Acute respiratory distress syndrome

What is sepsis? How to spot, manage and prevent it

Retrieved on: 
Sunday, April 23, 2023
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Sepsis, a life threatening condition, happens when the body has an excessive immune response to an infection in the blood stream.

Key Points: 
  • Sepsis, a life threatening condition, happens when the body has an excessive immune response to an infection in the blood stream.
  • The Conversation Africa’s Ina Skosana spoke to pathologists from the National Institute of Communicable Diseases about the illness and its impact.

What causes sepsis?

    • There are common causes of sepsis.
    • Infections of the central nervous system (meningitis) as well as skin and soft tissue (surgical site, wounds or burns) are also common causes of sepsis.

Who is at risk of sepsis?

    • But babies up to one month old and people older than 65 years have a higher risk of developing the condition.
    • Prolonged hospital stays or admission to an intensive care unit (ICU) can also increase the risk of sepsis.

What are the symptoms of sepsis and septic shock?


    Symptoms of sepsis are not specific. These may include one or more of these:
    Septic shock is a progression of sepsis. It’s characterised by hypotension (low blood pressure), hypovolaemia (loss of bodily fluids such as water and blood) and organ dysfunction. Patients typically present with extreme confusion or loss of consciousness.

How is sepsis and septic shock diagnosed?

    • There are various tests available to diagnose sepsis and septic shock.
    • Sepsis and septic shock are clinical syndromes defined by a combination of signs, symptoms, laboratory and physiological abnormalities.
    • A variety of clinical variables and tools such as vital signs (heart rate, respiratory rate, temperature and blood pressure), laboratory blood tests (confirmation of infection) and clinical examinations have to be reviewed for sepsis screening.

How is sepsis managed?

    • Patients with sepsis need close monitoring and treatment in a hospital ICU.
    • Intravenous fluids should be started as soon as possible, preferably within the first three hours of sepsis being identified.

How is sepsis prevented?

    • In healthcare facilities prevention of the sepsis include practising appropriate infection prevention and control measures which can reduce infections by 50%.
    • Recognising sepsis early and introducing antibiotics treatment early can reduce the likelihood of sepsis progressing to mortality.
    • Anyone who has signs and symptoms of sepsis, even when the underlying infection is not apparent, should seek medical care immediately.

SeaStar Medical Announces Activation of First Clinical Site in Pivotal Trial with Selective Cytopheretic Device in Critically Ill Adults with Acute Kidney Injury

Retrieved on: 
Wednesday, April 19, 2023
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This trial, expected to include up to 30 U.S. sites, is evaluating the safety and efficacy of SeaStar Medical’s patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).

Key Points: 
  • This trial, expected to include up to 30 U.S. sites, is evaluating the safety and efficacy of SeaStar Medical’s patented, first-in-class, cell-directed Selective Cytopheretic Device (SCD) extracorporeal therapy in critically ill adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT).
  • “We recently received FDA approval to begin this pivotal trial and activated the first clinical site in record time, with many more sites expected to come onboard in the near term,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical.
  • The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective CytopheretIic Device - a randomiZEd clinical trial in Acute Kidney Injury) pivotal trial is expected to enroll up to 200 patients.
  • Breakthrough therapies receive many benefits, including a commitment by the FDA to expedite development and review.

Direct Biologics Reports Compelling Data as ExoFlo™ Expanded Access Program in Hospitalized COVID-19 Patients with Moderate-to-Severe ARDS Surpasses 100 Subjects

Retrieved on: 
Wednesday, April 19, 2023
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“We are pleased to report compelling findings from more than 100 patients with respiratory failure due to COVID-19 who were treated with ExoFlo as part of our expanded access program.

Key Points: 
  • “We are pleased to report compelling findings from more than 100 patients with respiratory failure due to COVID-19 who were treated with ExoFlo as part of our expanded access program.
  • To date, 103 patients have been enrolled and treated in the program.
  • Further, patients younger than 65 were discharged from the hospital earlier and had more ventilator-free days than patients 65-85.
  • In addition, the trial will evaluate the efficacy of ExoFlo in ARDS subtypes to better understand the disease process.

Direct Biologics Announces FDA Authorization to Expand Ongoing Phase 3 Clinical Study of ExoFlo™ to All-Cause Moderate-to-Severe ARDS

Retrieved on: 
Tuesday, April 4, 2023
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In addition, the trial will evaluate the efficacy of ExoFlo in ARDS subtypes to better understand the disease process.

