Bone remodeling

NiTime™-A New Generation Of Clear Aligners Solve for Patient Compliance: OrthoFX™ Announces Nationwide Availability Of The First and Only FDA Cleared Aligners Designed Explicitly For Shorter Wear Time

Retrieved on: 
Wednesday, May 1, 2024

FREMONT, Calif., May 1, 2024 /PRNewswire/ -- Founded by a team of industry pioneers, OrthoFX™, today announced the new generation of advanced clear aligner polymer, NiTime™ Clear Aligners. NiTime is the first and only clear aligner system explicitly designed for shorter wear time and cleared by the U.S Food and Drug Administration (FDA) 510(k), and is now available nationwide for doctors to treat all classes of dental malocclusions. OrthoFX will showcase the new breakthrough material at the AAO (American Association of Orthodontists) Annual Meeting in New Orleans, May 3-6, 2024.

Key Points: 
  • FREMONT, Calif., May 1, 2024 /PRNewswire/ -- Founded by a team of industry pioneers, OrthoFX™, today announced the new generation of advanced clear aligner polymer, NiTime™ Clear Aligners.
  • OrthoFX will showcase the new breakthrough material at the AAO (American Association of Orthodontists) Annual Meeting in New Orleans, May 3-6, 2024.
  • Predictable Precision - Designed for better predictability and compliance, 92% of NiTime Aligner treatments were completed without refinements*.
  • NiTime Aligners are meticulously designed to support favorable cellular physiology, fostering an ideal environment for biological tissue remodeling.

Biosimilars Pipeline Report: Comprehensive Analysis of Prolia & Xgeva Denosumab Candidates Emerges - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 14, 2023

The "Denosumab (Prolia & Xgeva) Biosimilars Pipeline Review" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Denosumab (Prolia & Xgeva) Biosimilars Pipeline Review" report has been added to ResearchAndMarkets.com's offering.
  • Denosumab biosimilars, which are currently under extensive study for their efficacy and safety as potential alternatives to established bone-modifying agents, are at the forefront of this pharmaceutical research wave.
  • The therapeutic agent at the center of this analysis, Denosumab, is a human monoclonal antibody with a specific function to inhibit RANKL, a crucial mediator in bone remodeling.
  • The arrival of this pivotal information will undoubtedly serve as a springboard for strategic decisions and policy development within the burgeoning biosimilars sector.

Paragon 28 Launches BEAST™ Cortical Fibers Expanding its Biologics Portfolio

Retrieved on: 
Tuesday, November 14, 2023

Paragon 28, Inc. (NYSE: FNA) is pleased to announce the launch of its BEAST™ Cortical Fibers which provide an osteoinductive porous structure for cellular attachment and an osteoinductive potential to aid in cellular differentiation and bone formation.

Key Points: 
  • Paragon 28, Inc. (NYSE: FNA) is pleased to announce the launch of its BEAST™ Cortical Fibers which provide an osteoinductive porous structure for cellular attachment and an osteoinductive potential to aid in cellular differentiation and bone formation.
  • These loose cortical fibers are engineered to complement specific surgical applications in the foot and ankle and are flexible upon hydration allowing for application even in extremely challenging fusion locations.
  • The cortical matrix absorbs bioactive fluid including bone marrow aspirate and supports cellular infiltration to drive efficient bone remodeling.
  • With this comprehensive portfolio, Paragon 28® provides its customers with innovative biologic solutions for reconstruction and trauma.

Dimension Inx Announces First Surgical Cases Utilizing CMFlex™ Synthetic Bone Graft - The First 3D-printed Regenerative Bone Graft Product Cleared by the FDA

Retrieved on: 
Wednesday, October 4, 2023

CHICAGO, Oct. 4, 2023 /PRNewswire/ -- Dimension Inx , a biomaterials platform company, today announced that CMFlex™, the first 3D-printed regenerative bone graft product with FDA approval, has been successfully used in its first clinical cases.

Key Points: 
  • CHICAGO, Oct. 4, 2023 /PRNewswire/ -- Dimension Inx , a biomaterials platform company, today announced that CMFlex™, the first 3D-printed regenerative bone graft product with FDA approval, has been successfully used in its first clinical cases.
  • CMFlex is a 3D-printed synthetic bone graft used for various bony defects in oral and maxillofacial surgical applications.
  • Dimension Inx combines these base materials into a proprietary, microstructurally porous composite material, Hyperelastic Bone®, as first published in Science Translational Medicine in 2016.
  • CMFlex is currently available to a limited number of key surgeons with a broader release to follow later in 2024.

CartiHeal Announces First Commercial Implantation of Agili-C™ in the US

Retrieved on: 
Wednesday, July 26, 2023

The Agili-C implant features a bi-phasic design that supports both bone remodeling and cartilage regeneration.

