Biopsy

Madrigal Pharmaceuticals Announces U.S. Availability of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic NASH with Moderate to Advanced Liver Fibrosis

Retrieved on: 
Tuesday, April 9, 2024
Diagnosis, Biopsy, Fatty liver disease, Cirrhosis, Exercise, F2, Patient, Prescription, MD, Diet, Fibrosis, Pharmacy, NASH, Therapy, FDA, THR, JD

I can finally tell my appropriate patients with moderate to advanced fibrosis that we have an approved treatment to help improve fibrosis and resolve NASH.

Key Points: 
  • I can finally tell my appropriate patients with moderate to advanced fibrosis that we have an approved treatment to help improve fibrosis and resolve NASH.
  • Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program.
  • This program is designed to help patients navigate insurance and affordability challenges and provide co-pay support for eligible patients.
  • Madrigal has also established a patient assistance program (PAP) to help patients with no insurance access Rezdiffra.

World First Use of Lightpoint's SENSEI® Drop-In Gamma Probe in Bladder Cancer Surgery Performed in Spain

Retrieved on: 
Tuesday, March 26, 2024
Diagnosis, Biopsy, Sentinel lymph node, Radiation, Prostate cancer, Patient, ASX, SLN, Prostate, Bladder cancer, Hospital, TLX, Lymph node, Health technology, Medtech, AA, Medical imaging

SENSEI® is smaller than an AA battery and designed specifically for robotic-assisted and minimally invasive surgery.

Key Points: 
  • SENSEI® is smaller than an AA battery and designed specifically for robotic-assisted and minimally invasive surgery.
  • The miniature size and proprietary features make the technology ideal for tight surgical spaces such as around the bladder.
  • Radio-guided surgery has historically been limited by the fact that gamma probes are generally only suitable for open surgery.
  • Nynke van den Berg, General Manager Medical Technologies (MedTech) at Telix added, “A first bladder cancer procedure with the SENSEI® drop-in gamma probe is a significant milestone for Telix and the Lightpoint team.

Natera Announces New Data From Two Studies Extending the Clinical Validation of Its Prospera™ Heart dd-cfDNA Test for Heart Transplant Recipients

Retrieved on: 
Monday, April 8, 2024
Research, Surgery, Genetics, Clinical Trials, Cardiology, Biotechnology, Health, General Health, Science, Biopsy, Reward, Plasma, International Society, Cohort (statistics), Physician, Risk, AUC, Nucleic acid thermodynamics, Patient, Journal, DNA, Lung transplantation, Heart transplantation, MD, NIH, NTRA, Hospital, Molecule, Bangladesh Technical Education Board, Medicare, Oportunidades, Annual general meeting, NPV

“We are encouraged by the results of these two prospective studies,” said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera.

Key Points: 
  • “We are encouraged by the results of these two prospective studies,” said Sangeeta Bhorade, MD, chief medical officer of organ health at Natera.
  • That study showed the Prospera Heart test had an overall area under the curve (AUC) of 0.86 for identifying acute rejection in over 800 samples from 200 adults with heart transplants.
  • The DTRT-2 (DNA-Based Transplant Rejection Test) study, published recently in Pediatric Transplantation , was sponsored by the National Institutes of Health (NIH).
  • A total of 487 samples from 160 heart transplant recipients were evaluated, of which 78 were pediatric and 82 were adult patients.

EmeritusDX Announces Launch of FDA Approved Therascreen BRAF and KRAS Tests, Expanding Molecular Testing Capabilities

Retrieved on: 
Monday, April 8, 2024
Biopsy, Mutation, Colorectal cancer, Encorafenib, Cetuximab, Patient, Cancer, BRAF, Panitumumab, CRC, FDA, Physician, Health, Pharmaceutical industry

LAKE FOREST, Calif., April 8, 2024 /PRNewswire-PRWeb/ -- EmeritusDX, a leading cancer diagnostics and information company, is excited to announce the launch of the FDA-approved therascreen® BRAF and KRAS tests. These innovative products represent a significant advancement in the company's molecular testing menu and aligns perfectly with its strategy of enhancing patient care.

