Osteoblast

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.

Bone Solutions Receives 510(k) Clearance for Expanded Indications of Use for Mg OSTEOCRETE in Intervertebral Body Fusion Procedures

Retrieved on: 
Tuesday, February 13, 2024

Bone Solutions Inc. , an orthobiologics technology company located in Colleyville, Texas, announced today 510(k) clearance of Mg OSTEOCRETE from the U.S. Food and Drug Administration (FDA) for use in the intervertebral body disc space, including cervical, thoracic, and lumbar fusion procedures.

Key Points: 
  • Bone Solutions Inc. , an orthobiologics technology company located in Colleyville, Texas, announced today 510(k) clearance of Mg OSTEOCRETE from the U.S. Food and Drug Administration (FDA) for use in the intervertebral body disc space, including cervical, thoracic, and lumbar fusion procedures.
  • This expanded indication allows surgeons and patients to further benefit from the advantages of the Bone Solutions proprietary magnesium-based technology.
  • Mg OSTEOCRETE is a fast-setting bone substitute that remodels into bone over time through creeping substitution.
  • The magnesium component of Mg OSTEOCRETE is the significant differentiator from other bone substitutes on the market.

Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 3, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 3, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Eladynos, abaloparatide, Date of authorisation: 12/12/2022, Revision: 3, Status: Authorised

NextCure Publishes Non-Clinical Data Demonstrating Anti-Siglec-15 Treatment Prevented Bone Loss Due to Immobilization from Acute Spinal Cord Injury

Retrieved on: 
Thursday, December 21, 2023

The data demonstrated that NC605, a novel anti-Siglec-15 (S15) antibody, prevented bone loss, but more importantly preserved bone strength in animal models of severe immobilization resulting from acute spinal cord injury.

Key Points: 
  • The data demonstrated that NC605, a novel anti-Siglec-15 (S15) antibody, prevented bone loss, but more importantly preserved bone strength in animal models of severe immobilization resulting from acute spinal cord injury.
  • Following spinal cord injury, patients typically suffer rapid and extensive bone loss.
  • While anti-resorptive therapies have shown some efficacy in inhibiting bone loss, these agents also inhibit bone formation.
  • Blood and bone structure analyses revealed that the anti-S15 antibody was able to greatly inhibit bone resorption while maintaining bone formation and quality.

RevBio Receives FDA Approval to Conduct a First-in-Human Clinical Trial for its Regenerative Bone Adhesive for Cranial Flap Fixation

Retrieved on: 
Friday, December 8, 2023

This approval was largely predicated on the successful pivotal preclinical and surgeon handling testing conducted by the company.

Key Points: 
  • This approval was largely predicated on the successful pivotal preclinical and surgeon handling testing conducted by the company.
  • As part of the surgical closure process, the cranial flap is secured back into place with plates and screws.
  • The kerf line, however, is typically not sealed, which compromises the ability of the flap to integrate with the surrounding bone.
  • “We are truly excited to move this project into the clinical phase of testing,” said Brian Hess, CEO and Founder of RevBio.

Blocking Abnormal Stem Cell Signal during Aging Lessens Related Bone Loss

Retrieved on: 
Wednesday, September 27, 2023

The study, led by researchers from NYU Grossman School of Medicine, found that blocking the signaling pathway, called Notch, in aging skeletal stem cells caused a "massive increase" in bone mass and restored lost bone-healing ability during aging.

Key Points: 
  • The study, led by researchers from NYU Grossman School of Medicine, found that blocking the signaling pathway, called Notch, in aging skeletal stem cells caused a "massive increase" in bone mass and restored lost bone-healing ability during aging.
  • The study results revolve around immature stem cells, which have the capacity to mature into more than one cell type.
  • Aging is known to come with loss of the ability of stem cells to become bone-making cells, with related skeletal deterioration among the most common causes of age-associated impairment.
  • "Our newly gained knowledge opens potential therapeutic avenues to overcome age-related bone loss by manipulating down-stream effectors for Notch signaling in these stem cells."

