Systemic inflammatory response syndrome

Accurate Identification of Sepsis using SeptiCyte® RAPID and Comparison with other Biomarkers Presented at Society of Critical Care Medicine (SCCM) Critical Care Congress 2024

Retrieved on: 
Monday, January 22, 2024

SEATTLE and BRISBANE, Australia, Jan. 22, 2024 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced  that data validating the use of SeptiCyte® RAPID in differentiating sepsis from systemic inflammatory response syndrome (SIRS) was selected for presentation on Sunday, January 21, during the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress in Phoenix, Arizona, January 21 to 23, 2024.

Key Points: 
  • Immunexpress Chief Medical Officer Dr. Roy Davis presented the poster entitled, "Accurate Sepsis Identification Using SeptiCyte® RAPID & Other Biomarkers of Systemic Inflammation" in a Research Snapshot theatre and fielded questions afterward in a Q&A discussion.
  • "The data demonstrate that no combination of biomarkers outperformed SeptiScore alone, or models including SeptiScore, at identifying sepsis," said Dr. Roy Davis, MD, PhD, MHA, Chief Medical Officer of Immunexpress.
  • "This is clinically meaningful as it demonstrates that SeptiCyte RAPID can be used to help diagnose sepsis more accurately than current sepsis diagnostic tools or clinical variables.
  • SeptiCyte RAPID isn't intended to be used as a standalone test, but in this study adding other biomarkers to SeptiScore didn't appreciably increase the diagnostic certainty of differentiating sepsis from SIRS."

CalciMedica Reports Second Quarter 2023 Financial Results and Provides Clinical & Corporate Updates

Retrieved on: 
Thursday, August 10, 2023

LA JOLLA, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) -- CalciMedica Inc. (“CalciMedica”) (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • LA JOLLA, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) -- CalciMedica Inc. (“CalciMedica”) (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today reported financial results for the second quarter ended June 30, 2023.
  • “Following the completion of our reverse merger in March 2023, CalciMedica has taken critical steps to accelerate clinical activities with our lead compound, Auxora,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica.
  • Patient enrollment from additional sites is expected to begin in the fourth quarter of 2023.
  • The majority of costs stemming from the reverse merger have been expensed including the payment of accrued transaction expenses in the second quarter.

Morris Animal Foundation selects 10 fellowship studies for funding

Retrieved on: 
Tuesday, May 30, 2023

DENVER, May 30, 2023 /PRNewswire/ -- Morris Animal Foundation announced it is funding 10 new fellowship studies, with two of the studies funded by longtime donor Sally R. McIntosh.

Key Points: 
  • DENVER, May 30, 2023 /PRNewswire/ -- Morris Animal Foundation announced it is funding 10 new fellowship studies, with two of the studies funded by longtime donor Sally R. McIntosh.
  • The studies will focus on a variety of topics, including deadly infections in dogs, immune response disorders in horses and amphibian conservation.
  • "Our Fellowship Training program is one of the most impactful investments we can make for animal health research," said Dr. Kathy Tietje, Chief Program Officer at Morris Animal Foundation.
  • McIntosh made her first gift to Morris Animal Foundation to advance greyhound health research in 2009 and since then, has expanded her support into other areas of animal health research, including wildlife health.

CalciMedica Reports First Quarter 2023 Financial Results and Provides Clinical & Corporate Updates

Retrieved on: 
Monday, May 15, 2023

LA JOLLA, Calif., May 15, 2023 (GLOBE NEWSWIRE) -- CalciMedica Inc. (“CalciMedica”) (OTCQB: CALC), a clinical-stage biopharmaceutical company focused on developing therapies for life-threatening inflammatory diseases with high unmet need, today reported financial results for the first quarter ended March 31, 2023.

