Diabetic foot ulcer

BioStem Technologies Reports Record First Quarter Revenue of $41.9 Million

Retrieved on: 
tisdag, maj 14, 2024
Quality, Marketing, Diabetic foot ulcer, DFU, Patent, EDT, Bank statement, Conference, VLU, Mouth ulcer, Growth, OTC, GAAP, Regenerative medicine, Medtech, History, Pharmaceutical industry

POMPANO BEACH, Fla., May 14, 2024 (GLOBE NEWSWIRE) -- BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of placental-derived biologics, today reported financial results for the first quarter ended March 31, 2024.

Key Points: 
  • Jason Matuszewski, CEO of BioStem, commented, “BioStem had an outstanding first quarter.
  • Revenue reached $41.9 million, nearly 71 times higher than revenue of roughly $0.6 million for last year’s comparable quarter.
  • Net revenue grew to $41.9 million in the first quarter of 2024 compared to $0.6 million in the first quarter of 2023.
  • Adjusted EBITDA income was $7.9 million in the first quarter of 2024 compared to an Adjusted EBITDA loss of ($1.0) million in the first quarter of 2023.

NOVEL OMEZA® OCM™ WOUND HEALING PLATFORM COMBINED WITH OFFLOADING IN PATIENTS WITH DIABETIC FOOT ULCERS DEMONSTRATED DRAMATIC HEALING RATES WITHIN 12 WEEKS OR LESS

Retrieved on: 
fredag, maj 3, 2024
Collagen, ProMedica, Mortality, University, Patient, Debridement, Diabetes, DFU, Conference, Foot, Diabetic foot ulcer, Peptide, PAR, European Wound Management Association, Wound healing, Clinical trial, EWMA, Plastic, Disease, Pharmaceutical industry

"We're extremely encouraged by the final results of our clinical trial evaluating Omeza®'s OCM™ platform, which showed significant healing—and in over half the cases, complete closure—of patients' diabetic wounds in twelve weeks or less.

Key Points: 
  • "We're extremely encouraged by the final results of our clinical trial evaluating Omeza®'s OCM™ platform, which showed significant healing—and in over half the cases, complete closure—of patients' diabetic wounds in twelve weeks or less.
  • Patients also reduced or eliminated weight bearing on the affected foot, known as offloading, to support healing.
  • A control group received current standards of wound care, including offloading, debridement, collagen, hypochlorite solution, and/or wound dressings containing silver alginate.
  • Five patients had DFUs that were greater than 12 months old, and 3 of those patients had 100% PAR.

FibroBiologics Presents Data from Dermal Fibroblast Spheroid-based Treatment of Chronic Wounds in a Diabetes Mouse Model at Advanced Wound Care Summit USA

Retrieved on: 
torsdag, april 4, 2024
Diabetes, Fibroblast, EGFR, Warfarin necrosis, Risk, Communication, IL-6, Form, Diabetic foot ulcer, Conditional sentence, Patient, Research, Mouse, Gamma ray, Trial of the century, HDF, Hyperglycemia, Acceleration, Wound healing, Cytokine, Therapy, Cellular senescence, Interleukin, VEGF, Pharmaceutical industry

These findings will be presented via an oral and poster presentation at the Advanced Wound Care Summit USA in Boston, MA, April 16-17.

Key Points: 
  • These findings will be presented via an oral and poster presentation at the Advanced Wound Care Summit USA in Boston, MA, April 16-17.
  • Diabetic foot ulcers (DFUs) are prevalent in individuals with diabetes, with approximately 33 million people impacted globally.
  • FibroBiologics' research aims to address this issue by investigating the potential of using human dermal fibroblast (HDF) spheroids in promoting and accelerating the wound healing process in diabetic patients.
  • "These results support the potential of HDF spheroids to expedite the healing process of chronic wounds associated with diabetes," said Dr. Khoja.

Spectral AI Announces 2023 Fourth Quarter and Full Year Financial Results

Retrieved on: 
onsdag, mars 27, 2024
De novo, DFU, Diabetic foot ulcer, Certification, Burn, Government, Development, FY, MDAI, Patient, Research, History, Artificial intelligence, Classification, Sale, Standard of care, Human services, Research and development, Wound healing, Trial of the century, Clinical trial, ASPR, ISO, FDA, Administration, Food, Pharmaceutical industry

DALLAS, March 27, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the fourth quarter (“Q4 2023”) and full year (“FY 2023”) ended December 31, 2023 and provided an update on its ongoing business activities.

