Ischemia

IR-MED’s AI-Powered Infra-Red Spectrographic Decision Support System PressureSafe Device Demonstrates High Efficacy in Detecting Pressure Injuries with 96% Accuracy: Potential to Set a New Standard of Care

Retrieved on: 
Monday, July 17, 2023
Clalit Health Services, Pressure, Interim, Health, Bed, Eye, HMO, Rabin Medical Center, Biomarker, Trial of the century, Wheelchair, U.S. FDA, Ischemia, Patient, FDA, Skin, Safety, Medical imaging, Petah Tikva

PressureSafe demonstrated very high efficacy in noninvasively detecting the presence and absence of pressure injuries below the skin’s surface.

Key Points: 
  • PressureSafe demonstrated very high efficacy in noninvasively detecting the presence and absence of pressure injuries below the skin’s surface.
  • Pressure injuries can occur when a patient must stay in a wheelchair or bed and isn’t able to move.
  • Currently, visual inspection is used to detect and classify pressure injuries according to depth, width, degree of tissue loss, and presence of granulated tissue.
  • $26.8 billion is spent each year to prevent and treat pressure injuries that result from long-term pressure on hard surfaces such as wheelchairs and beds.

Caeregen Therapeutics Receives $1.4 Million Phase 2 SBIR Grant from NIH/NEI to Advance Development of Regenerative Medicine Clinical Candidate CTR-107 (Noregen™) for Retinal Diseases

Retrieved on: 
Monday, July 17, 2023
Research, FDA, Neurology, Clinical Trials, Biotechnology, Health, Pharmaceutical, Optical, Science, Retina, Neuron, Priority review, Ranibizumab, Central nervous system, Macular degeneration, Ear, NEI, STTR, Marketing, SBIR, Eye, Paratriathlon, Gene expression, Bangladesh Technical Education Board, FEVR, EMA, Blood, Orphan drug, Ischemia, National Eye Institute, RPD, Norrie disease, Diabetic retinopathy, Therapy, IND, NIH, Pharmaceutical industry

Caeregen is initially developing CTR-107 for the treatment of a rare inherited disorder of retinal blood vessel formation, Familial Exudative Vitreoretinopathy (FEVR).

Key Points: 
  • Caeregen is initially developing CTR-107 for the treatment of a rare inherited disorder of retinal blood vessel formation, Familial Exudative Vitreoretinopathy (FEVR).
  • “The NIH grant will support the nonclinical development program of CTR-107 and accelerate our investigational new drug (IND) submission to begin clinical trials," said Walter Capone, CEO of Caeregen Therapeutics.
  • Retinal disease is the leading cause of vision loss in developed countries and is the fastest growing cause of blindness globally.
  • When injected into the eye, CTR-107 may regenerate retinal blood vessels and neurons, restoring retinal function and counteracting vision loss due to FEVR and other retinal diseases.

TheracosBio Announces Commercial Availability of Brenzavvy™ (bexagliflozin) for the Treatment of Adults with Type 2 Diabetes

Retrieved on: 
Thursday, July 13, 2023
Health, Diabetes, Research, Pharmaceutical, Science, Biotechnology, Diabetic neuropathy, Type 2 diabetes, Tenderness, Dialysis, Gangrene, Pain, Urinary tract infection, A1C, Incidence, Patient, Risk, Insulin, Ulcer, Fasting, Pancreatitis, Diet, Urine, PBC, Cardiovascular disease, Urination, Vomiting, Cost Plus Drugs, Hypoglycemia, FDA, Death, Exercise, DPP4, Chronic kidney disease, Amputation, Creatinine, Hypotension, Dehydration, Metabolic acidosis, Fever, EGFR, CVD, Osteomyelitis, History, Abdominal pain, Ischemia, Blood, Erythema, Metformin, Swelling, Type, Moyamoya disease, Knee, Blood pressure, Medicine, Infection, Pyelonephritis, Food, Hospital, Fatal, Necrotizing fasciitis, Glomerular filtration rate, Diabetic ketoacidosis, Perineum, Calorie, SGLT2, Ketoacidosis, Acute kidney injury, Nausea, Bexagliflozin, Female, Pharmaceutical industry, Dietary supplement, Meat

BRENZAVVY is not recommended for patients with type 1 diabetes mellitus and may increase the risk of diabetic ketoacidosis in these patients.

Key Points: 
  • BRENZAVVY is not recommended for patients with type 1 diabetes mellitus and may increase the risk of diabetic ketoacidosis in these patients.
  • BRENZAVVY treatment can be initiated in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) greater than or equal to 30 mL/min/1.73 m2.
  • "We are excited to offer Brenzavvy to our patients with diabetes," said Mark Cuban, co-founder of Mark Cuban Cost Plus Drug Company.
  • "TheracosBio is breaking new ground by making this product available to consumers at a transparent, low price.

