Intervertebral disc

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

Retrieved on: 
Wednesday, February 7, 2024

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).

Key Points: 
  • 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.

BioRestorative Therapies and Northwell Health Enter into Agreement to Participate in the Company’s Phase 2 Clinical Trial

Retrieved on: 
Monday, May 8, 2023

(“BioRestorative”, “BRTX” or the “Company”) (NASDAQ: BRTX ) , a clinical stage company focused on stem cell-based therapies, today announced that it has signed a clinical trial agreement with Northwell Health, New York State's largest health care provider and private employer, and Northwell’s Feinstein Institutes for Medical Research.

Key Points: 
  • (“BioRestorative”, “BRTX” or the “Company”) (NASDAQ: BRTX ) , a clinical stage company focused on stem cell-based therapies, today announced that it has signed a clinical trial agreement with Northwell Health, New York State's largest health care provider and private employer, and Northwell’s Feinstein Institutes for Medical Research.
  • The signing of the agreement will allow Northwell Health to participate in BioRestorative Therapies ongoing Phase 2 clinical trial targeting chronic lumber disc disease (cLDD).
  • BRTX-100 is currently being evaluated in connection with a Phase 2 clinical trial to treat cLDD.
  • The partnership will enable Northwell to participate in BioRestorative’s clinical trial targeting patients suffering from chronic lumbar disc disease.

DiscGenics Announces Positive Two-Year Clinical Data from Study of Discogenic Progenitor Cell Therapy for Degenerative Disc Disease

Retrieved on: 
Monday, January 23, 2023

SALT LAKE CITY, Jan. 23, 2023 /PRNewswire/ -- DiscGenics, Inc., a clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced positive two-year clinical data from its first-in-human clinical study of IDCT (rebonuputemcel), an allogeneic discogenic progenitor cell therapy for lumbar degenerative disc disease (DDD).

Key Points: 
  • SALT LAKE CITY, Jan. 23, 2023 /PRNewswire/ -- DiscGenics, Inc. , a clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced positive two-year clinical data from its first-in-human clinical study of IDCT (rebonuputemcel), an allogeneic discogenic progenitor cell therapy for lumbar degenerative disc disease (DDD).
  • In the low dose IDCT group (3,000,000 cell/mL; n=20), there was a trend in improvement of clinical outcomes, though inconsistent.
  • The 60-subject study was designed to evaluate the safety and preliminary efficacy of IDCT for the treatment of symptomatic lumbar degenerative disc disease versus vehicle and saline controls.
  • DiscGenics has submitted a full clinical study report to the U.S. Food & Drug Administration's (FDA) Office of Tissues and Advanced Therapies (OTAT).

Dr. Christopher Ames to Join Aclarion as a Key Opinion Leader Surgeon Advisor

Retrieved on: 
Thursday, December 22, 2022

Aclarion’s Nociscan solution is the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine.

Key Points: 
  • Aclarion’s Nociscan solution is the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine.
  • Biomarker data is entered into proprietary algorithms to highlight if a disc may be a source of pain.
  • Dr. Ames is joining the effort to bring greater clarity to the diagnosis of chronic low back pain through the Aclarion KOL program.
  • Dr. Ames is one of the foremost thinkers translating data driven applications to real patient care,” said Brent Ness, CEO of Aclarion.

Aclarion Adds to Strong Patent Portfolio with Notice of Allowance for New U.S. Patent Application Addressing Key Pain Indicator Biomarker

Retrieved on: 
Thursday, December 1, 2022

Broomfield, CO, Dec. 01, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algorithms to help physicians identify the location of chronic low back pain, announced today that it has received a Notice of Allowance for its US Patent Application 16/224,590 titled “Magnetic Resonance Spectroscopy System and Method for Diagnosing Pain or Infection Associated with Propionic Acid”. 

Key Points: 
  • Conventional imaging (lumbar MRI) for Chronic Low Back Pain offers important structural information but struggles to identify the actual source of pain.
  • Aclarions Nociscan solutionisthe first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine.
  • Biomarker data is entered into proprietary algorithms to highlight if a disc may be a source of pain.
  • This information may prove critical in supporting the optimal treatment of low back pain when infection is the underlying cause of pain.

