BiomEdit Announces USDA Finding of No Significant Impact Letter for Non-Antibiotic Poultry Biologic, Clearing Path to Field Safety Trials

Regulatory milestone allows product to proceed to final phase of USDA conditional licensure process for necrotic enteritis prevention in broiler chickens

GREENFIELD, Ind., Nov. 13, 2025 /PRNewswire/ -- BiomEdit, Inc., a pioneering animal health biotechnology company, today announced it has received a Finding of No Significant Impact (FONSI) letter from the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) for BE-101, its lead candidate for the prevention of mortality caused by necrotic enteritis (NE) in broiler chickens. The milestone follows APHIS' environmental and risk assessment of BE-101 and advances the program to the final phase of evaluation.

After thorough evaluation, USDA concluded that the proposed field use of BE-101 would not significantly impact the environment—issuing a Finding of No Significant Impact—and cleared the product to proceed toward field safety trials. Once BiomEdit's manufacturing partner, Diamond Animal Health, completes USDA requirements for pre-license serials, BE-101 will be eligible for shipment to field sites for testing, targeted to begin in early Q1 2026.

"The FONSI letter represents another key regulatory milestone as we work to deliver a first-of-its-kind solution for poultry producers," said Aaron Schacht, Chief Executive Officer of BiomEdit. "Necrotic enteritis causes an estimated $6 billion in annual losses globally, yet producers have few effective non-antibiotic tools. BE-101 has the potential to fill that gap with a practical, scalable biologic approach."

BE-101 is an engineered probiotic vectored antibody (pvAb™) biologic designed to neutralize Clostridium perfringens toxins—the primary cause of NE-related mortality and productivity loss in poultry. In commercial-like challenge studies, BE-101 demonstrated significant improvements in mortality reduction, feed conversion, and bird weight gain.

Development Progress
The BE-101 development program remains on track for conditional licensure by Q4 2026, with several key milestones recently achieved:

• Successful completion of engineering batches, a critical step in commercial manufacturing readiness
• Initiation of pre-license serial batch manufacture, now at the halfway mark
• Ongoing USDA review of the field safety study protocol, with feedback expected before year-end to enable initiation of field safety trials early in 2026.

Completion of pre-licensing serial manufacture, serial testing, and field safety trials represent the final requirements for conditional licensure. BE-101 will be the first product BiomEdit advances to commercial launch since its founding in 2022.

Upon full licensure, BE-101 will be commercialized under the brand name Optavant™ and will represent the first non-antibiotic biologic specifically designed to combat NE while improving flock health and production outcomes.

About BiomEdit
BiomEdit, Inc., is an animal health microbial biotechnology company leveraging the power of the microbiome and synthetic biology to develop next-generation solutions for livestock and pet health. Founded in 2022, BiomEdit is backed by leading investors including Anterra Capital, Viking Global, Nutreco, AgriZeroNZ, Elevate, and Betagro Ventures among others. www.biomedit.com

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SOURCE BiomEdit