Monocyte

Manuscript Published on Multiorgan Failure Patients Treated with SeaStar Medical’s Selective Cytopheretic Device Who Achieved Transplant Eligibility

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水曜日, 5月 22, 2024

DENVER, May 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces the publication of a manuscript citing four case studies in which critically ill patients between the ages of 22 months and 71 years with multiorgan failure who were treated with the Selective Cytopheretic Device (SCD) successfully stabilized and improved their clinical status prior to stem cell or liver transplant, or left ventricular assist device implantation. The abstract was published in peer-reviewed Transplantation Direct, which is available here.

Key Points: 
  • The abstract was published in peer-reviewed Transplantation Direct, which is available here .
  • Titled “Increasing Eligibility to Transplant Through the Selective Cytopheretic Device (SCD): A Review of Case Reports Across Multiple Clinical Conditions,” the manuscript by S. Iyer, C. Pino, L. Yessayan, S. Goldstein, M. Weir, A. Westover, D. Catanzaro, K. Chung and H.D.
  • Humes notes that a stable, minimum physiological health status is required for patients to qualify for transplant or artificial organ to ensure the recipient has sufficient reserve to survive the perioperative transplant period.
  • “The SCD was well tolerated, with no serious device-related adverse events, infections or signs of immuno-depletion observed in any patient.

aTyr Pharma to Present Poster Describing Efzofitimod’s Mechanism of Action at the American Thoracic Society 2024 International Conference

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水曜日, 5月 15, 2024

The poster will be available on the aTyr website once presented.

Key Points: 
  • The poster will be available on the aTyr website once presented.
  • These findings suggest that efzofitimod may have broad therapeutic potential in diseases where myeloid cells play a central role in pathology, including ILD.
  • Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 to resolve inflammation without immune suppression and potentially prevent the progression of fibrosis.
  • These forms of ILD have limited therapeutic options and there is a need for safer and more effective, disease-modifying treatments that improve outcomes.

SeaStar Medical Reports First Quarter 2024 Financial Results and Provides a Business Update

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火曜日, 5月 14, 2024

DENVER, May 14, 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 three months ended March 31, 2024 and provides a business update.

Key Points: 
  • DENVER, May 14, 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 three months ended March 31, 2024 and provides a business update.
  • In March 2024 the Company sponsored an industry symposium titled “ New Therapies in Pediatric Acute Kidney Injury ” at the AKI & CRRT 2024 conference.
  • Mr. Green brings to SeaStar Medical extensive financial experience at public medical device and therapeutics companies.
  • The net loss for the first quarter of 2024 was $12.7 million, or $0.19 per share on 67.1 million weighted-average shares outstanding.

Pixelgen Technologies Announces Peer-Review Publication on Molecular Pixelation Technology in Nature Methods

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水曜日, 5月 8, 2024

STOCKHOLM, May 8, 2024 /PRNewswire/ -- Pixelgen Technologies, a leader in spatial proteomics for single cells, announced today that researchers from Pixelgen, the Karolinska Institute, Imperial College of London, and the Royal Institute of Technology in Sweden have demonstrated a ground-breaking sequencing-based method for identifying the relative locations of highly-multiplexed immunologically relevant proteins in single cells, in a peer-reviewed article published in Nature Methods. The Molecular Pixelation (MPX) technology used in the study is the first to demonstrate spatial proteomics of single cells without light, enabling multiplexing, throughput, and spatial resolution in 3D for proteomics-level single cell research.

Key Points: 
  • The Molecular Pixelation (MPX) technology used in the study is the first to demonstrate spatial proteomics of single cells without light, enabling multiplexing, throughput, and spatial resolution in 3D for proteomics-level single cell research.
  • The study, titled "Molecular Pixelation: Spatial Proteomics of single cells by sequencing," illustrates the ability of a DNA-barcode-based strategy to identify and visualize in 3D the spatial protein organization of immune cell receptors.
  • How immune cell surface receptors are organized relative to each other, and their behavior control many of a cell's vital functions.
  • Researchers have traditionally studied spatial surface protein organization with microscopy, using fluorophore-labeled antibodies on immobilized samples or with flow cytometry.

BioVie Presents Data Showing Potential for Bezisterim (NE3107) to Reduce Inflammation and Restore Homeostasis in a Manner Correlated with Alzheimer’s Disease and Biomarker Endpoints

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木曜日, 4月 25, 2024

The DNA methylation dataset assessed the extent of DNA methylation on roughly 965,000 individual sites where methyl groups can be attached to the patients’ DNA.

