BELOIT, Wis.--(BUSINESS WIRE)--NorthStar Medical Technologies, LLC, (“NorthStar” or the “Company”) a global innovator in the production and distribution of radioisotopes used for medical imaging and therapy, today announced the closing of a $100 million secured financing with funds managed by Oberland Capital Management LLC (“Oberland Capital”). NorthStar received $75 million at closing with the ability to draw an additional $25 million prior to December 31, 2020 at the Company’s option. NorthStar will primarily use proceeds from the financing to increase domestic production capacity for the medical radioisotope molybdenum-99 (Mo-99), complete programs to improve the efficiency of the production of Mo-99, implement additional enhancements for the RadioGenix System (technetium Tc 99m generator) and continue to advance its R&D activities. Approved by the FDA and commercialized in 2018, the RadioGenix System uses reliable, domestic, non-uranium based Mo-99 to supply customers with the critical diagnostic imaging radioisotope technetium-99m (Tc-99m).
“This financing agreement with Oberland Capital enables us to execute on our clearly defined strategy to build solid, sustainable momentum for NorthStar as a fully commercial enterprise,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “Market uptake for RadioGenix Systems continues in line with our strategy, with RadioGenix Systems increasingly providing customers with the important medical radioisotope Tc-99m for patients’ diagnostic tests - on time and when they need them. This funding provides NorthStar with the means to continue investment in additional RadioGenix System enhancements and to expand production capacity for non-uranium based Mo-99, including the almost complete 20,000 square foot expansion of our facility in Beloit, Wisconsin. We anticipate that the building expansion will more than double processing capacity for Mo-99 Source Vessels upon completion and FDA approval. We are also working toward final validation of two state-of-the-art fill lines at our Columbia, Missouri facility that, pending expected FDA approval this year, will substantially increase the number of Mo-99 Source Vessels we are able to ship to customers weekly. NorthStar is further investing in the future with additional planned expansions and ongoing R&D activities, all with the aim to meet customer demand and ensure reliable, non-uranium based radioisotope supply for U.S. markets.”
“Oberland Capital is a recognized leader in global healthcare-focused investments, and we are pleased to have their support and confidence,” said Paul Estrem, Senior Vice President and Chief Financial Officer of NorthStar. “Oberland Capital engaged with us to understand our business and capital needs and demonstrated flexibility in creating a cash efficient transaction that will support our continued growth as a company.”
“Our investment in NorthStar aligns with our strategy of investing in commercial-stage healthcare companies with differentiated products serving significant unmet needs. As the first domestic producer of Mo-99 in more than 30 years, NorthStar’s innovative technology has the potential to provide the U.S. healthcare system with reliable supply of the much-needed diagnostic imaging radioisotope Tc-99m, and we are pleased to have the opportunity to partner with NorthStar and contribute to the Company’s growth,” said Andrew Rubinstein, Managing Partner of Oberland Capital.
About the RadioGenix® System
The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium/non-highly enriched uranium based 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 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 Oberland Capital
Oberland Capital, a private investment firm with over $1.2 billion in capital commitments since inception, is focused exclusively on investing in the global healthcare industry and specializes in flexible investment structures customized to meet the specific capital requirements and strategic objectives of transaction partners. Oberland Capital’s broad suite of financing solutions includes monetization of royalty streams, acquisition of future product revenues, creation of project-based financing structures, and investments in traditional debt and equity. With a combination of deep industry knowledge and extensive structured finance experience, the Oberland Capital team has a history of creating value for its transaction partners. The firm was founded in 2013 by Jean-Pierre Naegeli and Andrew Rubinstein.
For more information, please visit www.oberlandcapital.com or contact Johnna Schifilliti at (212) 257-5850.
About NorthStar Medical Technologies, LLC (NorthStar)
NorthStar Medical Radioisotopes is a global innovator in the production and distribution of radioisotopes used for medical imaging and therapy. Founded in 2006 and based in Beloit, Wisconsin, NorthStar Medical Technologies is the parent organization of several wholly-owned subsidiaries, including 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. For more information, visit: www.northstarnm.com
