Intralytix Receives FDA Regulatory Clearance for Phage-Based Campylobacter Technology

Columbia, Maryland, USA – October 7, 2021. Intralytix, Inc. announced today that its food safety product, CampyShield™, has received GRAS (Generally Recognized as Safe) recognition from the Food and Drug Administration (FDA), GRAS No: GRN 000966.

CampyShield™ is a non-chemical antimicrobial preparation containing three to eight bacteriophages lytic for Campylobacter, for use as an antimicrobial on raw red meat, including whole carcasses, primals, subprimals, cuts, trimmings, and organs, and raw poultry, including carcasses and parts. The preparation has been determined to be safe and effective in managing contamination of various foods with Campylobacter bacteria. The active ingredients of CampyShield™ are naturally occurring lytic bacteriophages that selectively and specifically kill Campylobacter species, including strains belonging to the two most common disease-causing species of Campylobacter: C. jejuni and C. coli.

Campylobacter infections typically occur from consuming contaminated food or water, and are characterized by diarrhea (often bloody), fever, and nausea. More severe illness can occur, including bloodstream infection. Campylobacter infection can also result in long-term consequences, such as arthritis, irritable bowel syndrome, and Guillain-Barré syndrome. "Campylobacter spp. are arguably the leading bacterial causes of foodborne illness in the United States, causing an estimated 1.5 million illnesses each year in this country" stated Dr. Alexander Sulakvelidze, Intralytix's President and CEO. "People can get Campylobacter infection by eating raw or undercooked poultry or other foods, including seafood, meat, and produce. CampyShield™ can help reduce the incidence or severity of such illnesses." Dr. Sulakvelidze added "Intralytix continues to be the World leader in the development of bacteriophage-based products for food safety. The company has the largest in the World portfolio of the FDA- and USDA-approved phage products for food safety applications on the market, including phage preparations for managing major foodborne bacterial pathogens Listeria monocytogenes, STEC E. coli (including E. coli O157:H7), Salmonella spp., and Shigella spp. We are pleased to add yet another bacteriophage-based food safety product to the arsenal of our nation's food manufacturers."

Intralytix, Inc is a biotechnology company focused on using its core bacteriophage/phage technology platform to improve human health through the development and commercialization of innovative products for food safety, veterinary applications and human therapeutics and probiotics. For product inquires or to place an order, email Intralytix at sales@intralytix.com or call 1-877-ITXPHAGE (489-7424) and select option 1.

For more information, contact Dr. Alexander Sulakvelidze (410-625-2533 or asulakvelidze@intralytix.com).