Clinical study design

SeaStar Medical Reports 2023 Financial Results and Provides a Business Update

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수요일, 4월 17, 2024
Mortality, FDA, Nephrology, Risk, Nephron, Partnership, Hepatorenal syndrome, Acute kidney injury, ICU, White, AKI, Chronic kidney disease, Monocyte, Heart failure, SCD, Dialysis, CRRT, CKRT, KRT, Inflammation, Safety, Insurance, Clinical study design, Therapy, Clinical trial, G&A, Sepsis, University, HDE, Survival rate, Neutrophil, Acute respiratory distress syndrome, Patent, Cardiorenal syndrome, European Journal, Physician, Manuscript, Bank statement, Standard of care, Pharmaceutical industry

DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update.

Key Points: 
  • DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update.
  • “Lastly, I’m pleased that we have filed our Form 10-K for 2023, which includes restated 2022 financial statements,” said Mr. Schlorff.
  • Mr. Green brings to SeaStar Medical extensive financial experience at public medical device and therapeutics companies.
  • The Company reported cash of $176,000 as of December 31, 2023, compared with $47,000 as of December 31, 2022.

Daxor Corporation CEO and President Michael Feldschuh Provides Corporate Update in Letter to Shareholders

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월요일, 3월 18, 2024
Department of Defence, Food and Drug Administration, Burn, Learning, Patient, BVA, Sale, Nature, Statistics, Investment, Note, LVAD, ICU, Duke, Form, Blood volume, NIH, Heart failure, Length of stay, American College, Operation, Hand, Health, Food, Sepsis, Acceleration, Letter, Proxy, Knowledge, Research, Hospital, Acquisition, CLIA, Clinical study design, Family, FDA, Consultant, Annual general meeting, Diagnosis, RCT, Financial statement, Growth, Syncope, Mortality, National Institutes of Health, Nursing care plan, Bangladesh Technical Education Board, Net, Government, Physician, Medicine, Pharmaceutical industry

We have never been more focused on our mission and goals. Every team member at Daxor sees both the remarkable strides the company has made over the past year solidifying its position as the global leader in blood volume measurement technology and the promise of what our rapid expansion means for both the company and the tens of millions of patients whose care we are eager to significantly improve. In every area 2023 and the strong start of 2024 has shown substantial progress for the company -- in revenue growth, new customer acquisitions, increasing utilization of our products by existing customers, next generation systems completed and under Food and Drug Administration (FDA) review, positive clinical studies, new patents granted and pending, successful National Institutes of Health (NIH) grant awards, Department of Defense (DoD) contracts awarded, and further research and development for groundbreaking products set to launch in subsequent fiscal years. I will detail below more in these areas but first wish to review why our company’s mission to commercialize the products that enable optimal patient care is so vital.

Key Points: 
  • Oak Ridge, TN, March 18, 2024 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology today issued a corporate update in a Letter to Shareholders filed in its certified shareholder report on Form N-CSR on March 15, 2023 from CEO & President, Michael Feldschuh.
  • Many of these markers are costly, some are invasive, and none are accurate – in contrast to Daxor’s proven 98% accurate system.
  • Care teams cannot effectively treat what they do not correctly diagnose, so our rapid accurate diagnostic test is a game-changer.
  • Daxor has been reporting as an investment company under the Investment Company Act of 1940 since January 1, 2012.

AliveGen Announces Successful Completion of Phase 1b Multiple-Ascending Dose Clinical Trial for ALG-801

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월요일, 3월 18, 2024
Health, Other Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Atrophy, Clinical study design, Obesity, PD, DSM-IV codes, Weight, Liver disease, Doctor of Philosophy, MD, Trial of the century, Woman, Pharmacovigilance, Fibrosis, Clinical trial, TGF, Triple test, Chronic kidney disease, Therapy, Family, HQ, Pharmaceutical industry

AliveGen USA Inc. (AliveGen), a clinical-stage biopharmaceutical company dedicated to developing first-in-class and best-in-class therapeutics for treating muscle wasting, metabolic disorders, and neuromuscular diseases, is delighted to announce the successful completion of its Phase 1b multiple-ascending dose (MAD) clinical trial for ALG-801.

Key Points: 
  • AliveGen USA Inc. (AliveGen), a clinical-stage biopharmaceutical company dedicated to developing first-in-class and best-in-class therapeutics for treating muscle wasting, metabolic disorders, and neuromuscular diseases, is delighted to announce the successful completion of its Phase 1b multiple-ascending dose (MAD) clinical trial for ALG-801.
  • Study Design: The Phase 1b MAD study is a randomized double-blind placebo-controlled trial in postmenopausal women.
  • Next Step: Following the successful Phase 1b MAD study, AliveGen plans to advance ALG-801 to Phase 2 clinical development.
  • “We are grateful to the healthy volunteers and healthcare professionals who actively participated in our Phase 1b clinical trial,” said HQ Han, MD, PhD, CEO of AliveGen.