Key Points: 
  • In addition, the trial will evaluate the efficacy of ExoFlo in ARDS subtypes to better understand the disease process.
  • In March 2022, ExoFlo received Regenerative Medicine Advanced Therapy, or RMAT, designation by the FDA, which provides opportunities to expedite ExoFlo’s clinical development for ARDS.
  • “FDA authorization to expand our ongoing Phase 3 clinical trial to all-cause ARDS marks a defining moment for regenerative medicine.
  • In fact, ExoFlo is one of a small handful of biologics that has demonstrated adequate tolerability and clinical activity to gain allowance by the FDA for Phase 3 evaluation in moderate-to-severe ARDS,” said Amy Lightner, M.D., Chief Medical Officer of Direct Biologics.

SeaStar Medical Reports 2022 Financial Results and Provides a Business Update

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Friday, March 31, 2023
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DENVER, March 30, 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, provides a business update and reports financial results for the year ended December 31, 2022.

Key Points: 
  • DENVER, March 30, 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, provides a business update and reports financial results for the year ended December 31, 2022.
  • “We are focusing on executing near-term milestones that will advance our business,” said Eric Schlorff, SeaStar Medical CEO.
  • The NEUTRALIZE-AKI trial is expected to enroll up to 200 patients at up to 30 U.S. medical centers.
  • In March 2023 SeaStar Medical closed a $3.3 million first tranche of a $9.8 million private placement convertible debt offering.

CytoSorbents Highlights New Clinical Data from Current Studies at the Live 42nd International Symposium on Intensive Care & Emergency Medicine (ISICEM)

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Wednesday, March 22, 2023
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Prof. Peter Pickkers (Radboud University Nijmegen, The Netherlands) will focus on the ability of CytoSorb to reduce circulating cytokines during systemic inflammation in a robust controlled human study.

Key Points: 
  • Prof. Peter Pickkers (Radboud University Nijmegen, The Netherlands) will focus on the ability of CytoSorb to reduce circulating cytokines during systemic inflammation in a robust controlled human study.
  • CytoSorb is being increasingly used as a ‘go-to’ therapy option for critically ill patients suffering from a broad range of life-threatening illnesses, especially septic shock.
  • Treating physicians and health care professionals around the world have directly experienced the beneficial impact of our therapy on their patients.
  • We are excited to reconnect with key opinion leaders, customers, and partners from the global medical community to share our latest experiences and clinical studies with them.

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

Retrieved on: 
Monday, March 20, 2023
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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.

Direct Biologics Reports Compelling Results From Phase 2 Trial With ExoFlo™ in Hospitalized Patients With Respiratory Failure or Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19

Retrieved on: 
Tuesday, March 14, 2023
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“We are pleased to report compelling findings that provide hope to the thousands of patients around the world with respiratory failure and moderate-to-severe ARDS due to COVID-19.

Key Points: 
  • “We are pleased to report compelling findings that provide hope to the thousands of patients around the world with respiratory failure and moderate-to-severe ARDS due to COVID-19.
  • Findings demonstrated a significant survival benefit in ExoFlo-treated patients with respiratory failure due to COVID-19.
  • The FDA has granted Direct Biologics an allowance to proceed with a Phase 3 trial of ExoFlo-15 mL compared with placebo, randomized 1:1.
  • This multisite global trial will look at 60-day all-cause mortality in patients who meet Berlin criteria for moderate-to-severe ARDS.

MediciNova Announces Additional Extension of BARDA Contract to Develop MN-166 (ibudilast) as a Medical Countermeasure Against Chlorine Gas-induced Lung Injury

Retrieved on: 
Thursday, March 9, 2023
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LA JOLLA, Calif., March 09, 2023 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA), a part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services, to repurpose MN-166 (ibudilast) as a potential medical countermeasure (MCM) against chlorine gas-induced lung damage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI).

Key Points: 
  • LA JOLLA, Calif., March 09, 2023 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ: MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA), a part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services, to repurpose MN-166 (ibudilast) as a potential medical countermeasure (MCM) against chlorine gas-induced lung damage such as acute respiratory distress syndrome (ARDS) and acute lung injury (ALI).
  • The contract was amended to extend the period of performance until May 31, 2023.
  • This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50121C00022.

Omega Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, March 1, 2023
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“2022 was a pivotal year for Omega, marked by tremendous progress and consistent execution.

Key Points: 
  • “2022 was a pivotal year for Omega, marked by tremendous progress and consistent execution.
  • Research and development (R&D) expenses for the fourth quarter of 2022 were $25.7 million, compared to $14.7 million for the fourth quarter 2021.
  • General and administrative (G&A) expenses for the fourth quarter of 2022 were $5.4 million, compared with $5.7 million for the fourth quarter of 2021.
  • Net loss for the fourth quarter of 2022 was $30.8 million, compared with $20.9 million for the fourth quarter of 2021.