Key Points: 
  • LA JOLLA, Calif., May 15, 2023 (GLOBE NEWSWIRE) -- CalciMedica Inc. (“CalciMedica”) (OTCQB: CALC), a clinical-stage biopharmaceutical company focused on developing therapies for life-threatening inflammatory diseases with high unmet need, today reported financial results for the first quarter ended March 31, 2023.
  • Net Loss: Net loss was $19.3 million, or $23.43 per share (basic and diluted), for the three months ended March 31, 2023.
  • Clinical Updates and Anticipated Milestones:
    In April, 2023, CalciMedica initiated the ex-US expansion of its Phase 2b clinical trial in acute pancreatitis patients (CARPO) in India with an investigator meeting and expects to begin enrolling patients in India in the second quarter of 2023.
  • On March 30, 2023, the Company’s common stock was suspended from trading on Nasdaq due to non-compliance with Nasdaq listing requirements.

Immunexpress to Present Data at ECCMID 2023 Indicating that SeptiCyte® RAPID Differentiates Sepsis from Non-Sepsis in Patients with Uncertain Initial Diagnosis

Retrieved on: 
Wednesday, April 5, 2023

The poster presentation, entitled "CLARIFYING UNCERTAINTY IN SEPSIS DIAGNOSIS USING A GENE EXPRESSION ASSAY," #P1673, will be presented in-person at ECCMID on April 16th, 2023, in Copenhagen, Denmark.

Key Points: 
  • The poster presentation, entitled "CLARIFYING UNCERTAINTY IN SEPSIS DIAGNOSIS USING A GENE EXPRESSION ASSAY," #P1673, will be presented in-person at ECCMID on April 16th, 2023, in Copenhagen, Denmark.
  • Additionally, Immunexpress will host a presentation entitled "SeptiCyte RAPID, a unique qPCR host response assay for the rapid and early detection of sepsis," at the ECCMID Innovation Theatre on April 17th, 2023, at 12:30 p.m. CET.
  • The 143 indeterminate patients included in the study were reviewed again, requiring a final adjudication of SIRS or sepsis performed by forced diagnosis with SeptiCyte RAPID.
  • By differentiating sepsis from SIRS, care teams are able to more confidently prescribe antibiotics for sepsis patients as an essential part of their care plan."

Immunexpress to Present Data at ISICEM 2023 Indicating that SeptiCyte® RAPID Outperforms Other Rapid Measures for Sepsis Diagnosis

Retrieved on: 
Tuesday, March 21, 2023

The poster presentation, entitled "Performance of a Molecular Host Response Assay in Patients Suspected of Sepsis and Stratified by qSOFA," will be presented on March 21, 2023.

Key Points: 
  • The poster presentation, entitled "Performance of a Molecular Host Response Assay in Patients Suspected of Sepsis and Stratified by qSOFA," will be presented on March 21, 2023.
  • The abstract will be published in Critical Care Medicine and will be available at www.septicyte.com/references .
  • SeptiCyte® RAPID differentiates sepsis positive patients from sepsis negative patients irrespective of qSOFA stratification (AUC 0.82 in qSOFA ≥2, AUC 0.81 in qSOFA
  • SeptiCyte RAPID outperformed other markers of sepsis at separating both higher and lower mortality ICU cases from patients that did not have sepsis.

CalciMedica Announces Closing of Merger with Graybug Vision and Concurrent Private Placement

Retrieved on: 
Monday, March 20, 2023

LA JOLLA, Calif., March 20, 2023 (GLOBE NEWSWIRE) -- CalciMedica Inc. (CalciMedica) (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing therapies for life-threatening inflammatory diseases with high unmet need, today announced the closing of its previously announced merger with Graybug Vision, Inc. CalciMedica’s stock will commence trading on March 21, 2023 on the Nasdaq Global Market under the trading symbol “CALC”.

Key Points: 
  • Immediately prior to the closing of the merger, CalciMedica completed the previously announced private placement of $10.3 million.
  • “With the closing of this merger, CalciMedica enters into a pivotal new phase of its future development, and we are extremely thankful to have partnered with Graybug for this transformational deal,” said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica.
  • Immediately following the merger, CalciMedica had approximately 5.5 million shares of common stock outstanding.
  • In connection with the merger, the parties waived the condition that the shares of Graybug Vision, Inc. common stock to be issued to CalciMedica stockholders in the merger be approved for listing on Nasdaq as of the closing of the merger.

