AKI

Rockwell Medical Promotes Tim Chole to Chief Commercial Officer

Retrieved on: 
torsdag, maj 30, 2024
Other Manufacturing, Medical Supplies, Other Science, Research, Packaging, General Health, Logistics, Supply Chain Management, Manufacturing, Medical Devices, Small Business, Public Relations, Investor Relations, Human Resources, Other Transport, Marketing, Trucking, Communications, Transport, Professional Services, Social Media, Health, Science, Allergan, Patient, Economics, Rockwell Medical, AKI, Actavis, Dialysis, Kidney disease, University, Gambro, SVP, Baxter International, Product marketing, The Company, Therapy, Kidney, Pharmaceutical industry

Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that Tim Chole was promoted to Chief Commercial Officer, reporting to the Company's President and CEO, Dr. Mark Strobeck.

Key Points: 
  • Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that Tim Chole was promoted to Chief Commercial Officer, reporting to the Company's President and CEO, Dr. Mark Strobeck.
  • Mr. Chole joined Rockwell Medical in December 2019 as SVP, Sales and Marketing.
  • Mr. Chole has more than 20 years' experience in commercial leadership roles for pharmaceutical and medical device companies.
  • Prior to joining Rockwell Medical, Mr. Chole served as the Director of Product Marketing and Professional Education for hearing implants at Cochlear Americas.

Unicycive Therapeutics Delivers Multiple Presentations on Oxylanthanum Carbonate (OLC) and UNI-494 at the European Renal Association Congress

Retrieved on: 
tisdag, maj 28, 2024
Patient, European Renal Association, Pharmacokinetics, ATP, SAD, AKI, Acute kidney injury, Kidney disease, LOS, Dialysis, Index, DGF, BID, Therapy, Histology, Safety, NGAL, Chronic kidney disease, MD, Congress, Animal, CKD, Rat, Incidence, Biomarker, Kidney, Nanotechnology, Poster, TID, Hyperphosphatemia, Aes, Sevelamer, ERA, Pharmaceutical industry

LOS ALTOS, Calif., May 28, 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 several presentations were delivered on the Company’s two product candidates, oxylanthanum carbonate (OLC) and UNI-494, at the 61st European Renal Association (ERA) Congress. OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator initially targeting acute kidney injury (AKI).

Key Points: 
  • UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator initially targeting acute kidney injury (AKI).
  • This data compliments our previously reported data in the intravenous (IV) form of UNI-494.
  • The study concluded that UNI-494 is a potential candidate for prevention of delayed graft function (DGF) and other clinical conditions resulting from AKI.
  • Oxylanthanum Carbonate (OLC) Presentation Details:
    Results: This oral presentation evaluated the effects of tenapanor and OLC on phosphate excretion in rats.

SeaStar Medical Reports First Quarter 2024 Financial Results and Provides a Business Update

Retrieved on: 
tisdag, maj 14, 2024
Neutrophil, Risk, European Journal, FDA, Chronic kidney disease, Accounting, Cardiorenal syndrome, Research, Therapy, G&A, CRRT, Acute kidney injury, Standard of care, Sepsis, Bangladesh Technical Education Board, Inflammation, Hospital, University, ICU, Patent, Nephron, Acute respiratory distress syndrome, Division, KRT, University of Michigan, AKI, Dialysis, Clinical trial, CKRT, Safety, Marketing, HDE, PMA, SCD, Internal medicine, Clinical study design, Hepatorenal syndrome, HUD, Heart, Heart failure, Manuscript, Monocyte, Mortality, Survival rate, Quality of life, White, Pharmaceutical industry

DENVER, May 14, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three months ended March 31, 2024 and provides a business update.

Key Points: 
  • DENVER, May 14, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three months ended March 31, 2024 and provides a business update.
  • In March 2024 the Company sponsored an industry symposium titled “ New Therapies in Pediatric Acute Kidney Injury ” at the AKI & CRRT 2024 conference.
  • Mr. Green brings to SeaStar Medical extensive financial experience at public medical device and therapeutics companies.
  • The net loss for the first quarter of 2024 was $12.7 million, or $0.19 per share on 67.1 million weighted-average shares outstanding.