The National Center on Intensive Intervention Adds Classworks® Evidence-Based Reading Intervention to Academic Interventions Tools Chart

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화요일, 4월 2, 2024
Clinical study design, DBI, Learning, Literacy, Student, MTSS, Nursing

DULUTH, Ga., April 2, 2024 /PRNewswire-PRWeb/ -- Classworks®, an award-winning special education and tiered intervention platform, is validated by the National Center on Intensive Intervention (NCII) as an evidence-based reading intervention. The best-in-class program is listed on the Academic Intervention Tools Chart and joins Classworks Universal Screener and Progress Monitoring in the company's highly rated, NCII-validated offerings.

Key Points: 
  • Classworks®, an award-winning special education and tiered intervention platform, is validated by the National Center on Intensive Intervention (NCII) as an evidence-based reading intervention.
  • The best-in-class program is listed on the Academic Intervention Tools Chart and joins Classworks Universal Screener and Progress Monitoring in the company's highly rated, NCII-validated offerings.
  • DULUTH, Ga., April 2, 2024 /PRNewswire-PRWeb/ -- Classworks®, an award-winning special education and tiered intervention platform, is validated by the National Center on Intensive Intervention (NCII) as an evidence-based reading intervention.
  • The best-in-class program is listed on the Academic Intervention Tools Chart and joins Classworks Universal Screener and Progress Monitoring in the company's highly rated, NCII-validated offerings.

Real-World Data on Human Milk-Based Fortification Reveals Limitations of Protocol Designs of Two RCTs

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화요일, 2월 6, 2024
Growth, Mortality, Bronchopulmonary dysplasia, Hospice and palliative medicine, NEC, Standard of care, BPD, NICU, Disease, Patient, Incidence, Sepsis, RCT, Clinical study design, Isabella Tree, BMBF, Risk, Exclusive, Vulnerable, FAAP, Birth weight, Standard, Necrotizing enterocolitis, Gestational age, Hospital, Dietary supplement

DUARTE, Calif., Feb. 6, 2024 /PRNewswire/ -- Optimizing nutrition for premature infants remains an important focus in neonatal care. More than 20 peer-reviewed studies of 5,000+ preterm infants demonstrated that, compared to bovine milk-based fortifiers (BMBF), Prolacta Bioscience's human milk-based fortifiers (HMBF) improve growth and development1-7 and provide clinically significant reductions in comorbidities.1,2,8-20 The health benefits from the use of HMBF have also shown significant annual cost savings for hospitals.8 More than 100,000 critically ill and preterm infants have received Prolacta's human milk-based nutritional products.21

Key Points: 
  • While the RCTs were intended to provide a head-to-head comparison between fortifier products, the feeding protocols fundamentally differed.
  • HMBF recommendations for best outcomes regarding the day fortification should begin and the speed at which feeds are advanced were not followed in either study.
  • Given these known risks, randomizing extremely premature infants to day-one fortification with BMBF would unjustly endanger this vulnerable patient population.
  • Extensive real-world data affirm EHMD adoption enables critical health improvements for premature infants and major cost reductions for hospitals.

Edema Clinical Trials Market Poised for Robust Growth with 5.7% CAGR by 2030: Emphasis on Phase-II Studies and North America's Dominant Role - ResearchAndMarkets.com

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목요일, 1월 11, 2024
Health, Clinical Trials, Other Health, Pediatrics, Research, Incidence, Edema, Clinical study design, Disease, Safety, USD, Nature, Growth, Pharmaceutical industry

Marking a compound annual growth rate (CAGR) of 5.7% between 2023 and 2030, this growth reflects the escalating incidence of edema as a result of various underlying health conditions.

Key Points: 
  • Marking a compound annual growth rate (CAGR) of 5.7% between 2023 and 2030, this growth reflects the escalating incidence of edema as a result of various underlying health conditions.
  • Acknowledging its pivotal role in furthering clinical research endeavors, phase-II trials are notably responsible for determining the therapeutic efficacy and safety of potential treatments for edema.
  • The findings of the report underscore the critical nature of advancing treatment modalities through clinical trials to confront the challenges posed by edema.
  • With a diverse range of participants and multi-phase studies, the field is set to witness transformative developments over the coming years.

SeaStar Medical Reports Third Quarter 2023 Financial Results and Provides a Business Update

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화요일, 11월 14, 2023
Chronic kidney disease, Neutrophil, Acute respiratory distress syndrome, STEC-HUS, Cardiorenal syndrome, Safety, Food, Hepatorenal syndrome, University, AKI, HDE, Risk, ICU, Clinical trial, Monocyte, Mortality, CBER, Sepsis, Patient, Nephrology, Insurance, Research, Letter, Dialysis, Approvable letter, FDA, G&A, Child, Standard of care, Acute kidney injury, Partnership, Nephron, Clinical study design, R, Hospital, SCD, Physician, CKRT, Karger Publishers, PMA, HIV disease progression rates, Pharmaceutical industry, Nursing, Dietary supplement, Cryptocurrency

DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.