Boston Scientific Receives FDA Clearance for LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System

Retrieved on: 
Friday, February 3, 2023

MARLBOROUGH, Mass., Feb. 3, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System, the first ureteroscope system with the ability to monitor intrarenal pressure in real-time during ureteroscopy procedures.

Key Points: 
  • MARLBOROUGH, Mass., Feb. 3, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System, the first ureteroscope system with the ability to monitor intrarenal pressure in real-time during ureteroscopy procedures.
  • The LithoVue Elite System, comprised of the single-use digital flexible ureteroscope and the StoneSmart™ Connect Console, builds on many of the features of the original LithoVue™ System with significant next-generation innovations.
  • The LithoVue Elite System is the latest device in the Boston Scientific single-use imaging portfolio, developed with physician feedback to advance patient care and eliminate infection risk associated with ineffective reprocessing of reusable scopes.
  • For more information about kidney stone solutions from Boston Scientific, please visit www.bostonscientific.com/LithoVueElite or StoneSmart.com .

Graybug and CalciMedica Enter into Definitive Merger Agreement

Retrieved on: 
Monday, November 21, 2022

REDWOOD CITY, Calif. and LA JOLLA, Calif., Nov. 21, 2022 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY) (Graybug) and CalciMedica Inc. (CalciMedica) today announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on further developing CalciMedica’s lead product candidate Auxora™, a proprietary, intravenous-formulated, small molecule calcium-release activated calcium (CRAC) channel inhibitor, to treat life-threatening inflammatory diseases, such as acute pancreatitis (AP), asparaginase-associated pancreatitis (AAP), acute kidney injury (AKI), and acute hypoxemic respiratory failure (AHRF), for which there are no currently approved therapies. Auxora, which modulates the immune response and protects against tissue cell injury, has been studied in four completed efficacy clinical trials, demonstrating positive and consistent clinical results, as well as a favorable safety profile. Subject to each company’s stockholder approval, the combined company is expected to trade on the Nasdaq Global Market.

Key Points: 
  • After completing a comprehensive strategic review, we determined that the proposed merger with CalciMedica would provide the best return for Graybug stockholders moving forward, said Frederic Guerard, Pharm.D., Chief Executive Officer of Graybug.
  • Im extremely pleased to announce this proposed merger with Graybug, which comes at a pivotal time for our company, said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica.
  • The merger agreement provides that the board of directors of the combined company will be composed of seven members, five selected by CalciMedica and two selected by Graybug.
  • In connection with the merger, Graybug intends to file with the SEC preliminary and definitive proxy statements relating to the proposed merger and any other relevant documents.

Blessing Health targets smarter sepsis surveillance with Wolters Kluwer

Retrieved on: 
Wednesday, August 24, 2022

Each year in the United States, sepsis accounts for 270,000 deaths and costs nearly $27 billion making it one of the largest cost drivers for U.S. hospitals.1 To quickly identify and best care for patients with sepsis or sepsis shock, Blessing Health System (Blessing), an integrated health system in Quincy, Illinois, has selected POC Advisor from Wolters Kluwer, Health .

Key Points: 
  • Each year in the United States, sepsis accounts for 270,000 deaths and costs nearly $27 billion making it one of the largest cost drivers for U.S. hospitals.1 To quickly identify and best care for patients with sepsis or sepsis shock, Blessing Health System (Blessing), an integrated health system in Quincy, Illinois, has selected POC Advisor from Wolters Kluwer, Health .
  • The move expands Blessing's adoption of Wolters Kluwer's clinical surveillance suite by adding POC Advisor to its Sentri7 infection prevention and pharmacy surveillance solutions.
  • The first signs of sepsis: early and accurate detection
    Blessing employs a collaborative approach to sepsis symptom detection and management with various care settings across the health system.
  • This sepsis surveillance solution monitors patients in real-time to better identify and alert on sepsis cases allowing clinicians to intervene earlier.