Polyp

EQS-News: Mainz Biomed Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm for Integration into Pivotal FDA PMA Clinical Trial for Next-Gen CRC Test

Retrieved on: 
Venerdì, Maggio 3, 2024
FDA, Cancer, CDC, Colorectal cancer, CRC, Trial of the century, Polyp, Patient, Colonoscopy, FIT, Gene expression, Messenger, Biomarker, PMA, Medical imaging

“We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.

Key Points: 
  • “We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.
  • Hence these results represent a critical milestone on our path to launching our FDA PMA pivotal study ReconAAsense, which is planned to recruit up to 15,000 patients.
  • Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT.
  • The Company plans to publish results of this study at a major medical conference during the second quarter of 2024.

Mainz Biomed Reports Positive Topline Results from Pooled Study Evaluating Novel mRNA Biomarkers and Proprietary AI Algorithm for Integration into Pivotal FDA PMA Clinical Trial for Next Generation Colorectal Cancer Diagnostic

Retrieved on: 
Giovedì, Aprile 25, 2024
FDA, Cancer, CDC, Colorectal cancer, CRC, Trial of the century, Polyp, Patient, Colonoscopy, FIT, Gene expression, Messenger, Biomarker, PMA, Medical imaging

“We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.

Key Points: 
  • “We conducted this pooled study to fine-tune the minimal biomarker set to be used to optimize sensitivity and specificity of the results in Mainz Biomed’s next generation CRC screening tool.
  • Following colonoscopy and any applicable histopathology, subjects were classified into groups: CRC, advanced adenoma, non-advanced adenoma, no findings, or non-colorectal cancer.
  • Each subject outcome was compared to the results from the next generation test incorporating the novel mRNA biomarkers and FIT.
  • The Company plans to publish results of this study at a major medical conference during the second quarter of 2024.

Emtora Clinical Data to be Highlighted in Podium Presentation at Prestigious 2024 Digestive Disease Week Annual Meeting

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Martedì, Aprile 30, 2024
Research, Other Health, General Health, Pharmaceutical, Oncology, Infectious Diseases, Hospitals, Genetics, Surgery, Clinical Trials, Science, Biotechnology, Health, REDUCE, Cancer prevention, Gastroenterology, Safety, MD, FAP, Polyp, Gastrointestinal tract, Patient, Physician, Endoscopy, DDW, Research institute, Quality of life, Pharmaceutical industry

Emtora Biosciences, Inc., a privately-held, San Antonio-based biotechnology company developing a novel reformulated version of a previously-approved drug today announced the acceptance of an abstract for oral presentation at the upcoming Digestive Disease Week (“DDW”) Annual Meeting.

Key Points: 
  • Emtora Biosciences, Inc., a privately-held, San Antonio-based biotechnology company developing a novel reformulated version of a previously-approved drug today announced the acceptance of an abstract for oral presentation at the upcoming Digestive Disease Week (“DDW”) Annual Meeting.
  • DDW is the world’s premier meeting for physicians, researchers, and industry in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery, which will take place in Washington D.C. May 18-21, 2024.
  • FAP is an incurable systemic disease for which no approved chemo-preventive agent exists.
  • Presentation: PHASE IIA TRIAL OF ENCAPSULATED RAPAMYCIN (ERAPA) IN PATIENTS WITH FAMILIAL ADENOMATOUS POLYPOSIS TO REDUCE INTESTINAL POLYP BURDEN: 6 MONTH INTERIM RESULTS

Phathom Pharmaceuticals Launches Direct-to-Consumer Campaign, “VOQUEZNA Can Kick Some Acid”

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Martedì, Marzo 26, 2024
Connected, HIV-1, Amazon Prime Video, Breast milk, Face, Hypoesthesia, Patient, Chronic pain, Clostridioides, Heartburn, Lymph, Magnesium, Diarrhea, Myalgia, Spine, Allergy, Muscle weakness, Vonoprazan, Stomach, Vitamin, Dizziness, Potassium, Hip, Risk, Tongue, Chills, DTC, Safety, Food, PPI, Rash, Food and Drug Administration, GERD, Enzyme inhibitor, Skin, Esophagitis, HIV, Rilpivirine, Kidney, FDA, Esophagus, B-12, Weakness, Infection, Indigestion, Smart TV, Seizure, Inflammation, Polyp, Calcium, Extrapyramidal system, Bone fracture, Nausea, Spasm, Urine, Fever, Clostridioides difficile, Bleeding, Blood, Wrist, Blister, Vitamin B12, Human, Medicine, Pharmaceutical industry

FLORHAM PARK, N.J., March 26, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announces the launch of its new broadcast ad and full-scale, Direct-to-Consumer (DTC) campaign, “VOQUEZNA Can Kick Some Acid,” to raise awareness of its powerful first-in-class treatment and encourage people to speak to their doctor about this new treatment option. VOQUEZNA (vonoprazan) is indicated for the healing and maintenance of healing of all severities of Erosive Esophagitis (EE), also referred to as Erosive GERD, and for the relief of related heartburn. VOQUEZNA represents the first major innovation to the U.S. Erosive GERD market in over 30 years.1

Key Points: 
  • The campaign will also be featured on consumer-facing platforms across Facebook, Instagram, waiting room TVs in doctor offices, and digital banner ads.
  • “Phathom is excited to launch our first campaign directly to, and for, the people whose lives we strive to improve every day.
  • To view a video of the “VOQUEZNA Can Kick Some Acid” commercial, click here.
  • Talk with your healthcare provider about the possibility of fundic gland polyps if you have been on VOQUEZNA for a long time.