Phoenix Children's Expands Pediatric Orthopedic Surgery Team with Hire of Globally Renowned Brittle Bone Expert

Retrieved on: 
Monday, September 11, 2023

Maegen Wallace, MD, MBA , a pediatric orthopedic surgeon and expert in osteogenesis imperfecta, or brittle bone disease, joined the Herbert J. Louis Center for Orthopedics and Sports Medicine at Phoenix Children's last month.

Key Points: 
  • Maegen Wallace, MD, MBA , a pediatric orthopedic surgeon and expert in osteogenesis imperfecta, or brittle bone disease, joined the Herbert J. Louis Center for Orthopedics and Sports Medicine at Phoenix Children's last month.
  • At the Herbert J. Louis Center for Orthopedics and Sports Medicine at Phoenix Children's, Dr. Wallace will focus on lower-extremity issues, osteogenesis imperfecta and other rare skeletal diseases .
  • On the research front, she will continue her work to define best clinical practices for patients with brittle bone disease and uncover new treatment options.
  • "Phoenix Children's emphasis on research and the chance to work once again with Dr. Halanski are what drew me to Phoenix Children's," said Dr. Wallace.

Preclinical Data Demonstrate Potential Application of Anti-Siglec-15 Treatment in Bone Disease

Retrieved on: 
Tuesday, September 5, 2023

While anti-resorptive therapies have shown some efficacy in inhibiting bone loss, these agents also inhibit bone formation.

Key Points: 
  • While anti-resorptive therapies have shown some efficacy in inhibiting bone loss, these agents also inhibit bone formation.
  • In preclinical testing, NC605 has been shown to prevent bone loss by inhibiting osteoclast maturation and bone resorption by binding S15, which is expressed on the cell surface of immature osteoclasts and upregulated in differentiated osteoclasts.
  • Blood and bone structure analyses revealed that the anti-S15 antibody was able to greatly inhibit bone resorption while maintaining bone quality.
  • Title: Development of a Novel Therapeutic, anti-Siglec-15 Antibody, to Reduce Bone Loss and Enhance Bone Integrity after Acute Spinal Cord Injury-induced Immobilization

Global Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) Strategic Research Report 2023: Activities of 110+ Leading MSC Companies, Including their Core Technologies and Products - ResearchAndMarkets.com

Retrieved on: 
Friday, April 7, 2023

The "Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) - Advances & Applications, 2023" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) - Advances & Applications, 2023" report has been added to ResearchAndMarkets.com's offering.
  • MSCs are multipotent cells that can differentiate into a variety of cell types, including but not limited to osteoblasts, chondrocytes, myocytes, and adipocytes.
  • Therefore, this global strategic report details the activities of 113 leading MSC companies, including their core technologies and products under development.
  • This global strategic report includes:
    Market size determination for the global MSC market, segmented by Geography and Business Segment
    Recent business developments related to MSCs, including strategic collaborations and partnerships
    Company profiles for MSC market competitors, including their products, services, and technologies under development

Genes that Form Specific Bones In the Womb Heal them Later in Life

Retrieved on: 
Monday, March 20, 2023

NEW YORK, March 20, 2023 /PRNewswire/ -- Genes long known to control the formation of bones before birth also control bone healing later in life, a new study found.   

Key Points: 
  • NEW YORK, March 20, 2023 /PRNewswire/ -- Genes long known to control the formation of bones before birth also control bone healing later in life, a new study found.
  • Such adjustments guide immature stem cells as they multiply and mature in the womb, say the study authors, to become heart muscle, nerves, bones, etc., and in the right places.
  • Bone is among the tissues that keep pools of stem cells on hand into adulthood, ready to mature into needed replacement cells that maintain healthy tissue and heal broken bones.
  • During aging, such stem cells become depleted, the researchers say, resulting in weaker bones that are more likely to fracture and slower to heal.