Saghmos Therapeutics Announces Issuance of Patent in Japan for Phase 3-Ready Cardiorenal Metabolic Modulator ST-62516

Retrieved on: 
tisdag, maj 14, 2024
Health, Clinical Trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, Diabetes, Patient, AKI, Acute kidney injury, Risk, Patent, Moyamoya disease, FDA, Therapy, Ageing, Safety, Trimetazidine, Chronic kidney disease, MD, Growth, CKD, Percutaneous coronary intervention, PCI, Myocardial infarction, DCRI

Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced that the Japanese Patent Office has issued Japanese Patent No.

Key Points: 
  • Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced that the Japanese Patent Office has issued Japanese Patent No.
  • 7474463 for its Phase 3-ready product, ST-62516 (trimetazidine), a cardiorenal metabolic modulator.
  • The patent will provide exclusivity through 2037, with broad claims for the reduction of acute kidney injury in patients with chronic kidney disease (CKD) undergoing procedures with contrast dyes.
  • "We are excited about the continued growth of Saghmos’ patent estate, with a new Japanese patent, in addition to the issued US patent and a Notice of Allowance for a second US patent,” commented Anna Kazanchyan, MD, Founder and CEO of Saghmos Therapeutics.

InsightRX Unveils Apollo Gold, a Powerful New Tier of the Apollo Analytics Platform

Retrieved on: 
tisdag, april 30, 2024
Health, Acute kidney injury, Apollo, AKI, Patient, SAN, Organization, Risk, Pharmaceutical industry

InsightRX Apollo provides customers with real-time metrics on the effectiveness of precision medicine programs, enabling users to identify clinical impact, recognize opportunities for improvement, and accelerate process improvement initiatives.

Key Points: 
  • InsightRX Apollo provides customers with real-time metrics on the effectiveness of precision medicine programs, enabling users to identify clinical impact, recognize opportunities for improvement, and accelerate process improvement initiatives.
  • "Facilitating data-informed decisions through robust analytics is core to our mission," stated Sirj Goswami, Ph.D., CEO and co-founder of InsightRX.
  • Apollo Gold represents a significant step forward in precision, offering a pathway to actionable data that will benefit patients, clinicians, provider organizations, and the entire healthcare system."
  • A key use case for Apollo is to monitor antibiotic stewardship programs.

SeaStar Medical Reports 2023 Financial Results and Provides a Business Update

Retrieved on: 
onsdag, april 17, 2024
Mortality, FDA, Nephrology, Risk, Nephron, Partnership, Hepatorenal syndrome, Acute kidney injury, ICU, White, AKI, Chronic kidney disease, Monocyte, Heart failure, SCD, Dialysis, CRRT, CKRT, KRT, Inflammation, Safety, Insurance, Clinical study design, Therapy, Clinical trial, G&A, Sepsis, University, HDE, Survival rate, Neutrophil, Acute respiratory distress syndrome, Patent, Cardiorenal syndrome, European Journal, Physician, Manuscript, Bank statement, Standard of care, Pharmaceutical industry

DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update.

Key Points: 
  • DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update.
  • “Lastly, I’m pleased that we have filed our Form 10-K for 2023, which includes restated 2022 financial statements,” said Mr. Schlorff.
  • Mr. Green brings to SeaStar Medical extensive financial experience at public medical device and therapeutics companies.
  • The Company reported cash of $176,000 as of December 31, 2023, compared with $47,000 as of December 31, 2022.

St. Michael’s Hospital Joins the Phase II Trial of LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
tisdag, april 16, 2024
Pillar, Phase, Patient, Reperfusion, Kidney, Inflammation, Arch, Hospital, Randomness, OTCQB, Science Advances, IRI, TMX Group, Kidney disease, Research, Acute kidney injury, Ischemia, Yolo Bypass, Oxygen, Liver, User experience, Unity Health Toronto, Injury, Regeneration, Placebo-controlled study, AKI, Ethics, Pharmaceutical industry

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

Key Points: 
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.
  • Details of the Phase II trial, entitled “ Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery” can be viewed at clinicaltrials.gov .
  • There is no therapeutic treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients.

