Non-alcoholic fatty liver disease

Nanox.AI’s HealthCCSng AI Solution Reveals ~60% of Patients in Study had Previously Undetected Risk of a Cardiovascular Event from Routine Chest CTs

Retrieved on: 
Thursday, September 28, 2023
Clalit Health Services, Insurance, CE, Fatty liver disease, CT, Radiation, European Heart Journal: Cardiovascular Imaging, Osteoporosis, Rabin Medical Center, Cardiovascular disease, HMO, CT scan, Trial of the century, Radiology, CAC, Patient, Physician, Non-alcoholic fatty liver disease, Mortality, FDA, LTD, Artifact, Disease, Medical device, Medical imaging

NEVE ILAN, Israel, Sept. 28, 2023 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an innovative medical imaging technology company, today announced that HealthCCSng, an AI-powered solution created by Nanox’s deep-learning medical imaging analytics subsidiary, Nanox.AI, was used in a clinical study evaluating routine CT scans and found that 58% of patients unknowingly had moderate to severe levels of coronary artery calcium (CAC), a proven indicator of future cardiac events. The study was sponsored by Nanox.AI and conducted by the Beilinson Hospital, one of the largest and most renowned multidisciplinary medical institutions in Israel, and utilized Nanox.AI’s HealthCCSng, an FDA-cleared and CE marked tool designed specifically for cardiac health assessment.

Key Points: 
  • Nanox.AI’s HealthCCSng solution utilizes medical imaging data from routine chest CT scans to automatically quantify and analyze CAC category.
  • CAC is the strongest predictor of future cardiac events, with patients in the highest category being over 20 times more likely to suffer a cardiac event.
  • “The patients in this study received routine CT scans that had nothing to do with a cardiac concern.
  • HealthCCSng supports clinicians in diagnosing patients with cardiovascular disease who were previously undetected, while stratifying such patients so that they can obtain the appropriate preventative cardiac care and treatment.

An Unforgettable Evening at Westmount Public Library Draws Rave Reviews

Retrieved on: 
Friday, September 22, 2023
Knowledge, Canada, Liver disease, Obesity, NASH, Diabetes, Culture, Liver, Human, Fatty liver disease, Language, Metabolism, Medicine, Westmount Public Library, Non-alcoholic fatty liver disease, Diagnosis, NAFLD, Health, Empowerment, Dietary supplement, Hepatology, Elastography

TORONTO, Sept. 22, 2023 (GLOBE NEWSWIRE) -- On the evening of September 19, 2023, the Fatty Liver Alliance, a Canadian not-for-profit charity, hosted, at the Westmount Public Library, in Westmount, Quebec, an extraordinary event that saw an overwhelming turnout of 50 community members.

Key Points: 
  • TORONTO, Sept. 22, 2023 (GLOBE NEWSWIRE) -- On the evening of September 19, 2023, the Fatty Liver Alliance, a Canadian not-for-profit charity, hosted, at the Westmount Public Library, in Westmount, Quebec, an extraordinary event that saw an overwhelming turnout of 50 community members.
  • This Café Scientifique community education event is a unique opportunity for an in-depth understanding of liver disease, diabetes, and metabolic health.
  • The evening was a blend of information, interaction, and insight, as evidenced by one attendee's remark: "This event exceeded all expectations.
  • The importance of the topic, notably fatty liver, was underscored by numerous participants, with many calling for greater public awareness.

Elevar Therapeutics Joins Benefactors Council of Blue Faery, Leading Hepatocellular Carcinoma Advocacy Group

Retrieved on: 
Tuesday, September 19, 2023
Camrelizumab, Medical Affairs Bureau, Partnership, Carcinoma, NASH, Hepatocellular carcinoma, Hepatitis B, Research, Non-alcoholic fatty liver disease, Patient, Chronic liver disease, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cirrhosis, HCC, Food, Pharmaceutical industry, Nursing

Blue Faery’s Benefactors Council comprises corporations and/or individuals committed to giving an annual gift for HCC research, educational programs, patient advocacy events and/or corporate sponsorships.

Key Points: 
  • Blue Faery’s Benefactors Council comprises corporations and/or individuals committed to giving an annual gift for HCC research, educational programs, patient advocacy events and/or corporate sponsorships.
  • “Elevar is inspired by Blue Faery’s efforts to raise understanding of and advocate for patients with hepatocellular carcinoma and their families,” said Elevar Vice President of Medical Affairs Bill Strickland.
  • “As Elevar Therapeutics enters the final stages of clinical development for its promising HCC therapy, Blue Faery is delighted to welcome the company to our Benefactors Council,” said Andrea Wilson Woods, president, founder and founding director of Blue Faery.
  • “Elevar recognizes that success in taking on HCC means working together to advocate for those in need.

