Dialysis

Investigation of Community Health Systems, Inc. (CYH) Announced by Holzer & Holzer, LLC

Retrieved on: 
Friday, March 1, 2024

ATLANTA, March 01, 2024 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Community Health Systems, Inc. (“Community Health” or the “Company”) (NYSE: CYH) complied with federal securities laws.

Key Points: 
  • ATLANTA, March 01, 2024 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Community Health Systems, Inc. (“Community Health” or the “Company”) (NYSE: CYH) complied with federal securities laws.
  • If you purchased Community Health stock and suffered a loss on that investment, you are encouraged to contact Corey Holzer, Esq.
  • Since its founding in 2000, Holzer & Holzer attorneys have played critical roles in recovering hundreds of millions of dollars for shareholders victimized by fraud and other corporate misconduct.
  • Holzer & Holzer, LLC has paid for the dissemination of this promotional communication, and Corey Holzer is the attorney responsible for its content.

Kidney Month: 31 Day of Action to Equip and Empower People to Fight Kidney Disease

Retrieved on: 
Thursday, February 29, 2024

During Kidney Month, AKF calls on members of the kidney community and the general public to join in solidarity in support of everyone affected by kidney disease.

Key Points: 
  • During Kidney Month, AKF calls on members of the kidney community and the general public to join in solidarity in support of everyone affected by kidney disease.
  • One of the hallmarks of Kidney Month at AKF is Kidney Action Week , which will be held March 18-22.
  • This free, virtual event will bring together patients, nephrologists, renal dieticians, caregivers and other kidney experts for a weeklong series of sessions about a variety of topics related to kidney disease, including dialysis, kidney disease prevention, kidney-friendly eating, transplant, innovations in kidney disease and more.
  • In addition, people with kidney disease have a higher chance of developing other health problems, such as heart disease.

Simple HealthKit Launches Expanded Kidney Health Evaluation for Patients with Diabetes (KED) Program to Help Payers Improve Patient Health, Boost STAR Ratings & Meet HEDIS Measures

Retrieved on: 
Monday, February 26, 2024

At the heart of the program is Simple HealthKit’s new Expanded Kidney Health Test, which evaluates kidney function and kidney damage, and is available via in-clinic or at-home settings.

Key Points: 
  • At the heart of the program is Simple HealthKit’s new Expanded Kidney Health Test, which evaluates kidney function and kidney damage, and is available via in-clinic or at-home settings.
  • Diabetes is the leading cause of chronic kidney disease (CKD)—about 1 in 3 adults with diabetes have CKD.
  • At-home kidney health tests could drastically reduce Medicare expenditures associated with CKD, while boosting Star Ratings, and satisfying KED HEDIS® measures for MY2024.
  • Simple HealthKit already works with multiple payers across the U.S. including government agencies, universities and private healthcare plans like Imperial Health.

Ardelyx Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 22, 2024

WALTHAM, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • During the fourth quarter of 2023, IBSRELA U.S. net product sales revenue was $28.1 million, reflecting 26% growth compared to the third quarter of 2023.
  • Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.
  • U.S. net product sales revenue in the fourth quarter of 2023 were $2.5 million.
  • U.S. net product sales revenue in 2023 for XPHOZAH was $2.5 million following its commercial launch in November 2023.

Where You Live Impacts Your Ability to Save a Life Through Living Organ Donation, According to the 2024 American Kidney Fund Report Card

Retrieved on: 
Thursday, February 22, 2024

Receiving a kidney from a living donor is the best option for someone in need of a new kidney.

Key Points: 
  • Receiving a kidney from a living donor is the best option for someone in need of a new kidney.
  • However, six states – Alabama, Montana, New Hampshire, Tennessee, South Dakota and Vermont – have zero policy protections (F grade) for living organ donors.
  • How All 50 States + DC Fared on the 2024 State of the States: American Kidney Fund Report Card
    Currently, chronic kidney disease (CKD) affects more than 1 in 7 adults in the U.S.
  • “Where you live should not impact whether you are able to save a life through kidney donation, but our 2024 Report Card suggests that this may be the case.

