Poly Group LeadershipCraig A. Kalmer, COO
• 20+ years in Pharma & Healthcare• Prseident/CEO of Advanced ChemTech• Strong background in business development &
contract manufacturing
Thomas A. Hopkins, PHD, CSO• 35+ years in Pharma R&D/Operations• Development Chemist - Morton Thiokol• Sr. Organic Chemist - Eli Lilly• Pilot Plant Mgr. - Advanced ChemTech• Director of Pharma Ops - CreoSalus
Poly Group LLC. Company Overview
• Poly Group is an Indiana LLC formed in 2010 with the mission of developing and commercializing N950 technology and is the exclusive world wide licensee of the patented technology.
• Poly Group is located at the Purdue Research Park in New Albany, IN.
A Growing Problem• There is a growing concern over
antibiotic/antimicrobial resistance with few new technologies introduced over the last 20 years.
• Antimicrobial technology fights or prevents diseases by killing or stopping the growth of microorganisms.
• In 2016, the FDA/EPA had Data calls of a number of chemical antimicrobial ingredients, including triclosan, due to their toxicity profiles.
• As various chemical ingredients have been removed from registration, new antibacterial technologies are needed.
A Novel Solutionto the Problem
N950 combines a bio-compatible monomer and an antimicrobial monomer to create a family of polymers that is both safe AND effective.
N950 is a technology rather than a single use product and has applications in multiple products and end uses.
In order to maximize both its utility and possible revenue, Poly Group will make our technology available to companies who manufacture or sell into those end use products and markets.
Patent & Trademarks
Poly Group currently has one patent(US8,343,473B2) for N950-9010 and threepatents pending. Additional patentable IPis also being developed. Trademark ™applications have also been submittedand are continuously updated.
N950-90-10 Regulatory Status
• N950 is approved and registered as a Materials Preservative antimicrobial by the US EPA and may be manufactured and sold at both State and Federal levels.
• Additional approvals and registrations are sought for Food contact, Disinfection and Cosmetics following GLP testing.
• Poly Group intends to broaden its EPA registration to include health claims for certain end uses..
• Poly Group is currently working with partners to secure FDA approvals in medical devices which will open further medical application opportunities.
Woven Textiles• Bedding, wall coverings,
carpet, linens, uniforms, and other woven textiles.
• An attractive replacement for silver, triclosan, and other additives.
Plastics, Resins,Rubber & Latex• Injection Molding• Extrusion• Dip Coating• Film Processes• Powder Coatings
N950-9010 Technology:Recent ActivitiesN950 has shown efficacy against an established biofilm; very significant finding.
Recently discovered methodology allowing integration into water born architectural coatings as well as steel coatings and packaging coatings. .
Exploiting surfactant properties intrinsic to N950 for preparation of a latex mixture suitable for coating binder systems.
*Patent application filed
*Patent application filed
N950 Efficacy & SafetyToxicology & Mutagenesis
Toxicology MutagenesisOral DermalInhalationEye Irritation/two typesDermal IrritationSensitization
Category 4Category 4Category 4Category 3Category 4Category 4
IndependentUSEPA/GLP testing proves:
• Exteremely limited toxicity• Non-mutagenic
N950Efficacy & SafetyEfficacy AssessmentTesting performed by third party laboratories. A variety of pathogenic Gram positive and Gram negative bacteria were tested, including:
• Pseudomonus aeruginosa• E. Coli• Salmonella enterica• Staphylococcus aureus (MRSA)• Candida Albicans• Enterococcus faecalis (VRE)• Klebsiella pneumoniae• Bacillus cereus• MS2 Bacteriophage (virus)• Candida auris (fungus)• Candida albicans (Fungus)
*N950 eradicatesestablished biofilms
N950 Efficacy & SafetyEfficacy Assessment Efficacy studies performed on Surfaces and in Aqueous Solutions
N950 eradicates established biofilms
Study Methods Conducted• JIS 2801 activity and efficacy• Standard Zone of inhibition test • MIC/MBC• Germicidal spray Studies• Biofilm using the MBEC Assay • Quantitative Time Kill Test(liquid)
Powder Coated Plaques with Efficacy Studies Before & After 1,000 Hour Salt Water Wear Testing of N950
Vertical DevelopmentPartnerships
• Poly Group LLC offers partners market exclusivity via Vertical Development Agreements.
• Poly Group will assist partners, if necessary, with the registration process enabling them to bring their exclusive application of N950 technology to the market in an efficient manner.
Acknowledgements
MicroChem LaboratoryKevin Biller The Powder Coating Research Group
Lillian Hardin Visual Arts Director Bridge Builder Strategies
Dr. James Snyder University of Louisville HospitalDr. Thomas Hopkins Poly Group LLC.