synergy Biomedical, LLC, a developer of innovative biomaterial products, today announced the launching of BIOSPHERE® FLEX SP EXTREMITIES, Synthetic Bioactive Bone Graft. Using Synergy’s proprietary BIOSPHERE® Technology, BIOSPHERE® FLEX SP Extremities is a sheet putty composed of innovative spherical bioactive glass granules combined with a porous collagen/sodium hyaluronate ...
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Cerapedics Announces Commercial Launch of i-FACTOR+ Matrix in Canada
Cerapedics, a private ortho-biologics company, today announced the full commercial availability of i-FACTOR+ MATRIX for surgical implantation in Canada. “We are excited to announce that i-FACTOR+ Matrix is now fully available in Canada through our distributor Surgi-One and can be used in both spine and general orthopedic applications,” said Glen Kashuba, Chief Executive Officer of ...
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Bonesupport – Supplementary Us Denovo Application Submitted
BONESUPPORT™, an emerging leader in orthobiologics for the management of bone injuries, today announced that the company has submitted a supplementary De Novo application to the US Food and Drug Administration (FDA) to obtain a market approval for the company’s antibiotic-releasing product CERAMENT® G. The application is specified for the indication osteomyelitis (bone infection) ...
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SurGenTec® Announces First-of-its-Kind FDA Clearance for its 3D GraftRasp System™ Including Key Spine Indications
The 3D GraftRasp System is the only device to receive FDA clearance that allows for both decortication of bone and the delivery of autograft, allograft or synthetic bone graft. It is approved for general orthopedic use and spine procedures. “In spine procedures, the transverse processes and facet joints may now be targeted in a more efficient and effective surgical technique pioneered by ...
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LaunchPad Medical Wins a Coveted $1.8 Million Michigan-Pittsburgh-Wyss Regenerative Medicine Center Grant
LaunchPad Medical, Inc. announced that it has received follow-on support of up to $1.8 million from the Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center which was funded by the National Institute of Dental and Cranial Research (U24-DE029462) to improve the translation of promising tissue engineering and regenerative medicine technologies for dental, oral, and craniofacial clinical ...
By RevBio Inc.
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