FDA Grants Humanitarian Device Exemption Approval to SeaStar Medical’s Selective Cytopheretic Device for Pediatric Acute Kidney Injury

Retrieved on: 
Thursday, February 22, 2024

DENVER, Feb. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that the U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) Approval Order to the Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) for use in children weighing 10 kilograms or more with acute kidney injury (AKI) due to sepsis or a septic condition requiring kidney replacement therapy (KRT). This is the first product in the Company’s newly branded Quelimmune product family, and the Quelimmune pediatric device can now be commercially marketed as a Humanitarian Use Device (HUD).

Key Points: 
  • This is the first product in the Company’s newly branded Quelimmune product family, and the Quelimmune pediatric device can now be commercially marketed as a Humanitarian Use Device (HUD).
  • In clinical studies, Quelimmune for pediatric AKI has been shown to reduce mortality rates and dialysis dependency in clinical studies.
  • “We appreciate the FDA’s willingness to work collaboratively with SeaStar Medical and our advisors to grant HDE approval to Quelimmune for pediatric use,” Mr. Schlorff added.
  • SeaStar Medical is currently focused on its NEUTRALIZE-AKI pivotal clinical trial to evaluate Quelimmune therapy in the larger adult AKI population, while exploring other applications for this device.

Nuwellis’ Distribution Partner, SeaStar Medical, Receives FDA Humanitarian Device Exemption for Pediatric Selective Cytopheretic Device Quelimmune™

Retrieved on: 
Thursday, February 22, 2024

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), has received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for Quelimmune™, its pediatric Selective Cytopheretic Device.

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), has received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for Quelimmune™, its pediatric Selective Cytopheretic Device.
  • Nuwellis has an exclusive U.S. license and distribution agreement with SeaStar Medical to distribute Quelimmune and will market and distribute the device to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy.
  • “The pediatric segment of our business has gained significant traction since the 2020 FDA clearance of our Aquadex device for pediatric patients weighing 20kg or more – growing at a compound annual growth rate (CAGR) of over 30%.
  • Clinical studies have demonstrated Quelimmune’s potential to eliminate dialysis dependency, shorten intensive care unit time, and restore the lives of critically ill pediatric patients.

Sigyn Therapeutics™ Announces Filing of 2023 Annual Report on SEC Form 10-K

Retrieved on: 
Wednesday, February 21, 2024

SAN DIEGO, CA, Feb. 21, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – Sigyn Therapeutics, Inc. (“Sigyn Therapeutics” or the “Company”) (OTCQB: “SIGYD” – “SIGY”), a development-stage medical technology company, announced today the filing of its Form 10-K annual report with the United States Securities and Exchange Commission ("SEC") for the year-ended December 31, 2023.

Key Points: 
  • SAN DIEGO, CA, Feb. 21, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – Sigyn Therapeutics, Inc. (“Sigyn Therapeutics” or the “Company”) (OTCQB: “SIGYD” – “SIGY”), a development-stage medical technology company, announced today the filing of its Form 10-K annual report with the United States Securities and Exchange Commission ("SEC") for the year-ended December 31, 2023.
  • The annual report can be accessed on the SEC's website at www.sec.gov or on the Company's website at www.sigyntherapeutics.com under the "investors" section.
  • On January 31, 2024, the Company completed a 1-for-40 reverse split of its common stock.
  • In 2023, net cash used in operating activities was approximately $1.4 million, as compared to approximately $1.8 million in 2022.

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

Retrieved on: 
Thursday, March 7, 2024

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.

OneLegacy’s Community Wellness Event and Panel Inspired Hundreds of South LA Participants to Become Their Own Health Advocates

Retrieved on: 
Wednesday, March 6, 2024

Hundreds of local residents visited the Baldwin Hills Crenshaw Plaza this past Saturday to attend OneLegacy’s Connecting the Dots: Hip Hop & Health Community Event and Panel.

Key Points: 
  • Hundreds of local residents visited the Baldwin Hills Crenshaw Plaza this past Saturday to attend OneLegacy’s Connecting the Dots: Hip Hop & Health Community Event and Panel.
  • The event also included free haircuts, manicures, yoga and wellness sessions, COVID-19 tests, and fresh produce, followed by a health panel.
  • (Photo: Business Wire)
    The panel was moderated by impact Producer, Artepreneur, and HBCU graduate Maleena Lawrence and featured California Black Health Network’s Executive Director, Rhonda Smith, who shared vital information about African Americans and health.
  • Snow also participated in the panel, sharing their personal experiences with healthcare and promoting health advocacy among African Americans.