Biopsy

4DMT Reports First Quarter 2024 Financial Results and Operational Highlights

Retrieved on: 
torsdag, maj 9, 2024
FDA, Regenerative medicine, Research, Choroideremia, Biopsy, European Medicines Agency, Injection, Overalls, Inflammation, Food, Alpha-1 antitrypsin, Cystic fibrosis, Chelsea Handler, Intravitreal administration, Conference, Retina, Atypical hemolytic uremic syndrome, DME, Angiogenesis, PRISM, AMD, Safety, Security (finance), Cash, Retinitis pigmentosa, Exercise, PRIME, EMA, NHP, Clinical trial, A1AT, ASRS, ARVO, ECFS, Șaeș, Cubic foot, Patient, Society, Geographic atrophy, Pharmaceutical industry

“The first quarter of 2024 kicks off another transformative year for 4DMT with exceptional progress across our product pipeline and platform in multiple therapeutic areas, particularly our lead program 4D-150 in large market VEGF-driven retinal diseases,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.

Key Points: 
  • “The first quarter of 2024 kicks off another transformative year for 4DMT with exceptional progress across our product pipeline and platform in multiple therapeutic areas, particularly our lead program 4D-150 in large market VEGF-driven retinal diseases,” said David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.
  • R&D Expenses: Research and development expenses were $27.9 million for the first quarter of 2024, as compared to $22.4 million for the first quarter of 2023.
  • G&A Expenses: General and administrative expenses were $10.3 million for the first quarter of 2024, as compared to $8.0 million for the first quarter of 2023.
  • Net Loss: Net loss was $32.4 million for the first quarter of 2024, as compared to net loss of $28.7 million for the first quarter of 2023.

CEL-SCI Receives FDA Go-Ahead for Its Confirmatory Study of Multikine in the Treatment of Head & Neck Cancer

Retrieved on: 
onsdag, maj 8, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Randomized controlled trial, Safety, Food, Terminal, Survival, PET, ESMO, Patient, Physician, Biopsy, Head, Standard of care, Pharmaceutical industry

“Through this discussion and agreement with the FDA, we have achieved a tremendous milestone for people who are newly diagnosed with head and neck cancer.

Key Points: 
  • “Through this discussion and agreement with the FDA, we have achieved a tremendous milestone for people who are newly diagnosed with head and neck cancer.
  • The confirmatory study will be a randomized controlled trial with two arms: Multikine treatment plus standard of care versus standard of care alone.
  • The FDA accepted the selection criteria and the proposed study design, which now permits CEL-SCI to enroll patients in the confirmatory study.
  • The goal of our smaller confirmatory study is to confirm these positive results in a prospectively defined target population.

14 Studies Presented at AUA 2024 Show Decipher Tests’ Ability to Help Personalize Care for Prostate and Bladder Cancer Patients and Advance Disease Understanding

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måndag, maj 6, 2024
Oncology, Health, Technology, Health Technology, Genetics, Artificial Intelligence, Biotechnology, RUO, University, Prostate, NCCN, RC, International, RP, Risk, Grade, American Urological Association, Survival, Neoadjuvant therapy, PSA, Columbia University, Integration, Research, Pathology, GSC, Prostate cancer, Prostate-specific antigen, University of Michigan, Patient, NOC, Urology, Intelligence, AUA, MRI, Biopsy, Gene expression, Diagnosis, MUSIC, Waiting, Bladder cancer, Radical, Medical imaging

(Nasdaq: VCYT), a leading cancer diagnostics company, today announced that data from 14 presentations at AUA 2024, the annual meeting of the American Urological Association, show that the Decipher Prostate and Decipher Bladder Genomic Classifiers provide better prognostic information for patients with prostate and bladder cancer, compared to standard approaches.

Key Points: 
  • (Nasdaq: VCYT), a leading cancer diagnostics company, today announced that data from 14 presentations at AUA 2024, the annual meeting of the American Urological Association, show that the Decipher Prostate and Decipher Bladder Genomic Classifiers provide better prognostic information for patients with prostate and bladder cancer, compared to standard approaches.
  • They also show that the research-use-only Decipher GRID (Genomic Resource for Intelligent Discovery) tool is helping to advance scientific understanding of these diseases.
  • Summary: The Decipher Prostate Genomic Classifier is associated with adverse pathology in patients eligible for Active Surveillance (AS) who were treated with radical prostatectomy (RP).
  • Podium Presentation PD42-03 : Understanding Population-Wide Genomic Risk Distribution and Integrating Clinical-Genomic Risk for Prognostication in Prostate Cancer.

