Biosafety

Prenosis Inc. Appoints Leadership Team for Commercialization In Hospitals

Retrieved on: 
Wednesday, October 4, 2023

CHICAGO, Oct. 4, 2023 /PRNewswire/ -- Prenosis, Inc., an artificial intelligence company enabling precision medicine for abnormal immune responses in acute care, announced today the appointment of Robin Carver, RN, MSN, CIC as Vice President, Health System Engagement, Brian Bray as Vice President, Technology, and an expanded role for Carlos Lopez-Espina as Senior Vice President of Research & Development. Prenosis also announced the addition of Pratik Sinha, MD, PhD, to the company's scientific advisory board.

Key Points: 
  • Prenosis also announced the addition of Pratik Sinha, MD, PhD, to the company's scientific advisory board.
  • Carver and Mr. Bray, executives with over 40 years of combined experience in advancing technology in hospitals, will serve on the executive management team and lead the company's expansion in healthcare systems.
  • "Robin, Brian and Carlos' leadership in commercialization, integration and data will add significant value to the company as we enter the next phase of Prenosis' growth," said Reddy.
  • Prenosis developed its core resource--the world's largest biobank and dataset for decoding abnormal immune responses in acute care--in partnership with over eleven U.S. hospitals.

T2 Biosystems Receives FDA 510(k) Clearance for the T2Biothreat Panel

Retrieved on: 
Tuesday, September 19, 2023

LEXINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel.

Key Points: 
  • LEXINGTON, Mass., Sept. 19, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the T2Biothreat™ Panel.
  • The FDA 510(k) clearance allows the company to immediately begin marketing and selling the T2Biothreat Panel in the U.S. market.
  • The U.S. clinical evaluation to support the FDA 510(k) submission included testing of the T2Biothreat Panel at MRIGlobal, a Biosafety Level 3 laboratory specializing in biothreat pathogens, and Ochsner Medical Center.
  • The T2Biothreat Panel is able to detect the six aforementioned biothreat pathogens within four hours providing clinicians with the needed information to appropriately treat infected patients.

NIH Awards Prenosis With Two Grants Totaling $4.8 million to Enable Precision Medicine for Sepsis

Retrieved on: 
Wednesday, July 12, 2023

CHICAGO, July 12, 2023 /PRNewswire/ -- Prenosis, Inc., an artificial intelligence company enabling precision medicine in acute care, announced today that it has been awarded two Phase 2 SBIR grants totaling $4.8M in funding by the National Institute of General Medical Sciences (NIGMS), a division of the National Institute of Health (NIH). The grants will study the use of Prenosis's Immunix™ Artificial Intelligence platform for acute immune states. Prenosis has built a collection of artificial intelligence algorithms, broad clinical data, deep biological data, and biobanked samples of patients suspected of sepsis, in addition to detailed information about their treatment regime. The goal is to better understand how patients' health states rapidly evolve in acute care environments.

Key Points: 
  • Prenosis has built a collection of artificial intelligence algorithms, broad clinical data, deep biological data, and biobanked samples of patients suspected of sepsis, in addition to detailed information about their treatment regime.
  • The goal is to better understand how patients' health states rapidly evolve in acute care environments.
  • The outcomes of these studies could usher in a new era of predictive diagnostics, clinical decision support tools, improved clinical trials, and precision medicine drugs for sepsis.
  • Prenosis generates deep biological profiles of each patient by measuring critical sepsis biomarkers in its Biological Safety Level 2 lab in Chicago.

Prenosis Inc. Receives BARDA Contract to Study Utility of Its Sepsis Diagnostic Tool

Retrieved on: 
Wednesday, June 7, 2023

CHICAGO, June 7, 2023 /PRNewswire/ -- Prenosis Inc., an artificial intelligence company enabling precision medicine in acute care, announced today it has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), a component of the Administration for Strategic Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), a U.S. government agency.

Key Points: 
  • Prenosis has built a large, rapidly growing dataset and biobank from patients with sepsis and other infections.
  • By leveraging its proprietary dataset and AI/ML techniques, Prenosis is creating precision medicine solutions, starting with a sepsis diagnostic tool.
  • Prenosis' Sepsis ImmunoScore™ intends to enable true precision medicine for infection in hospitals.
  • The Sepsis ImmunoScore™ is a pathogen-agnostic, host-based digital diagnostic (HBD) that uses clinical parameters and protein biomarkers to assess a patient's risk of sepsis within 24 hours.

NAMSA Expands MedTech Portfolio in Market Intelligence and Customer Research Services through its Acquisition of EU-Based SUAZIO

Retrieved on: 
Monday, March 27, 2023

NAMSA , a world-leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today its acquisition of SUAZIO , an EU-based strategic consultancy providing global market research services to medical device and IVD developers.

Key Points: 
  • NAMSA , a world-leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today its acquisition of SUAZIO , an EU-based strategic consultancy providing global market research services to medical device and IVD developers.
  • “NAMSA is very enthusiastic to expand its global strategic consulting services with the addition of SUAZIO,” commented Dr. Christophe Berthoux , NAMSA CEO.
  • “Client insights and precise market research are what power the true value of novel medical technologies and product acceptance.
  • With the SUAZIO Team, NAMSA will expand its Client reach even further and strengthen the delivery of its full continuum development services to the global MedTech industry,” Dr. Berthoux concluded.

