SHINE Technologies has marked a significant milestone for its medical isotope Ilumira (n.c.a. lutetium-177), celebrating one year of commercial success with global expansion reaching 19 countries and achieving over 95% on-time, in-full delivery performance. The nuclear fusion company's radioisotope product has established a strong foothold in the global nuclear medicine market since its launch in June 2024.
Commercial Performance and Global Reach
Ilumira has demonstrated robust commercial growth, expanding its distribution network across Asia, Europe, Australia, and the Middle East. The isotope pairs with cancer-targeting molecules to deliver radiation directly to tumors, offering patients a more focused and less harmful approach to cancer treatment. SHINE positions itself as one of the only U.S.-based manufacturers of this critical isotope.
"What excites me most about Ilumira's first year is knowing it's already making a difference for cancer patients around the world," said Greg Piefer, SHINE's founder and CEO. "Every shipment represents hope. And with a global customer footprint, we're helping expand access to life-saving therapy with the quality and reliability this industry and these patients need."
Clinical Applications and Research Impact
SHINE supplies Ilumira to cancer treatment centers, clinical trials, and research institutions worldwide. Notable customers include Blue Earth Therapeutics, WARF Therapeutics, the University of Wisconsin–Madison, and Cincinnati Children's Hospital. The company also supports targeted radiopharmaceutical development for GlyTherix and Antelope Surgical Solutions.
The isotope has enabled breakthrough research, including a University of Wisconsin–Madison study that demonstrated a 100% survival rate in kidney cancer models with 8-20x greater efficacy in vivo compared to other compounds in development. Dr. Reinier Hernandez, Assistant Professor of Medical Physics and Radiology at the University of Wisconsin-Madison, noted that "the consistently high purity and reliability of SHINE's Lu-177 have allowed us to conduct our studies with a level of precision difficult to achieve before."
Production Capacity and Quality Standards
SHINE produces Ilumira at its Cassiopeia facility in Janesville, Wisconsin, with current capacity for 100,000 doses per year and potential expansion to 200,000 doses. The facility's consistent performance and scalable output position the company to meet rising demand for n.c.a. Lu-177. The product's high specific activity and purity have established it as a best-in-class option for oncologists, radiopharmaceutical innovators, and researchers.
Strategic Expansion and Regulatory Progress
SHINE has submitted a centralized Marketing Authorization Application to the European Medicines Agency (EMA) to market Ilumira across the European Union. Additionally, the company entered a definitive agreement to acquire the SPECT radiopharmaceutical division of Lantheus, a provider of diagnostic isotopes used in millions of procedures annually.
The acquisition vertically integrates SHINE into the Tc-99m generator business and strengthens distribution capabilities for upcoming isotopes such as molybdenum-99. Combined with the company's Chrysalis production facility, expected to begin operations by 2027, these strategic moves build a foundation for long-term leadership in nuclear medicine.
Pipeline Development and Funding
SHINE's isotope pipeline includes high-demand products such as terbium-161 and molybdenum-99, supported by strategic U.S. and European partnerships. In 2024, the company secured $32 million in funding from the U.S. Department of Energy's NNSA and €10.5 million alongside the University Medical Center Groningen to accelerate isotope development and supply.
The company has established distribution partnerships with Modawina Medical Company, Primo Biotech, and Sumitomo Corporation of Americas, further expanding its global reach in the nuclear medicine market.
