Lipopolysaccharide

Impacts of Extreme Weather on Interior Design Examined in New Research

Retrieved on: 
Thursday, March 28, 2024
Climate Change, Manufacturing, Construction & Property, Interior Design, Environmental Health, Research, Green Technology, Textiles, Environment, Science, Chemicals, Plastics, Health, Temperature, Interior, Climate change, Built environment, Trust, Risk, Education, Humidity, Climate, Bacteria, Virus, Heat, Design, Carbon, Lipopolysaccharide, Weather, Dust, Society, CIRI, Atmosphere, Multimedia, ASID, Allergen, Risk management

Focusing on the intersection between science and interior design, “ASID Impact of Design Brief: Climate, Building Resiliency & Human Health” is the first of two free resources from ASID and CIRI.

Key Points: 
  • Focusing on the intersection between science and interior design, “ASID Impact of Design Brief: Climate, Building Resiliency & Human Health” is the first of two free resources from ASID and CIRI.
  • The brief explores how weather events impact the built environment and interior design, the effects of extreme weather on human health and building resilience, and insight into designing for the future.
  • The extreme weather brief will be followed by a second brief from the ASID-CIRI team; with the second focusing on the effects of heat.
  • “With the increase of extreme weather events and climate change, the interior design profession must be well-equipped to better understand and incorporate resilient solutions into their practices.

Spectral Medical Provides February Tigris Trial Update

Retrieved on: 
Wednesday, February 28, 2024
TSX, AME Publishing Company, Sepsis, Lipopolysaccharide, Randomized controlled trial, Patient, Septic shock, Pharmaceutical industry

TORONTO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Key Points: 
  • TORONTO, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
  • Robust enrollment activity continues throughout 2024:
    With 57 patients to full enrollment, the Company is entering the final push to fully enroll and finish the Tigris trial
    Currently 21 Tigris trial sites, with continued progress opening an additional four new, high quality clinical sites
    The Institute for Extracorporeal Life Support (San Antonio, TX) finalized and executed the Tigris clinical trial agreement
    Expect significant site onboarding activity throughout Q1/24, with final training scheduled at three of the remaining four sites

Sigyn Therapeutics™ Announces Filing of 2023 Annual Report on SEC Form 10-K

Retrieved on: 
Wednesday, February 21, 2024
SAN, Sepsis, Lipopolysaccharide, Toxicity, Inflammation, FDA, Form 10-K, Cardiovascular disease, Dialysis, IDE, Kidney disease, Annual report, Death, Patient, ESRD, Investigational device exemption, Mortality, Infection, Cancer, Pharmaceutical industry

SAN DIEGO, CA, Feb. 21, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – Sigyn Therapeutics, Inc. (“Sigyn Therapeutics” or the “Company”) (OTCQB: “SIGYD” – “SIGY”), a development-stage medical technology company, announced today the filing of its Form 10-K annual report with the United States Securities and Exchange Commission ("SEC") for the year-ended December 31, 2023.

Key Points: 
  • SAN DIEGO, CA, Feb. 21, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire – Sigyn Therapeutics, Inc. (“Sigyn Therapeutics” or the “Company”) (OTCQB: “SIGYD” – “SIGY”), a development-stage medical technology company, announced today the filing of its Form 10-K annual report with the United States Securities and Exchange Commission ("SEC") for the year-ended December 31, 2023.
  • The annual report can be accessed on the SEC's website at www.sec.gov or on the Company's website at www.sigyntherapeutics.com under the "investors" section.
  • On January 31, 2024, the Company completed a 1-for-40 reverse split of its common stock.
  • In 2023, net cash used in operating activities was approximately $1.4 million, as compared to approximately $1.8 million in 2022.

INVESTIGATION ALERT: Kaskela Law LLC Announces Shareholder Investigation of Integra LifeSciences Holdings Corp. (NASDAQ: IART) and Encourages Long-Term Investors to Contact the Firm

Retrieved on: 
Wednesday, February 14, 2024
Complaint, Acquisition, Integra, Boston, FDA, Lipopolysaccharide, Management control system, Pharmaceutical industry

PHILADELPHIA, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Kaskela Law LLC announces that it has commenced an investigation into Integra LifeSciences Holdings Corp. (NASDAQ: IART) (“Integra”) on behalf of the company’s long-term investors.

Key Points: 
  • PHILADELPHIA, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Kaskela Law LLC announces that it has commenced an investigation into Integra LifeSciences Holdings Corp. (NASDAQ: IART) (“Integra”) on behalf of the company’s long-term investors.
  • After receiving the 2018 Form 483, Integra issued a series of responses purporting to address the problems identified by the FDA.
  • Integra shareholders who purchased or acquired their shares prior to April 26, 2023 are encouraged to contact Kaskela Law LLC (D. Seamus Kaskela, Esq.
  • Kaskela Law LLC exclusively represents investors in securities fraud, corporate governance, and merger & acquisition litigation.

Spectral Medical Provides Early February Tigris Trial Update

Retrieved on: 
Monday, February 5, 2024
Clinical trial, TSX, University, Septic shock, Patient, PMX, Lipopolysaccharide, Randomized controlled trial, Sepsis

TORONTO, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Key Points: 
  • TORONTO, Feb. 05, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
  • Robust enrollment activity continues throughout 2024:
    Six patients enrolled in the month of January, which is the highest monthly enrollment experienced since the start of the Tigris study
    Closing in on the interim enrollment target of 90 patients (“Interim Enrollment”); at Interim Enrollment, Baxter has the option to make the second milestone payment to Spectral to maintain its PMX exclusive distribution rights.
  • Continue to make progress opening an additional six new, high quality clinical sites.
  • “Additionally, with 62 patients to go, we are entering the final push to fully enroll and finish the Tigris trial.”

