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SHINE Medical Technologies
IndustryMedical
FoundedJune 2010
FounderGregory Piefer
Headquarters
Monona, Wisconsin
Websitehttp://shinemed.com

SHINE Medical Technologies (SHINE), is an American company based in Monona, Wisconsin, that has a proprietary process to produce medical radioisotopes.[1] As of 2015, SHINE was in the process of acquiring regulatory approval to construct a facility in Janesville, Wisconsin to produce molybdenum-99 (Mo-99), an isotope used to make technetium-99m, which is used in medical imaging. The company hopes to begin production in 2018. It plans to produce around 1/4 of the world's supply of Mo-99,[2] which was in short supply globally in 2009 and 2010.[3] [4]

Company history

SHINE was founded in June 2010 by Gregory Piefer with technical assistance from Phoenix Nuclear Labs[3] and in partnership with several entities including Morgridge Institute for Research,[5] United States Department of Energy,[5] Los Alamos National Laboratory,[6] Argonne National Laboratory[7] and the University of Wisconsin–Madison.[8] In 2009, Piefer filed a patent for a new technology to produce Molybdenum-99 (Mo-99) without the use of a reactor, referred to below as the "SHINE process". The patent application is pending.[9] SHINE is an acronym for Subcritical Hybrid Intense Neutron Emitter.[10]

The SHINE process is intended to eliminate the need for a nuclear reactor and highly enriched uranium to produce isotopes for nuclear medicine. In 2013, the Los Alamos National Lab, in Los Alamos, New Mexico, demonstrated "the technical viability of the initial stage of Mo‐99 recovery" from a low-enriched uranium sulfate solution.[11] In August 2014, SHINE and Phoenix Nuclear Labs ran a 24-hour, 99% uptime, accelerator test.[12]

In 2012, SHINE and the Morgridge Institute for Research were awarded $20.6 million by the U.S. Department of Energy's Nuclear Security Administration to support the development of the SHINE process and construction of the company's manufacturing plant.[5]

In April 2014, SHINE signed a long term supply agreement with GE Healthcare for Mo-99.[13] In October 2014, Deerfield Management Company entered into a $125 million debt and equity financing agreement with SHINE.[14] In November 2014, SHINE signed a supply agreement with Lantheus Medical Imaging.[15]

SHINE plans to build its facility and begin commercial production in 2018[2] in Janesville, Wisconsin.[16] On May 8, 2015, the Nuclear Regulatory Commission (NRC) published a draft Environmental Impact Statement for the SHINE facility as part of its construction permitting process.[2] [17] On June 15, 2015, Argonne National Laboratory published a press release stating from their process demonstration, the analysis showed the Mo-99 met purity specifications of the industry standard,[18] the British Pharmacopoeia.[7]

Products

Molybdenum-99 decays into the diagnostic imaging agent technetium-99m,[19] which is administered to some 40,000 Americans every day, as of 2009.[20] Technetium-99m is the most widely used radioisotope in nuclear medicine, used in about 80% of nuclear medical procedures.[1] Technetium-99 is used in 16,000 scans per year in the US. It the most used isotope for medical diagnostic procedures and research. Some of those procedures include: myocardial perfusion imaging (stress tests), bone scans, cardiac scans, kidneys, lungs, liver, thyroid, and also for blood flow studies.[19]

The company plans to produce the following products:[21][22][23]

  • Molybdenum-99,[23] used for tumor imaging, infection/inflammation, thyroid, liver and bone scans, respiratory, myocardial perfusion (stress test) and other cardiovascular scans.[24]
  • Iodine-131,[23] used to treat thyroid cancer and other abnormal thyroid conditions, such as hyperthyroidism.[1]
  • Iodine-125,[23] used in a type of cancer therapy knows as brachytherapy,[25] treatment of prostate cancer and brain tumors. Also used to evaluate kidney function and diagnose deep vein thrombosis in the leg.[26]
  • Xenon-133,[23] inhaled as a gas to evaluate regional function in emphysema and other forms of chronic obstructive lung disease. Also used in blood flow images, especially in the brain.[27]

