Lipopolysaccharide

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.

Spectral Medical Provides Tigris Trial Update

Retrieved on: 
Thursday, December 14, 2023
Sepsis, EDEN, Septic shock, FDA, Mortality, Randomized controlled trial, Observational study, Lipopolysaccharide, PMX, TSX, Patient, Baxter International, Pharmaceutical industry

TORONTO, Dec. 14, 2023 (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, Dec. 14, 2023 (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.
  • Currently 20 Tigris trial sites, with near term onboarding of new, high quality clinical sites.
  • Clinical Trial Agreements (“CTA”) either executed or in final revision phase at six new clinical sites.
  • Dr. John Kellum, Chief Medical Officer of Spectral, commented, “Since the end of October, we experienced strong enrollment into Tigris despite the U.S. Thanksgiving holiday, with seven patient enrollments in the last eight weeks.

Spectral Medical Provides November Tigris Trial Update

Retrieved on: 
Monday, December 4, 2023
Sepsis, Risk, Probability, Septic shock, FDA, Mortality, Randomized controlled trial, Lipopolysaccharide, PMX, TSX, Patient, Pharmaceutical industry

Currently 20 Tigris trial sites, with near term onboarding of new, high quality clinical sites.

Key Points: 
  • Currently 20 Tigris trial sites, with near term onboarding of new, high quality clinical sites.
  • Dr. John Kellum, Chief Medical Officer of Spectral, commented, “In November we experienced strong enrollment into Tigris despite the U.S. Thanksgiving holiday, with five patient enrollments in the last six weeks.
  • Overall, we are rapidly advancing our Tigris trial and remain highly encouraged by the outlook, given the fact preliminary mortality data continues to exceed our expectations.”
    “We continue to be very bullish on the outcome of the Tigris trial.
  • Current results from Tigris are far in excess of this threshold,” said Chris Seto, Chief Executive Officer of Spectral.

Sigyn Therapeutics Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 14, 2023
Kidney disease, ESRD, Safety, SAN, Food, Therapy, Mortality, Patient, FDA, IDE, Lipopolysaccharide

SAN DIEGO, CA, Nov. 14, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire –Sigyn Therapeutics, Inc. (“Sigyn” or the “Company”) (OTCQB: SIGY), a development-stage medical technology company, today announces financial results for the third quarter ended September 30, 2023.

Key Points: 
  • SAN DIEGO, CA, Nov. 14, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire –Sigyn Therapeutics, Inc. (“Sigyn” or the “Company”) (OTCQB: SIGY), a development-stage medical technology company, today announces financial results for the third quarter ended September 30, 2023.
  • During the quarter, the Company continued its plan to initiate first-in-human studies of Sigyn TherapyTM and further advanced its endeavors to develop pipeline technologies to enhance the performance of cancer therapies.
  • For the quarter ended September 30, 2023, the Company had a loss from operations of approximately $642,814, compared to an operating loss of approximately $533,647 for the comparable period of 2022.
  • For complete financial results, please see Sigyn Therapeutics’ filings at www.sec.gov ,  and on the Company's website at www.SigynTherapeutics.com under "Financial Info" in the Investors section.

IART 2-DAY DEADLINE ALERT: Hagens Berman, National Trial Attorneys, Encourages Integra LifeSciences (IART) Investors with Substantial Losses to Contact the Firm Before Nov. 13th Deadline in Securities Fraud Class Action

Retrieved on: 
Saturday, November 11, 2023
SAN, Lipopolysaccharide, Person, EPS, FDA, Good manufacturing practice, Hagens Berman, PMA, Pharmaceutical industry, Life insurance, Integra, Boston

SAN FRANCISCO, Nov. 11, 2023 (GLOBE NEWSWIRE) -- Hagens Berman urges Integra LifeSciences Holdings Corp. (NASDAQ: IART) investors who suffered substantial losses to submit your losses now .

Key Points: 
  • SAN FRANCISCO, Nov. 11, 2023 (GLOBE NEWSWIRE) -- Hagens Berman urges Integra LifeSciences Holdings Corp. (NASDAQ: IART) investors who suffered substantial losses to submit your losses now .
  • Integra LifeSciences Holdings Corp. (IART) Securities Fraud Class Action:
    The litigation focuses on Integra’s disclosures related to the FDA’s findings of Good Manufacturing Practices violations at its Boston Facility.
  • 26, 2023, when Integra revealed that it paused production at the Boston Facility.
  • “We’re focused on investors’ losses and whether Integra misled investors about its compliance with worldwide Good Manufacturing Practices,” said Reed Kathrein, the Hagens Berman partner leading the investigation.

INTEGRA INVESTOR DEADLINE APPROACHING: Faruqi & Faruqi Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Integra To Contact Him Directly To Discuss Their Options

Retrieved on: 
Thursday, November 9, 2023
Lipopolysaccharide, LLP, Advertising, Patient, Woman, Infection, FDA, Boston, Failure, Court, PMA, Cryptocurrency, Dietary supplement, Pharmaceutical industry, Integra

NEW YORK, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Integra LifeSciences Holdings Corporation (“Integra” or the “Company”) (NASDAQ: IART) and reminds investors of the November 13, 2023 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

Key Points: 
  • Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Pennsylvania, California and Georgia.
  • 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.
  • Most significantly, the FDA found that Integra failed to adequately test for bacterial endotoxins in the medical devices manufactured at the Boston Facility.
  • Faruqi & Faruqi, LLP also encourages anyone with information regarding Integra’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others.

The Law Offices of Frank R. Cruz Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Integra LifeSciences Holdings Corporation (IART)

Retrieved on: 
Friday, November 10, 2023
Class Action Lawsuit, Professional Services, Legal, Defendant, PMA, Suite, Integra, Law, Lipopolysaccharide, FDA, Court, News, Pharmaceutical industry

The Law Offices of Frank R. Cruz reminds investors of the upcoming November 13, 2023 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who acquired Integra LifeSciences Holdings Corporation (“Integra” or the “Company”) (NASDAQ: IART ) common stock between March 11, 2019 and May 22, 2023, inclusive (the “Class Period”).

Key Points: 
  • The Law Offices of Frank R. Cruz reminds investors of the upcoming November 13, 2023 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who acquired Integra LifeSciences Holdings Corporation (“Integra” or the “Company”) (NASDAQ: IART ) common stock between March 11, 2019 and May 22, 2023, inclusive (the “Class Period”).
  • On this news, Integra’s stock price fell $4.64, or 7.9%, to close at $54.20 per share on April 26, 2023, thereby injuring investors.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

INTEGRA LIFESCIENCES 72 HOUR DEADLINE ALERT: Former Louisiana Attorney General and Kahn Swick & Foti, LLC Remind Investors With Losses in Excess of $100,000 of Deadline in Class Action Lawsuit Against Integra LifeSciences Holdings Corporation - IART

Retrieved on: 
Friday, November 10, 2023
Class Action Lawsuit, Professional Services, Legal, Integra, Lipopolysaccharide, District court, Firefighter, Court, News, Special warfare combatant-craft crewmen, KSF

This action is pending in the United States District Court for the District of New Jersey.

Key Points: 
  • This action is pending in the United States District Court for the District of New Jersey.
  • Integra and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
  • The case is Pembroke Pines Firefighters & Police Officers Pension Fund v. Integra LifeSciences Holdings Corporation, No.
  • About Kahn Swick & Foti, LLC
    KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation’s premier boutique securities litigation law firms.