End organ damage

Artificial Organs Global Market Report 2023: A Potential $17.7 Billion Opportunity by 2027 - Benefits of Artificial Organs Over Traditional Transplants Drive Market Expansion - ResearchAndMarkets.com

Retrieved on: 
Monday, November 13, 2023
Hospitals, Health, Surgery, Medical Supplies, Kidney disease, COPD, Artificial organ, Prevalence, Cardiomyopathy, Investment, Liver cancer, Pelvic floor dysfunction, End organ damage, Idiopathic pulmonary fibrosis, Pulmonary hypertension, Viral, Inflammation, Chronic obstructive pulmonary disease, Blood, Organ transplantation, Ageing, Infection, Myocarditis, Growth, Cystic fibrosis, Moyamoya disease, Organic, Accident, Sonova, LivaNova, Smoking, Blood pressure, Aquaculture, Dentistry

This report is a comprehensive study of the global artificial organs market.

Key Points: 
  • This report is a comprehensive study of the global artificial organs market.
  • It describes the artificial organs market, segmented by product type and region.
  • Based on product type, the market is segmented into artificial hearts, artificial kidneys, artificial lungs, artificial pancreases, and cochlear implants.
  • Emerge more prepared and stay at the forefront of the global artificial organs market.

Boston Medical Center to Offer First FDA-Approved Gene Therapy Treatment Program for Sickle Cell Disease

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Friday, December 8, 2023
BMC, Safety, Chronic pain, Life, Pulmonology, CRISPR Therapeutics, Therapy, Sickle cell disease, Disease, Risk, Vertex Pharmaceuticals, Clinical trial, Vertex, Patient, Nephrology, End organ damage, FDA, Conditional sentence, DSM-IV codes, CRISPR, Pain, Doctor of Philosophy, Volatile organic compound, SCD, Stroke, Blood, Boston Medical Center, Center of excellence, Pharmaceutical industry, Nursing, MD

BOSTON, Dec. 8, 2023 /PRNewswire/ -- Boston Medical Center (BMC), a national leader in the treatment of sickle cell disease for more than 50 years, announced today that it will offer the first-ever gene therapy treatment program for sickle cell disease that uses a type of novel genome editing technology. The new therapy leverages the latest advances in medical science to alleviate the severe painful vaso-occlusive crises (VOCs) associated with sickle cell disease, in a long-awaited step toward equity for a disproportionally impacted Black patient population.

Key Points: 
  • BOSTON, Dec. 8, 2023 /PRNewswire/ -- Boston Medical Center (BMC), a national leader in the treatment of sickle cell disease for more than 50 years, announced today that it will offer the first-ever gene therapy treatment program for sickle cell disease that uses a type of novel genome editing technology.
  • The announcement comes as the FDA today granted approval of this new therapy, jointly developed by Boston-based Vertex Pharmaceuticals and CRISPR Therapeutics of Switzerland, along with approval of another cell-based gene therapy for sickle cell disease.
  • BMC is the only hospital in New England to offer the Vertex Pharmaceuticals and CRISPR Therapeutics therapy to eligible adults with sickle cell disease.
  • "Boston Medical Center has a longstanding commitment to providing advanced clinical care to those with sickle cell disease," said Dr. Jean-Antoine Ribeil, MD, PhD, Clinical Director of the Center of Excellence in Sickle Cell Disease at Boston Medical Center and an internationally renowned hematologist who has dedicated his career to the development of gene therapies for patients with sickle cell disease and beta thalassemia.

FDA Approves First Gene Therapies to Treat Patients with Sickle Cell Disease

Retrieved on: 
Friday, December 8, 2023
Malignancy, VOC, DNA, Sickle cell disease, Abdominal pain, Headache, Patient, Research, Hemoglobin A, Cas9, CRISPR, Oxygen, Volatile organic compound, Recurrence, Fever, Mutation, Priority review, DSM-IV codes, Vomiting, Bone marrow, Hematology, China Biologic Products, Safety, Food, Multimedia, Rejection, HBF, Ronas Voe, Health, Person, Nausea, Throat, Mouth, Hispanic and Latino Americans, Public, Adolescence, Stomatitis, Risk, Tissue, Febrile neutropenia, History, End organ damage, Fetal hemoglobin, Animal, Pain, SCD, B cell, Regenerative medicine, Heated tobacco product, Disease, FDA, African Americans, Mouth ulcer, Vaccine, Cosmetics, Blood, Human services, Dietary supplement, Freedom, Pharmaceutical industry

Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S.

