April 15, 2025 — Sunshine Labs, a leading innovator in medical technologies for Substance Use Disorder (SUD), is pleased to announce an exclusive global distribution agreement (excluding the United States) with Sperenza Therapeutics for its flagship device, S.T. Genesis™, with its wholly owned subsidiary, Waxed International. This agreement with Speranza Therapeutics grants Waxed International exclusive sales rights and regulatory certification authority for S.T. Genesis™ in all international markets outside of the United States.
The S.T. Genesis™ is a Percutaneous Electrical Nerve Field Stimulator (PNFS) designed to deliver auricular neurostimulation therapy continuously for up to 120 hours. This state-of-the-art device offers a non-invasive, non-opioid solution to help patients manage withdrawal symptoms during detoxification, reducing the need for opioid agonist treatments—and in some cases, eliminating them entirely.
By administering targeted electrical pulses through fine needles positioned in the ear, S.T. Genesis™ stimulates key nerve pathways in a compact, wearable form factor that maximizes patient comfort and mobility.
“This exclusive distribution deal marks a pivotal moment for Sunshine Labs and our global commercialization strategy,” said a company spokesperson. “We are uniquely positioned to navigate international regulatory pathways and drive adoption in high-priority markets. This move not only amplifies our reach but also ensures strong alignment in delivering the S.T. Genesis™ to communities in critical need.”
The agreement includes exclusive authority for Waxed International to manage certification efforts with relevant international regulatory bodies, ensuring compliance and efficient market entry across key regions outside the U.S.
Highlights:
- Global Market Access: Exclusive distribution rights outside the US. Entry into international healthcare markets with increasing demand for innovative SUD treatments.
- Regulatory Control: Centralized global certification process enables streamlined access and consistent regulatory strategy.
- Scalable Revenue Opportunity: Broad international deployment of supports recurring medical device revenue.
- Mission-Aligned Innovation: Expanding access to evidence-based therapies to address SUD. Non-pharmacological options need to be available.
Sunshine Labs remains committed to delivering transformative solutions across the continuum of care for individuals living with SUD and those at risk due to the toxic drug supply.