NorthStar Medical Radioisotopes Announces Mo-99 Supply Update Presentation at Upcoming Society of Nuclear Medicine & Molecula...
June 19 2018 - 8:30AM
Business Wire
NorthStar Medical Radioisotopes, LLC (NorthStar), a company
involved in the production and distribution of radioisotopes used
for medical imaging, today announced that it will participate in a
panel session on molybdenum-99 (Mo-99) supply at the Society of
Nuclear Medicine and Molecular Imaging Annual Meeting (SNMMI), from
June 23 - 26, 2018, in Philadelphia, Pa. James T. Harvey, PhD,
Senior Vice President and Chief Science Officer of NorthStar, will
provide an update on advancements in Mo-99 production and the U.S.
Food and Drug Administration’s recent approval of NorthStar’s
RadioGenixTM System for producing the medically important
radioisotope technetium-99m using domestically sourced, non-uranium
based Mo-99.
Day, Date: Sunday, June 24, 2018 Session Title: CMIIT
Emerging Technologies: Outlook for Future Supply of Mo-99 Session
Time: 4:30 – 6:00 p.m. ET Presentation Time: 5:09 – 5:18 p.m. ET
Presenter: James T. Harvey, PhD Location: 112AB (Philadelphia
Convention Center)
NorthStar Medical Radioisotopes invites participants at this
year’s SNMMI Annual Meeting to visit the company at Exhibit Booth
815.
About the RadioGenixTM 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
INDICATION
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 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 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)
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 RadioGenixTM 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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Corporate:For NorthStar
Medical Radioisotopes, LLCLisa Holst, 678-471-9027Vice President
Sales and Marketinglholst@northstarnm.comorMedia:For
NorthStar Medical Radioisotopes, LLCPriscilla Harlan,
781-799-7917pharlan@shiningrockllc.com