The FNIH Announces Study Results Published in Nature Medicine Showing That Liver Disease Can Be Diagnosed Using Noninvasive Blood Tests

Retrieved on: 
Thursday, September 7, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Knowledge, FNIH, Partnership, Drug development, Therapy, NASH, Liver disease, Research fellow, AUROC, Non-alcoholic fatty liver disease, Biomarker, Doctor of Philosophy, Bangladesh Technical Education Board, DSM-IV codes, Patient engagement in Canada, Liver cancer, Foundation for the National Institutes of Health, Kidney, Patient, Risk, Blood, Liver, Fatty liver disease, Mortality, United, Digestive, FDA, MPH, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cirrhosis, Food, Safety, Biopsy, Medical imaging, Nature Medicine, MD

The research is part of the Biomarkers Consortium’s Noninvasive Biomarkers of Metabolic Liver Disease (NIMBLE) project, a public-private partnership bringing together the FDA, academic researchers, and industry partners to rigorously evaluate blood and imaging tests to measure the presence of liver disease.

Key Points: 
  • The research is part of the Biomarkers Consortium’s Noninvasive Biomarkers of Metabolic Liver Disease (NIMBLE) project, a public-private partnership bringing together the FDA, academic researchers, and industry partners to rigorously evaluate blood and imaging tests to measure the presence of liver disease.
  • Although several companies have developed such tests, none have met the burden of proof needed for FDA regulatory approval.
  • This lack of approval limits the use of these tests for diagnosing NASH and recruiting patients into studies to develop therapies.
  • For more information, visit Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE) | FNIH .

ENDRA Life Sciences' TAEUS De Novo Submission Advances to Next Stage of Review with FDA

Retrieved on: 
Wednesday, August 30, 2023
Health Technology, Health, Other Health, Medical Devices, Fatty liver disease, De novo, Non-alcoholic fatty liver disease, NDRA, Patient, De novo synthesis, Estar, NAFLD, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces that the Company's De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration (FDA).

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces that the Company's De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration (FDA).
  • “We are very pleased that our FDA De Novo submission has advanced to the substantive review stage," stated ENDRA's Chairman and Chief Executive Officer Francois Michelon.
  • On August 14, 2023, ENDRA submitted a De Novo request to the FDA using the electronic Submission Template And Resource (eSTAR) system.
  • On August 29, 2023, FDA informed ENDRA that the Company's submission was entering the substantive review period.

Pottsville Residents with Non-Alcoholic Steatohepatitis (NASH) Liver Disease Can Now Join New Research Study

Retrieved on: 
Monday, August 21, 2023
Other Health, Research, Men, Pharmaceutical, Consumer, Clinical Trials, Science, Women, Biotechnology, Seniors, Health, Diabetes, Liver, Obesity, NASH, Liver disease, Non-alcoholic fatty liver disease, Scar, Inflammation, Abdominal pain, Health care access among Dalits in India, Patient, Risk, Fatty liver disease, NAFLD, Principal, Cirrhosis, Fatigue, Disease, Pharmaceutical industry, Nursing

Nonalcoholic steatohepatitis (NASH) is an aggressive form of nonalcoholic fatty liver disease (NAFLD) where fat buildup in the liver can lead to inflammation and scarring, known as cirrhosis.

Key Points: 
  • Nonalcoholic steatohepatitis (NASH) is an aggressive form of nonalcoholic fatty liver disease (NAFLD) where fat buildup in the liver can lead to inflammation and scarring, known as cirrhosis.
  • The disease can cause severe liver damage with few or no symptoms.
  • The local setting provides residents of Pottsville and surrounding communities the option to participate in clinical trials close to home.
  • With a global network of over 150 research sites, Care Access supports research studies conducted by 14 of the top 20 biopharmaceutical companies.

ENDRA Life Sciences Reports Second Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Monday, August 14, 2023
Health, Other Science, Clinical Trials, Research, Science, Biotechnology, Proton, Fatty liver disease, EASL, International, Magnetic resonance, De novo, Classification, Marketing, German Diabetes Center, IP, Sale, Trial of the century, Congress, MRI, PIN, Non-alcoholic fatty liver disease, NDRA, Patient, NAFLD, European Association for the Study of the Liver, FDA, Magnetic resonance imaging, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pearson, Food, Medical imaging, Security (finance), Liver

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three and six months ended June 30, 2023 and provided a business update.

