NA24OARX021G0016

Purpose: Hatchery production is one of the largest costs and restraints to fin fish aquaculture and conservation fisheries.

Therefore spawning aids are ranked as a high priority drug by the Association of Fish and Wildlife Agencies-Drug Approval Working Group.

Project PI has successfully developed and demonstrated superiority of our slow release spawning implants in a large number of fish species and has been able to gain FDA eligibility for indexing.

However, the current manufacturing methodology, while safe and effective, is very labor & time intensive, and therefore a hurdle to scaling.

This proposal investigates a new manufacturing technology, innovative for veterinary drugs (including the aquaculture industry) and for our hormone active ingredient.

Three research trials must be completed to submit an amendment to our FDA indexing approvals and for commercialization: (1) Demonstrate the manufacturing methodology can produce an analytically stable hormone implant; demonstrate (2) target animal safety and (3) efficacy of the new implant in fish.

Target animals safety and efficacy trials will be completed at Project PI Live Advantage Bait Hatchery, and manufacturing trials and analytics will be completed by an FDA approved facility.

The ability to spawn fish in captivity will result in expansion of the commercial aquaculture and fisheries conservation industries.

Currently the U.S. has a $17 billion seafood trade deficit, with nearly 90% of the seafood we eat coming from abroad and over half of that from aquaculture (NOAA Fisheries, 2022).

Climate change and the changing ocean will only increase our dependency on aquaculture to fulfill this seafood gap and to aid in the conservation of imperiled species.

With the assistance of spawning aids, U.S. aquaculture production can become more competitive domestically as well as internationally, reducing our trade deficit and increasing GDP.

Currently there are no FDA approved spawning aids for non-ornamental fish on the market.

If successful, this project will enable switching our FDA indexed spawning implant to a new manufacturing technology, resulting in cheaper and more efficient commercialization.

From current estimates of spawning aid use and wholesale purchase cost, we estimate the spawning aids are a $30 million market, of which we feel our implant will capture 30% or more.

Live Advantage Bait

18 CLIMATE ADAPTATION AND MITIGATION 19 WEATHER-READY NATION 20 HEALTHY OCEANS 21 RESILIENT COASTAL COMMUNITIES AND ECONOMIES

11.021 - NOAA Small Business Innovation Research (SBIR) Program

National Oceanic and Atmospheric Administration (NOAA) [DOC]

Fort Pierce, Florida 349461409 United States

Single Zip Code

NOAA SBIR FY 2024 Phase I (NOAA-OAR-TPO-2024-2008184)