Regenative Labs announces groundbreaking Wharton's Jelly research demonstrating HCT/P compliance after processing

Retrieved on: 
Monday, August 15, 2022

PENSACOLA, Fla., Aug. 15, 2022 /PRNewswire/ -- Regenative Labs, a leading HCT/P manufacturer, has co-authored a pioneering paper together with experts from The Institute of Regenative Medicine and the Department of Pharmacology and Chemical Biology, Baylor College of Medicine.

Key Points: 
  • Regenative Labs has pioneered the use of perinatal tissue allografts and is pleased that this paper supports our current homologous use practices, consistent with our 361 status.
  • About Regenative Labs: Regenative Labs produces regenerative medicine products to address the root cause of a patient's conditions using Wharton's Jelly innovations rather than masking the pain with other treatments.
  • Regenative Labs works closely with scientists, physicians, hospitals, and surgery centers to constantly monitor and improve patient progress and outcomes for new product development.
  • Regenative Labs's expert product research and development team compliesFDA guidelines of minimal manipulation for homologous use.

BioRestorative Therapies Announces Notice of Allowance on Key Patent for its BRTX-100® Disc Program

Retrieved on: 
Wednesday, February 16, 2022

MELVILLE, N.Y., Feb. 16, 2022 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the “Company” or “BioRestorative”) (NASDAQ: BRTX), a clinical stage company focused on stem cell-based therapies, today announced that the United States Patent and Trademark Office has issued a notice of allowance for a patent application related to the Company’s BRTX-100® core clinical program.

Key Points: 
  • MELVILLE, N.Y., Feb. 16, 2022 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the Company or BioRestorative) (NASDAQ: BRTX), a clinical stage company focused on stem cell-based therapies, today announced that the United States Patent and Trademark Office has issued a notice of allowance for a patent application related to the Companys BRTX-100 core clinical program.
  • BioRestorative Therapies, Inc. ( www.biorestorative.com ) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells.
  • You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements.
  • The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

Histogen Provides Update on its Development Programs and Pipeline Focus

Retrieved on: 
Thursday, June 3, 2021

Therefore, we believe the best business decision at this time, is to redirect these resources towards our high value orthopedic programs.

Key Points: 
  • Therefore, we believe the best business decision at this time, is to redirect these resources towards our high value orthopedic programs.
  • HST 003 - we are on track to initiate our Phase 1/2 clinical study of HST 003 in June 2021.
  • HST 004 was also shown to both reduce inflammation and protease activity and upregulate aggrecan production in an ex vivo spinal disc model.
  • Histogen Inc. is a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the bodys natural process to repair and maintain healthy biological function.

Changing Lifestyle Habits to Influence the Growth of the Prosthetic Disc Nucleus Market across the Forecast Period of 2020-2030: TMR

Retrieved on: 
Thursday, March 11, 2021

The growing cases of degenerative intervertebral disc diseases have increased the demand for prosthetic disc nucleus to a considerable extent.

Key Points: 
  • The growing cases of degenerative intervertebral disc diseases have increased the demand for prosthetic disc nucleus to a considerable extent.
  • Therefore, all the aforementioned aspects will bring tremendous growth opportunities for the global prosthetic disc nucleus market across the forecast period of 2020-2030.
  • Using these capabilities, the TMR team has conducted intense research on various aspects associated with the prosthetic disc nucleus market.
  • The rise in the incidence of degenerative disc disorder will further propel the growth prospects of the prosthetic disc nucleus market.

Changing Lifestyle Habits to Influence the Growth of the Prosthetic Disc Nucleus Market across the Forecast Period of 2020-2030: TMR

Retrieved on: 
Thursday, March 11, 2021

The growing cases of degenerative intervertebral disc diseases have increased the demand for prosthetic disc nucleus to a considerable extent.

Key Points: 
  • The growing cases of degenerative intervertebral disc diseases have increased the demand for prosthetic disc nucleus to a considerable extent.
  • Therefore, all the aforementioned aspects will bring tremendous growth opportunities for the global prosthetic disc nucleus market across the forecast period of 2020-2030.
  • Using these capabilities, the TMR team has conducted intense research on various aspects associated with the prosthetic disc nucleus market.
  • The rise in the incidence of degenerative disc disorder will further propel the growth prospects of the prosthetic disc nucleus market.