Key Points: 
  • The Agili-C implant features a bi-phasic design that supports both bone remodeling and cartilage regeneration.
  • Dr. Zaslav commented, "Agili-C is a technology I and others in the surgical community have been watching and waiting on for over 10 years.
  • It is a novel implant supported by 4-years of data and counting from the multinational, randomized and controlled IDE clinical trial.
  • "This is a milestone achievement for everyone at CartiHeal and we would like to congratulate Dr. Zaslav on successfully performing our first commercial case in the US."

CartiHeal Announces First Commercial Implantation of Agili-C™ in the US

Retrieved on: 
Wednesday, July 26, 2023

The Agili-C implant features a bi-phasic design that supports both bone remodeling and cartilage regeneration.

Key Points: 
  • The Agili-C implant features a bi-phasic design that supports both bone remodeling and cartilage regeneration.
  • Dr. Zaslav commented, "Agili-C is a technology I and others in the surgical community have been watching and waiting on for over 10 years.
  • It is a novel implant supported by 4-years of data and counting from the multinational, randomized and controlled IDE clinical trial.
  • "This is a milestone achievement for everyone at CartiHeal and we would like to congratulate Dr. Zaslav on successfully performing our first commercial case in the US."

New Analyses of the MIRROR Randomized Controlled Trial in Uncontrolled Gout Presented at the 2023 EULAR European Congress of Rheumatology

Retrieved on: 
Wednesday, May 31, 2023

Presentations are part of expert discussions at the EULAR European Congress of Rheumatology , May 31 - June 3, 2023, in Milan.

Key Points: 
  • Presentations are part of expert discussions at the EULAR European Congress of Rheumatology , May 31 - June 3, 2023, in Milan.
  • Data presented from Horizon’s MIRROR randomized controlled trial (RCT), which evaluated KRYSTEXXA in combination with methotrexate for uncontrolled gout, provide further evidence of the impact of therapy on patient-reported outcomes (PROs), urate depletion and bone remodeling.
  • “Uncontrolled gout is far more painful and dangerous than most people know,” said Brian LaMoreaux, M.D., M.S., senior medical director, Horizon.
  • Bone erosion remodeling after depletion of monosodium urate deposition with intensive urate-lowering with pegloticase in patients with uncontrolled gout: MIRROR RCT dual-energy CT findings (POS0514)

Novadip Biosciences SA Announces First Pediatric Patient with Congenital Pseudoarthrosis of the Tibia Undergoes Implantation with NVD-003, an Autologous Tissue Regeneration Product, in Phase 1b/2a US/EU Clinical Trial

Retrieved on: 
Wednesday, May 17, 2023

The patient was treated at the Saint-Luc University Hospital in Brussels by Dr. Pierre-Louis Docquier, EU principal investigator for this study.

Key Points: 
  • The patient was treated at the Saint-Luc University Hospital in Brussels by Dr. Pierre-Louis Docquier, EU principal investigator for this study.
  • Dr. Docquier has considerable clinical experience using ASC-based therapies generated from Novadip’s 3M3 tissue regeneration platform in clinical and compassionate use settings.
  • The Phase 1b/2a trial will enroll four CPT patients between two and eight years of age in the US and EU.
  • The primary endpoint of the study is short-term safety of NVD-003 up to 12 months following grafting surgery (GS).

Medacta’s P-Family Hip System offering is now more complete with the introduction of the new SMS Collared Stem

Retrieved on: 
Wednesday, April 19, 2023

The SMS stem is a bone-preserving short femoral stem particularly indicated for patients with good bone quality and narrow femoral canal, classified as Dorr A femurs.

Key Points: 
  • The SMS stem is a bone-preserving short femoral stem particularly indicated for patients with good bone quality and narrow femoral canal, classified as Dorr A femurs.
  • Following the release of the SMS stem in 2017, the new SMS Collared was recently introduced, featuring an optimized collar design with MectaGrip coating on the inferior surface.
  • “The SMS non-collared stem has been a great option for patients with excellent bone quality and Dorr A femoral morphology.
  • The introduction of the SMS Collared stem represents a valuable addition to the P-Family System’s versatility and completeness.

Penn Dental Medicine Study Identifies Possible Target to Counter Bone Loss

Retrieved on: 
Wednesday, October 12, 2022

Diseases such as osteoporosis, arthritis, and periodontitis involve bone loss, and are linked with an overabundance of osteoclast activity.

Key Points: 
  • Diseases such as osteoporosis, arthritis, and periodontitis involve bone loss, and are linked with an overabundance of osteoclast activity.
  • The work identifies the protein IFT80 as a key player in keeping populations of osteoclasts in check.
  • Yang became interested in studying the role of IFT80 in hematopoietic stem cell lineage after an earlier study in Nature Cell Biology .
  • "With so many diseases related to excess bone loss, there is a big need to find ways to address bone loss and restore balance in bone remodeling," adds Yang.