Key Points: 
  • DALLAS, March 27, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced financial results for the fourth quarter (“Q4 2023”) and full year (“FY 2023”) ended December 31, 2023 and provided an update on its ongoing business activities.
  • “Spectral AI achieved much in 2023, and our progress along multiple fronts has continued into 2024,” said Peter M. Carlson, Chief Executive Officer.
  • “
    In September 2023, we were awarded the largest contract in our history from the US Government valued at up to $150.0 million.
  • All comparisons to Q4 2023 and FY 2023 are to the comparable periods ended December 31, 2022, unless otherwise stated.

Foot and Ankle Orthopaedic Surgeons Can Fill the Gap in Barriers to Care for Diabetic Patients

Retrieved on: 
måndag, februari 19, 2024
Diabetes, American Diabetes Association, Infection, Ankle, MD, Diabetic foot ulcer, Education, Ulcer, Foot, Surgeon, Risk, Amputation, Hartford, Connecticut, Deformity, Patient, Aronow, Presser foot, DRS, Dentistry

Rosemont, Ill., Feb. 19, 2024 (GLOBE NEWSWIRE) -- Foot and ankle orthopaedic surgeons can help fill the gap in barriers to access to diabetic foot care, according to survey results and presentations at the American Orthopaedic Foot and Ankle Society’s (AOFAS) Winter Meeting last month in Tampa, Florida.

Key Points: 
  • Rosemont, Ill., Feb. 19, 2024 (GLOBE NEWSWIRE) -- Foot and ankle orthopaedic surgeons can help fill the gap in barriers to access to diabetic foot care, according to survey results and presentations at the American Orthopaedic Foot and Ankle Society’s (AOFAS) Winter Meeting last month in Tampa, Florida.
  • The survey results discredited misconceptions that some healthcare professionals and the public may have that orthopaedic surgeons are unable or unwilling to treat diabetic foot diseases.
  • “Foot and ankle orthopaedic surgeons have the expertise and training to treat diabetic foot disease,” Dr. Aronow said.
  • Visit FootCareMD.org to learn more about foot and ankle orthopaedic surgeons and to find one in your area.

Spectral AI Announces Publication of Letter to Shareholders

Retrieved on: 
måndag, februari 5, 2024
DFU, Diabetic foot ulcer, MDAI, Burn, FDA, Artificial intelligence, Trial of the century, UKCA, Wound healing, Letter, Medical device

DALLAS, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced the publication of a Letter to Shareholders from the Company’s CEO and Co-founder, Wensheng Fan, and Chairman of the Board, Richard Cotton.

Key Points: 
  • DALLAS, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced the publication of a Letter to Shareholders from the Company’s CEO and Co-founder, Wensheng Fan, and Chairman of the Board, Richard Cotton.
  • The Letter to Shareholders addresses the Company’s progress along multiple fronts as it continues to evolve from a late-stage development company towards commercialization of its AI-driven DeepView System.
  • The Company believes that this proprietary platform technology can revolutionize the standard of care in wound assessment and treatment for burn and Diabetic Foot Ulcer (“DFU”) indications.
  • Highlights of the Letter to Shareholder include:
    The largest contract in the Company’s history, a $149 million award from BARDA that provides non-dilutive funding for ongoing product development and procurement.

Spectral AI Adds Additional Clinical Sites to Multi-Center Diabetic Foot Ulcer (DFU) Study

Retrieved on: 
måndag, oktober 16, 2023
Diagnosis, Probability, Physician, Doctor of Philosophy, Amputation, AI, Moyamoya disease, Diabetic foot ulcer, Health, Wound healing, DSM-IV codes, Spectral, Diabetes, Artificial intelligence, FDA, Database, CE, UKCA, MDAI, DFU, Infection, Medical device, Medical imaging, Statera BioPharma

The proprietary technology combines multi-spectral imaging and AI technology to provide clinicians with an immediate healing assessment of DFU’s for more accurate and timely diagnosis and therapeutic intervention.

Key Points: 
  • The proprietary technology combines multi-spectral imaging and AI technology to provide clinicians with an immediate healing assessment of DFU’s for more accurate and timely diagnosis and therapeutic intervention.
  • Participating investigators and clinical sites include:
    “We are pleased to announce the addition of seven additional clinical sites that will provide valuable data for Spectral AI’s DeepView® AI algorithm development,” said Mary Regan, PhD, VP of Clinical Affairs at Spectral AI.
  • “We have selected leading wound care providers for these sites as we have done in the past.
  • “The potential integration of AI imaging technology into our medical practice represents an advancement in patient care,” said Brian Inkrott, Founding Partner of Statera.

