NUB

Fractyl Health Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, April 1, 2024
Research, Glucose, Health, Congress, Obesity, Human, Drug discovery, Exercise, Glycated hemoglobin, DMR, ADAS, Partnership, Insulin, IDA, Patient, Weight loss, Michigan Medicine, Diabetes, Public expenditure, IDE, University, IPO, Tropism, Peptide, Transgene, Insulin resistance, Animal, NUB, Type 2 diabetes, Pancreas, Investigational New Drug, Therapy, Food, Marketing, FDA, Engineering, Annual general meeting, Pharmaceutical industry

BURLINGTON, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D) and obesity, today reported its fourth quarter and full year 2023 financial results and provided a business update.

Key Points: 
  • “In addition, we expect to complete enrollment of our pivotal Revitalize-1 study and are excited to report topline data in the fourth quarter of 2024.
  • The Company expects to complete enrollment in the first half of 2024 and report topline data in the fourth quarter of 2024.
  • In December 2023, Fractyl presented preclinical findings in an oral presentation at the World Congress of Insulin Resistance Diabetes and Cardiovascular Disease 2023 Annual Meeting.
  • Cash Position: As of December 31, 2023, Fractyl had approximately $33.2 million in cash and cash equivalents.

Fractyl Health Welcomes Dr. Timothy Kieffer as Chief Scientific Officer

Retrieved on: 
Thursday, September 14, 2023
Research, Medical Devices, Diabetes, Clinical Trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Insulin, Obesity, University, Therapy, Pancreas, PHD, AAV, NUB, Type 2, Acquisition, DSM-IV codes, Patient, Disease, Vertex Pharmaceuticals, Mortality, T2D, Infectious diseases (medical specialty), Pharmaceutical industry, MD

Fractyl Health, a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including type 2 diabetes (T2D) and obesity, proudly announces the appointment of Dr. Timothy Kieffer as its Chief Scientific Officer.

Key Points: 
  • Fractyl Health, a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including type 2 diabetes (T2D) and obesity, proudly announces the appointment of Dr. Timothy Kieffer as its Chief Scientific Officer.
  • Previously, as the Chief Scientific Officer at ViaCyte Inc., a company at the forefront of stem cell-derived treatments for diabetes, Dr. Kieffer played a pivotal role in advancing the firm's scientific strategy.
  • "I’m thrilled to be able to work with Dr. Kieffer to advance our scientific programs at Fractyl Health.
  • Taking his experience from academia to industry and now to Fractyl Health, Dr. Kieffer embodies a holistic understanding of the journey from research to real-world application.

Fractyl Health Announces Commercial Availability of Revita® in Germany and Successful First Procedure at 25th Düsseldorf International Endoscopy Symposium

Retrieved on: 
Tuesday, February 7, 2023
Biotechnology, Professional Services, Diabetes, Health, Pharmaceutical, Small Business, Medical Devices, Research, Science, Clinical Trials, Finance, Endocrinology, Diet, Hospital, Therapy, Patient, DSM-IV codes, Palo Alto Medical Clinic, HIV disease progression rates, Endoscopy, Risk, Associate, NUB, Clinic, Disease, Pharmaceutical industry, T2D

Fractyl Health, an organ-editing metabolic therapeutics company focused on pioneering a new approach to the treatment of type 2 diabetes (T2D), announced today the commercial availability of its Revita DMR System™ in Germany.

Key Points: 
  • Fractyl Health, an organ-editing metabolic therapeutics company focused on pioneering a new approach to the treatment of type 2 diabetes (T2D), announced today the commercial availability of its Revita DMR System™ in Germany.
  • Fractyl Health further announces that a live demonstration of a Revita procedure was successfully performed on February 3rd at EVK Hospital in Düsseldorf, Germany, at the 25th International Endoscopy Symposium.
  • The Revita System has a CE Mark in Europe and has recently established reimbursement in Germany under the NUB reimbursement process.
  • “The clinical development of the technology and procedure has demonstrated the key role of the gut in metabolic diseases, and specifically in T2D.

