About Us
The Problem
A muscle spasm, also known as a muscle cramp, can cause significant
pain, and can arise from trauma, strain, or stress.
Current topical treatments for muscle spasms such Blue Emu and Theraworks don't treat the spasm. They just provide symptomatic relief. Currently there is no FDA approved topical Anti-Spasmodic Agent on the market.
Funding Proposal and Regulatory Path
Prima Innovations would like to raise $1.5 M via SAFE note to complete IND enabling studies. These studies will include
- Formulation and package finalization
- IVRT and IVPT
- GLP Animal Studies
- IND-enabling toxicology studies
After IND filing, an additional $5-7 million will be needed to Phase I/II clinical trials. This will be raised through Series A funding.
The complete FDA approval cab achieved in about $25 million, which is a very small amount of money compared to its market potential.
Accidental Discovery
The spasmolytic or anti-spasmodic activity of PI-111 was an accidental discovery by Ms. Priti Shah, who is an Occupational Therapist and understands the muscle relaxation very well. Dr. Shah developed the concept further and they filed the patent. In 2023 Mandar retired from his previous job VP of R&D to develop this product further. Since then, the animal studies have been completed and mechanism of action has been established.