Duodenum

Fractyl Health Receives FDA IDE Approval for the Revita® Remain-1 Pivotal Study of Weight Maintenance in Obesity after Discontinuation of GLP-1 Based Drugs

Retrieved on: 
Monday, April 1, 2024
Harvard Medical School, Investigational device exemption, Human, Obesity, Cardiovascular disease, Exercise, Risk, Patient, Food and Drug Administration, Weight loss, IDE, MD, Diet, Pharmacotherapy, Duodenum, Hospital, T2D, Wellness, Pathology, Therapy, BMI, FDA, Endoscopy, Food, Pharmaceutical industry

BURLINGTON, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the “Company”), a metabolic therapeutics company focused on pioneering new approaches for the treatment of obesity and type 2 diabetes (T2D), today announced U.S. Food and Drug Administration (FDA) approval of a pivotal Investigational Device Exemption (IDE) to study Revita’s efficacy in maintaining weight loss following the discontinuation of GLP-1 receptor agonist (GLP-1RA) drug therapy, addressing a key unmet need in the treatment of obesity. Obesity affects over 40% of the US population and is a critical precursor to various highly morbid and expensive chronic conditions such as type 2 diabetes, metabolic dysfunction-associated fatty liver disease, and cardiovascular disease.

Key Points: 
  • The IDE approval launches the groundbreaking Remain-1 study, set to begin in the second half of 2024.
  • Remain-1 is a randomized, double-blind trial of Revita versus sham in patients who have lost at least 15% total body weight on tirzepatide therapy.
  • It is designed to be a pivotal study to potentially enable registrational filing for Revita for weight maintenance after GLP-1RA discontinuation.
  • The rationale for the Remain-1 pivotal study is based on a new need for therapeutic solutions that can offer durable weight maintenance without ongoing medical therapy.

Diabetes Research Study in Santa Clarita Evaluating a New Approach To Helping Patients

Retrieved on: 
Monday, February 26, 2024
Women, Other Health, Seniors, Radiology, Men, Research, Family, Medical Devices, Hospitals, Consumer, Science, Managed Care, Cardiology, FDA, Biotechnology, Diabetes, Surgery, Health, Multimedia, Blood, Liver disease, Obesity, Stroke, Splenic infarction, DMR, Risk, Type 2 diabetes, BMI, Patient, Insulin, Medicine, Insulin resistance, Kidney disease, Duodenum

A new diabetes research study is available in Santa Clarita, Calif., to evaluate a non-drug procedure that may help improve blood sugar without increasing medicines or insulin.

Key Points: 
  • A new diabetes research study is available in Santa Clarita, Calif., to evaluate a non-drug procedure that may help improve blood sugar without increasing medicines or insulin.
  • “For many people living with diabetes, controlling blood glucose levels is a difficult journey,” said Dr. Sina Tebi, Principal Investigator at Care Access - Santa Clarita.
  • The local setting provides residents of Santa Clarita and surrounding communities the option to participate in clinical studies close to home.
  • With a global network of over 200 research sites, Care Access supports research studies conducted by 14 of the top 15 biopharmaceutical companies.

Diabetes Research Study Evaluating a New Approach To Helping Patients Now Offered in Warwick

Retrieved on: 
Monday, February 26, 2024
Biotechnology, Diabetes, Health, Women, Seniors, Men, Research, Family, Consumer, Science, Clinical Trials, Multimedia, Blood, Liver disease, Obesity, Cardiovascular disease, Stroke, Splenic infarction, DMR, Risk, Type 2 diabetes, BMI, Patient, Insulin, Medicine, Insulin resistance, Kidney disease, Duodenum, Medical device

A new diabetes research study is available in Warwick, R.I., to evaluate a non-drug procedure that may help improve blood sugar without increasing medicines or insulin.

Key Points: 
  • A new diabetes research study is available in Warwick, R.I., to evaluate a non-drug procedure that may help improve blood sugar without increasing medicines or insulin.
  • (Photo: Business Wire)
    The combination of diabetes and obesity significantly increases one’s risk of heart attacks, stroke, liver disease, kidney disease, and other serious health problems.
  • Care Access is a global clinical research company helping to accelerate the future of medicine.
  • With a global network of over 200 research sites, Care Access supports research studies conducted by 14 of the top 15 biopharmaceutical companies.