PHAXIAM Provides Business and Financial Update For the First Half of 2023

Retrieved on: 
torsdag, september 21, 2023
DFU, Hip, Infection, IST, S. aureus, Bank statement, Fungal infection, Cutis marmorata telangiectatica congenita, Escherichia coli, Authorization, Financial statement, Staphylococcus, Trial of the century, Klebsiella pneumoniae, Pseudomonas aeruginosa, Diabetic foot ulcer, Patient, VAP, Risk, AAC, AMF, POC, Therapy, System, Diabetic foot, ANSM, Antibiotics, Pharmaceutical industry, Vaccine, Urinary tract infection, Lysin, Bloodstream infections

The company is awaiting a second AAC regulatory validation for PJI patients, associated with P. aeruginosa resistance from the ANSM.

Key Points: 
  • The company is awaiting a second AAC regulatory validation for PJI patients, associated with P. aeruginosa resistance from the ANSM.
  • On September 19, 2023, the company announced the extension of its portfolio to Klebsiella pneumoniae, a new resistant aggressive bacterial target.
  • Key financial figures for the first half of 2023 compared with the same period of the previous year are summarized below.
  • In the context of the Erytech-Pherecydes merger, PHAXIAM’s consolidated financial statements in IFRS standards include ex-Pherecydes financial results as of the date of the merger, i.e.

Spectral MD Holdings, Ltd. (“Spectral MD” or the “Company”) ISO 13485 Certification Received for AI-Driven DeepView® Wound Imaging System

Retrieved on: 
måndag, augusti 14, 2023
DFU, AIM, QMS, Culture, ISO, Spectral, SMD, Certification, Organization, Diabetic foot ulcer, Physician, Algorithm, ISO 13485, Artificial intelligence, Quality management system, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Wound healing, Medical device, DALLAS, Burn

ISO 13485 is an internationally recognized standard that ensures the quality of medical device design, development, and production.

Key Points: 
  • ISO 13485 is an internationally recognized standard that ensures the quality of medical device design, development, and production.
  • To receive certification, organizations must demonstrate that their Quality Management Systems (QMS) deliver medical devices and related services that consistently meet stringent customer and regulatory requirements.
  • Spectral MD’s receipt of ISO 13485 certification follows the completion of a comprehensive audit of the Company’s QMS undertaken by an Independent Registrar earlier this year.
  • Niko Pagoulatos, Chief Operating Officer of Spectral MD, said: “The receipt of ISO 13485 confirms Spectral MD’s status as a global provider of medical devices that meet the highest standards of quality, reliability, and safety.

Celularity Tissue Factor Gene Knockout of Allogeneic Stromal Cells Significantly Lowers Thrombotic Effects; Study Highlights Critical Importance of Gene Editing Capability

Retrieved on: 
torsdag, juni 1, 2023
ASC, CRISPR, CELU, Placenta, Gene, Thrombogenicity, Diabetic foot ulcer, ISCT, Immunomodulation, Instituto de Biologia Molecular e Celular, Cell, Multiple sclerosis, FSHD, Stem cell, Microsoft Exchange Server, Thrombosis, MSC, Facioscapulohumeral muscular dystrophy, TF, Data, Blood, Abdominal ultrasonography, Phenotype, International Society, Safety, Pharmaceutical industry, Vaccine, Cytotherapy

FLORHAM PARK, N.J., June 01, 2023 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a biotechnology company developing placental-derived allogeneic cell therapies and biomaterial products, announced today the online publication of preclinical data in Cytotherapy, the official journal of the International Society of Cell and Gene Therapy (ISCT).

Key Points: 
  • The paper, “Characterization of CRISPR/Cas9-edited human placental allogenic stromal cells with low tissue factor expression and reduced thrombotic effects,” (Huang, et al.
  • )1 examined methods to reduce the tissue factor expressed by allogeneic stromal cells (ASCs), which has been regarded as a safety concern in clinical applications as it may trigger thrombosis when ASCs are administered intravenously.
  • Thrombogenic risk has been identified in association with intravenous administration of mesenchymal stem cells (MSCs), both allogeneic and autologous.
  • These cells express procoagulant activity linked to the expression of tissue factor that, when in contact with blood, initiates coagulation.