Key Points: 
  • Sickle cell disease is a group of inherited blood disorders affecting approximately 100,000 people in the U.S.
  • The primary problem in sickle cell disease is a mutation in hemoglobin, a protein found in red blood cells that delivers oxygen to the body's tissues.
  • Casgevy, a cell-based gene therapy, is approved for the treatment of sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises.
  • In patients with sickle cell disease, increased levels of HbF prevent the sickling of red blood cells.

Lucio N. Gordan, MD is Lead Author of First Real-World Study Comparing Preferred Treatments for Multiple Myeloma

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Wednesday, November 22, 2023
Bone marrow, End organ damage, Immune system, Food, Multiple myeloma, DRD, Progression-free survival, Risk, FCS, Clinical trial, TIE, Patient, PFS, Lenalidomide, Death, HIV disease progression rates, Vaccine, Pharmaceutical industry, Dexamethasone, ScienceDirect

FORT MYERS, Fla., Nov. 22, 2023 /PRNewswire/ -- Medical oncologist Lucio N. Gordan MD, president and managing physician of Florida Cancer Specialists & Research Institute, LLC (FCS), is lead author of the first real-world study comparing the two preferred regimens recommended for the primary treatment of non-transplant patients with newly-diagnosed multiple myeloma, published recently in Science Direct. Results of the study to assess optimal clinical treatment strategies were reported in the article entitled, "Progression-Free Survival of Daratumumab (DRd) Versus Bortezomib Triplet Combination With Lenalidomide and Dexamethasone (VRd) in Transplant Ineligible Patients (TIE) With Newly Diagnosed Multiple Myeloma (NDMM): TAURUS Chart Review Study."

Key Points: 
  • Results of the study to assess optimal clinical treatment strategies were reported in the article entitled, "Progression-Free Survival of Daratumumab (DRd) Versus Bortezomib Triplet Combination With Lenalidomide and Dexamethasone (VRd) in Transplant Ineligible Patients (TIE) With Newly Diagnosed Multiple Myeloma (NDMM): TAURUS Chart Review Study."
  • However, previous to the TAURUS study, no direct head-to-head clinical trial had been conducted to compare the efficacy of the two regimens.
  • Cancerous tumors can weaken the body's immune system, damage bones and lead to end-organ damage.
  • MM is the second most common hematologic malignancy in the U.S. Two thirds of newly diagnosed patients are 65 years or older.

Cytovale Secures $84 Million Series C to Advance Commercialization of Transformative Sepsis Diagnostic Tool

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Wednesday, November 15, 2023
Septic, Attention, Sepsis, SAN, GHIC, Risk, ED, Patient, End organ damage, Probability, FDA, Partner, Norwest Venture Partners, MD, Infection, Death, Splenic infarction, Hospital, Mechanics, Face, Triage, Pharmaceutical industry, Nursing, Vaccine

SAN FRANCISCO, Nov. 15, 2023 /PRNewswire/ -- Cytovale®, a commercial-stage medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, today announced it has raised $84 million in Series C funding led by Norwest Venture Partners with participation by additional new investors Sands Capital and Global Health Investment Corporation (GHIC). The financing included participation from other new and existing investors, as well as the conversion of bridge notes. Cytovale will use the proceeds to bring its recently FDA-cleared rapid sepsis diagnosis test – IntelliSep® – to more hospital emergency departments (ED) and health systems in the United States, addressing historical diagnosis lag time that makes sepsis the leading cause of death in U.S. hospitals.