Key Points: 
  • LAKE FOREST, Calif., April 8, 2024 /PRNewswire-PRWeb/ -- EmeritusDX, a leading cancer diagnostics and information company, is excited to announce the launch of the FDA-approved therascreen® BRAF and KRAS tests.
  • These innovative products represent a significant advancement in the company's molecular testing menu and aligns perfectly with its strategy of enhancing patient care.
  • "The introduction of the therascreen® BRAF and KRAS portfolio is a testament to this commitment.
  • According to EmeritusDX's Chief Scientist, Dr. Vincent Funari, "The therascreen® BRAF and KRAS tests are a game-changer in personalized medicine for CRC patients.

Compass Therapeutics Reports 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Biopsy, NSCLC, Entrepreneurship, Carcinoma, DLL4, Patient, Neoplasm, PET, Merck, G&A, Doctor of Philosophy, MD, Insurance, IND, Mesothelioma, Research and development, CD137, Therapy, Paclitaxel, BTC, CRC, Melanoma, Stage 2, PD-L1, FDA, SCLC, PD-1, Pharmaceutical industry

Ended 2023 with $152 million in cash and marketable securities, which is expected to provide cash runway into mid-year 2026.

Key Points: 
  • Ended 2023 with $152 million in cash and marketable securities, which is expected to provide cash runway into mid-year 2026.
  • BOSTON, March 21, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today reported full 2023 financial results and provided business update.
  • The increase was primarily attributable to higher stock compensation expense of $1.0 million offset by lower insurance costs of $0.3 million.
  • During 2023, the Company decreased its cash position by $34.1 million, primarily from $40.6 million of net cash used in operating activities.

Tenaya Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 18, 2024
PKP2, Biopsy, ARV, Administration, Fast track (FDA), Gene editing, Patient, SAN, CGMP, BlackRock, HDAC6, Column, G&A, IND, Research and development, Clinical trial, HCM, Investment, Therapy, Antibody, MYBPC3, Safety, FDA, ARVC, Heart failure, LP, Pharmaceutical industry

SOUTH SAN FRANCISCO, Calif., March 18, 2024 (GLOBE NEWSWIRE) -- Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

Key Points: 
  • “Tenaya had a successful year of sustained execution in 2023 that meaningfully advanced our portfolio of genetic medicines for heart disease.
  • Research & Development (R&D) Expenses: R&D expenses were $22.9 million for the fourth quarter and $98.0 million for the full year ended December 31, 2023.
  • General & Administrative (G&A) Expenses: G&A expenses were $8.6 million for the fourth quarter and $33.2 million for the full year ended December 31, 2023.
  • Net Loss: Net loss was $29.9 million, or $0.40 per share for the fourth quarter ended December 31, 2023.

Merck’s Corporate Venture M Ventures Arm Backs Nucleai to Advance Its First-in-class Spatial AI Biomarker in Active Clinical Enrollment

Retrieved on: 
Wednesday, April 3, 2024
Research, Technology, Genetics, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Artificial Intelligence, Biopsy, Algorithm, Entrepreneurship, Intelligence, Patient, Tumor microenvironment, Merck, Marie Cassidy, Cancer, AI, Spacecraft, Merck Group, Investment, Clinical trial, Drug development, Pathology, Therapy, Machine learning, Section 32, Spatial analysis, Medicine, Medical imaging

By integrating AI algorithms for prospective patient enrollment in clinical trials, Nucleai is spearheading a first-in-field approach to personalized medicine.

Key Points: 
  • By integrating AI algorithms for prospective patient enrollment in clinical trials, Nucleai is spearheading a first-in-field approach to personalized medicine.
  • Nucleai's platform tailors therapy strategies to the intricate cellular landscape of each patient, optimizing clinical trial participant selection.
  • Leveraging AI and machine learning (ML), Nucleai analyzes pathology images and spatial data at the cellular and tissue levels.
  • This innovation marks a shift in disease diagnosis and treatment, offering an in-depth contextual view that underpins the development of novel therapeutics.

UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102

Retrieved on: 
Thursday, March 14, 2024
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Research, Biopsy, Conference, Carcinoma, Chemistry, Webcast, New Drug Application, Medac, Patient, Mitomycins, NDA, CMC, Software, Safety, Nephrectomy, Patent, Medicare, Investment, RTW, ATLAS, Ureteroscopy, Gesellschaft mit beschränkter Haftung, Food, Pharmaceutical industry

The first part of the submission was the Chemistry, Manufacturing and Controls (CMC) sections.

Key Points: 
  • The first part of the submission was the Chemistry, Manufacturing and Controls (CMC) sections.
  • The FDA indicated that evaluation of duration of complete response at 12-months from the pivotal ENVISION trial will be sufficient to support submission of the NDA.
  • The company plans to complete the submission in September 2024 with a potential FDA decision as early as the first quarter of 2025.
  • Generated annual net product revenue of $82.7 million in 2023, compared with $64.4 million in 2022 in representing ~28% annual growth.

Cellworks Personalized Therapy Biosimulation Study Produces Superior OS and DFS Predictions for Gastroesophageal Cancer Patients

Retrieved on: 
Monday, March 11, 2024
Technology, Biotechnology, Health, Other Health, Pharmaceutical, Oncology, Research, Software, General Health, Genetics, Health Technology, Science, Data Management, Clinical Trials, Biopsy, OS, HER2, Cancer, Radiation, Kingdom of Poland, Anthracycline, Survival, Disease, Neoadjuvant therapy, CBM, International Cancer Genome Consortium, TNM, University, Patient, Rated R, NGS, Biomarker, MSI, Artificial intelligence, Standard of care, DFS, TRI, MD, Medicine, TRG, Platinum, Publication, Biosimulation, OGA, Whole genome sequencing, PD-L1, Taxane, Medical imaging

The study also showed a significant association between a patient’s TRI score and disease-free survival (DFS) and tumor regression grade (TRG).

Key Points: 
  • The study also showed a significant association between a patient’s TRI score and disease-free survival (DFS) and tumor regression grade (TRG).
  • Despite progress in gastroesophageal cancer therapy, only a small proportion of patients attain long-term survival.
  • This study concluded that TRI scores for gastroesophageal adenocarcinoma patients predict OS and DFS beyond clinical factors.
  • These results highlight the clinical value of employing Cellworks biosimulation for personalized therapy selection and warrant additional clinical evaluation.

Aohua Endoscopy's AQ-300 is Recognized as "Endoscopy Product Innovation Award" by the Healthcare Asia Medtech Awards 2024

Retrieved on: 
Friday, March 29, 2024
Biopsy, CBI, Health, ENT, Endoscopy, Observation, Urology, Gastroenterology, Telescopic sight

SINGAPORE, March 29, 2024 /PRNewswire/ --  Medical equipment manufacturing company Aohua Endoscopy clinched the Endoscopy Product Innovation Award at the recently held Healthcare Asia Medtech Awards 2024 for its development of the Aohua 4K AQ-300 video endoscopy system, which offers an improved endoscopic diagnosis and treatment option.

Key Points: 
  • SINGAPORE, March 29, 2024 /PRNewswire/ --  Medical equipment manufacturing company Aohua Endoscopy clinched the Endoscopy Product Innovation Award at the recently held Healthcare Asia Medtech Awards 2024 for its development of the Aohua 4K AQ-300 video endoscopy system, which offers an improved endoscopic diagnosis and treatment option.
  • The awards program recognizes outstanding medical technology companies in Asia that are influencing the transformation of healthcare by excelling in medical device innovation, service delivery, and patient care.
  • When used in conjunction with Aohua's magnification endoscope, AQ-300 can guarantee that the image is clear even at high magnification.
  • It features dual-frame display support, which enables simultaneous observation of the same location in modes with CBI and white light.