Critical care

Cytovale's Rapid Sepsis Diagnostic Test Demonstrates Improved Patient Care and Cost Savings in Hospital Application

Retrieved on: 
tisdag, mars 19, 2024
Diagnosis, Sepsis, Conference, Infection, Risk, Patient, SAN, Food and Drug Administration, Hospital, Emergency medicine, Triage, Death, Intensive care medicine, Emergency department, Critical care, ED, Hospice and palliative medicine, Food, FDA, Health, Pharmaceutical industry

The test generates results in about 8 minutes using a standard blood draw, and can be seamlessly and efficiently integrated into existing care workflows.

Key Points: 
  • The test generates results in about 8 minutes using a standard blood draw, and can be seamlessly and efficiently integrated into existing care workflows.
  • Compared to controls, patients whose care was informed by IntelliSep testing spent less time in the hospital and benefited from more efficient triage, resulting in significant cost savings.
  • On average, the study showed that IntelliSep-informed care led to cost savings of:
    Taken together, this study showed an average cost savings of $1,429 per patient across the entire IntelliSep tested cohort.
  • The combination of cost savings for our patients, paired with a faster time to return home to their families, is a game changer."

The Inner Circle acknowledges Phillip A. Villanueva, MD, ABNS, as a Trusted Healthcare Professional

Retrieved on: 
onsdag, mars 13, 2024
Neurology, St. Thomas University, Temple University Hospital, Mentorship, Philosophy, Neuro, Chemistry, Medical degree, Education, Neuroscience, Temple University, University, General surgery, Critical care, Brain, St. Thomas University (Florida), Multimedia, Inner circle, ABNS

MEADOWBROOK, Pa., March 13, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Phillip A. Villanueva, MD, ABNS, is acknowledged as a Trusted Healthcare Professional for his contributions to the field of Neurosurgery.

Key Points: 
  • MEADOWBROOK, Pa., March 13, 2024 /PRNewswire/ -- Prominently featured in The Inner Circle, Phillip A. Villanueva, MD, ABNS, is acknowledged as a Trusted Healthcare Professional for his contributions to the field of Neurosurgery.
  • The doctor has also created a series of public service announcements to increase community awareness of brain trauma outside of his neurology practice.
  • Dr. Villanueva has been recognized for excellence in service many times in his career, including the Best Doctors in America Award in Neurological Surgery (2019-2020).
  • Dr. Villanueva would like to dedicate this honor to his mentors, Hubert Rosomoff, MD; Barth Green, MD; and Bradley Ruben, MD.

SeaStar Medical-Sponsored Symposium Featuring Experts Discussing Pediatric Acute Kidney Injury and the Selective Cytopheretic Device to be Webcast Live at AKI & CRRT 2024

Retrieved on: 
måndag, mars 11, 2024
Chronic kidney disease, FAAP, Multiple organ dysfunction syndrome, Medical director, Critical care, FDA, CKRT, SCD, Hospital, Risk, Conference, University, SeaStar, Acute kidney injury, AKI, CRRT, Nephrology, Pharmaceutical industry

DENVER, March 11, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces its sponsorship of an Industry Symposium titled “New Therapies in Pediatric Acute Kidney Injury” on March 13, 2024 at the 29th International Conference on Advances in Critical Care Nephrology – Updates in ICU Medicine: Controversies, Challenges and Solutions (AKI & CRRT 2024). The hybrid in-person and virtual conference is being held March 12-15 in San Diego.

Key Points: 
  • The hybrid in-person and virtual conference is being held March 12-15 in San Diego.
  • “Despite advancements in kidney replacement therapy, mortality rates in children with acute kidney injury (AKI) and multi-organ failure requiring continuous kidney replacement therapy (CKRT) remain at about 50%, and children who survive an AKI episode are at elevated risk of chronic kidney disease.
  • “It’s exciting to have recognized leaders in AKI and nephrology who serve on the SeaStar Medical Scientific Advisory Board participate in this symposium.
  • The discussion will highlight our technology, clinical data and the recent FDA approval of the SCD-PED, the first therapeutic device in our Quelimmune product family,” said Kevin Chung, MD, SeaStar Medical’s Chief Medical Officer.

Kamada Issues 2024 CEO Letter to Shareholders

Retrieved on: 
onsdag, mars 6, 2024
Acquisition, KMDA, CMV, Hospital, Division, EMA, CSL Behring, Letter, Physician, Critical care, FDA, Technology transfer, Food, Growth, FEV1, AAT, Immunoglobulin G, Safety, University, European Medicines Agency, Food and Drug Administration, Pan American Health Organization, Patient, Plasma, Research, Partnership, Pharmaceutical industry

The recently completed 2023 was another successful period in our commercial journey as a global leader in the specialty plasma-derived field.

