(505c) Development and Commercialization of MicroLyte® Ag Antimicrobial Matrix: A Start-up’s Journey

Authors: 
Pranami, G., Imbed Biosciences, Inc.
Crawford, E. C., Imbed Biosciences, Inc.
Agarwal, A., Imbed Biosciences, Inc.
Nelson, T. B., Imbed Biosciences, Inc.
O'Keefe, A. M., Imbed Biosciences, Inc.
More than 6.5 million U.S. patients are treated for chronic ulcers and another 2.1 million seek medical care for burns annually. These wounds, when infected, do not progress through the normal healing process. Recent advances include moist wound dressings impregnated with high loadings of silver, chlorhexidine, PHMB, or povidone iodine. These dressings achieve long-term release of antimicrobials (2-7 days), thus reducing frequency of dressing changes. However, they are high-capacity reservoirs that deposit large amounts of antimicrobials on tissue surface and can cause tissue toxicity and impaired healing. To overcome these limitations, Imbed Biosciences, Inc. (Imbed, Fitchburg, WI) has developed an ultrathin bioresorbable MicroLyte® Ag Antimicrobial Matrix comprised of a 20-μm thick polyvinyl alcohol (PVA) cast that is adhered to a 200-300 nm thick polyelectrolyte multilayer (PEM) nanofilm, which is assembled by sequential ‘layer-by-layer’ assembly of oppositely charged polyelectrolytes. PEM nanofilm permits in-situ formation of silver nanoparticles which allows precise control of the size, loading and uniformity of distribution of the nanoparticles across the nanofilms. When the matrix is placed on a moist wound surface, the polymeric matrix absorbs moisture, forms a soft conforming gel, and adheres conformably to the contours of underlying wound-bed. Silver nanoparticles dissolve gradually to provide sustained release of non-toxic levels antimicrobial silver ions for at least 3 days thus clearing microbial contamination on the wound bed and supporting normal wound healing. The matrix contains 100x less silver than commercial silver-based antimicrobial dressings (Acticoat®, Smith & Nephew), yet it kills > 99.99% of clinically relevant microbes including drug resistant MRSA and VRE. MicroLyte® Ag has received FDA 510k clearance (K153756) and has been used successfully to heal chronic wounds in thousands of patients in the US.

This talk will cover research and product development activities performed at Imbed to transform several years of academic research into a commercially viable FDA cleared product - MicroLyte® Ag. The discussion will include evolution of product design, in vitro and in vivo experiments for optimizing the product design and performance, production scale-up, quality control and regulatory approach, and clinical case studies.