Olympus Closes the Acquisition of Korean Gastrointestinal Stent Company, Taewoong Medical Co., Ltd

Retrieved on: 
Wednesday, January 24, 2024
Knowledge, Comment, GI, Duodenum, Patient, Esophagus, Stenosis, Name, Medtech, Gastrointestinal disease, Acquisition, Sale, Health, Biliary tract, Pharmaceutical industry

[2]

Key Points: 
  • [2]
    Taewoong Medical offers a variety of medical devices including metallic stents designed for biliary tract, esophagus, colon, and duodenum treatments.
  • Taewoong Medical will join Olympus' Therapeutic Solutions Division, helping Olympus become a comprehensive solutions provider in the GI market with varied GI EndoTherapy solutions by bringing together talent and technology.
  • The addition of Taewoong Medical to Olympus' portfolio will contribute to the company's focus on enhancing patient care pathways.
  • Comment from Kyong-min Shin, President and CEO of Taewoong Medical: "As a leading medical company, Taewoong Medical manufactures a vast range of medical equipment of our own designs.

Canon Medical Systems and Olympus Announce Business Alliance regarding Endoscopic Ultrasound Systems

Retrieved on: 
Monday, January 15, 2024
Oncology, Health, Medical Devices, Technology, Manufacturing, Other Manufacturing, Hardware, Life, Bile, Aplio, Pancreatic cancer, Philosophy, Canon Medical Systems Corporation, Amplitude, Patient, Olympus Corporation, ERCP, MRI, Diagnosis, Attention, Intervention, Gallbladder, Google Images, History, EUS, Jaundice, SMI, Neurosurgery, Endoscopy, Liver, Marketing, Stomach, Duodenum, Pancreas, Physician, Medical imaging

Canon Medical Systems Corporation (Canon Medical) and Olympus Corporation (Olympus), today announced that we have reached an agreement to collaborate on Endoscopic Ultrasound Systems.

Key Points: 
  • Canon Medical Systems Corporation (Canon Medical) and Olympus Corporation (Olympus), today announced that we have reached an agreement to collaborate on Endoscopic Ultrasound Systems.
  • Canon Medical will develop and manufacture diagnostic ultrasound systems used in Endoscopic Ultrasonography1 (EUS), and Olympus will perform the sales and marketing efforts.
  • Canon Medical has a history of more than 100 years in the diagnostic imaging systems business, including X-ray diagnostic systems, CT, MRI, and ultrasound diagnostic systems, and provides products and services to more than 150 countries and regions worldwide.
  • In the field of EUS, diagnostic ultrasound systems are very important, and we are pleased to have a cooperative relationship with Canon Medical, which has advanced ultrasound imaging technology.

Human medicines European public assessment report (EPAR): Pylobactell, 13C-urea, Date of authorisation: 07/05/1998, Revision: 12, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Urea, Medical Subject Headings, Marketing, European Commission, INN, Stomach, Heartburn, Infection, Allergy, Bloating, ATC, Helicobacter pylori, International, European, Nausea, Language, Inflammation, Duodenum, Laboratory, Water, Mass spectrometry, Indigestion, Peptic ulcer disease, Gastritis, Medication, Enzyme, Select, Committee, Patient, Carbon, Ammonia, Diagnosis, Anatomy, Medicine, Ulcer, Nature, IIA, CHMP, Medical device

Human medicines European public assessment report (EPAR): Pylobactell, 13C-urea, Date of authorisation: 07/05/1998, Revision: 12, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Pylobactell, 13C-urea, Date of authorisation: 07/05/1998, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR): Cufence, trientine dihydrochloride, Date of authorisation: 25/07/2019, Revision: 6, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Copper, Urine, Liver, Medical Subject Headings, Diarrhea, Marketing, Meal, Duodenitis, Roger Hawkins (drummer), DSM-IV codes, INN, Deficit spending, Metabolism, Stomach, ATC, Pain, Capsule, International, Tremor, Dysarthria, Ageing, Nausea, Language, Brain, Inflammation, Duodenum, European Medicines Agency, Wilson's disease, Dystonia, Select, Patient, Liver disease, Safety, Anatomy, IIA, Medical device

Human medicines European public assessment report (EPAR): Cufence, trientine dihydrochloride, Date of authorisation: 25/07/2019, Revision: 6, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Cufence, trientine dihydrochloride, Date of authorisation: 25/07/2019, Revision: 6, Status: Authorised

