U.S. Department of Energy’s National Nuclear Security Administration Honors NorthStar Medical Radioisotopes as First U.S. Producer of Medical Radioisotope Molybdenum-99 in Nearly 30 Years
- Award for Outstanding Achievement presented at 2018 Molybdenum-99
Topical Meeting -
NorthStar Medical Radioisotopes, LLC, a company involved in the
production and distribution of radioisotopes used for medical imaging,
today announced that it received an Award for Outstanding Achievement
from the U.S. Department of Energy’s National Nuclear Security
Administration (NNSA). The award recognizes NorthStar for being the
first producer of molybdenum-99 (Mo-99) in the United States in nearly
30 years. It was presented on behalf of NNSA by Peter H. Hanlon,
Assistant Deputy Administrator, Office of Material Management and
Minimization, at NNSA’s 2018 Annual Mo-99 Topical Meeting held in
Knoxville, Tenn., September 23-26, 2018. Approved by the U.S. Food and
Drug Administration (FDA) in February 2018, NorthStar’s RadioGenix®
System is an innovative, high tech radioisotope separation platform
indicated for use in producing the widely used medical radioisotope
technetium-99m (Tc-99m) from non-uranium based molybdenum-99 (Mo-99).
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NorthStar Medical Radioisotopes Receives NNSA’s Outstanding Achievement Award (Photo: Business Wire)
NorthStar participated in several key sessions at the meeting. The
Opening Plenary Session, “Supporting a Reliable, Non-HEU Mo-99 Supply,”
featured a presentation by James Harvey, PhD, SVP and Chief Science
Officer of NorthStar Medical Radioisotopes, who spoke about “Lessons
Learned: Path to Approval.” Dr. Harvey later presented an update on
domestic production of Mo-99 via neutron capture in a session devoted to
Mo-99 production projects and technologies.
“We are pleased to recognize NorthStar Medical Radioisotopes’
outstanding achievement for being the first producer of Mo-99 in the
United States in nearly 30 years,” said Peter H. Hanlon, Assistant
Deputy Administrator, Office of Material Management and Minimization,
NNSA, while presenting the Award for Outstanding Achievement at NNSA’s
2018 Annual Topical Meeting. “NorthStar’s success directly supports the
National Nuclear Security Administration’s goal to reduce the use of
highly enriched uranium in civilian commercial applications. NorthStar’s
efforts have resulted in a safer world while contributing to a stable
supply of this crucial medical radioisotope for American patients.”
“NNSA has partnered with NorthStar Medical Radioisotopes for seven years
to develop the RadioGenix System and modernize the neutron capture
process for the production Mo-99 without the use of uranium,” said
George Messina, Chairman Emeritus of NorthStar Medical Radioisotopes.
“It’s gratifying that our efforts became realized through the FDA’s
approval of the RadioGenix System. NNSA’s close collaboration,
outstanding working relationship and support of NorthStar have been
instrumental in achieving this success.”
“In addition to sincere appreciation for the support and efforts of
NNSA, I would like to recognize and thank our partners at the University
of Missouri Research Reactor (MURR®) for their important contribution to
the success of this project,” said Stephen Merrick, President and CEO of
NorthStar Medical Radioisotopes. “As a result of this highly successful
collaboration between government, academia and industry, NorthStar has
reached a transformative inflection point in our mission to provide a
reliable supply of Mo-99 produced without uranium to meet U.S.
healthcare needs and strengthen national security. The commercial launch
of the RadioGenix System is well underway, and we are ramping up
expansion activities to further increase production capacity for
domestically-produced Mo-99.”
The Mo-99 Topical Meeting is intended to serve as a workshop where
international and domestic policy and technical experts can gather to
present and discuss progress toward achieving the production of Mo-99
without the use of highly enriched uranium (HEU) in support of
nonproliferation objectives and global reliability of supply.
Partial funding for NorthStar’s technology was provided by the U.S.
Department of Energy’s National Nuclear Security Administration. Under
provisions of the American Medical Isotopes Production Act of 2012,
efforts have been made to establish domestic production of Mo-99 and to
promote the use of Mo-99 produced without reliance on highly enriched
uranium, which is a nuclear proliferation risk. NorthStar’s technology
uses stable isotopes of molybdenum, rather than enriched uranium,
thereby avoiding the national security and environmental risks
associated with enriched uranium.
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
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Adults for Salivary Gland Imaging and Nasolacrimal Drainage System
Imaging (dacryoscintigraphy).
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Adults and pediatric patients for Thyroid Imaging and Vesicoureteral
Imaging (direct isotopic cystography) for detection of vesicoureteral
reflux.
IMPORTANT RISK INFORMATION
-
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 www.fda.gov/medwatch.
For Full RadioGenix® System Prescribing
Information, click
here or visit https://www.northstarnm.com/wp-content/uploads/2018/04/PI_Rev04_23mar2018.pdf.
About NorthStar Medical Radioisotopes, LLC (NorthStar)
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:
www.northstarnm.com.
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