Key Points: 
  • The recently completed 2023 was another successful period in our commercial journey as a global leader in the specialty plasma-derived field.
  • Looking ahead, we expect the momentum from 2023 to extend throughout 2024, with profitability to be further increased as compared to last year.
  • These significant catalysts are propelling our continued annual double-digit profitable growth with substantial upside potential and limited downside risk.
  • On behalf of the entire Kamada team, we look forward to continuing to support patients and clinicians with the important lifesaving products that we develop, manufacture, and commercialize.

Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 by the U.S. Food and Drug Administration for the Prevention of Delayed Graft Function in Kidney Transplant Patients

Retrieved on: 
måndag, mars 4, 2024
DGF, Kidney, KATP, LOS, MD, Critical care, FDA, Food, Conference, Mitochondrion, ODD, Therapy, Patient, AKI, Kidney disease, Diagnosis, CRRT, Kidney transplantation, Pharmaceutical industry

LOS ALTOS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.

Key Points: 
  • LOS ALTOS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.
  • UNI-494 is a cytoprotective agent that elicits an ischemic preconditioning effect by activating KATP channels in mitochondria to restore mitochondrial function.
  • “We are pleased to announce that the FDA has granted orphan drug designation to UNI-494 for the prevention of delayed graft function after kidney transplantation, an unmet medical need for which there are no FDA-approved drugs,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • “Obtaining ODD is an important milestone in the development of UNI-494 that may provide certain tax credits for qualified clinical trials, exemption of user fees, and the potential for seven years of market exclusivity after approval.

RS BioTherapeutics Creates Therapeutic Expert Council to Provide Guidance on Development of First-in-Class Agent Focused on Chronic Obstructive Pulmonary Disease and Idiopathic Pulmonary Fibrosis

Retrieved on: 
onsdag, februari 21, 2024
TEC, IPF, University, Idiopathic disease, Division, Assistant, Critical care, Idiopathic pulmonary fibrosis, Chronic obstructive pulmonary disease, Clinical research, Outline of health sciences, Consultant, Respiratory Medicine, Death, SUNY, Observation, Harvard Medical School, COPD, Pharmaceutical industry

CUMBERLAND, Md., Feb. 21, 2024 (GLOBE NEWSWIRE) -- RS BioTherapeutics, whose mission is to develop life-changing medicines for the millions of people suffering from diseases characterized by pulmonary inflammation, is pleased to announce the formation of its Therapeutic Expert Council (TEC).

Key Points: 
  • CUMBERLAND, Md., Feb. 21, 2024 (GLOBE NEWSWIRE) -- RS BioTherapeutics, whose mission is to develop life-changing medicines for the millions of people suffering from diseases characterized by pulmonary inflammation, is pleased to announce the formation of its Therapeutic Expert Council (TEC).
  • The TEC will help guide the development of RS BioTherapeutics’ first-in-class, steroid-free agent, RSBT-001, in development for Chronic Obstructive Pulmonary Disease (COPD), the third leading cause of death in the world; and Idiopathic Pulmonary Fibrosis (IPF), a rare disease with no cure that claims 40,000 lives each year in the U.S.
  • All have exceptional credentials and are uniquely qualified to help support the development of our first investigational compound, RSBT-001.
  • I’m excited to collaborate with them and look forward to engaging their diverse perspectives spanning the fields of COPD, IPF, and other diseases characterized by pulmonary inflammation.”

Amring Pharmaceuticals Inc. Announces Name Change to Nordic Pharma, Inc. Under New Nordic Group, B.V. Ownership

Retrieved on: 
måndag, mars 4, 2024
Biotechnology, Pharmaceutical, Optical, Health, Acquisition, Ophthalmology, Critical care, FDA, Drainage, DED, Telecanthus, Patient

Amring Pharmaceuticals Inc. (“Amring”) announces its name change to Nordic Pharma, Inc. on March 4, 2024, following the change in ownership of the company from SEVER Life Sciences, B.V. to Nordic Group, B.V., a subsidiary of SEVER Life Sciences B.V., which occurred on June 1, 2023.