InvisiShield Technologies Collaborates with Gladstone Institutes to Accelerate Development of Intranasal Preventatives against SARS-CoV-2, Influenza, and RSV

Retrieved on: 
Monday, March 20, 2023

InvisiShield Technologies Ltd., a pre-clinical-stage biotechnology company focused on developing intranasal preventives for major disease-causing respiratory viruses, today announced a collaboration with Gladstone Institutes to develop intranasal preventatives against airborne infection, including SARS-CoV-2, influenza, and respiratory syncytial virus (RSV).

Key Points: 
  • InvisiShield Technologies Ltd., a pre-clinical-stage biotechnology company focused on developing intranasal preventives for major disease-causing respiratory viruses, today announced a collaboration with Gladstone Institutes to develop intranasal preventatives against airborne infection, including SARS-CoV-2, influenza, and respiratory syncytial virus (RSV).
  • Gladstone has made significant contributions to better understanding and developing new therapies for a range of viral diseases, including HIV/AIDS and COVID-19.
  • The collaboration aims to develop intranasal preventatives that can protect individuals from viral infections, including SARS-CoV-2, the virus that causes COVID-19, as well as influenza and RSV.
  • InvisiShield Technologies and Gladstone are committed to advancing medical research and addressing unmet medical needs.

Tomi Environmental Solutions, Inc. Reports 40% Increase in Fourth Quarter Revenue

Retrieved on: 
Thursday, March 16, 2023

FREDERICK, Md., March 16, 2023 (GLOBE NEWSWIRE) -- TOMI Environmental Solutions, Inc.® (“TOMI”) (NASDAQ: TOMZ), a global company specializing in disinfection and decontamination utilizing its premier Binary Ionization Technology (BIT) platform through its SteraMist brand of products, today announced its financial results for the fourth quarter and year ended December 31, 2022.

Key Points: 
  • Furthermore, we continue to see positive signs in the marketplace as our fourth quarter solution sales grew by 31% compared to our prior year fourth quarter.
  • Financial Results for the year ended December 31, 2022, compared to December 31, 2021
    Total net revenue was $8,338,000 compared to $7,754,000, an increase of $584,000, or 8%.
  • 60% growth in 2022 fourth quarter sales compared to the third of quarter 2022.
  • TOMI will hold a conference call to discuss Fourth Quarter and Year End 2022 results at 4:30 p.m.

T2 Biosystems Announces Positive Results upon Completion of U.S. Clinical Evaluation for the T2Biothreat Panel

Retrieved on: 
Monday, February 13, 2023

LEXINGTON, Mass., Feb. 13, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced positive results upon completion of the U.S. clinical evaluation for the T2Biothreat™ Panel.

Key Points: 
  • LEXINGTON, Mass., Feb. 13, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced positive results upon completion of the U.S. clinical evaluation for the T2Biothreat™ Panel.
  • “We are extremely pleased with the results of the clinical evaluation.
  • Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.
  • The results of the clinical trial demonstrated very high sensitivity and specificity across all six targets.

Ginkgo Bioworks Provides Preliminary Unaudited 2022 Revenue Highlights and Business Review

Retrieved on: 
Wednesday, January 11, 2023

BOSTON, Jan. 11, 2023 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, announced today preliminary performance updates for the year ended December 31, 2022. Among the results, Ginkgo highlighted that it expects to meet its previously disclosed guidance ranges for Total revenue and the commencement of new Cell Programs in 2022 based on its preliminary unaudited estimates. A business review including a discussion of Ginkgo's biopharma capabilities and end-to-end services offerings will be featured in a presentation today at the 41st Annual J.P. Morgan Healthcare Conference.

Key Points: 
  • ET)
    BOSTON, Jan. 11, 2023 /PRNewswire/ -- Ginkgo Bioworks (NYSE: DNA), which is building the leading platform for cell programming and biosecurity, announced today preliminary performance updates for the year ended December 31, 2022.
  • Among the results, Ginkgo highlighted that it expects to meet its previously disclosed guidance ranges for Total revenue and the commencement of new Cell Programs in 2022 based on its preliminary unaudited estimates.
  • A business review including a discussion of Ginkgo's biopharma capabilities and end-to-end services offerings will be featured in a presentation today at the 41st Annual J.P. Morgan Healthcare Conference.
  • Lastly, we ended the year with about $1.3 billion in cash, providing a margin of safety to the business as we continue to scale.

Sitero Launches Biosafety Advisory Board, Naming Renowned Experts to Provide Guidance on Biosafety Compliance

Retrieved on: 
Tuesday, January 10, 2023

MIAMI, Jan. 10, 2023 /PRNewswire/ -- Sitero has launched a first-of-its kind Biosafety Advisory Board and named several renowned biosafety experts as inaugural board members.

Key Points: 
  • MIAMI, Jan. 10, 2023 /PRNewswire/ -- Sitero has launched a first-of-its kind Biosafety Advisory Board and named several renowned biosafety experts as inaugural board members.
  • The board will advise Sitero on its biosafety services, helping ensure that the company provides industry-leading support for biosafety compliance.
  • The Sitero Biosafety Advisory board is the latest investment that Sitero is making in their Biosafety and IBC offerings due to their recent and expected continued growth in the space.
  • "Their efforts will be instrumental in delivering best practices in biosafety to inform our work at Sitero and advance the biosafety profession."