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NorthStar Medical Technologies Updates Progress on Actinium-225 Radioisotope Program

NorthStar Medical Technologies (NorthStar), a company involved in the
development, production and distribution of radioisotopes for medical
imaging and therapeutics, today provided a progress update on its
actinium-225 (Ac-225) radioisotope program. Ac-225 is a high energy
alpha-emitting radioisotope with potential therapeutic applications as a
Targeted Alpha Therapy (TAT) for certain cancers and HIV. Because of
limitations in current production technology, clinical research and
commercial use of Ac-225 is severely constrained by chronic short
supply. NorthStar is building upon previously completed proof of concept
initiatives to progress towards commercial-scale production of Ac-225
and its daughter radioisotope, bismuth-213 (Bi-213).

“In line with our mission to deliver solutions for unmet needs in
radioisotope development and production, NorthStar continues to progress
our Ac-225 program,” said George Messina, Founder, Chairman and Chief
Executive Officer. “Ac-225 is an under-utilized medical radioisotope
with great potential in targeted therapy for patients with serious
diseases such as acute myeloid leukemia (AML), infectious diseases such
as HIV and potentially certain heart diseases such as atherosclerosis.
However, clinical research is extremely limited due to availability of
Ac-225. We believe that NorthStar is well-positioned to deliver
innovative technology solutions to meet this challenge, as evidenced by
the recent U.S. Food and Drug Administration approval of our novel
RadioGenix™ System for producing technetium-99m from domestic,
non-uranium based molybdenum-99. We intend to apply the same expertise
and proven experience to advance Ac-225 commercial production. Pending
successful development and FDA approval, RadioGenix technology may also
have applications in using Ac-225 to produce the medical radioisotope
Bi-213 for multiple therapies.”

“NorthStar has completed successful initial testing for Ac-225
production scale-up in collaboration with select institutions and
laboratories,” said James T. Harvey, PhD, Senior Vice President and
Chief Science Officer of NorthStar. “The process involves high energy
proton irradiation of thorium targets to produce Ac-225. Further
scale-up efforts are underway, to resolve Ac-225 and Bi-213 supply
challenges, provide commercially relevant quantities of this important
radioisotope and advance clinical research.”

About Targeted Alpha Therapy (TAT)

Targeted alpha-particle therapy (or TAT) is an investigational method of
targeted radionuclide therapy for various cancers and infectious
diseases. It employs radioactive alpha-emitting substances which undergo
decay to treat diseased tissue at close proximity. TAT has the potential
to provide highly targeted treatment, especially to microscopic tumor
cells. Targets include leukemias, lymphomas, gliomas, melanoma,
peritoneal carcinomatosis and HIV.

About Medical Radioisotopes -Actinium-225
(Ac-225)/Bismuth-213 (Bi-213); Molybdenum-99 (Mo-99)/Technetium-99m
(Tc-99m)

Actinium-225 (Ac-225) and its daughter isotope bismuth-213 (Bi-213) are
high energy alpha emitting radioisotopes. They are attractive for
medical purposes because they combine the ability to carry sufficient
radiation energy to cause cell death in targeted cells with a
sufficiently short half-life to limit unwanted radioactivity in
patients. Ac-225 and Bi-213 are the mainstays for preclinical and
clinical studies of targeted alpha therapy and have been identified as
optimal TAT radioisotopes. However, current supply of Ac-225 is severely
constrained and can only meet demand for a very limited number of
patients annually. NorthStar is developing a proprietary process for
commercial-scale production of Ac-225 to meet demand for clinical
research and treatment.

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 have
the potential to 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 many of the concerns related to the management of toxic waste
associated with Mo-99 production from enriched uranium.

About NorthStar Medical Technologies, LLC (NorthStar)

NorthStar Medical Radioisotopes, founded in 2006 and based in Beloit,
Wis., and NorthStar Nuclear Therapies, LLC are wholly-owned subsidiaries
of NorthStar Medical Technologies, LLC. NorthStar 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. For more information,
visit: www.northstarnm.com

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

IMPORTANT RISK INFORMATION

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.

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