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NorthStar Medical Radioisotopes Announces FDA Approval of Beloit, Wis. Facility for RadioGenix™ System Manufacturing and Provides Update on Commercial Launch Status


- Approval enables expanded manufacturing capacity and supports
commercial launch of RadioGenix Systems to produce critically important
diagnostic imaging radioisotope technetium-99m from domestic,
non-uranium based molybdenum-99 -

NorthStar Medical Radioisotopes, LLC (NorthStar), a company involved in
the production and distribution of radioisotopes used for medical
imaging, today announced that the U.S. Food and Drug Administration
(FDA) has approved the company's Beloit, Wis. cGMP facility to
manufacture the RadioGenix System and associated materials. Approval of
the Beloit manufacturing facility follows FDA's recent approval of the
RadioGenix System for producing the medically important radioisotope
technetium-99m (Tc-99m) using domestically sourced, non-uranium based
molybdenum-99 (Mo-99). The approval was made through a Prior Approval
Supplement to the recently approved RadioGenix System New Drug
Application 202158 and is the first step for NorthStar in expanding its
manufacturing capacity. In addition to this manufacturing approval,
NorthStar has initiated the RadioGenix System commercial launch.

"NorthStar has quickly achieved several key milestones in advancing our
strategically planned RadioGenix System roll-out," said George P.
Messina, Chairman and CEO of NorthStar. "First, the FDA approval of our
Beloit manufacturing facility enables us to scale up production and
expand capacity to meet anticipated customer demand. The approval came
well in advance of the anticipated FDA action date. Second, we are also
very pleased to announce that the commercial launch of the RadioGenix
System has commenced, with the first contract signed and the first
installation scheduled at a customer site. This important event marks
another milestone in NorthStar's commitment to provide the United States
healthcare system with a reliable, domestic non-uranium based Mo-99
supply for production of the important medical diagnostic imaging
radioisotope, technetium-99m. We anticipate shipping additional
RadioGenix Systems as potential customers receive licensing amendments
for their sites, and look forward to sharing our progress."

"FDA approval for manufacturing in Beloit, Wis., means that NorthStar
now has the capability to scale up and expand our RadioGenix
manufacturing volume four-fold," said Stephen Merrick, President and
Chief Operating Officer of NorthStar. "The cGMP facility houses the
manufacturing and quality control operations required to produce
RadioGenix Systems, consumable kits and spare parts. Also, as recently
announced, we have begun construction of additional manufacturing space
for activities related to the processing of Mo-99, the material used by
the RadioGenix System to generate the medically important isotope

The 50,000 square foot facility at 1800 Gateway Boulevard, Beloit, Wis.
includes NorthStar corporate headquarters, development, manufacturing
and quality control operations. NorthStar has additional expansion
activities underway and planned in Beloit on its 33-acre campus that
will support the continued scale-up of production.

About the RadioGenix™ System
The RadioGenix System is an
innovative, high tech system that is approved for processing
non-uranium/non-highly enriched uranium molybdenum-99 (Mo-99) for the
production of the important medical radioisotope, technetium-99m
(Tc-99m). Prior to availability of RadioGenix technology, the U.S.
supply chain for Mo-99 has been subject to frequent and sometimes severe
interruptions which negatively impact patient healthcare. Approved by
the U.S. Food and Drug Administration in February 2018, the RadioGenix
System is the first and only on-site, automated isotope separation
system of its kind for use with non-uranium/non-highly enriched uranium
based Mo-99.

Indication and Important Risk Information About
the RadioGenix™ System and Sodium Pertechnetate Tc 99m Injection USP


The RadioGenix™ System is a technetium Tc-99m generator used to produce
Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m
Injection is a radioactive diagnostic agent and can be used in the
preparation of FDA-approved diagnostic radiopharmaceuticals.

Sodium Pertechnetate Tc 99m Injection is also indicated in

  • Adults for Salivary Gland Imaging and Nasolacrimal Drainage System
    Imaging (dacryoscintigraphy).
  • Adults and pediatric patients for Thyroid Imaging and Vesicoureteral
    Imaging (direct isotopic cystography) for detection of vesicoureteral


  • Allergic reactions (skin rash, hives, or itching) including
    anaphylaxis have been reported following the administration of Sodium
    Pertechnetate Tc 99m Injection. Monitor all patients for
    hypersensitivity reactions.
  • Radiation risks associated with the use of Sodium Pertechnetate Tc 99m
    Injection are greater in children than in adults and, in general, the
    younger the child, the greater the risk owing to greater absorbed
    radiation doses and longer life expectancy. These greater risks should
    be taken firmly into account in all benefit-risk assessments involving
    children. Long-term cumulative radiation exposure may be associated
    with an increased risk of cancer.
  • Temporarily discontinue breastfeeding. A lactating woman should pump
    and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate
    Tc 99m Injection administration.
  • Sodium Pertechnetate Tc 99m Injection should be given to pregnant
    women only if the expected benefits to be gained clearly outweigh the
    potential hazards.
  • Only use potassium molybdate Mo-99, processing reagents, saline and
    other supplies, including kits, provided by NorthStar Medical
    Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection
    after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached
    or when the 12 hour expiration time from elution is reached, whichever
    occurs earlier.

To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Medical
Radioisotopes, LLC at 1-844-438-6659; or FDA at 1-800-332-1088 or

For Full RadioGenix™ System Prescribing Information, click
or visit

About Medical Radioisotopes - Molybdenum-99 (Mo-99) and
Technetium-99m (Tc-99m)

Tc-99m is a radioisotope used in a
variety of diagnostic testing procedures. It is currently the most
widely used medical radioisotope in the United States, used in more than
10 million diagnostic procedures annually. Tc-99m-based
radiopharmaceuticals are used to diagnose and stage heart disease,
cancer, infection, inflammation and other conditions.

Tc-99m is derived from the radioisotope Mo-99. The United States uses
about 50% of the world's Mo-99/Tc-99m for medical purposes, but U.S.
supply of Mo-99 has been completely reliant on foreign sources and
subject to frequent and sometimes protracted interruptions which
negatively impact patient healthcare. Other Mo-99 producers continue to
use enriched uranium in their processing which poses significant
environmental concerns. NorthStar's technology uses stable isotopes of
molybdenum to produce Mo-99 domestically without incurring the concerns
related to the management of toxic waste associated with Mo-99
production from enriched uranium.

About NorthStar Medical Radioisotopes, LLC (NorthStar)
Medical Radioisotopes is a nuclear medicine technology company committed
to providing the United States with reliable and environmentally
friendly radioisotope supply solutions to meet the needs of patients and
to advance clinical research. The Company's first product is the
RadioGenix™ System, an innovative and flexible platform technology
initially approved by the U.S. Food and Drug Administration in February
2018 for the processing of non-uranium/non-highly enriched uranium based
molybdenum-99 (Mo-99), the parent isotope of technetium-99m (Tc-99m),
which is currently the most widely used diagnostic radioisotope for
medical purposes. NorthStar's proprietary and patented technologies
include non-uranium based molybdenum-99 domestic production methods,
patented separation chemistry systems, patented sterilization systems
and a technology platform that potentially allows expanded product
offerings to provide solutions in both the diagnostic and therapeutic
markets. Founded in 2006 and based in Beloit, Wis., NorthStar Medical
Radioisotopes, LLC is a wholly-owned subsidiary of NorthStar Medical
Technologies, LLC. For more information, visit:

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