Kaneka Acquires Japan Medical Device Technology

Retrieved on: 
Wednesday, December 6, 2023
Surgery, Medical Devices, Health, Cardiology, Medical Supplies, Atherosclerosis, Human body, Restenosis, Kaneka, Research, Biliary tract, Artery, Extremities, Esophagus, Metal, Sirolimus, Coronary artery disease, Risk, Corporation, Multimedia, FIH, Duodenum, Thrombosis, Blood, Human, Trachea, Kaneka Corporation, Pharmaceutical industry

Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Minoru Tanaka)(TOKYO:4118) has acquired all shares of Japan Medical Device Technology Co., Ltd. (Headquarters: Kamimashiki-gun, Kumamoto; President: Shuzo Yamashita) (hereinafter JMDT), a developer and manufacturer of medical devices, on November 30, 2023, and made it a wholly owned subsidiary.

Key Points: 
  • Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Minoru Tanaka)(TOKYO:4118) has acquired all shares of Japan Medical Device Technology Co., Ltd. (Headquarters: Kamimashiki-gun, Kumamoto; President: Shuzo Yamashita) (hereinafter JMDT), a developer and manufacturer of medical devices, on November 30, 2023, and made it a wholly owned subsidiary.
  • In particular, stenting*1 for the treatment of coronary artery diseases such as atherosclerosis has a market worth 30 billion yen in Japan, and Kaneka is aiming to expand its business in this area.
  • It is a medical device that widens tubular parts of the human body (blood vessels, trachea, esophagus, duodenum, colon, biliary tract, etc.)
  • [Japan Medical Device Technology Co., Ltd.]

Fractyl Health Reports Durable Improvement in Glucose Control, Weight Loss, and Insulin Reduction in T2D Patients Using Revita® in Open Label Phase of Revitalize 1 Pivotal Study at the American Diabetes Association 83rd Scientific Sessions

Retrieved on: 
Monday, June 26, 2023
Health, Diabetes, Other Health, Managed Care, Clinical Trials, Pharmaceutical, Biotechnology, Glycated hemoglobin, Insulin, Therapy, Duodenum, SGLT2, Patient, American Diabetes Association, Glas, FPG, Human, Glucose, Safety, Disease, Pharmaceutical industry, T2D

The study explored the safety and efficacy of Revita®, an endoscopic procedure using hydrothermal ablation to target the duodenum in conjunction with empagliflozin.

Key Points: 
  • The study explored the safety and efficacy of Revita®, an endoscopic procedure using hydrothermal ablation to target the duodenum in conjunction with empagliflozin.
  • In subjects enrolled in the study thus far, treatment with Revita has shown rare and mild device-related adverse events.
  • The Revitalize 1 pivotal study is ongoing, with Fractyl Health set to complete enrollment in the first half of 2024.
  • These promising results bring us closer to our goal at Fractyl Health, which is to control and, ultimately, eradicate T2D.

Glyscend Therapeutics Announces Positive Topline Phase 2a Clinical Results and Progress with GLY-200, a First-in-Class Treatment for Type 2 Diabetes and Obesity

Retrieved on: 
Wednesday, May 31, 2023
Health, Diabetes, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, Exercise, Royal Adelaide Hospital, Parameter, Insulin, Obesity, Adelaide, University, Diet, MBBS, Endocrine system, Type 2 diabetes, Glucose, Novel, Duodenum, PYY, Appetite, Doctor of Philosophy, Phase 1, MD, Patient, Physician, American Diabetes Association, Metformin, Bariatric surgery, Therapy, T2D, Treatment, Safety, Disease, Human, Pharmaceutical industry, Medical device, Dietary supplement, Medicine

T2D and obesity are worldwide endemics with millions of people in need of more effective ways to manage their disease.

Key Points: 
  • T2D and obesity are worldwide endemics with millions of people in need of more effective ways to manage their disease.
  • “Type 2 diabetes and obesity are extremely common chronic diseases where the outcome of most therapeutic options is suboptimal.
  • “These Phase 2a data provide clinical evidence that duodenal exclusion may be possible with a non-invasive, orally administered, pharmaceutical treatment.
  • He will discuss therapeutic targets in the gut for the treatment of T2D and obesity.