Altamira Therapeutics Announces Collaboration with Heqet Therapeutics on Nanoparticle-Delivered Non-Coding RNAs for Cardiac Regeneration

Retrieved on: 
Wednesday, July 5, 2023
Heart failure, Moyamoya disease, Heart, Nanoparticle, Myocardial infarction, Therapy, Small RNA, Necrosis, American Heart Association, Head, Heqet, Altamira, RNA, Cardiac muscle, King's College London, Imperial College London, Regeneration, Ischemia, MD, Patient, School, Liver, Mortality, Science, Facial muscles, Pharmaceutical industry, Vaccine

Altamira Therapeutics Ltd. (“Altamira” or the “Company”) (Nasdaq:CYTO), a company dedicated to developing and commercializing RNA delivery technology for targets beyond the liver, today announced that it has entered into a collaboration and option agreement with Heqet Therapeutics s.r.l.

Key Points: 
  • Altamira Therapeutics Ltd. (“Altamira” or the “Company”) (Nasdaq:CYTO), a company dedicated to developing and commercializing RNA delivery technology for targets beyond the liver, today announced that it has entered into a collaboration and option agreement with Heqet Therapeutics s.r.l.
  • Based in Turin, Italy, Heqet is a biotech spin-out from King’s College London.
  • Under the terms of the agreement, Heqet will test nanoparticles based on Altamira’s OligoPhore delivery platform and comprising certain non-coding RNAs (ncRNAs) in the regeneration of damaged heart tissue following myocardial infarction in animal models.
  • We believe that our peptide-based OligoPhore platform for RNA delivery has the potential to serve as a safe and effective vehicle for engineering controlled local cardiac regeneration.”

Arch Biopartners Receives Permission From U.S. FDA to Proceed With Phase II Acute Kidney Injury Trial

Retrieved on: 
Tuesday, June 27, 2023
User experience, Science Advances, Oxygen, OTCQB, Arch, IRI, Inflammation, Ethics, AKI, Data monitoring committee, Nephrology, Ischemia, Acute kidney injury, Patient, TMX Group, Risk, Randomness, Cardiology, Kidney, Quality control, Reperfusion, Liver, Phase, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Safety, National Research Council, Placebo-controlled study, Pharmaceutical industry

LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the lungs, liver and kidneys.

Key Points: 
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the lungs, liver and kidneys.
  • The IND application included preclinical data, Phase I and Phase II clinical data to date, manufacturing processes, and the protocol design for the CS-AKI Phase II trial.
  • There will be an independent Data Safety Monitoring Board which will monitor the safety of the patients enrolled in the trial.
  • Cardiac surgery-associated AKI is often caused by ischemia reperfusion injury (IRI) that reduces blood flow and thus oxygen (ischemia) in the kidney causing kidney cell damage.

Fresenius Kabi Launches Vasopressin Injection, USP Expanding U.S. Critical Care Portfolio

Retrieved on: 
Wednesday, June 14, 2023
General Health, Pharmaceutical, Health, Cardiology, Blood pressure, Hypersensitivity, Bradycardia, Tachycardia, Indometacin, Use, Fresenius (company), Allergy, Safety, Hyponatremia, Multimedia, USP, Cardiac output, Endo International, Ischemia, Hospital, Patient, Catecholamine, FDA, Diabetes insipidus, Hypotension, Skin, Beta blocker, SIADH, Pharmaceutical industry, Birth control, Vaccine, Dentistry, Vasopressin

Fresenius Kabi announced today the availability in the United States of Vasopressin Injection, USP, a generic equivalent to Vasostrict®.

Key Points: 
  • Fresenius Kabi announced today the availability in the United States of Vasopressin Injection, USP, a generic equivalent to Vasostrict®.
  • Fresenius Kabi Vasopressin Injection, USP is an approved treatment option for adults with vasodilatory shock and is available in a 20 Units per 1 mL Single Dose Vial.
  • Fresenius Kabi produces Vasopressin Injection, USP in the United States where the company has invested nearly $1 billion on an advanced manufacturing and distribution network dedicated to serving U.S. hospitals and health systems.
  • To learn more about how Fresenius Kabi is strengthening America’s supply chain of care, please visit “ More in America .”
    Please see Important Safety Information below.