Neovasc Announces German Reimbursement Renewal

Retrieved on: 
Wednesday, February 1, 2023
German Institute for Medical Documentation and Information, TSX, Hospital, Piping and plumbing fitting, Patient, Ineke van Wetering, NUB, Health insurance

VANCOUVER and MINNEAPOLIS, Feb. 01, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Neovasc, Inc. (“Neovasc” or “the Company”) ( NASDAQ , TSX : NVCN) today announced the German Institute for the Hospital Remuneration System (“InEK”) has awarded the Neovasc Reducer™ (“Reducer”), a CE-Marked medical device for the treatment of refractory angina, NUB Status 1 designation for 2023.

Key Points: 
  • VANCOUVER and MINNEAPOLIS, Feb. 01, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – Neovasc, Inc. (“Neovasc” or “the Company”) ( NASDAQ , TSX : NVCN) today announced the German Institute for the Hospital Remuneration System (“InEK”) has awarded the Neovasc Reducer™ (“Reducer”), a CE-Marked medical device for the treatment of refractory angina, NUB Status 1 designation for 2023.
  • The NUB process opens the path for negotiations between hospitals and health insurers for the reimbursement of new medical treatments in the German healthcare system.
  • For 2023, 329 German hospitals applied for the Reducer NUB, up from 256 in 2022, and they can now negotiate full reimbursement coverage for the Reducer therapy.
  • “Once again, our team has been successful in securing positive reimbursement in Germany,” commented Fred Colen, Chief Executive Officer of Neovasc.

Stimwave Technologies Receives Reimbursement Authorization in Germany

Retrieved on: 
Tuesday, April 5, 2022
Biotechnology, General Health, Medical Devices, Hospitals, Health, PNS, Freedom, Peripheral nerve stimulation, Ineke Hans, NUB, HF, Hospital, Pain, Government, German Institute for Medical Documentation and Information, SCS, CE marking, Chronic pain, Technology, DRG, Brain, Physician, Spinal cord, Hyperreflexia, FDA, Patient, Health insurance, Medical device

Today Stimwave Technologies announced that it has received additional reimbursement authorization in Germany, one of the Companys largest commercial markets outside of the United States.

Key Points: 
  • Today Stimwave Technologies announced that it has received additional reimbursement authorization in Germany, one of the Companys largest commercial markets outside of the United States.
  • The German Institute for Hospital Remuneration (InEK) has granted Stimwave Technologies Freedom PNS and SCS products Status 1 designation under its NUB funding process.
  • Being designated NUB Status 1 entitles hospitals in Germany that submitted a NUB application to negotiate reimbursement in addition to DRG payment with statutory health insurers.
  • These designations are based on the InEKs belief that Stimwave Technologies chronic pain management products are innovative medical devices, that previously lacked sufficient payment.

Hansa Biopharma and German payer head association agree on reimbursement price for Idefirix® (imlifidase) as desensitization treatment for highly sensitized kidney transplant patients

Retrieved on: 
Tuesday, March 15, 2022
Survival, Immunoglobulin G, European Medicines Agency, Mortality, Commercial, Quality of life, Program, Patient, NUB, Nasdaq Stockholm, ESRD, EU, Hansa, AMNOG, State, Nasdaq, National Association, Chronic kidney disease, Risk, Dialysis, Kidney transplantation, EMA, Antibody, Hlas, Safety, Transplant, Degenerative disease, Medicine, Kidney disease, Company, Research, Cancer, CEO, DSA, Kidney failure, European Market Infrastructure Regulation, Priority, Kidney, European, Health insurance, Dentistry, Pharmaceutical industry, Medical device, Agency, Imlifidase

This completes, within the foreseen 12 month timeline, the AMNOG (Medicines Market Reorganization Act) process for Idefirix in Germany.

Key Points: 
  • This completes, within the foreseen 12 month timeline, the AMNOG (Medicines Market Reorganization Act) process for Idefirix in Germany.
  • At Hansa, our commitment is to significantly improve the lives of highly sensitized patients in Germany who are waiting for a potentially life-saving kidney transplant," says Sren Tulstrup, President and CEO, Hansa Biopharma.
  • "Highly sensitized kidney patients have previously had very limited access to kidney transplants due to the lack of effective desensitization treatments, and they often have no alternative but to remain on long-term dialysis."
  • Hansa has developed a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients.

