Dialysis

SeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients

Retrieved on: 
Tuesday, March 12, 2024
CKRT, Randomness, Sepsis, Survival rate, Neutrophil, Monocyte, AKI, Humanitarian Device Exemption, Patient, Hospital, Acute respiratory distress syndrome, Mortality, Acute kidney injury, Standard of care, MD, HDE, KRT, Safety, Dialysis, Chronic kidney disease, SCD, FDA, Food, Pharmaceutical industry

DENVER, March 12, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, provides updates on the acute kidney injury (AKI) programs it is developing with its patented, first-to-market, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill patients with AKI.

Key Points: 
  • “We now have 21 subjects enrolled across five clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which is intended to evaluate the safety and efficacy of our SCD in adult AKI patients.
  • Additional sites are progressing through the site activation and contract completion process,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We expect the pace of enrollment will accelerate as more medical centers come onboard.
  • With the Approval Order, SeaStar Medical can build Quelimmune Clinical Kits into inventory in parallel to the hospital approvals process.

MarinHealth Medical Center Becomes First Hospital in Northern California to Successfully Implant AVEIR™ DR, the World’s First Dual Chamber Leadless Pacemaker System

Retrieved on: 
Friday, April 5, 2024
Cardiology, Biotechnology, Surgery, General Health, Health, Medical Devices, Hospitals, Health Technology, VR, Communication, Infection, Atrial fibrillation, Risk, Immunosuppression, Patient, Cardiac electrophysiology, MD, Life, Stroke, Leg, Engineering, Heart, Dialysis, San Francisco Bay Area, FDA, Food, Medical device

MarinHealth Medical Center today announced the successful implantation of an AVEIR™ DR pacemaker system, becoming the first hospital in Northern California to insert the world’s first dual chamber leadless pacemaker system.

Key Points: 
  • MarinHealth Medical Center today announced the successful implantation of an AVEIR™ DR pacemaker system, becoming the first hospital in Northern California to insert the world’s first dual chamber leadless pacemaker system.
  • “MarinHealth is proud to be at the forefront in the clinical care of heart rhythm disorders.
  • Now, we are excited to become the first center in Northern California to offer dual chamber leadless pacemaker technology, which provides yet another state-of-the-art solution for heart rhythm patients in our community,” said Anita Chandrasena, MD , Chief Medical Officer of MarinHealth.
  • Roughly one-tenth the size of a traditional pacemaker, the dual chamber AVEIR leadless pacing system is made up of two devices: a ventricular (VR) and an atrial (AR) leadless pacemaker.

Rockwell Medical Expands Global Distribution in the Dominican Republic and Bermuda

Retrieved on: 
Thursday, April 4, 2024
Packaging, Logistics, Supply Chain Management, Manufacturing, Other Health, Public Relations, Investor Relations, Marketing, Communications, Medical Devices, Social Media, Small Business, Human Resources, Science, Other Transport, Professional Services, Trucking, Medical Supplies, Health, Transport, Managed Care, Other Science, General Health, Research, Rockwell Medical, The Company, AMI, Peritoneal dialysis, Senior, Dialysis, Vaccine

Rockwell Medical signed a five-year distributor agreement with BioNuclear through which BioNuclear may import, sell, promote and distribute Rockwell Medical's hemodialysis concentrates products within the Dominican Republic.

Key Points: 
  • Rockwell Medical signed a five-year distributor agreement with BioNuclear through which BioNuclear may import, sell, promote and distribute Rockwell Medical's hemodialysis concentrates products within the Dominican Republic.
  • The amended distribution agreement between Rockwell Medical and AMI expands the list of hemodialysis products that AMI is purchasing from the Company, includes purchasing commitments, and generates a profit margin consistent with Rockwell Medical's gross margin guidance for 2024.
  • "This updated distribution agreement with Rockwell Medical affords us the ability to serve and deliver more high-quality, life-sustaining products to the fragile dialysis population in Bermuda."
  • "The global reach of our hemodialysis concentrates products continues to grow," said Tim Chole , Senior Vice President, Sales and Marketing at Rockwell Medical.