Olaris, Inc. to present data on metabolomic changes observed during DCD heart perfusion prior to successful transplant at the American Transplant Congress 2023 Meeting

Retrieved on: 
Monday, June 5, 2023
Heart, Surgeon, MGH, Surgery, Perfusion, DRS, Research, Biomarker, Ischemia, Patient, DCD, Machine learning, Metabolomics, Medicine, Annual general meeting, Reperfusion, Hospital, ATC, Transplant, Massachusetts General Hospital, Metabolite, Heart transplantation, Dentistry, Medical device

FRAMINGHAM, Mass., June 5, 2023 /PRNewswire-PRWeb/ -- Olaris, Inc., a precision medicine company leveraging metabolomics and machine learning to discover and develop its myOLARIS™ diagnostics products, is pleased to announce that the company's study on the metabolic changes occurring in donor hearts after Donation after Circulatory Death (DCD) heart transplant has been selected for a poster presentation on June 5th at the upcoming American Transplant Congress (ATC) 2023 Annual Meeting, to be held June 3rd-7th in San Diego, CA.

Key Points: 
  • Metabolite reprogramming observed in donor hearts after circulatory death and prior to transplant suggests exciting possibility for improved biomarkers to assess DCD heart quality.
  • The ATC 2023 presentation will describe data from a multi-year collaboration between Olaris and an elite team of heart transplant surgeons and researchers at Massachusetts General Hospital, including Drs.
  • The collaboration was formed with the goal of identifying biomarkers of heart damage due to ischemia and reperfusion during DCD heart transplant.
  • They found that several metabolites were consistently altered over time, reflecting metabolic reprogramming in the DCD hearts during machine perfusion.

Humacyte First Quarter 2023 Financial Results and Business Update

Retrieved on: 
Friday, May 12, 2023
Infection, JDRF, Kidney disease, Biologics license application, Surgeon, File, Conference call, AC 25.1309-1, Aneurysm, Survival, Research, Trauma center, Sale, Dialysis, Regenerative medicine, Incidence, Polytetrafluoroethylene, Ischemia, Journal, Publication, Patient, Investment, Level, HUMA, Host, Hemodialysis, BVP, FDA, HAV, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Conference, Food, Safety, Fistula, Pharmaceutical industry, Hospital, Video game, Trauma

DURHAM, N.C., May 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced financial results for the first quarter ended March 31, 2023, and highlighted recent corporate accomplishments.

Key Points: 
  • ET today -
    DURHAM, N.C., May 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced financial results for the first quarter ended March 31, 2023, and highlighted recent corporate accomplishments.
  • There was no revenue for the first quarter of 2023, compared to $0.2 million for the first quarter of 2022.
  • Research and development expenses were $17.3 million for the first quarter of 2023, compared to $16.3 million for the first quarter of 2022.
  • Net cash used in operations was $18.6 million for the first quarter of 2023 compared to $18.8 million for the first quarter of 2022.

Marizyme, Inc.: Marizyme Announces IP Developments for DuraGraft® and its Pipeline of Products

Retrieved on: 
Wednesday, May 10, 2023
LLP, CE, Chronic kidney disease, Private law, Creatinine, Endovascular aneurysm repair, Enzyme, Burn, IP, Incidence, Ischemia, Patent, Epithelium, Growth, Dentons, Skin, Disease, Pharmaceutical industry

The issued patents and allowed patent applications protect DuraGraft, a first-in-class CE marked intra-operative graft storage solution used during bypass surgeries.

Key Points: 
  • The issued patents and allowed patent applications protect DuraGraft, a first-in-class CE marked intra-operative graft storage solution used during bypass surgeries.
  • DuraGraft is the only approved product to preserve and protect vascular grafts during bypass and other vascular surgeries.
  • The patent application relates to a method for mixing two reagents to produce a detectable reaction in a microfluidic chip.
  • Dentons has been consistently ranked for the past years as a top leading life sciences and health care law firm.

HeartSciences Announces Completion of Patient Enrollment for FDA Pivotal Study of MyoVista wavECG

Retrieved on: 
Tuesday, May 9, 2023
HSCS, Diabetes, LV, Heart, ECG, Myocarditis, Intelligence, Facial muscles, Hypertension, Fibrosis, Ischemia, Patient, Physician, Artificial intelligence, AI, Automated ECG interpretation, Medical device, Circulation

Southlake, Texas, May 09, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-based medical technology company focused on transforming ECGs/EKGs to save lives through the early detection of heart disease, today announces completion of patient enrollment for its MyoVista wavECG pivotal study for FDA De Novo submission.

Key Points: 
  • Southlake, Texas, May 09, 2023 (GLOBE NEWSWIRE) -- Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-based medical technology company focused on transforming ECGs/EKGs to save lives through the early detection of heart disease, today announces completion of patient enrollment for its MyoVista wavECG pivotal study for FDA De Novo submission.
  • The study commenced in 2021 and is a prospective, multi-center study to validate the diagnostic performance of the MyoVista wavECG AI algorithm for the detection of impaired left ventricular relaxation.
  • We have invested years in artificial intelligence R&D and have designed our first product, the MyoVista, to detect cardiac dysfunction at an early stage.
  • We are grateful to the clinical institutions and physicians involved in our pivotal study for their diligent work over the past couple of years.