Expanding Access to Life-Saving Harm Reduction Solutions
BOCA RATON, Fla. and TORONTO, June 25, 2025 Sunshine Labs is proud to announce a strategic global partnership with Speranza Therapeutics, a leader in medical device innovation and addiction medicine. This collaboration marks a major milestone in our mission to expand access to clinically effective harm reduction tools, pharmaceuticals, and medical devices across North America and to key international markets.
A Shared Vision for Harm Reduction and Innovation
Sunshine Labs, with headquarters in Canada and operating under Health Canada’s Controlled Drugs and Substances Act, has established itself as a pioneer in the regulation, research, and delivery of pharmaceutical-grade treatments. Through our wholly owned subsidiary, Oryx Biomed, we provide research-ready substances and innovative therapies to partners in the United Kingdom, Australia, the European Union, and beyond.
By joining forces with Speranza Therapeutics, we are poised to accelerate the development and distribution of science-backed solutions for addiction, mental health, and overdose prevention. Together, we are committed to equipping clinicians, healthcare providers, and researchers with the tools they need to address today’s most urgent public health challenges.
Key Areas of Collaboration
Medical Devices: The partnership will expand access to Speranza’s ST Genesis™ Neurostimulation Device for Detox, a non-invasive, non-opioid therapy for managing withdrawal symptoms. Sunshine Labs will also advance its own next-generation Naloxone delivery system, designed for rapid overdose response.
Psychedelics for Therapeutic Use: We will support ongoing clinical trials and research into the therapeutic potential of psychedelics for PTSD, substance use disorder, and treatment-resistant mental health conditions.
Compounding Pharmacy Services:
Our collaboration will deliver personalized, high-quality formulations for complex psychiatric and behavioral health needs.
Pharmaceutical-Grade Treatments: All products will meet 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, all U.S. activities will remain fully compliant with American regulatory requirements.
Leadership Perspectives
“This partnership represents a shared mission,” said Donovan Edwards, CEO of Sunshine Labs. “Sunshine Labs and Speranza 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.”
Sal J. Rafanelli, President and CEO of Speranza Therapeutics, added, “We’re honored to join forces with Sunshine Labs. 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.”
Looking Ahead
This 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. We look forward to sharing more updates as we work together to deliver life-saving solutions and transform care for individuals and communities worldwide.
About Sunshine Labs
Sunshine Labs is a Canadian-based biosciences company dedicated to creating solutions to end the toxic drug crisis through innovation, research, and global partnerships.
About Speranza Therapeutics
Speranza Therapeutics is a medical device and pharmaceutical company focused on delivering clinically effective therapeutics and technology to patients with complex medical conditions across the United States and internationally.