Fujifilm Receives 510(k) Clearance for CAD EYE®, New AI-Powered Endoscopic Imaging Technology for Colonic Polyp Detection

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Mercoledì, Marzo 20, 2024
Colonoscopy, LCI, Documentation, Adenoma, EYE, Colorectal cancer, Conditional sentence, Risk, White Light, Polyp, APC, Assist, AI, Woman, Workflow, System, Safety, Swedish Health Services, Endoscopy, FDA, Health, CAD, Medical device

Lexington, Mass., March 20, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Healthcare Americas Corporation , a leading provider of endoscopic imaging and endosurgical solutions, received 510(k) clearance for CAD EYE, the company’s novel AI detection system for endoscopic imaging.

Key Points: 
  • Lexington, Mass., March 20, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Healthcare Americas Corporation , a leading provider of endoscopic imaging and endosurgical solutions, received 510(k) clearance for CAD EYE, the company’s novel AI detection system for endoscopic imaging.
  • CAD EYE® enables real-time detection of colonic mucosal lesions such as polyps and adenomas during colonoscopy procedures, supporting endoscopists in their ability to detect and remove pre-cancerous lesions, regardless of size, shape and color.
  • Consisting of a compatible expansion unit (the Fujifilm EX-1) and endoscopy support software (EW10-EC02), CAD EYE is an evolution of Fujifilm’s ELUXEO® Endoscopic Imaging System, featuring AI image processing functionality customized for the integration with the system’s processor and the endoscope.
  • CAD EYE, ELUXEO and LCI are registered trademarks of FUJIFILM Corporation in various jurisdictions.

Intelligent Scopes Launches Helga AI-GEP™, an AI Platform for Gastroenterology with the Commencement of Validation of its AI Software Tool for Colon Cancer

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Lunedì, Marzo 4, 2024
Urology, ISC, Overalls, Polyp, Adenoma, Extrapyramidal system, Classification, Cancer, Health, Patient, Diagnosis, Research, Gastroenterology, Hyperplasia, Workflow, Medical device

NEW YORK and LONDON, March 04, 2024 (GLOBE NEWSWIRE) -- Intelligent Scopes Corp, specializing in state-of-the-art image enhancement and precision AI software solutions for gastroenterology and urology, is pleased to announce the completion of its AI platform for gastroenterology, namely, Helga AI-GEP™.

Key Points: 
  • NEW YORK and LONDON, March 04, 2024 (GLOBE NEWSWIRE) -- Intelligent Scopes Corp, specializing in state-of-the-art image enhancement and precision AI software solutions for gastroenterology and urology, is pleased to announce the completion of its AI platform for gastroenterology, namely, Helga AI-GEP™.
  • The platform will offer computer aided devices for detection, classification and characterization of lesions and tissue irregularities in the colon (colon cancer) and the upper gastrointestinal tract (esophageal and gastric cancer).
  • Validation is commencing with its AI software tool, namely, Helga iCAP™ for the detection of colonic conditions.
  • As such, Intelligent Scopes collaborates with key stakeholders including clinicians, academia, and equipment manufacturers to provide tools that can aid endoscopists in providing optimal care to patients.

Fujifilm Receives 510(k) Clearance for SCALE EYE®, a Novel Endoscopic Imaging Technology for Measuring Colonic Lesions

Retrieved on: 
Lunedì, Febbraio 26, 2024
Polyp (medicine), Colonoscopy, FDA, Polyp, EYE, Risk, Fujifilm, Colorectal polyp, PMID, Malignancy, Instrument, Subjectivity, NYU Langone Health, SCALE, Neoplasm, Hepatology

LEXINGTON, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Healthcare Americas Corporation, a leading provider of endoscopic imaging and endosurgical solutions, has been granted FDA 510(k) clearance for SCALE EYE, a new endoscopic imaging technology and part of its expanding ELUXEO Endoscopic Imaging System.

Key Points: 
  • LEXINGTON, Mass., Feb. 26, 2024 (GLOBE NEWSWIRE) -- FUJIFILM Healthcare Americas Corporation, a leading provider of endoscopic imaging and endosurgical solutions, has been granted FDA 510(k) clearance for SCALE EYE, a new endoscopic imaging technology and part of its expanding ELUXEO Endoscopic Imaging System.
  • Measurement time was 2.8 seconds using SCALE EYE, compared to 8 seconds when measuring with forceps.
  • Comparing size measurement of colorectal polyps using a novel virtual scale endoscope, endoscopic ruler or forceps: A preclinical randomized trial.
  • Introduction and preliminary evaluation of novel endoscope with pinpoint laser technology for adequate size estimation of colon lesions.