DoseMe Expands Global Footprint as Premier Hospitals and Cancer Centers across Australia Continue to Adopt Bayesian Dosing

Retrieved on: 
onsdag, april 17, 2024
Software, Pharmaceutical, Oncology, Health, Infectious Diseases, Hospitals, Health Technology, Technology, Mortality, Austin Hospital, Royal North Shore Hospital, Aminoglycoside, Hospital, Risk, Vancomycin, Safety, Research, Royal Perth Hospital, Attention, Acute kidney injury, HITRUST, Patient, Toxicity, AKI, Medicine, Algorithm, Pharmacist, Growth, Pharmaceutical industry

DoseMe , a leading provider of model-informed precision dosing (MIPD) software, is pleased to announce the continued growth in Australia.

Key Points: 
  • DoseMe , a leading provider of model-informed precision dosing (MIPD) software, is pleased to announce the continued growth in Australia.
  • The precision dosing software has informed over 400,000 dosing decisions, benefiting more than 10,000 patients and gaining the trust of over 1,000 clinicians nationwide.
  • “It is exciting to see the global demand around precision dosing, with Australia continuing to be a trailblazer,” said Paul Edwards, CEO of DoseMe.
  • This surge in clientele was boosted by strategic partnerships worldwide, underscoring DoseMe's commitment to global expansion and continuous innovation to deliver advanced precision dosing.

Saghmos Therapeutics Announces Collaboration with Duke Clinical Research Institute to Optimize Phase 3 Cardio-Renal Metabolic Study

Retrieved on: 
onsdag, april 17, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Cardiology, FDA, Kidney disease, Risk, Percutaneous coronary intervention, Safety, Moyamoya disease, Diabetes, PCI, Acute kidney injury, IND, Patient, Myocardial infarction, DCRI, Cardiovascular disease, Multimedia, AKI, Therapy, Chronic kidney disease, Ageing

Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced it will partner with the Duke Clinical Research Institute (DCRI) to optimize all aspects of and plan the operationalization of Saghmos’ Phase 3 study for its cardio-renal metabolic modulator ST-62516.

Key Points: 
  • Saghmos Therapeutics, Inc. (Saghmos), a privately held biopharmaceutical company, announced it will partner with the Duke Clinical Research Institute (DCRI) to optimize all aspects of and plan the operationalization of Saghmos’ Phase 3 study for its cardio-renal metabolic modulator ST-62516.
  • “We are honored to collaborate with the DCRI and its high caliber academic and clinical leadership, as well as its operational experts to optimize all aspects of our Phase 3 study,” commented Anna Kazanchyan, M.D., Founder and CEO of Saghmos Therapeutics.
  • “DCRI has conducted many groundbreaking cardiovascular studies, and their deep knowledge of this area is invaluable to Saghmos.”
    “We are delighted to work with Saghmos.
  • ST-62516 could benefit all people undergoing a PCI, not just those with comorbidities, to reduce the threat of AKI and MACKE after PCI.

Roivios Secures FDA Breakthrough Device Designation for JuxtaFlow® RAD, Showcases Pioneering Data at Society of Cardiovascular Anesthesiologists Annual Meeting

Retrieved on: 
fredag, april 26, 2024
FDA, Kidney disease, Society, Nursing care plan, SCA, RAD, Food, Research, ICU, Breakthrough, Acute kidney injury, Duke University, Oxygen, Patient, Cardiopulmonary bypass, AKI

This landmark recognition, fueled by the encouraging outcomes of the BIPASS-AKI feasibility study , coincides with the unveiling of pioneering research at the Society of Cardiovascular Anesthesiologists (SCA) Annual Meeting.

Key Points: 
  • This landmark recognition, fueled by the encouraging outcomes of the BIPASS-AKI feasibility study , coincides with the unveiling of pioneering research at the Society of Cardiovascular Anesthesiologists (SCA) Annual Meeting.
  • The Breakthrough Device Designation emphasizes the JuxtaFlow® RAD's potential to profoundly change the treatment paradigm for patients facing kidney disease during cardiac surgery.
  • John Erbey, CEO of Roivios, reflected on the significance of this achievement saying, "Securing the Breakthrough Device Designation marks a crucial milestone for Roivios and underscores our dedication to advancing kidney health innovation.
  • For more information about Roivios and the JuxtaFlow® Renal Assist Device, please visit Roivios.com .