FDA Progress + Manufacturing Scale: Inside Pirouette Pharma's Latest Round

Pirouette Pharma CEO Conor Cullinane returns to Inside Startup Investing to share the company’s progress since its last Wefunder raise—spanning FDA engagement, IND planning, and major steps toward scalable manufacturing. Pirouette is building a disc-shaped, push-button delivery system for injectable medications—aiming to turn the “violent, error-prone” experience of legacy auto-injectors into something closer to the Staples Easy Button: push once, and the device handles the rest. Chris and Conor discuss why intimidation and usability are major barriers in today’s injection landscape, how Pirouette is approaching OTC naloxone via a combination-product regulatory pathway, what a pharmacokinetic study looks like, and why Pirouette is investing in manufacturing capacity to support both commercialization and pharma partnerships.   Chapters  00:44 What Pirouette is building 03:42 Progress since last raise 06:26 FDA pathway explained 09:08 PK study + size/cost/timeline 13:07 Partnerships vs. standalone commercialization 16:15 Revenue timing + adoption expectations 20:12 Manufacturing scale plan 23:34 Founder “why” 26:07 Investor close