Speranza Therapeutics and Sunshine Labs Announce Strategic Global Partnership to Expand Access to Life-Saving Harm Reduction Solutions

BOCA RATON, Fla. and TORONTO, June 25, 2025 /PRNewswire/ -- Speranza Therapeutics is proud to announce a strategic partnership with Sunshine Labs, a global leader in harm reduction, safer supply, and science-backed therapeutic innovation. This groundbreaking collaboration is a significant milestone in expanding access to clinically effective medical devices, pharmaceuticals, and harm reduction tools across the United States and key international markets.

Sunshine Labs, headquartered in Canada and operating under Health Canada's Controlled Drugs and Substances Act, is at the forefront of transforming how controlled substances are regulated, studied, and administered. Through its wholly owned subsidiary, Oryx Biomed, Sunshine Labs delivers pharmaceutical-grade treatments and research-ready substances to four continents — including the United Kingdom, Great Britain, Northern Ireland, Australia, and European Union member states.

Together, Speranza Therapeutics and Sunshine Labs will work to equip providers, clinicians, and researchers with innovative solutions that address addiction, mental health challenges, and overdose prevention. Key areas of collaboration include:

1. Medical Devices – Including Speranza's ST Genesis Neurostimulation Device for Detox, and Sunshine Labs' advanced Naloxone delivery system, designed to support rapid response in overdose scenarios.
2. Psychedelics for Therapeutic Use – Supporting ongoing clinical trials and research focused on PTSD, substance use disorder, and treatment-resistant mental health conditions.
3. Compounding Pharmacy Services – Delivering personalized, high-quality treatment formulations for complex psychiatric and behavioral health needs.
4. Pharmaceutical-grade Treatments – All products are manufactured to the highest cGMP and euGMP standards, ensuring quality, consistency, and compliance across global markets.

Note: While Sunshine Labs produces pharmaceutical-grade controlled substances for research and approved medical use in select international jurisdictions, distribution and use in the United States will remain compliant with all applicable U.S. regulatory guidelines.

"This partnership represents a shared mission," said Donovan Edwards, CEO of Sunshine Labs. "Speranza and Sunshine Labs are aligned in our commitment to disruptive innovation and compassionate care. Together, we are equipping providers and researchers with safer, science-based tools to meet today's public health challenges head-on."

Speranza Therapeutics brings deep expertise in U.S. regulatory landscapes and a strong track record in advancing medical device innovation. Known for its pioneering work in addiction medicine and pain management, Speranza is committed to eliminating barriers to treatment access — especially for patients with chronic or underserved conditions.

"We're honored to join forces with Sunshine Labs," said Sal J. Rafanelli, President and CEO of Speranza Therapeutics. "Their leadership in regulatory innovation and global distribution is unmatched. We are especially excited about expanding access to the ST Genesis Device through this partnership — not only in Canada, but also in the UK, Great Britain, Northern Ireland, Australia, and throughout the European Union. Together, we are driving meaningful clinical outcomes for those who need them most."

This strategic alliance reflects a mutual commitment to clinical excellence, global collaboration, and a future where harm reduction and mental health care are accessible, evidence-based, and stigma-free.

About Speranza Therapeutics

Speranza Therapeutics is a medical device and pharmaceutical company that is dedicated to making meaningful, more efficient and cost-effective changes in delivering medical devices and drugs to patients in the United States. Their success is the collective result of visionary leaders and dedicated clinicians focused on disrupting the norm, improving care, and making an important difference in the lives of patients with complex medical conditions. Their guiding principle is simple: to remove the inherent challenges in delivering treatment to patients in need through proven, clinically effective therapeutics and technology.

For more information, contact our Marketing Manager Lauren Saccone, [email protected]

SOURCE Speranza Therapeutics