Joe Byrd (Cherokee Nation Principal Chief)

Agendia® Names Joyce A. O'Shaughnessy, MD as New Principal Investigator for FLEX Study

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화요일, 10월 10, 2023
Diagnosis, Gene expression, Knowledge, Internal medicine, MS, Biology, Research, Breast cancer, School, MD, FLEX, Society, American Society of Clinical Oncology, Radiation, Baylor, American Association for Cancer Research, Science, Natural history, Neoplasm, Woman, Genomics, Joe Byrd (Cherokee Nation Principal Chief), Sarah Cannon Research Institute, Patient, Oncology, Medical imaging, MammaPrint

IRVINE, Calif. and AMSTERDAM, Oct. 10, 2023 /PRNewswire/ -- Agendia®, Inc., a global leader in innovative genomic technology and diagnostic tests, announced today that Dr. Joyce A. O'Shaughnessy, MD has been appointed as the new National Principal Investigator for the FLEX Study, a real-world, large-scale, prospective, observational breast cancer study (NCT03053193) intended to enable the discovery of novel gene expression profiles, through the capture of whole transcriptome and extensive clinical data, to expand knowledge and improve precision in the management of breast cancer.

Key Points: 
  • Dr. O'Shaughnessy is board certified in both internal medicine as well as medical oncology and focuses her practice and clinical research on breast cancer treatment.
  • To date, more than 14,000 patients have been successfully enrolled in the FLEX Study, with representation of various ages, races, ethnicities, and health statuses.
  • "We are honored to have Dr. Joyce O'Shaughnessy join our efforts as the National Principal Investigator for the landmark FLEX Study.
  • For more information about Agendia and the FLEX Study, visit www.agendia.com and follow Agendia on Facebook , Twitter ,  and LinkedIn .

Stimdia Medical Inc. Initiates FDA Approved IDE Pivotal Trial to Investigate Impact of Neuromuscular Stimulation on Mechanically Ventilated Patients

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화요일, 10월 3, 2023
Science, Research, General Health, Health, FDA, Medical Devices, Health Technology, Other Health, Hospice and palliative medicine, Medicine, Inhalation, Atrium Health, Louisiana State University, Carolinas Medical Center, Diaphragm, Neck, Sale, PNS, Patient, Standard of care, Physician, Nursing, Division, ICU, Nursing care plan, Joe Byrd (Cherokee Nation Principal Chief), Trauma, Weaning, Critical Care Medicine (journal), Medical device, Medical imaging, Pharmaceutical industry

Stimdia Medical, a medical device company developing innovative technologies to improve respiratory care, today announced the initiation of its FDA approved pivotal trial to investigate the impact of phrenic nerve stimulation (PNS) on the time to liberate patients from mechanical ventilation.

Key Points: 
  • Stimdia Medical, a medical device company developing innovative technologies to improve respiratory care, today announced the initiation of its FDA approved pivotal trial to investigate the impact of phrenic nerve stimulation (PNS) on the time to liberate patients from mechanical ventilation.
  • The ReInvigorate Study is a randomized, controlled trial that will enroll approximately 420 patients who are receiving mechanical ventilation in the intensive care unit (ICU).
  • Patients will be randomly assigned to receive PNS therapy utilizing Stimdia’s proprietary pdSTIMTM System or standard of care alone.
  • It is great to be able to investigate this new therapy in our patients who are having difficulties regaining independent breathing.

BioAlberta Annual Achievement Awards

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금요일, 9월 29, 2023
Research, Neurology, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Fedora, Mentorship, Doctor of Philosophy, Patient, Aneurysm, Ghana UK-Based Achievement Awards, ALS, Disease, University, Biomedical engineering, Organization, Wallace H. Coulter Department of Biomedical Engineering, Medicine, Chairperson, III, Neurosurgery, Biomarker, History, Thought, Alberta Government Telephones, Blood, Biomedicine, Ecosystem, Joe Byrd (Cherokee Nation Principal Chief), Breast cancer, Pharmaceutical industry, Management, Medical device, Tobacco, Oil

BioAlberta announced the recipients of its 2023 Achievement Awards in recognition of the outstanding contributions of the individuals and companies whose innovation and achievements have contributed to the growing success of Alberta's life sciences sector.

Key Points: 
  • BioAlberta announced the recipients of its 2023 Achievement Awards in recognition of the outstanding contributions of the individuals and companies whose innovation and achievements have contributed to the growing success of Alberta's life sciences sector.
  • The awards were presented at BioAlberta’s 25th Anniversary Health and Life Sciences Showcase & Awards Dinner, held in Edmonton on September 28th.
  • This award acknowledges a company that has shown significant achievement within the marketplace and Alberta’s business community through strong performance or a leadership role.
  • Accepting this award, Dr. Rinker said: “Thank you to BioAlberta, the life sciences community and supporters for this award on the behalf of my entire team.