Samsara Vision Awarded NUB Status 1 Reimbursement Designation for SING IMT™

Retrieved on: 
Thursday, March 10, 2022
Biotechnology, Surgery, Medical Devices, Health, Optical, AMD, IMT, NUB, Patient, Physician, Risk, Marketing, Research, Ineke Hans, SING, Hope, Vision, FDA, Pressure, Visual acuity, Severe cognitive impairment, Quality of life, Person, Neues Sehen, Person-centered therapy, Injection, German Institute for Medical Documentation and Information, Forward-looking statement, Hospital, Intellectual property, Intraocular pressure, Unitary state, Eye, Technology, Method, Knowledge, Ownership, Standard of care, Disease, Legislation, Love, Health insurance, Dentistry, Entertainment, Medical device, SING IMT, Samsara Vision, SING IMT, SAMSARA VISION

Comprised of ultra-precision micro-optics, the SING IMT is implanted during typical, out-patient cataract surgery.

Key Points: 
  • Comprised of ultra-precision micro-optics, the SING IMT is implanted during typical, out-patient cataract surgery.
  • After recovering from surgery, the patients work closely with a low vision specialist and occupational therapists to learn how to use their new vision.
  • Because AMD is a progressive disease, over time, patients have adapted with the loss of vision in the central field of vision.
  • The most common risks of the SING IMT surgery include inflammatory deposits or precipitates on the device and increased intraocular pressure.

Neovasc Announces German Reimbursement Renewal and Commercial Progress

Retrieved on: 
Tuesday, February 8, 2022
NASDAQ, German Institute for Medical Documentation and Information, GLOBE, Perfusion, Ineke van Wetering, Angina, NUB, Adrenal insufficiency, Company, Heart, Union, Hospital, Patient, 500th SS Parachute Battalion, Blood, Muscle tissue, Adoption, TSX, Piping and plumbing fitting, Pharmaceutical industry, Health insurance, Cardiology

The NUB process opens the path for negotiations between hospitals and health insurers for the reimbursement of new medical treatments in the German healthcare system.InEK is responsible for prioritizing new therapies inGermanythrough the NUB process.

Key Points: 
  • The NUB process opens the path for negotiations between hospitals and health insurers for the reimbursement of new medical treatments in the German healthcare system.InEK is responsible for prioritizing new therapies inGermanythrough the NUB process.
  • Our team has been focused on securing broad reimbursement coverage for Reducer so more patients can benefit from the therapy, commented Fred Colen, Chief Executive Officer of Neovasc.
  • Obtaining NUB Status 1 for 2022 from the German reimbursement authorities is a vital component of our overall strategy.
  • In the past several quarters, we have had significant reimbursement wins in Germany, France, the U.K., and the United States.

Fractyl Health Receives Reimbursement Authorization in Germany for Revita DMR® System

Retrieved on: 
Tuesday, February 8, 2022
Biotechnology, Hospitals, Diabetes, Health, Prediabetes, Trial of the century, Ineke van Wetering, Government, Insulin, Medicare, NUB, Hospital, Research, Program, Risk, Culture, FDA, Patient, Center, CEO, CMS, Therapy, Entrepreneurship, Diabetes, Regulation of tobacco by the U.S. Food and Drug Administration, Disease, Health, Food, Centers for Medicare & Medicaid Services, Lists of diseases, Mortality, Internal medicine, Pharmaceutical industry, T2D, Revita®, the Revitalize T2D Clinical Development Program, Fractyl Health, REVITA®, THE REVITALIZE T2D CLINICAL DEVELOPMENT PROGRAM, FRACTYL HEALTH

Hospitals in Germany that submitted a NUB application are now entitled to negotiate reimbursement for Revita with the German statutory health insurance system.

Key Points: 
  • Hospitals in Germany that submitted a NUB application are now entitled to negotiate reimbursement for Revita with the German statutory health insurance system.
  • German hospitals may now negotiate full reimbursement from the national health insurance system for its use in their patients in clinical studies and/or real-world evidence generation in a commercial setting.
  • This reimbursement decision comes on the heels of a Coverage with Evidence Development decision for Revita from the German health technology assessment authority (the G-BA) in 2021.
  • The challenge of T2D in Germany is continuously growing, and recent research advances have not reduced its endemic proportions.