Olympus and the Colorectal Cancer Alliance Offer a Reminder About the Importance of Preventive Cancer Screenings

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Martedì, Marzo 5, 2024
Large intestine, PCP, Incidence, American Cancer Society, Woman, Texture, Gastroenterology, Colorectal cancer, Colonoscopy, TXI, Physician, Extrapyramidal system, ADR, Polyp, Colorectal Cancer Alliance, CRC, FIT, Learning, Risk, Adenoma, Health, History, USPSTF, Cancer, Patient, Diagnosis, CCA, Medical imaging

CENTER VALLEY, Pa., March 5, 2024 /PRNewswire/ -- As the American Cancer Society reports an increase in death rates from colorectal cancer for patients under the age of 50,1 Olympus Corporation of the Americas and the Colorectal Cancer Alliance (CCA) offer a reminder about the importance of preventive screenings and knowing your family health history.

Key Points: 
  • CENTER VALLEY, Pa., March 5, 2024 /PRNewswire/ -- As the American Cancer Society reports an increase in death rates from colorectal cancer for patients under the age of 50,1 Olympus Corporation of the Americas and the Colorectal Cancer Alliance (CCA) offer a reminder about the importance of preventive screenings and knowing your family health history.
  • More than 20 years ago, colorectal cancer (CRC) was known to be the fourth-leading cause of cancer death in men and women under the age of 50, according to the American Cancer Society.
  • Now, CRC is the leading cause of cancer death for men under the age of 50 and the second leading cause for women under 50.
  • Colorectal cancer is preventable, and the power to prevent it rests in your hands."

Olympus Distribution of EndoClot® Showing Steady Adoption in the U.S.

Retrieved on: 
Venerdì, Marzo 1, 2024
Static pressure, Traction, Blood, Physician, Tropical ulcer, Dissection, SIS, Polyp, Starch, Hemostasis, Artifact, Internationalized domain name, AMP, Inflammation, Adenoma, Safety, ESD, GI, Water, Classification, Perforated ulcer, CO2, PHS, Patient, Bleeding, Trauma, Perforation, Medical imaging

EndoClot products are used by more than 700 accounts, including most of the country's top-ranked (by size) Integrated Delivery Networks (IDNs).

Key Points: 
  • EndoClot products are used by more than 700 accounts, including most of the country's top-ranked (by size) Integrated Delivery Networks (IDNs).
  • Since their launch, EndoClot products have been discussed in close to 20 relevant professional education courses offered via Olympus Continuum, providing physicians with peer-demonstrations of EndoClot technology capabilities during procedures.
  • "Olympus knew that EndoClot technology would be important to improving procedure efficiencies and contributing to improved patient outcomes," said Patrick Romano, Vice President, GI Business Unit Leader, Olympus Corporation of the Americas.
  • A new video highlighting use of the EndoClot PHS and EndoClot SIS has been developed to provide more information: https://www.youtube.com/watch?v=QlCaoiM2Eo0 .

With Colorectal Cancer Rates Rising, the American Cancer Society and Colorectal Cancer Alliance Join Forces to Increase Screening

Retrieved on: 
Giovedì, Febbraio 29, 2024
Large intestine, Ulcerative colitis, Incidence, American Cancer Society, Woman, Crohn's disease, Diet, Colorectal cancer, Smoking, Cancer, ACS, Hereditary nonpolyposis colorectal cancer, Weight loss, Polyp, Colorectal Cancer Alliance, Exercise, Calcium, Meat, Risk, Weakness, Survival rate, Alaska Natives, Vegetable, Rectum, USPSTF, Fatigue, Chronic pain, Death, Black, Locator, Ageing, Dairy

ATLANTA, Feb. 29, 2024 /PRNewswire/ -- The American Cancer Society (ACS) and the Colorectal Cancer Alliance (Alliance) are joining forces on Your Colon is 45 - an initiative aimed at promoting colorectal cancer screening for individuals aged 45 and above.

Key Points: 
  • ATLANTA, Feb. 29, 2024 /PRNewswire/ -- The American Cancer Society (ACS) and the Colorectal Cancer Alliance (Alliance) are joining forces on Your Colon is 45 - an initiative aimed at promoting colorectal cancer screening for individuals aged 45 and above.
  • According to the American Cancer Society's Cancer Fact & Figures, 2024 report , colorectal cancer is now the leading cause of cancer death in men and the second in women under 50 years old.
  • "By joining forces with the Colorectal Cancer Alliance, we can reach more individuals and empower them with vital information that can save lives."
  • Matching an American Cancer Society 2018 update to colorectal cancer screening guidelines , and the Alliance's call for earlier screening, the United States Preventive Services Task Force (USPSTF) released a recommendation statement lowering the age to begin colorectal cancer screening from age 50 to age 45 in 2021.