XyloCor Therapeutics Presents Phase 2 Data Highlighting Safety and Efficacy of XC001 at the European Society of Cardiology (ESC) Congress 2023

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금요일, 8월 25, 2023
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Heart, Pericardium, Duke University School of Medicine, Prevalence, ESC Congress, Angina, Cardiovascular disease, Quality of life, European Society of Cardiology, PET, Blood, Congress, VEGF, Ischemia, Patient, ST depression, European Society of Gene and Cell Therapy, ESC, Joe Byrd (Cherokee Nation Principal Chief), Therapy, Positron emission tomography, Safety, Pharmaceutical industry

The findings underscore its strong potential as a novel therapeutic approach for the treatment of this disabling condition.

Key Points: 
  • The findings underscore its strong potential as a novel therapeutic approach for the treatment of this disabling condition.
  • XC001 met all of its safety and exploratory objectives and showed potential transformative benefits for the patient population.
  • Among the notable topline results presented at the ESC Congress 2023 included:
    VEGF gene therapy with XC001 administered via minimally invasive transepicardial delivery was generally well tolerated.
  • “We are excited to share data that provides evidence for angiogenesis and a promising efficacy and tolerability profile for XC001.

Results from XyloCor Therapeutics’ Phase 1 Portion of EXACT Trial of XC001 for Cardiovascular Disease Published in Circulation: Cardiovascular Interventions

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목요일, 8월 3, 2023
Science, Cardiology, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, Duke University School of Medicine, Gene, Cardiovascular disease, Quality of life, AATS, Cardiothoracic surgery, Patient, Article, American Association for Thoracic Surgery, Cell, American Society of Gene and Cell Therapy, Joe Byrd (Cherokee Nation Principal Chief), Therapy, Society, Robert Turner (professor of medicine), Safety, Pharmaceutical industry

XyloCor Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, announced today that Circulation: Cardiovascular Interventions has published results from the Phase 1 portion of its Phase 1/2 clinical trial (EXACT) of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina.

Key Points: 
  • XyloCor Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, announced today that Circulation: Cardiovascular Interventions has published results from the Phase 1 portion of its Phase 1/2 clinical trial (EXACT) of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina.
  • “Patients with refractory angina are highly symptomatic and have an exceedingly poor quality of life.
  • “We would like to acknowledge all of the authors for their contributions in highlighting the promise of XC001 and thank patients and their families for their participation in the EXACT trial.
  • This established a dose of 1×1011 viral particles for future clinical research of XC001.

XyloCor Therapeutics Reports Sustained Results in 12-Month Extension of Phase 2 EXACT Clinical Trial of XC001 Novel Gene Therapy for Refractory Angina

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화요일, 7월 18, 2023
Science, Cardiology, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, Exercise, Heart, Duke University School of Medicine, Angina, Cardiovascular disease, Chest pain, Blood, Nitroglycerin, Patient, Joe Byrd (Cherokee Nation Principal Chief), Therapy, Safety, TED, Pharmaceutical industry

Earlier this year, XyloCor reported positive results from the primary study period for the Phase 2 portion EXACT trial at six months.

Key Points: 
  • Earlier this year, XyloCor reported positive results from the primary study period for the Phase 2 portion EXACT trial at six months.
  • “These 12-month data build upon the positive results achieved at the 3- and 6-month marks of the trial.
  • The six-month primary study period in the Phase 2 portion of the EXACT trial was followed by a month 12 follow up period.
  • "These results further enhance our confidence that we are on the right path for transforming outcomes in cardiovascular disease.”

First U.S. Patients Implanted with Innovative FIRE1 Remote Heart Failure Monitoring System in Early Feasibility Study

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화요일, 7월 11, 2023
General Health, Health, Cardiology, Medical Devices, Heart failure, Richard M. Ross Heart Hospital, Physician, Heart, Principal investigator, MD, Patient, Division, Columbia University Vagelos College of Physicians and Surgeons, Surgeon, Weill Cornell Medicine, University College London Hospitals NHS Foundation Trust, Joe Byrd (Cherokee Nation Principal Chief), Medical device, Medicine

FIRE1 today announced that the first U.S. patients have been successfully implanted with its FIRE1™ System for remote heart failure monitoring in an Early Feasibility Study.

Key Points: 
  • FIRE1 today announced that the first U.S. patients have been successfully implanted with its FIRE1™ System for remote heart failure monitoring in an Early Feasibility Study.
  • The study will assess FIRE1’s novel solution to improve outcomes for heart failure patients.
  • The first patient was implanted at Austin Heart, Texas, where Kunjan Bhatt, MD, leads the study as Principal Investigator and Thomas McMinn, MD, performed the implants.
  • “We are delighted to announce the first implants in the U.S. of this new, transformative technology for patients with chronic heart failure,” said Dr. Bhatt.