Key Points: 
  • "Sepsis is a dangerous, fast-moving condition that can result in death if not identified and treated quickly," said Cytovale CEO Ajay Shah.
  • "Our flagship diagnostic tool, IntelliSep, with a blood-to-answer time frame of under 10 minutes, helps healthcare providers recognize sepsis early and make critical, time-sensitive clinical decisions.
  • Sepsis is the leading cause of death in U.S. hospitals, with more than one-third of all in-hospital deaths attributed to the condition.
  • About 80% of sepsis patients present to the ED , where it can be difficult to discern from ordinary infections or other conditions that can mimic sepsis.

Nuwellis’ Strategic Partner, SeaStar Medical, Receives FDA Approvable Letter for Its Pediatric Selective Cytopheretic Device

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Tuesday, October 31, 2023
FDA, HDE, Food, SCD, MD, Acute kidney injury, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, AKI, Dialysis, Immune system, SeaStar, Intensive care medicine, CKRT, Letter, Hospice and palliative medicine, Sepsis, End organ damage, Patient, Label, Failure, Pharmaceutical industry

MINNEAPOLIS, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its strategic partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for its pediatric Selective Cytopheretic Device (SCD-PED).

Key Points: 
  • MINNEAPOLIS, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its strategic partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), received an Approvable Letter from the U.S. Food and Drug Administration (FDA) for its pediatric Selective Cytopheretic Device (SCD-PED).
  • The Approvable Letter indicates that SeaStar Medical’s Humanitarian Device Exemption (HDE) application substantially meets the requirements for an Approval Order and outlines remaining administrative steps that must be finalized before the HDE can be active for commercialization.
  • For the SCD-PED, these include revisions to product labeling and minor modifications to the post-approval study plan.
  • Nuwellis and SeaStar Medical previously announced an exclusive U.S. license and distribution agreement for Nuwellis to distribute the SCD-PED.

Boehringer Ingelheim achieves major milestone in chronic kidney disease: aldosterone synthase inhibitor on top of empagliflozin delivers promising results in Phase II trial

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Friday, November 3, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Standard of care, University of Washington School of Medicine, Hyperkalemia, Oxford, Pressure, Albuminuria, SGLT2, Kidney, HIV disease progression rates, Society, American Society of Nephrology, Population 1 (album), Chronic kidney disease, Phase, Boehringer Ingelheim, Clinical trial, ASN, Hypertension, Aldosterone, Risk, Kidney disease, University, Serum, ASI, CKD, Safety, End organ damage, Patient, Ingelheim am Rhein, Pharmaceutical industry, UACR, Medicine

Boehringer Ingelheim today announced promising 14-week Phase II data for BI 690517, a novel selective aldosterone synthase inhibitor (ASi).

Key Points: 
  • Boehringer Ingelheim today announced promising 14-week Phase II data for BI 690517, a novel selective aldosterone synthase inhibitor (ASi).
  • “With over 1 billion people worldwide affected by these conditions, the potential to help reduce the pressure on healthcare systems and patients is immense.
  • We are proud to be leading the way in this field and are excited to move forward with the upcoming Phase III trial to further investigate the potential of this novel compound on top of standard of care including empagliflozin."
  • Hyperkalemia occurred at a rate typical for a CKD population,1 and most episodes did not require medical treatment or BI 690517 discontinuation.1

Nkarta Receives FDA Clearance of IND Application for NKX019 in Lupus Nephritis

Retrieved on: 
Tuesday, October 17, 2023
Investment, Food, Lupus nephritis, Division, Death, Cytarabine, NKG2D, Risk, Rituximab, IND, Safety, University, AML, Conference call, AID, Brattleboro Retreat, Autoimmune disease, Dialysis, FDA, B-cell lymphoma, Workforce, Department of Medicine – University of Pamplona, Lupus, ET, CAR, Immune system, Patient, End organ damage, Rheumatic Disease Clinics of North America, LN, Kidney disease, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, SAN, MRD, NK, University of Massachusetts Chan Medical School, Parikh, Conference, Investigational New Drug, SLE, NHL, Pharmaceutical industry, Vaccine, Cryptocurrency, Nursing, LD, Rheumatology, Medicine

