NorthStar Medical Radioisotopes Announces FDA Approval of Beloit, Wis. Facility for RadioGenixTM 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 –
BELOIT, Wis. – July 24, 2018 – 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 Tc-99m.”
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 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 RadioGenixTM 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 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.
For NorthStar Medical Radioisotopes, LLC
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For NorthStar Medical Radioisotopes, LLC