Mortality

Walking 5,000 Steps Three Times Per Week Could Add Three Years to Life Expectancy

Retrieved on: 
Tuesday, March 12, 2024

“Healthy habits can profoundly extend the quality and length of life,” said Adrian Gore, Founder of Discovery Vitality.

Key Points: 
  • “Healthy habits can profoundly extend the quality and length of life,” said Adrian Gore, Founder of Discovery Vitality.
  • People aged 65 and older saw a 52% reduction in their mortality risk after sustaining a habit of 7,500 steps three or more times per week.
  • People who sustain a habit of 10,000 steps three times a week for three years can reduce their type 2 diabetes risk by up to 41%.
  • Increasing the frequency of exercise to four or more times a week saw a 57% reduction in the risk of developing type 2 diabetes.

Large, Real-world Studies Demonstrate Continued Excellent Outcomes for Patients Receiving Edwards SAPIEN TAVR

Retrieved on: 
Monday, March 11, 2024

Edwards Lifesciences (NYSE: EW) announced today at Cardiovascular Research Technologies (CRT) 2024 the compelling results from two large, real-world studies based on TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards SAPIEN valve platform.

Key Points: 
  • Edwards Lifesciences (NYSE: EW) announced today at Cardiovascular Research Technologies (CRT) 2024 the compelling results from two large, real-world studies based on TVT Registry data that demonstrated continued excellent outcomes for patients treated with the Edwards SAPIEN valve platform.
  • In a second study presented during the late-breaking clinical trials session, small Edwards SAPIEN TAVR valves demonstrated equally excellent outcomes at 3 years as compared to larger SAPIEN TAVR valve sizes.
  • The study found that all Edwards TAVR platforms demonstrated excellent PVL results.
  • An analysis of 8,100 propensity matched patients across more than 800 sites in the United States found that patients treated with a 20mm Edwards SAPIEN valve demonstrated excellent all-cause mortality and stroke outcomes at 3-years, equivalent to those receiving 23, 26 and 29mm SAPIEN valve sizes.

Pathway to Cures Announces First Entrepreneur in Residence

Retrieved on: 
Monday, March 11, 2024

Pathway to Cures (P2C) announced today its first Entrepreneur in Residence (EIR), Leonard Valentino, M.D.

Key Points: 
  • Pathway to Cures (P2C) announced today its first Entrepreneur in Residence (EIR), Leonard Valentino, M.D.
  • Dr. Valentino most recently served as President and CEO of the National Bleeding Disorders Foundation (NBDF) and was instrumental in bringing Pathway to Cures into reality.
  • Pathway to Cures is the venture philanthropy fund of the NBDF focused on early-stage companies developing cures, therapies, or enabling technologies in support of the inheritable blood and bleeding disorders community.
  • “My role as Entrepreneur in Residence for Pathway to Cures will be to provide guidance into the consideration and support of new opportunities for catalyzing transformative therapies and cures.

Kidney Patients Raise National Health Alert on Phosphorus

Retrieved on: 
Thursday, April 4, 2024

WASHINGTON, April 4, 2024 /PRNewswire/ -- The American Association of Kidney Patients (AAKP), the oldest and largest independent kidney patient consumer organization in the U.S., is raising public awareness on April 5, National Phosphorus Awareness Day, about the devastating impacts of unmanaged phosphorus levels in individuals with advanced chronic kidney disease (CKD).

Key Points: 
  • Kidney patients are at an increased risk for high phosphorus (termed hyperphosphatemia) due to their decreased kidney function and an inability to excrete excess nutrients, including phosphorus.
  • Kidney patients are medically complex and typically manage multiple co-related health conditions including hyperphosphatemia , hyperkalemia , CKD associated pruritis (CKD-aP) , and more .
  • Kidney patients and all people of goodwill involved in the fight to improve kidney health are making their voices heard by contacting their U.S.
  • Since 1969, The American Association of Kidney Patients has been a patient-led organization driving policy discussions on kidney patient care choice and medical innovation.

Microbion's Topical Pravibismane Phase 1b Moderate or Severe Diabetic Foot Ulcer Infection Study is Published in International Wound Journal

Retrieved on: 
Thursday, April 4, 2024

and VANCOUVER, BC, April 4, 2024 /PRNewswire/ - Microbion Corporation today announced that the company has published results from its topical pravibismane Phase 1b study in the peer-reviewed International Wound Journal.