See also

References

  1. ^ a b c "Radioisotopes in Medicine". world-nuclear.org. Retrieved 1 July 2015.
  2. ^ a b c Newman, Judy. "Environmental report supports SHINE Medical's plan to build radioisotope plant in Janesville". Wisconsin State Journal. Wisconsin State Journal. Retrieved 10 July 2015.
  3. ^ a b Forrest, Wayne (November 19, 2014). "SHINE aims to alleviate Mo-99 shortage". Medicalphysicsweb.org. Retrieved July 9, 2015.
  4. ^ Noorden, Richard Van (December 11, 2013). "Radioisotopes: The medical testing crisis". Nature. 504: 202. ISSN 0028-0836. Retrieved 14 July 2015.
  5. ^ a b c "Morgridge Institute, SHINE win $20.6M federal award". Milwaukee Business Journal. May 8, 2012. Retrieved July 1, 2015.
  6. ^ "Domestic production of medical isotope Mo-99 moves a step closer". Los Alamos National Lab. May 13, 2013.
  7. ^ a b Cunningham, Greg (June 15, 2015). "Argonne confirms new commercial method for producing medical isotope". Argonne National Lab.
  8. ^ Mattmiller, Brian (October 10, 2014). "Spinoff SHINE Medical hits major funding milestone".
  9. ^ "Device and Method for Producing Medical Isotopes", US Patent & Trademark Office, May 1, 2009, accessed July 1, 2015
  10. ^ Chemerisov, S. (December 11, 2015). "Development of the mini-SHINE/MIPS experiments" (PDF). Argonne National Laboratory.
  11. ^ May, Iain [Los Alamos National Laboratory]. "SciTech Connect: A Technical Demonstration of the Initial Stage of Mo-99 Recovery from a Low Enriched Uranium Sulfate Solution". osti.gov. Retrieved 11 June 2015.
  12. ^ "SHINE Medical and Phoenix Nuclear achieve key technical milestone with 24-hour accelerator test". dotmed.com. Retrieved June 11, 2015.
  13. ^ "SHINE Medical Technologies to Supply moly-99 to GE healthcare". dotmed.com. Retrieved July 1, 2015.
  14. ^ "Deerfield Management Signs $125 Million Term Sheet with SHINE Medical Technologies, Inc.", Yahoo Finance,
  15. ^ Newman, Judy. "SHINE signs contract with Lantheus Medical Imaging". Wisconsin State Journal. Retrieved 11 June 2015.
  16. ^ "Janesville working with medical isotope maker on incentive agreement". gazettextra.com. January 25, 2012. Retrieved June 11, 2015.
  17. ^ Blake, E. Michael. "The campaign to resume domestic production of molybdenum-99". Nuclear News. 57 (12). American Nuclear Society: 37. ISSN 0029-5574.
  18. ^ The British Pharmacopoeia Commission (2015). British Pharmacopoeia. United Kingdom: TSO Publishers. p. 712. ISBN 978-0-11-322987-1.
  19. ^ a b "Report of the Expert Review Panel on Medical Isotope Production" (PDF). Canadian Institute for Neutron Scattering. November 30, 2009.
  20. ^ "Medical Isotopes Hearing, U.S. Senate Committee on Energy and Natural Resources, 111th Congress". gpo.gov. December 3, 2009. Retrieved 1 July 2015.
  21. ^ Introduction to the Environmental Report (PDF). nrc.gov (Report). SHINE Medical Technologies. December 3, 2014.
  22. ^ "Shine Medical Technologies receives $150,000 National Science Foundation grant". Milwaukee-Wisconsin Jornal Sentinal. Retrieved 10 July 2015.
  23. ^ a b c d e "SHINE brings a light of hope to cancer and heart patients". In Business Madison. August 2012. Retrieved July 11, 2015. In addition to molybdenum-99, SHINE will also be able to make Iodine-131, Iodine-125, and Xenon-133.
  24. ^ "Production and Supply of Molybdenum-99" (PDF). iaea.org. Retrieved July 11, 2015.
  25. ^ "Iodine-125 brachytherapy for brain tumours – a review". Radiation Oncology. Retrieved 10 July 2015.
  26. ^ "Isotopes Used in Medicine". Radiochemistry.org. Retrieved 10 July 2015.
  27. ^ "Xenon Xe 133 (Inhalation Route)". Mayo Clinic. Retrieved 10 July 2015.

External links

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