SBIR-STTR Award

LivOnyx: Development and Evaluation of a Device to Rapidly Sanitize and Dry Hands (in 3-5 seconds) and Prevent Healthcare Associated Infections
Award last edited on: 11/12/2019

Sponsored Program
SBIR
Awarding Agency
NIH : CDC
Total Award Amount
$150,000
Award Phase
1
Solicitation Topic Code
NCZVBED
Principal Investigator
Carmela Mascio

Company Information

Livonyx Inc (AKA: Livonyx)

224 Denby Road Suite 215
Allston, MA 02134
   (603) 765-0491
   N/A
   www.livonyx.com
Location: Single
Congr. District: 07
County: Suffolk

Phase I

Contract Number: 1R43CK000523-01A1
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
2017
Phase I Amount
$150,000
Healthcare associated infections (HAIs) pose significant harm to neonates. HAIs are associated with increased risk of death and longer hospital stays for the infant as well as poor neurological developmental and physical growth in the early childhood years. According to a 2011 CDC report, there were an estimated 722,000 HAIs in U.S acute care hospitals, resulting in 75,000 deaths and up to $20 billion in healthcare costs, yearly. In hospitals and other clinical environments, transfer of pathogens on the hands of healthcare workers is considered an important mechanism for passing pathogenic organisms to unsuspecting patients. The importance of good hand hygiene in clinical environments is well established and handwashing or the use of alcohol-containing rubs are methods that generally work, but each has significant limitations including: the amount of time required is prohibitive; alcohol rubs do not have activity against Clostridium difficile spores or non-enveloped viruses like norovirus; current hand hygiene methods are subject to significant variability. The primary objective of this project is to generate the efficacy and safety data needed to apply hypochlorous acid solutions in a novel automated hand sanitization system that will be fast (3-5s), will leave hands dry, and will be located near the patient, especially infants, to significantly improve the frequency and quality of hand hygiene procedures. Previously LivOnyx demonstrated feasibility of the thinSpray fluid dispensing system using a minute volume of various antiseptic spray to quickly inactivate clinically-relevant bacterial pathogens, such as susceptible Escherichia coli, Staphylococcus aureus, Acinetobacter baumannii, Enterococcus faecalis and Pseudomonas aeruginosa in addition to vancomycin resistant E. faecium, ampicillin resistant E. coli, multidrug resistant Klebsiella pneumoniae, and methicillin resistant S. aureus. LivOnyx proposes to investigate the following specific aims to expand on previous work. Specific Aim 1 Quantification of hypochlorous acid antiseptic efficacy against clinically-relevant bacterial pathogens. This phase of the project uses a large volume assay to determine minimum antiseptic concentrations and contact times required to achieve defined reductions of bacteria deposited onto porous surfaces. Specific Aim 2: Evaluation of a cultured human skin model for irritation and toxicity following exposure to aqueous hypochlorous acid solutions. This phase of the project is based on use of the MatTek Epiderm™ product to predict key aspects of the response of human skin to hypochlorous acid solutions. Initial assessments of aqueous hypochlorous acid solutions will be conducted according to MatTek's In Vitro EpiDerm™ Skin Irritation Test protocol.Specific Aim 3: Development of an engineering test-bed that can spray a minute thickness film of hypochlorous acid, uniformly across mock hand features to enable quantification of the reduction of bacteria on 3-d surfaces. Although we have seen promising results using our current test-bed to spray antiseptic reagent on small flat surfaces, an eventual hand-sanitizing product must achieve efficacy on significantly larger 3-d surfaces with curvature. The successful completion of this proposal will position the company to continue development of innovative, better hand hygiene products for the neonatal and broader hospital markets.

Public Health Relevance Statement:
Project Narrative Healthcare associated infections (HAIs) pose substantial harm to hospitalized neonates and older patients alike. According to a 2011 Center for Disease Control and Prevention (CDC) report, t here are an estimated 722,000 HAIs in U.S acute care hospitals, resulting in 75,000 deaths and up to $20 billion in healthcare costs, annually. In hospitals and other clinical environments, transfer of pathogens on the hands of healthcare workers is considered an important mechanism for passing pathogenic organisms to unsuspecting patients, thus the objective of this proposal is to investigate the efficacy and safety of a novel, fast, automated hand sanitization system that will be in the right place at the right time (near the patient) to clean hands the right way, every time.

Project Terms:
No Project Terms available.

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
----
Phase II Amount
----