Key Points: 
  • and VANCOUVER, BC, April 4, 2024 /PRNewswire/ - Microbion Corporation today announced that the company has published results from its topical pravibismane Phase 1b study in the peer-reviewed International Wound Journal.
  • The manuscript titled "Topical Pravibismane as Adjunctive Therapy for Moderate or Severe Diabetic Foot Infections: A Phase 1b Randomized, Multi-Center, Double-Blind, Placebo-Controlled Trial" is available for free download at International Wound Journal's website ( https://doi.org/10.1111/iwj.14817 ).
  • This therapeutic objective is currently being assessed in our recently completed, 12-week Phase 2 study in moderately infected, chronic diabetic foot ulcers."
  • The published manuscript describes in detail the Phase 1b study that was designed to evaluate the safety and efficacy of pravibismane in managing moderate or severe chronic diabetic foot ulcer infections.

FDA Approves New Antibiotic for Three Different Uses

Retrieved on: 
Wednesday, April 3, 2024

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

Infinant Health Announces Submission of Orphan Drug Designation Application

Retrieved on: 
Tuesday, April 2, 2024

DAVIS, Calif., April 2, 2024 /PRNewswire/ -- Infinant Health, a privately-held company focused on changing the trajectory of human health, one baby at a time, announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its drug candidate INF108 for the prevention of necrotizing enterocolitis in pre-term infants.

Key Points: 
  • DAVIS, Calif., April 2, 2024 /PRNewswire/ -- Infinant Health, a privately-held company focused on changing the trajectory of human health, one baby at a time, announced it has filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for its drug candidate INF108 for the prevention of necrotizing enterocolitis in pre-term infants.
  • The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics.
  • Orphan Drug Designation would qualify INF108 for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain activities, eligibility for orphan drug grants, and the waiver of certain administrative fees.
  • The receipt of Orphan Drug Designation status does not change the regulatory requirements or process for obtaining marketing approval.

China Medical University Hospital Develops "AISIA" to Diagnose Acute Ischemic Stroke in 90 Seconds to Assist Doctors in Making Medical Decisions

Retrieved on: 
Tuesday, April 2, 2024

The models analyze NCCT and CTP images to detect acute ischemic stroke, as well as to identify the ischemic core and penumbra.

Key Points: 
  • The models analyze NCCT and CTP images to detect acute ischemic stroke, as well as to identify the ischemic core and penumbra.
  • This assist physicians in making decision of acute ischemic stroke management.
  • This system can determine the presence of acute ischemic stroke in approximately 90 seconds.
  • In this way, the facilitated AISIA platform means a lot for ischemic stroke patients and medical experts as well.

Quest Diagnostics and Broad Clinical Labs to Evaluate Whole Genome Sequencing as First-Line Genetic Test for Developmental Delay

Retrieved on: 
Tuesday, April 2, 2024

SECAUCUS, N.J., April 2, 2024 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, and Broad Clinical Labs, the world expert in whole genome sequencing (WGS), today announced a research collaboration designed to demonstrate the clinical value of WGS as a first-line genetic test for postnatal diagnosis of developmental delay disorders.

Key Points: 
  • "We are delighted to bring the experience and expertise of Broad Clinical Labs to this innovative collaboration with Quest.
  • "This type of collaboration between commercial laboratories and research institutions is vital to advance the field of genetic testing and increase utility and economic value."
  • While the ACMG recommends WGS for first-line genetic testing for intellectual disability and developmental delay, some providers continue to follow prior guidelines that recommend chromosomal microarray (CMA) as a first-line test.
  • Broad Clinical Labs is a leader in human whole genome sequencing, having sequenced over 600,000 genomes in service of its mission to accelerate the understanding and diagnosis of human disease.

Key Proteo Submits De Novo Application to FDA for its First Newborn Screening Kit

Retrieved on: 
Friday, March 29, 2024

SEATTLE, March 29, 2024 /PRNewswire/ -- Key Proteo, a pioneering proteomics diagnostics company specializing in the enhanced early detection of rare but treatable genetic disorders, today announced that it has submitted a de novo classification request to the U.S. Food and Drug Administration (FDA) for its first in vitro diagnostic Key Proteo Newborn Screening Kit. The novel proteomics-based screening panel addresses a critical, unmet need to aid in the early identification of four treatable rare genetic disorders that current newborn screening programs do not typically test for, including Wilson Disease (WD), Wiskott-Aldrich Syndrome (WAS), X-linked Agammaglobulinemia (XLA) and Adenosine Deaminase Deficiency (ADA). Early screening has the potential to enable timely intervention that can help change the clinical trajectory and relieve the burden of disease for patients and their families afflicted by these potentially devastating disorders.

Key Points: 
  • The submission of Key Proteo's Newborn Screening Kit 1 comes after screening over 22,000 newborn samples in an ongoing pilot study in Washington state.
  • Subsequently, Key Proteo successfully completed a clinical study that included 3,294 newborn samples analyzed at 3 sites across North America.
  • The in vitro diagnostic Key Proteo Newborn Screening Kit 1 will only be available for commercialization once the FDA has completed its process.
  • Currently, Key Proteo Newborn Screening Kit 1 is available as an RUO offering.