AngioDynamics Reports Fiscal Year 2024 Third Quarter Financial Results; Updates Fiscal Year 2024 Guidance to Reflect Asset Divestiture

Retrieved on: 
Thursday, April 4, 2024
Health, Oncology, Cardiology, Medical Devices, Radio, MED, Dialysis, Pulmonary embolism, Growth, Patient, News, Nanoknife, Cancer, Public expenditure, Table, APEX, Quality of life, PICC, Radiofrequency ablation, IP, GAAP, Patent, Starburst, FDA, Medical laboratory scientist, Pharmaceutical industry

Net sales for the third quarter of fiscal year 2024 were $66.0 million, an increase of 8.0% compared to the prior-year quarter.

Key Points: 
  • Net sales for the third quarter of fiscal year 2024 were $66.0 million, an increase of 8.0% compared to the prior-year quarter.
  • U.S. net sales in the third quarter of fiscal 2024 were $55.8 million, an increase of 5.9% from sales of $52.7 million a year ago.
  • GAAP reported gross margin was 47.7%, a decrease of 250 basis points compared to the third quarter of fiscal 2023.
  • On a pro forma basis, gross margin for the third quarter of fiscal 2024 was 51.1%, a decline of 290 basis points from the third quarter of fiscal 2023.

Equillium Announces Positive Topline Data from the Type B Portion of the Phase 1b EQUALISE Study of Itolizumab in Lupus Nephritis

Retrieved on: 
Monday, April 1, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, EOS, Itolizumab, Week, S1P, Dialysis, Type, AMP, Exercise, Ono Pharmaceutical, Infection, Lymphocytopenia, Patient, Serum albumin, Peripheral edema, CD6, Lupus, EULAR, EGFR, Therapy, Proteinuria, ALC, Lupus nephritis, Nursing

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients.

Key Points: 
  • Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced positive topline data from the Type B portion of the Phase 1b EQUALISE study evaluating itolizumab in lupus nephritis patients.
  • Key topline data from the Type B portion of the EQUALISE study in lupus nephritis:
    Subjects were highly proteinuric: baseline mean UPCR of 4.9 g/g.
  • Itolizumab treatment (over 6 months) was also associated with reductions in absolute lymphocyte counts (ALC), another known pharmacodynamic effect.
  • Two subjects had at least one serious adverse event, none of which were related to study treatment.

Rockwell Medical Named 'Great Place to Work' for Second Year in a Row

Retrieved on: 
Monday, March 25, 2024
Medical Devices, Medical Supplies, Human Resources, Hospitals, Health Technology, Professional Services, Other Health, Managed Care, Health, Dialysis, Trust, Human, Patient, Rockwell Medical, The Company, Accreditation, Human resources, Kidney disease

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 it has been certified as a Great Place to Work® for the second year in a row.

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 it has been certified as a Great Place to Work® for the second year in a row.
  • "We are proud to be named a 'Great Place to Work' for the second year in a row," said Lesley Spriggs, Vice President of Human Resources at Rockwell Medical.
  • "This accreditation is a genuine reflection of how our employees feel about their experiences working at Rockwell, where we encourage and foster authenticity, trust, leadership and innovation.
  • Looking to grow your career at a company that puts its people first?

Rockwell Medical Achieves Profitability on an Adjusted EBITDA Basis in the Fourth Quarter 2023 and Record Net Sales, Gross Profit and Gross Margin for the Full-Year 2023

Retrieved on: 
Thursday, March 21, 2024
Medical Devices, Packaging, Transport, Manufacturing, Biotechnology, General Health, Health, Logistics, Supply Chain Management, Science, Other Science, Rockwell Medical, The Company, Kidney disease, Patient, Sale, Investment, Dialysis, Security, LP, Cryptocurrency

Net sales for the three months ended December 31, 2023 were $22.1 million.