New Study Demonstrates Avenda Health's Unfold AI to Better Predict Focal Therapy Success by 77% Percent as Compared to Standard Methods

Retrieved on: 
onsdag, maj 8, 2024
UCLA, FDA, ECS, AI, American Urological Association, Health, Unfold, MD, PSA, Doctor of Philosophy, Prostate cancer, GG5, Patient, GG1, Physician, AUA, MRI, Biopsy, UCLA Health, Neoplasm, GG, Quality of life, Cryotherapy, Medical imaging

CULVER CITY, Calif., May 8, 2024 /PRNewswire/ -- Avenda Health, an AI healthcare company creating the future of personalized prostate cancer care, unveils the results of a new UCLA study examining the role of AI in identifying tumor margins and predicting the efficacy of focal therapy treatments. The study titled "Software to Determine Extent of Tumor Margins in Focal Therapy," was presented at the 2024 American Urological Association's (AUA) annual meeting by Wayne Brisbane, MD, assistant professor at UCLA Health. It demonstrated that Unfold AI, Avenda Health's AI-powered cancer mapping technology, was a better predictor of focal therapy success than other factors, including the size or grade of the tumor.

Key Points: 
  • It demonstrated that Unfold AI , Avenda Health's AI-powered cancer mapping technology, was a better predictor of focal therapy success than other factors, including the size or grade of the tumor.
  • In the study, FDA-cleared Unfold AI technology was retrospectively applied to 118 previously untreated men undergoing hemi-gland cryotherapy for prostate cancer ablation.
  • MRI-guided biopsies, both targeted and systematic, were performed before cryotherapy and six months after cryotherapy to assess treatment outcomes.
  • "This more comprehensive approach enhances our ability to predict treatment outcomes and tailor interventions effectively to individual patient needs."

TAR-200 monotherapy shows greater than 80% complete response rate in patients with high-risk non-muscle-invasive bladder cancer

Retrieved on: 
fredag, maj 3, 2024
FDA, Congress, Cancer, Urinary tract infection, Urinary diversion, Safety, Carcinoma, Survival, Johnson & Johnson, Immunotherapy, CRS, Abstract, Cohort, BCG, Disease, Bladder cancer, Dysuria, Patient, Metastasis, Medicine, NMIBC, AUA, Biopsy, BTD, Urination, Interim, Food and Drug Administration, SAN, Pharmaceutical industry

SAN ANTONIO, May 3, 2024 /PRNewswire/ -- Johnson & Johnson announced today updated results from Cohort 2 of the Phase 2b SunRISe-1 study evaluating the efficacy and safety of investigational TAR-200 monotherapy in patients with BCG-unresponsive high-risk non–muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ, who are ineligible for, or decline, radical cystectomy. These data were featured today in a plenary session (Abstract #P2-01) at the 2024 American Urological Association Annual Meeting (AUA) taking place May 3-6, 2024, in San Antonio, Texas.

Key Points: 
  • "These results address an area of high unmet need for bladder sparing therapies in this patient population."
  • Results included an evaluation of 85 patients (median age of 71 years old: range 40-88; 32.9% with concurrent papillary disease) who received TAR-200 monotherapy.
  • The centrally confirmed complete response (CR) rate was 82.8% by urine cytology and/or biopsy (95% confidence interval [CI], 70.6-91.4).
  • Seven patients (8.2%) had Grade 3 or higher TRAEs and four patients (4.7%) had one or more serious TRAEs.

SciBase supports clinicians during US Skin Cancer Awareness Month

Retrieved on: 
torsdag, maj 2, 2024
Education, American Academy, Cancer, Risk, Skin, Bed, Survival, Skin cancer, Tanning, Melanoma, Patient, Biopsy, Plastic surgery, Medical imaging

STOCKHOLM, May 2, 2024 /PRNewswire/ -- SciBase Holding AB ("SciBase") (STO: SCIB), a pioneer in skin cancer detection and prevention, and prediction in dermatology, further deepens their commitment to patients and dermatologists during US Skin Cancer Awareness Month by highlighting the importance of early detection and prevention of skin cancer and helping improve outcomes for clinicians and patients.

Key Points: 
  • STOCKHOLM, May 2, 2024 /PRNewswire/ -- SciBase Holding AB ("SciBase") (STO: SCIB), a pioneer in skin cancer detection and prevention, and prediction in dermatology, further deepens their commitment to patients and dermatologists during US Skin Cancer Awareness Month by highlighting the importance of early detection and prevention of skin cancer and helping improve outcomes for clinicians and patients.
  • The entire month of May is dedicated to Skin Cancer Awareness to draw focus on the most common cancer in the United States - skin cancer.
  • Melanoma is the most dangerous and lethal form of skin cancer and accounts for the vast majority of skin cancer deaths.
  • At SciBase, our emphasis on skin cancer awareness month demonstrates how seriously we take the importance of patients having  an annual full body skin exam performed by a dermatologist.

Eloxx Pharmaceuticals Provides ELX-02 and ZKN-013 Program Updates

Retrieved on: 
tisdag, april 16, 2024
FDA, Genetics, Drug discovery, ADPKD, Mutation, IPS, Food, Prevalence, Proteinuria, Organoid, OTC, Kidney, Gene, Orphan, RNA, Partnership, UPCR, Almirall, U.S. FDA, FAP, IND, RDEB, Disease, SAD, Patient, Biopsy, Clinical trial, Polycystic kidney disease, ODD, Food and Drug Administration, PKD, Pharmaceutical industry

WATERTOWN, Mass., April 16, 2024 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (OTC: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today provided program updates for ELX-02 and ZKN-013, including Orphan Drug Designation (ODD) for ELX-02.