Key Points: 
  • DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.
  • “Recent clinical and regulatory successes have significantly improved and strengthened our company’s prospects,” said Eric Schlorff, SeaStar Medical CEO.
  • SeaStar Medical expects regulatory approval for the SCD-ADULT in the first half of 2025 and commercial launch in the second half of 2025.
  • The Company issued two convertible notes each for $0.5 million in August 2023 and a third convertible note for $0.5 million in September 2023.

Viridian Therapeutics Announces Positive Clinical Data in Healthy Volunteer Study and Selects VRDN-003 as Potential Best-in-Class Subcutaneous anti-IGF-1R Program with Extended Half-Life for Pivotal Development in Thyroid Eye Disease

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월요일, 12월 18, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Well, Pivotal, Therapy, TED, Graves' ophthalmopathy, PD, ADAS, Serum, Data, Patient, Clinical study design, Cavg, Cmin, Pharmacology, Half-life, Trial of the century, Stiffness, Growth, Pharmaceutical industry, Vaccine, Copper, Viridian

“The data reinforce our confidence in VRDN-003’s rapid development as a low-volume, self-administered, subcutaneous product.

Key Points: 
  • “The data reinforce our confidence in VRDN-003’s rapid development as a low-volume, self-administered, subcutaneous product.
  • VRDN-003 is designed to maintain the clinical response of VRDN-001 IV while significantly increasing patient convenience.
  • Dosing Flexibility for Pivotal Development: VRDN-003 modeling demonstrates dosing flexibility for the program’s anticipated global pivotal development.
  • Based on these positive results and the expected development timeline for VRDN-003, both VRDN-001 SC and VRDN-002 SC development have been deprioritized.

NanoVibronix Announces Agreement for Clinical Study of UroShield at the University of Michigan

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화요일, 11월 28, 2023
Medical Devices, Health, University, Clinical Trials, Education, Urinary tract infection, Food, Hope, Patient, Research, FDA, SAW, Pain, Quality of life, Clinical study design

NanoVibronix, Inc. (Nasdaq: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced it has signed a Research Agreement with the Regents of the University of Michigan for a Randomized Control Trial (“RCT”) study of UroShield.

Key Points: 
  • NanoVibronix, Inc. (Nasdaq: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced it has signed a Research Agreement with the Regents of the University of Michigan for a Randomized Control Trial (“RCT”) study of UroShield.
  • Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., said, “We are partnering with a team of distinguished researchers at the University of Michigan to further advance clinical evidence of the efficacy of UroShield.
  • The first phase of the study will include a validation pilot of 20 patients in advance of the full study.
  • We look forward to receiving the researchers’ conclusions and hope for positive outcomes for patients in the study.

Biomea Fusion Announces Two Poster Presentations at Upcoming ASH Annual Meeting 2023

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목요일, 11월 2, 2023
Trae tha Truth, ECOG, Vomiting, CYP3A4, WT, Abstract, NPM1, KMT2A, OBD, PK, DLT, TKD, Cancer, Diabetes, ORR, Clinical study design, Safety, Patient, Cohort, HSCT, SETBP1, CR, DSM-IV codes, NUP214, DOR, Dicarboxylic acid, CRi, ASH, CD135, QT interval, RFS, FLT3, Arm, Cellular, FMS, Transplant, ALL, Toxic leukoencephalopathy, Gene family, Survival, Postcholecystectomy syndrome, DS, Trial of the century, Incidence, CRC, Infrared spectroscopy correlation table, AL, Osteopathic medicine in Canada, MN1, BID, CNS, KRAS, ATD, NUP98, Society, WBC, Pharmacokinetics, CLL, Acute leukemia, Common, ITD, Toxicity, AML, Cardiovascular disease, Pharmaceutical industry, Dentistry, Vaccine, Decitabine, DLBCL

Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.

Key Points: 
  • Both BMF-219 and BMF-500 were originated in-house with Biomea’s proprietary FUSION™ system platform, which discovers and designs next-generation covalent-binding small molecule product candidates.
  • Methods: Doses of BMF-219 are escalated independently for each indication, initially in single-subject cohorts followed by a “3 + 3” design.
  • A subsequent amendment introduced quotas for KMT2Ar (MLL1r), NPM1 and other known menin-dependent mutations: CEBP/A, MLL1-PTD, MN1, NUP98, NUP214, PICALM-AF10, SETBP1.
  • The study was initiated in July 2023 and will enroll ~110 participants at approximately 30 sites.