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 with Speranza Therapeutics for its flagship device, the 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. Clinical use has shown up to a 90% reduction in COWS (Clinical Opiate Withdrawal Scale) scores, dramatically decreasing withdrawal severity allowing for successful transition to Medication-Assisted Treatment (MAT).
This is particularly relevant when initiating Suboxone or long-acting buprenorphine therapies such as Sublocade. Research shows that when withdrawal symptoms are mitigated, rates of successful MAT induction and patient retention increase significantly. This approach can work effectively in outpatient settings and remote areas where treatment options are not available.
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 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.
Organizations such as the First Nations Health Authority (FNHA) and the BC Centre for Disease Control support access to long-acting buprenorphine therapies, like Sublocade, as part of best-practice care for opioid use disorder. The ability of S.T. Genesis™ to reduce or mitigate precipitated withdrawal strengthens the clinical pathway to these treatments.
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.