(1)

Key Points: 
  • (1)
    The multi-center, open label, dose escalation clinical trial will assess the safety and clinical activity of NKX019 in patients with refractory LN.
  • “The clearance of Nkarta’s IND for NKX019 in lupus nephritis is an important achievement for Nkarta, and we feel NK cell therapy is ideally suited for the treatment of autoimmune disease,” said Paul J. Hastings, President and CEO of Nkarta.
  • Nkarta announced today the opening of a new cohort in its Phase 1 study of NKX019 in r/r NHL.
  • Nkarta management will discuss its program in autoimmune disease and other corporate updates on Tuesday, October 17, at 8:00 a.m.

Fibronostics Announces Partnership with Stone Diagnostics

Retrieved on: 
Tuesday, October 10, 2023
Partnership, Social prescribing, Guideline, United, Health care, Biomarker, Customer support, Prevalence, AI, ROSA, Liver, Chronic liver disease, AASLD, Rock (geology), Chemistry, Growth, Biopsy, Patient, End organ damage, Steatosis, Fibrosis, DSM-IV codes, Physician, Liver disease, EASL, MAFLD, Medical imaging, Medical device

SANTA ROSA BEACH, Fla. and SINGAPORE, Oct. 10, 2023 /PRNewswire/ -- Fibronostics , a global leader in non-invasive, AI-driven diagnostic testing for *MAFLD/MASH patients, announced today a strategic partnership with Stone Diagnostics, a leading provider of laboratory services in the United States.

Key Points: 
  • SANTA ROSA BEACH, Fla. and SINGAPORE, Oct. 10, 2023 /PRNewswire/ -- Fibronostics , a global leader in non-invasive, AI-driven diagnostic testing for *MAFLD/MASH patients, announced today a strategic partnership with Stone Diagnostics, a leading provider of laboratory services in the United States.
  • Stone Diagnostics will provide Physicians and their patients end to end service to enable Physicians to assess chronic liver disease with Fibronostics' benchmark product, LIVERFASt™.
  • Stone Diagnostics' combination of scaled operational excellence and leading digital capabilities leveraging MyHealthAI is ideal and vital to serve doctors using LIVERFASt™ to screen, identify and monitor *MAFLD/MASH patients.
  • "We are delighted to partner with Stone Diagnostics to provide LIVERFASt™ to the medical community", said Fibronostics CEO Sven Henrichwark.

ImmPACT Bio Granted FDA Fast Track Designation for IMPT-514 for the Treatment of Both Active, Refractory Lupus Nephritis and Systemic Lupus Erythematosus

Retrieved on: 
Tuesday, October 10, 2023
Food, Risk, Mortality, LOS, Cancer, FDA, Fast track (FDA), CAR, Immune system, FTD, End organ damage, LN, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lupus, SLE, Patient, Pharmaceutical industry

LOS ANGELES, Oct. 10, 2023 /PRNewswire/ -- ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for IMPT-514, a potential first-in-class CD19/CD20 CAR-T therapy for the treatment of patients with active refractory lupus nephritis (LN) and systemic lupus erythematosus (SLE). In August 2023, ImmPACT Bio received FDA clearance to initiate clinical development of IMPT-514 in an open label Phase 1b/2 dose escalation trial in participants with active, refractory SLE.

Key Points: 
  • In August 2023, ImmPACT Bio received FDA clearance to initiate clinical development of IMPT-514 in an open label Phase 1b/2 dose escalation trial in participants with active, refractory SLE.
  • "SLE is a systemic, chronic, multi-organ autoimmune disease associated with increased risk of mortality, progressive organ damage, and reduced health-related quality of life.
  • "To address these limitations, IMPT-514 was designed as a one-time treatment option with potential to reset the immune system through deep B-cell depletion.
  • We look forward to dosing the first patient in our Phase 1b/2 trial for the treatment of active, refractory SLE expected in early 2024."