FOR IMMEDIATE RELEASE
GREENFIELD, IND. (November 13, 2025) – 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 CPerf LLV* (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 CPerf LLV* (BE-101) and advances the program to the final phase of evaluation.
After thorough evaluation, USDA concluded that the proposed field use of CPerf LLV* (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, CPerf LLV* (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. CPerf LLV* (BE-101) has the potential to fill that gap with a practical, scalable biologic approach.”
CPerf LLV* (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, CPerf LLV* (BE-101) demonstrated significant improvements in mortality reduction, feed conversion, and bird weight gain.
Development Progress: The CPerf LLV* (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. CPerf LLV* (BE-101) will be the first product BiomEdit advances to commercial launch since its founding in 2022. Upon full licensure, CPerf LLV* (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, Inc.: 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.
Media Contact: Julie Lawless, julie.lawless@lawlesscomms.com, +1 615-585-5861