Key Points: 
  • Amring Pharmaceuticals Inc. (“Amring”) announces its name change to Nordic Pharma, Inc. on March 4, 2024, following the change in ownership of the company from SEVER Life Sciences, B.V. to Nordic Group, B.V., a subsidiary of SEVER Life Sciences B.V., which occurred on June 1, 2023.
  • The change in the corporate name provides for better alignment strategically with the parent company headquartered in the Netherlands and its subsidiaries worldwide.
  • Nordic Pharma will be launching LACRIFILL in the U.S. in Q2 2024 followed by a global rollout.
  • Charlotte Phelps, CEO of Nordic Pharma said, “The strategic acquisition and merger of the US business unit is a cornerstone of Nordic Pharma's global expansion.

Dr. David Yamane was awarded the Star Research Award at the 2024 Critical Care Congress for the presentation of the HYPERACT Study - a randomized controlled trial demonstrating Vapotherm's High Velocity Therapy effectively treats moderate-severe acute exa

Retrieved on: 
onsdag, mars 6, 2024
VAPO, Hospital, Incidence, Doctor of Philosophy, Periodic breathing, Randomized controlled trial, Critical care, ED, Society, Chronic obstructive pulmonary disease, SCCM, Face, Disease, Patient, Congress, OTCQX, British Journal of Anaesthesia, Mortality, Critical Care Medicine (journal), COPD, Pressure, PCO2

The award is in recognition of the HYPERACT study – a new multi-center, randomized controlled trial which offers high velocity therapy as an additional, more comfortable, option for clinicians treating acute exacerbations of moderate-severe COPD.

Key Points: 
  • The award is in recognition of the HYPERACT study – a new multi-center, randomized controlled trial which offers high velocity therapy as an additional, more comfortable, option for clinicians treating acute exacerbations of moderate-severe COPD.
  • Acute exacerbations of COPD contribute to over 600K emergency room (ER) visits and 140K deaths annually in the US alone.
  • "This study concludes that high velocity therapy provides similar clinical results and statistically superior patient reported comfort compared to mask-based therapies."
  • (3)
    Dr. Yamane was presented with the award at the 2024 Critical Care Congress on January 23rd, 2024, in Phoenix, AZ.

Liberty Bankers Insurance Group Introduces Four New Supplemental Health Products

Retrieved on: 
tisdag, mars 5, 2024
Critical care, Hospital, Heart, Life, Stroke, Health

DALLAS, March 5, 2024 /PRNewswire/ -- Liberty Bankers Insurance Group (LBIG), a nationally recognized provider of life, health, and wealth products, today announces the launch of four new supplemental health products through Liberty Bankers Life Insurance Company. In addition to Hospital Indemnity Plus, the Plus Series product line now offers Accident Plus, Cancer Plus, Critical Care Plus, and Heart and Stroke Plus.

Key Points: 
  • Plus Series Product Line Includes Accident, Cancer, Critical Care, and Heart and Stroke Plans
    DALLAS, March 5, 2024 /PRNewswire/ -- Liberty Bankers Insurance Group (LBIG), a nationally recognized provider of life, health, and wealth products, today announces the launch of four new supplemental health products through Liberty Bankers Life Insurance Company.
  • The new products are available through the company's independent agent distribution channel in 17 states, with additional states launching in the near future.
  • "In addition to our currently available Hospital Indemnity Plus coverage, we are excited to have expanded our product line," said Dave Peters, senior vice president, supplemental health division at Liberty Bankers Insurance Group.
  • "The flexibility of these products allows agents to customize benefits to fit the needs, wants, and budget of their clients."

FDA Approves First Medication to Help Reduce Allergic Reactions to Multiple Foods After Accidental Exposure

Retrieved on: 
fredag, februari 16, 2024
Human services, Allergy, Fever, Division, Research, Food allergy, Polyp (medicine), Sinusitis, Hazelnut, Cosmetics, Multimedia, Hypersensitivity, Dietary supplement, Critical care, FDA, Food, Immunoglobulin E, Infection, Asthma, Anaphylaxis, Peanut allergy, Skin, Vomiting, Emergency, Vaccine, Risk, Animal, Safety, Heated tobacco product, Arthralgia, History, Milk, Malignancy, Rash, Public, Patient, Adrenaline, Peanut, Priority review

Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.

Key Points: 
  • Xolair is intended for repeated use to reduce the risk of allergic reactions and is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.
  • "While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs."
  • Current treatment requires strict avoidance of the food(s) the patient is allergic to, and prompt administration of epinephrine to treat anaphylaxis should accidental exposures occur.
  • Xolair is the first FDA-approved medication to reduce allergic reactions to more than one type of food after accidental exposure.