Key Points: 
  • Net sales for the three months ended December 31, 2023 were $22.1 million.
  • Net sales for the twelve months ended December 31, 2023 were $83.6 million, representing a 15% increase over the same period in 2022.
  • Gross margin for the twelve months ended December 31, 2023 was 10%, representing an increase from 6% gross margin for the same period in 2022.
  • During the fourth quarter of 2023, Rockwell Medical lowered its outstanding debt from $9.5 million to $8.0 million.

Vertex Announces FDA Clearance of Investigational New Drug Application for VX-407 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Retrieved on: 
Thursday, March 21, 2024
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, Clinical Trials, Death, Autosome, VRTX, Growth, Disease, PC1, Patient, Kidney failure, Kidney transplantation, Polycystic kidney disease, IND, Vertex Pharmaceuticals, PKD1, Vertex, ADPKD, Dialysis, Cystic fibrosis, Food, Pharmaceutical industry

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for VX-407, an investigational first-in-class small molecule corrector that targets the underlying cause of autosomal dominant polycystic kidney disease (ADPKD) in patients with a subset of PKD1 genetic variants.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for VX-407, an investigational first-in-class small molecule corrector that targets the underlying cause of autosomal dominant polycystic kidney disease (ADPKD) in patients with a subset of PKD1 genetic variants.
  • ADPKD is the most common inherited kidney disease, with an estimated 250,000 people in the U.S. and Europe living with ADPKD; however, there are no treatments currently available that address the underlying causal biology of the disease.
  • ADPKD is a life-shortening genetic kidney disease characterized by the growth of numerous kidney-enlarging cysts that impair kidney function and can ultimately lead to kidney failure, requiring dialysis or kidney transplantation, and premature death.
  • The majority of ADPKD cases are caused by variants in the PKD1 gene, which encodes the polycystin 1 (PC1) protein.

eGenesis Announces World’s First Successful Transplant of Genetically Engineered Porcine Kidney in a Living Patient

Retrieved on: 
Thursday, March 21, 2024
Research, Other Health, General Health, Oncology, Hospitals, Genetics, Surgery, Clinical Trials, Science, Biotechnology, FDA, Health, Other Science, Pelvic floor dysfunction, MGH, Kidney disease, Gene, Organization, Survival, Massachusetts General Hospital, Transplant, Inflammation, Immunosuppression, Kidney failure, Mortality, Coagulation, Hope, Doctor of Philosophy, Expanded access, Quality of life, Genome, Transgene, Hospital, Kidney, Dialysis, CD40L, Courage, Kidney transplantation, Medicine, Dentistry

eGenesis , a biotechnology company developing human-compatible engineered organs to address the global organ shortage, today announced the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

Key Points: 
  • eGenesis , a biotechnology company developing human-compatible engineered organs to address the global organ shortage, today announced the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.
  • Following the procedure, the patient is in good condition and recovering well at MGH.
  • Yet the demand for organs far outpaces supply, with more than 90,000 individuals on the kidney waitlist and approximately 25,000 kidney transplants performed each year.
  • Decades of progress in cross-species transplantation, accelerated by the advancement of modern genome editing tools and next-generation sequencing, have enabled eGenesis to progress genetically engineered organs to the clinical setting.

Community Health Systems, Inc. (CYH) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Investors to Seek Compensation for Alleged Wrongdoings

Retrieved on: 
Thursday, March 14, 2024
Class Action Lawsuit, Professional Services, Legal, CYH, Community, Community Health Systems, Manager, Community health, News, DOJ, Annual report, Dialysis

Attorney Advertising--Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Community Health Systems, Inc. (“Community Health” or “the Company”) (NYSE: CYH).

Key Points: 
  • Attorney Advertising--Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Community Health Systems, Inc. (“Community Health” or “the Company”) (NYSE: CYH).
  • Investors who purchased Community Health securities are encouraged to obtain additional information and assist the investigation by visiting the firm’s site: bgandg.com/CYH .
  • On February 21, 2024, Community Health disclosed in its Annual Report for 2023 that it was under investigation by the U.S. Department of Justice (“DOJ”).
  • Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that represents investors in securities fraud class actions and shareholder derivative suits.