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reported financial results for the three and six months ended June 30, 2023 and provided a business update.
  • Highlights from the second quarter of 2023 and recent weeks include:
    Submitted a De Novo Request to the U.S. Food and Drug Administration (FDA) for the TAEUS liver system.
  • During the second quarter, ENDRA secured four additional patents, including one in the U.S. and three in China.
  • Net loss in the second quarter of 2023 was $2.6 million, or $0.43 per share, compared with a net loss of $3.6 million, or $1.17 per share, in the second quarter of 2022.

ENDRA Life Sciences Submits De Novo Request for its TAEUS® System Liver Fat Application to the U.S. FDA

Retrieved on: 
Monday, August 14, 2023
FDA, Medical Devices, Health, Clinical Trials, Health Technology, Proton, Fatty liver disease, Magnetic resonance, De novo, Classification, Trial of the century, Non-alcoholic fatty liver disease, NDRA, Patient, NAFLD, Magnetic resonance imaging, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pearson, Food, Medical imaging

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces the submission of a De Novo request to the U.S. Food and Drug Administration (FDA) for the TAEUS system.

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces the submission of a De Novo request to the U.S. Food and Drug Administration (FDA) for the TAEUS system.
  • The TAEUS system is ENDRA’s proprietary device that is intended to offer clinicians a tool for the non-invasive assessment of fatty liver tissue, as an aid in the management of patients with Non-Alcoholic Fatty Liver Disease (NAFLD).
  • The submission included patient scans from established clinical study sites comparing TAEUS liver fat fraction estimates to MRI-PDFF (Magnetic Resonance Imaging Proton Density Fat Fraction), which is the gold standard for clinical measurement of liver fat fraction.
  • TAEUS estimates of liver fat fraction were strongly correlated to MRI-PDFF scores with a Pearson correlation coefficient of r=0.78.

Better Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Wednesday, August 9, 2023
Neurology, Cardiology, Pharmaceutical, Health, FDA, Diabetes, Clinical Trials, Other Health, Insurance, Federation, Cognitive behavioral therapy, Partnership, De novo, Therapy, Regulation Fair Disclosure, Authorization, Wholesale acquisition cost, NASH, Marketing, Disclosure, Type 2 diabetes, PDT, Research, Better, Element, Trial of the century, WAC, Patient, Data, System, Non-alcoholic fatty liver disease, Fatty liver disease, System for Award Management, Webcast, NAFLD, SAM, Regulation of tobacco by the U.S. Food and Drug Administration, T2D, Regulation, Food, Pharmaceutical industry, Life insurance, Cryptocurrency

(NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics to treat cardiometabolic diseases, today reported financial results for the second quarter 2023 and provided an update on progress towards achieving key corporate milestones.

Key Points: 
  • (NASDAQ: BTTX), a pioneer in developing prescription digital therapeutics to treat cardiometabolic diseases, today reported financial results for the second quarter 2023 and provided an update on progress towards achieving key corporate milestones.
  • Completed Multiple Financing Transactions: In April 2023, Better Therapeutics announced a private placement financing for gross proceeds of approximately $6.5 million before deducting offering expenses payable by the Company.
  • In July 2023, Better Therapeutics announced the completion of an additional $6.7 million in net proceeds from multiple equity transactions.
  • Better Therapeutics periodically provides other information for investors on its corporate website, http://www.bettertx.com , and its investor relations website, https://investors.bettertx.com .

Lumos Pharma Reports Second Quarter 2023 Financial Results, Provides Clinical Update

Retrieved on: 
Wednesday, August 9, 2023
ENDO, LUMO, KOL, Non-alcoholic fatty liver disease, Bank statement, SDS, Clinical trial, ESPE, GH, PIN, User experience, Investment, Webcast, NAFLD, Growth, Research, Transgender hormone therapy, AHV, Pharmaceutical industry, Birth control, Dietary supplement, Medical device, The Hague

Encouraging Interim Data from OraGrowtH Trials Presented at ENDO 2023, Highlighted in KOL Webinar

Key Points: 
  • Encouraging Interim Data from OraGrowtH Trials Presented at ENDO 2023, Highlighted in KOL Webinar
    AUSTIN, Texas, Aug. 09, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc .
  • (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for Pediatric Growth Hormone Deficiency (PGHD) through Phase 2 clinical trials, today announced financial results for the second quarter ended June 30, 2023.
  • Cash on hand as of June 30, 2023 is expected to support operations for at least 12 months following the date of the filing of our second quarter 2023 financial statements.
  • ET today to discuss its financial results and to give an update on clinical programs.