Spectral Medical Provides January Tigris Trial Update

Retrieved on: 
Tuesday, January 30, 2024
Clinical trial, TSX, University, Septic shock, Patient, PMX, Lipopolysaccharide, Randomized controlled trial, Sepsis

TORONTO, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Key Points: 
  • TORONTO, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
  • University of Texas Health Sciences Center at Houston finalized and executed the Tigris clinical trial agreement; the Company anticipates another Texas-based site to execute its clinical trial agreement in the coming days.
  • The robust enrollment activity throughout January puts Spectral within striking distance of our interim enrollment milestone of 90 patients, which is expected to play as a major catalyst for the Company,” said Chris Seto, Chief Executive Officer of Spectral Medical.
  • “Additionally, with 65 patients to go, we are entering the final push to fully enroll and finish the Tigris trial.”

Basilea announces acquisition of preclinical antibiotics program from Spexis

Retrieved on: 
Monday, January 15, 2024
Escherichia coli, World Health Organization, Patient, Gram-negative bacteria, Colistin, Partnership, Beta-lactam, Infection, Transmembrane protein, Bacteria, Klebsiella, Intellectual property, CHF, Lipopolysaccharide, Klebsiella pneumoniae, Vaccine

We are excited by the addition of this new program to our growing pipeline and to continue the development of this targeted antibiotics class, which has the potential to address an unmet medical need in the treatment of severe bacterial infections in the hospital.”

Key Points: 
  • We are excited by the addition of this new program to our growing pipeline and to continue the development of this targeted antibiotics class, which has the potential to address an unmet medical need in the treatment of severe bacterial infections in the hospital.”
    The antibiotics were developed within Spexis’ Outer Membrane Protein Targeting Antibiotics (OMPTA) program and selectively disrupt the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria.
  • This results in a loss of the integrity of the outer cell membrane, intracellular accumulation of lipopolysaccharides and killing of the bacteria.
  • The program was funded in part by CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator).2 This underscores the potential of this novel class of antibiotics.
  • In addition, Basilea assumes the rights and obligations of Spexis, including potential low single-digit percentage royalties on sales, under licensing agreements.

Spectral Medical Enrolls Patient 82 in Its Phase 3 FDA Tigris Septic Shock Trial

Retrieved on: 
Wednesday, January 10, 2024
Baxter International, PMX, Lipopolysaccharide, Septic shock, Mortality, Patient, Sepsis, TSX, Randomized controlled trial, Nursing

TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

Key Points: 
  • TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late-stage theranostic company advancing therapeutic options for sepsis and septic shock, today provided an update on the Company’s Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
  • Initiated 2024 with robust site activity to start the new year:
    Enrolled patient 82 during the first week of January.
  • This resumes the strong enrollment into Tigris which we experienced since holding our Investigator Meeting this past May.
  • “Additionally, with 68 patients to go, we are entering the final push to fully enroll and finish the Tigris trial.”

Sigyn Therapeutics Releases Letter to Shareholders

Retrieved on: 
Thursday, January 4, 2024
Fresenius Medical Care, FDA, Hope, Health, Cancer, Inflammation, Patent, Lipopolysaccharide, Kidney disease, Horizon, Annual report, Death, University, IDE, Letter, Merck, Dialysis, Sepsis, Life, Antibody, Mortality, Therapy, Risk, Toxicity, Patient, Acquisition, AB toxin, ESRD, Hospital, Infection, SAN, DaVita Inc., Community-acquired pneumonia, Horizon Therapeutics, Roivant Sciences, Cardiovascular disease, Security (finance), Pharmaceutical industry

SAN DIEGO, CA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- Sigyn Therapeutics, Inc. (“Sigyn” or the “Company”) (OTCQB: SIGY), a development-stage medical technology company, today announced the release of a shareholder letter authored by Chairman and Chief Executive Officer, Jim Joyce.

Key Points: 
  • SAN DIEGO, CA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- Sigyn Therapeutics, Inc. (“Sigyn” or the “Company”) (OTCQB: SIGY), a development-stage medical technology company, today announced the release of a shareholder letter authored by Chairman and Chief Executive Officer, Jim Joyce.
  • The goal of this letter is to help you better understand our opportunities, our challenges, and decision-making processes.
  • In that submission, our endeavors were solely predicated on the development and clinical advancement of Sigyn TherapyTM.
  • This information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties.

INTEGRA ALERT: Bragar Eagel & Squire, P.C. is Investigating Integra LifeSciences Holdings Corp. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Friday, December 15, 2023
Telephone, Letter, FDA, Lipopolysaccharide, Complaint, Integra, P.C, Infection, Patient, PMA

Our investigation concerns whether the board of directors of Integra have breached their fiduciary duties to the company.

Key Points: 
  • Our investigation concerns whether the board of directors of Integra have breached their fiduciary duties to the company.
  • In October 2018, the FDA inspected the Boston Facility and found that Integra was in violation of the good manufacturing practice requirements of the Quality System Regulation.
  • Consequently, on November 2, 2018, the FDA issued a Notice of Inspectional Observations on Form 483 (the “2018 Form 483”) to put Integra on notice of those violations.
  • Most significantly, the FDA found that Integra failed to adequately test for bacterial endotoxins in the medical devices manufactured at the Boston Facility.