Key Points: 
  • Eloxx has significantly advanced the development of ELX-02 for the treatment of Alport syndrome with Nonsense Mutations (NMAS).
  • “The recent ELX-02 program updates, including Orphan Drug Designation for ELX-02 for the treatment of Alport Syndrome highlights the significant unmet medical needs of Alport Syndrome patients with Nonsense Mutations,” said Sumit Aggarwal, President and Chief Executive Officer of Eloxx.
  • The designation was based on a review of the prevalence of NMAS and the data from the Proof-of-concept Phase 2 Study that Eloxx announced top-line results for in 2023.
  • In March 2024, Eloxx announced an exclusive license agreement with Almirall to develop and commercialize ZKN-013 in orphan indications including RDEB and FAP with nonsense mutations.

Organovo Announces Positive Phase 2 Results for FXR314 in Metabolic Dysfunction-Associated Steatohepatitis (MASH) Showing Both Reduction in Liver Fat Content and Strong Safety and Tolerability Compared to Placebo

Retrieved on: 
måndag, april 15, 2024
Itch, TE, MASH, MRE, Clinical trial, Incidence, Patient, Clinical, Apolipoprotein, Safety, FXR, Biopsy, Dietary supplement

Treatment-emergent adverse events were mostly mild to moderate in severity, with incidence comparable between FXR314 3 mg, 6 mg, and placebo.

Key Points: 
  • Treatment-emergent adverse events were mostly mild to moderate in severity, with incidence comparable between FXR314 3 mg, 6 mg, and placebo.
  • “The key findings of this study are that once daily oral FXR314 demonstrated statistically significant liver fat reduction and excellent tolerability.
  • A total of 214 patients were randomized in a 1:1:1 ratio to either 3 mg or 6 mg of FXR314, or placebo.
  • The Company expects that detailed findings of this study (Clinical trial registry NCT047773964) will be presented at an upcoming conference.

bioAffinity Technologies Advances New Product Development Initiatives to Accelerate Next Phase of Growth

Retrieved on: 
onsdag, april 24, 2024
Other Defense, FDA, Other Health, Radiology, Pharmaceutical, Surgery, Oncology, Medical Devices, Defense, Genetics, Military, Clinical Trials, Biotechnology, Science, Research, Health, Doctor of Philosophy, University, Chronic obstructive pulmonary disease, Lung cancer, DOD, Prognosis, University of Texas System, Artificial intelligence, Sputum, Molecular and Cellular Biology, BIAF, Lung, Patient, Principal, Observational study, Cellular senescence, New product development, Biopsy, BAMC, Bronchoalveolar lavage, BAL, COPD, Medical imaging

The second test under development analyzes sputum to improve detection of chronic obstructive pulmonary disease (COPD).

Key Points: 
  • The second test under development analyzes sputum to improve detection of chronic obstructive pulmonary disease (COPD).
  • COPD is an inflammatory lung disease that causes breathing-related problems and irreversible airflow obstruction for an estimated 16 million Americans, according to the Centers for Disease Control.
  • Dr. Elzi earned his Ph.D. in Molecular and Cellular Biology from the University of Washington, in conjunction with the Fred Hutchinson Cancer Research Center.
  • He subsequently performed post-doctoral research at the Bonfils Blood Center and University of Colorado Department of Surgery, where he studied the molecular mechanisms of transfusion-related lung injury.

$3.84 Bn Biopsy Devices Market, Size, Global Forecast Report 2024-2030 Featuring Cardinal Health, Hologic, Danaher, BD and Co, Boston Scientific, Medtronic, Olympus, and CONMED - ResearchAndMarkets.com

Retrieved on: 
tisdag, april 23, 2024
Health, Oncology, Medical Devices, Insight, Cancer, WHO, Magnetic resonance imaging, World Health Organization, Prostate biopsy, Woman, Research, Trauma, Traction, Lung biopsy, Needle, Attention, Disease, Biopsy, Infection, Diagnosis, Breast biopsy, Liver biopsy, Medical imaging

The increasing occurrence of cancers globally drives growth within the biopsy devices market.

Key Points: 
  • The increasing occurrence of cancers globally drives growth within the biopsy devices market.
  • Innovations like Vacora, Finesse Ultra Breast Biopsy System, and Celero VAB gadgets will bolster the boom trajectory of the biopsy devices market.
  • The biopsy devices market is segmented based on application into Breast Biopsy, Lung Biopsy, Prostate Biopsy, Liver Biopsy, Gastroenterology Biopsy, and Others.
  • Due to their superior imaging technologies and specialized information, diagnostic and imaging facilities are among the segments gaining traction within the global biopsy devices market.