Key Points: 
  • The DNA methylation dataset assessed the extent of DNA methylation on roughly 965,000 individual sites where methyl groups can be attached to the patients’ DNA.
  • But these data provide evidence that bezisterim may have the potential to help keep people healthier for a longer time as we age,” said Cuong Do, BioVie’s President and CEO.
  • “BioVie believes that DNA methylation may not need to constantly increase as we age, and thus the progression of age-related disease may not be uni-directional.
  • This suggests that bezisterim disrupted the negative consequences of DNA methylation that promotes inflammation and restored homeostasis.

SeaStar Medical Reports 2023 Financial Results and Provides a Business Update

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水曜日, 4月 17, 2024

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.

The United States FDA Awards Orphan Drug Designation (ODD) to NM5072 for Treating Paroxysmal Nocturnal Hemoglobinuria (PNH)

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月曜日, 4月 15, 2024

The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.

Key Points: 
  • The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.
  • CLEVELAND, April 15, 2024 (GLOBE NEWSWIRE) -- NovelMed today announced that the Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to NM5072, an Alternative Pathway (AP) blocker anti-Properdin antibody, for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).
  • NM5072 is another drug in our pipeline that has received Orphan Drug Designation in the United States.
  • Among these, Paroxysmal Nocturnal Hemoglobinuria (PNH) emerges as a prominent indication for complement blockers heading towards FDA approval.

Factor Bioscience to Deliver Seven Presentations at the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting

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火曜日, 4月 23, 2024

CAMBRIDGE, Mass., April 23, 2024 /PRNewswire/ -- Factor Bioscience Inc., a Cambridge-based biotechnology company focused on developing mRNA and cell-engineering technologies, announced its participation in the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting to be held in Baltimore, MD from May 7-11, 2024. Factor will deliver seven presentations, representing the company's most expansive presentation of data to date.

Key Points: 
  • CAMBRIDGE, Mass., April 23, 2024 /PRNewswire/ -- Factor Bioscience Inc., a Cambridge-based biotechnology company focused on developing mRNA and cell-engineering technologies, announced its participation in the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting to be held in Baltimore, MD from May 7-11, 2024.
  • Factor will deliver seven presentations, representing the company's most expansive presentation of data to date.
  • "Factor will deliver seven presentations, representing the company's most expansive presentation of data to date."
  • For more information about the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, visit annualmeeting.asgct.org .

Mallinckrodt Announces 2024 Extracorporeal Immunomodulation Award

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日曜日, 4月 14, 2024

DUBLIN, April 14, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmacy company, today announced that submissions for its 2024 Extracorporeal Immunomodulation Award (EIA) will open on 13 April 2024 during the 50th Annual Meeting of the European Bone Marrow Transplant Meeting (EBMT), Europe's largest annual congress in blood and bone marrow transplantation and cellular therapies. In recognition of 30 years since clinicians first used ECP to successfully treat chronic GvHD,1 Mallinckrodt, provider of immunomodulatory therapy via Extracorporeal Photopheresis (ECP) and manufacturer of the world's only fully integrated, validated, ECP system, is pleased to mark this important milestone by this year dedicating the award to the study of ECP for cGvHD.

Key Points: 
  • Host Disease (cGvHD), this year's grant is to be dedicated to research in cGvHD --
    DUBLIN, April 14, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmacy company, today announced that submissions for its 2024 Extracorporeal Immunomodulation Award (EIA) will open on 13 April 2024 during the 50th Annual Meeting of the European Bone Marrow Transplant Meeting (EBMT), Europe's largest annual congress in blood and bone marrow transplantation and cellular therapies.
  • "Mallinckrodt has pioneered ECP immunomodulation through its THERAKOSTM CELLEXTM Photopheresis System and is pleased to support continued research that further contributes to this field of medicine," said Peter Richardson, MRCP (UK), Executive Vice President & Chief Scientific Officer.
  • Entries to the 2024 EIA Award will close on 1 September 2024.
  • This event will be presented by the GvHD Hub, and supported through an unrestricted educational grant from Therakos, Mallinckrodt.

SeaStar Medical Provides Updates on Enrollment of Adult Pivotal Clinical Study and Commercial Launch of Quelimmune, FDA-Approved in Pediatric Patients

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火曜日, 3月 12, 2024

DENVER, March 12, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, provides updates on the acute kidney injury (AKI) programs it is developing with its patented, first-to-market, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill patients with AKI.

Key Points: 
  • “We now have 21 subjects enrolled across five clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which is intended to evaluate the safety and efficacy of our SCD in adult AKI patients.
  • Additional sites are progressing through the site activation and contract completion process,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • “We expect the pace of enrollment will accelerate as more medical centers come onboard.
  • With the Approval Order, SeaStar Medical can build Quelimmune Clinical Kits into inventory in parallel to the hospital approvals process.