Diuretic

Johnson & Johnson Vision Care Receives FDA Approval for ACUVUE® Theravision™ with Ketotifen - World's First and Only Drug-Eluting Contact Lens

Retrieved on: 
Wednesday, March 2, 2022
Risk, Smoker, Diuretic, Swimming, Lens, Infection, Injury, Lake, Abnormality, Presbyopia, Motion sickness, ACUVUE, Dry, Health, Severe cognitive impairment, Eye, Corneal ulcer, Ketotifen, Mouth, Awareness, Solution, Cornea, Lens (anatomy), Time, Eye care professional, Visual acuity, Medicine, Water, Eyelid, Nursing, Saliva, List, THE, Conjunctiva, Incidence, Health care, Camera, Telescopic sight, Personal protective equipment, Cosmetics, Inspection, Abrasive

Problems with contact lenses or lens care products could result in serious injury to the eye.

Key Points: 
  • Problems with contact lenses or lens care products could result in serious injury to the eye.
  • *Johnson & Johnson Vision represents the products and services of Johnson & Johnson Surgical Vision, Inc., Johnson & Johnson Vision Care, Inc., and the affiliates of both.
  • The Johnson & Johnson Medical Device Companies comprise the surgery, orthopedics, vision, and interventional solutions businesses within Johnson & Johnson's Medical Devices segment.
  • Thomas Swinnen is an employee of Johnson & Johnson Vision Care, Inc.
    1Pall, B., Gomes, P., Yi, F., & Torkildsen, G. (2019).

Nuwellis, Inc. Announces Fourth Quarter and Full Year 2021 Financial Results

Retrieved on: 
Tuesday, March 1, 2022
GLOBE, Omicron, Category, Ultrafiltration, Webcast, Critical care, Growth, Investment, Pediatrics, Diuretic, COVID-19, Company, SG, Private Securities Litigation Reform Act, Net, Adult, Hospital, Science, Overload, Nasdaq, Forward-looking statement, Patient, COVID, CEO, Heart failure, Hypervolemia, SEC, Pharmaceutical industry, Cryptocurrency

Revenue for the fourth quarter of 2021 was $1.6 million, compared to $2.0 million the prior year period.

Key Points: 
  • Revenue for the fourth quarter of 2021 was $1.6 million, compared to $2.0 million the prior year period.
  • When comparing fourth quarter of 2021 to the pre-pandemic fourth quarter of 2019, U.S. product revenue increased 20%.
  • In the fourth quarter of 2021, Pediatrics posted positive sequential growth due to increased patient census in numerous accounts following an uncharacteristically low third quarter.
  • Selling, general and administrative (SG&A) expenses for the fourth quarter of 2021 were $4.1 million, representing a decline of 7% compared to the prior year period and 12% below third quarter of 2021 levels.

Nuwellis, Inc. Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, February 22, 2022
GLOBE, Employment, NASDAQ, Diuretic, Acceleration, Adult, Hospital, Science, Overload, Nasdaq, Patient, Hypervolemia, Pharmaceutical industry

The equity awards were approved in accordance with NASDAQ Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.

Key Points: 
  • The equity awards were approved in accordance with NASDAQ Listing Rule 5635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan.
  • The option awards have an exercise price of $1.10 per share, the closing price of Nuwellis common stock on February 22, 2022, the date of the grants.
  • Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation.
  • All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.

Nuwellis Initiates REVERSE-HF Study to Evaluate Ultrafiltration for Heart Failure Patients with Fluid Overload

Retrieved on: 
Thursday, February 17, 2022
Overload, Ultrafiltration, Patient, Learning, Hypervolemia, Mortality, Company, Science, Lenox Hill Hospital, SEC, Forward-looking statement, Nephrology, Diuretic, Private Securities Litigation Reform Act, Nasdaq, Heart, Heart failure, Adult, Safety, Sodium, Division, University, Growth, Hospital, COVID-19, GLOBE, Randomized controlled trial, Pharmaceutical industry, Medicine

Traditional diuretics can result in mixed outcomes, and people with heart failure who are experiencing fluid overload dont always respond to them, said Dr. Pinney.

Key Points: 
  • Traditional diuretics can result in mixed outcomes, and people with heart failure who are experiencing fluid overload dont always respond to them, said Dr. Pinney.
  • Heart failure can disrupt normal kidney functions and lower their ability to remove sodium from the body, which can cause excessive water retention resulting in fluid overload.
  • Over 1 million heart failure hospitalizations occur annually in the United States, and fluid overload is the predominant cause.
  • The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and predictable method of removing excess fluid from patients suffering from hypervolemia (fluid overload).

Sequana Medical Receives Certification Under MDR, the New European Medical Device Regulation

Retrieved on: 
Monday, February 14, 2022
Overload, Patient, Cirrhosis, Quality of life, Judgement, Company, Medicine, Interim, Diuretic, RED, Heart failure, Adult, Fluid, Safety, Ascites, Sodium, NASH, Abdominal cavity, Congestion, FDA, DSR, Liver disease, Hypervolemia, Urination, Trial of the century, Pharmaceutical industry, EU, Benelux

GHENT, Belgium, Feb. 14, 2022 (GLOBE NEWSWIRE) -- Sequana Medical NV (Euronext Brussels: SEQUA, the “Company” or “Sequana Medical”), an innovator in the treatment of diuretic-resistant fluid overload in liver disease, malignant ascites and heart failure, today announces it has received Medical Device Regulation (MDR) certification from its Notified Body, the British Standards Institution (BSI), ensuring continuous market access of the alfapump system in the European Union (EU).