Late-Breaking Data for Cytovale’s IntelliSep® Sepsis Test Further Validate its Potential to Aid in Rapid, Clinically Actionable Sepsis Diagnosis in Emergency Departments

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월요일, 5월 22, 2023
Nursing, Medical Devices, Vitamins, Supplements, Medical Supplies, Infectious Diseases, Hospitals, FDA, Biotechnology, Managed Care, Health, Infection, Critical care, ISI, Probability, Our Lady of the Lake Regional Medical Center, Sepsis, Hospital, Prostate cancer, LSU Health Sciences Center New Orleans, ATS, DC, Band 3 anion transport protein, Death, EDS, American Thoracic Society, International Conference on Population and Development, Patient, Risk, Protocol, Septic, Research, Joe Byrd (Cherokee Nation Principal Chief), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Conference, Every Minute, Food, Band I, Breast cancer, Rock Band 2, Medical device, Pharmaceutical industry

These data were presented for the first time today as a late-breaking poster presentation at the American Thoracic Society (ATS) International Conference in Washington, DC.

Key Points: 
  • These data were presented for the first time today as a late-breaking poster presentation at the American Thoracic Society (ATS) International Conference in Washington, DC.
  • “These results validate the efficacy and efficiency of IntelliSep as a diagnostic aid that may improve sepsis triage when incorporated into existing clinical protocols."
  • In this study, which included 572 patients, the IntelliSep test identified three statistically distinct bands of sepsis probability with an increasing likelihood of sepsis.
  • Cytovale anticipates making the IntelliSep test commercially available within the next quarter.

XyloCor Therapeutics Reports Positive Topline Safety and Efficacy Results from Phase 2 EXACT Clinical Trial of XC001 Novel Gene Therapy for Refractory Angina

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목요일, 1월 26, 2023
Health, Genetics, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Duke University School of Medicine, Blood, Angina, Safety, PET, Patient, Therapy, Heart, FDA, Exercise, Joe Byrd (Cherokee Nation Principal Chief), Cardiovascular disease, Pharmaceutical industry, Medical imaging

XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced completion of the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) designed to assess the safety and preliminary evidence of efficacy of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina.

Key Points: 
  • XyloCor Therapeutics, a clinical-stage biopharmaceutical company developing novel gene therapies for cardiovascular disease, today announced completion of the Phase 2 portion of its Phase 1/2 clinical trial (EXACT) designed to assess the safety and preliminary evidence of efficacy of lead gene therapy candidate XC001 (encoberminogene rezmadenovec) in patients with refractory angina.
  • There were no safety issues related to drug product or unexpected serious adverse events related to XC001 administration.
  • Six-month data from 28 patients in the Phase 2 portion of the study showed improvements in several key efficacy measures, including reduction in ischemic burden.
  • Six months after treatment, nearly half of all subjects were able to conduct ordinary physical activity without causing angina.

FDA Clears Cytovale’s® IntelliSep® Sepsis Test, First in a New Class of Emergency Department-Focused Diagnostic Tools

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수요일, 1월 18, 2023
Pharmaceutical, Finance, Medical Devices, Infectious Diseases, Hospitals, Data Management, Professional Services, Technology, Practice Management, Nursing, Clinical Trials, Managed Care, Medical Supplies, General Health, FDA, Biotechnology, Health, Health Technology, Cell, Our Lady of the Lake Regional Medical Center, Hospital, Prostate cancer, Infection, Critical care, LSU Health Sciences Center New Orleans, Heart, Septic, Pressure, CMS, Death, Centers for Medicare & Medicaid Services, Manifest and latent functions and dysfunctions, MD, Risk, Band, Food and Drug Administration, Research, United, Sepsis Alliance, Medicare, Band I, Sepsis, Food, Diagnosis, Patient, Band 3 anion transport protein, Breast cancer, Probability, Joe Byrd (Cherokee Nation Principal Chief), Medical device, Medical imaging

IntelliSep is a groundbreaking diagnostic tool that helps clinicians recognize sepsis and supports critical time-sensitive clinical decisions, providing test results in under 10 minutes.

Key Points: 
  • IntelliSep is a groundbreaking diagnostic tool that helps clinicians recognize sepsis and supports critical time-sensitive clinical decisions, providing test results in under 10 minutes.
  • The first in a new class of ED-focused diagnostic tools that assess host response, the test is a simple, fast, and intuitive solution that provides actionable answers directly from a standard blood draw.
  • IntelliSep categorizes patients into three bands according to their probability of sepsis, with Band 1 indicating low probability of sepsis and Band 3 indicating high probability of sepsis.
  • "Every minute is crucial in identifying sepsis, and IntelliSep has the potential to transform clinical approaches to sepsis triage and diagnosis and save countless lives."