Key Points: 
  • The alfapump is Sequana Medicals unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination.
  • DSR is Sequana Medicals proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.
  • Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure.
  • You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

Sequana Medical receives certification under MDR, the new European Medical Device Regulation

Retrieved on: 
Monday, February 14, 2022
Overload, Patient, Cirrhosis, Quality of life, Judgement, Company, Medicine, Interim, Diuretic, RED, Heart failure, Adult, Fluid, Safety, Ascites, Sodium, NASH, Abdominal cavity, Congestion, FDA, DSR, Liver disease, Hypervolemia, Urination, Trial of the century, Pharmaceutical industry, EU, Benelux

The alfapump is Sequana Medicals unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination.

Key Points: 
  • The alfapump is Sequana Medicals unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination.
  • DSR is Sequana Medicals proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.
  • Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure.
  • You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

Sequana Medical to present at BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference

Retrieved on: 
Thursday, February 3, 2022
Abdominal cavity, Hypervolemia, Safety, Patient, Cirrhosis, Liver disease, Congestion, Trial of the century, NASH, Diuretic, Judgement, DSR, Sodium, Overload, Medicine, Adult, Fluid, Company, Heart failure, Interim, Ascites, Urination, FDA, Quality of life, RED, Pharmaceutical industry, Benelux, EU

The alfapump is Sequana Medicals unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination.

Key Points: 
  • The alfapump is Sequana Medicals unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination.
  • DSR is Sequana Medicals proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.
  • Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure.
  • You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

Sequana Medical to present at BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference

Retrieved on: 
Thursday, February 3, 2022
Abdominal cavity, Hypervolemia, Safety, Patient, Cirrhosis, Liver disease, Congestion, Trial of the century, NASH, Diuretic, Judgement, DSR, Sodium, Overload, Medicine, Adult, Fluid, Company, Heart failure, Interim, Ascites, Urination, FDA, Quality of life, RED, Pharmaceutical industry, Benelux, EU

The alfapump is Sequana Medicals unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination.

Key Points: 
  • The alfapump is Sequana Medicals unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination.
  • DSR is Sequana Medicals proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.
  • Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure.
  • You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.

New Category III CPT Code for the Nuwellis Aquadex Ultrafiltration System is Now in Effect

Retrieved on: 
Tuesday, January 25, 2022
Ultrafiltration, Diuretic, EDEN, Growth, Nasdaq, Adult, Forward-looking statement, Review, COVID-19, SEC, Health, Medicare, Category, Private Securities Litigation Reform Act, Hypervolemia, AMA, Science, Hospital, Company, Indian Medical Association, CPT, Overload, Patient, American Medical Association, Quality of life, GLOBE, CEO, Health care, Medical device, Pharmaceutical industry, Medicaid

Healthcare providers can utilize this code when using Aquadex to deliver ultrafiltration to adult and pediatric patients ( 20kg).

Key Points: 
  • Healthcare providers can utilize this code when using Aquadex to deliver ultrafiltration to adult and pediatric patients ( 20kg).
  • The Category III CPT code will expand access for patients experiencing the burden of fluid overload.
  • The specific code for ultrafiltration was granted by the American Medical Association (AMA) in July 2021 after a thorough review and validation that the Aquadex technology met the criteria for a Category III CPT code.
  • The approved Therapeutic Ultrafiltration Category III CPT code will be in effect for at least five years, or until a Category I code is established.

SEQUANA MEDICAL ANNOUNCES NEW SHARE CAPITAL AMOUNT AND NEW NUMBER OF SHARES

Retrieved on: 
Friday, January 21, 2022
Patient, Fluid, RED, Congestion, Safety, Adult, DSR, Urination, NASH, Ascites, Overload, Heart failure, Company, Cirrhosis, Quality of life, Hypervolemia, Medicine, Interim, FDA, Liver disease, Diuretic, Judgement, Sodium, Abdominal cavity, Trial of the century, Pharmaceutical industry, EU, Benelux

The alfapump is Sequana Medical's unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination.

Key Points: 
  • The alfapump is Sequana Medical's unique, fully implanted wireless device that automatically pumps fluid from the abdominal cavity into the bladder, where it is naturally eliminated through urination.
  • DSR is Sequana Medical's proprietary approach to managing sodium and fluid overload through use of a sodium-free infusate administered into the abdominal cavity.
  • Sequana Medical has combined its proven alfapump and proprietary DSR therapy, and is developing the alfapump DSR, a breakthrough approach to fluid overload due to heart failure.
  • You should not place undue reliance on forward-looking statements, which reflect the opinions of Sequana Medical only as of the date of this press release.