NorthStar Medical Technologies, LLC Announces Appointment of Paul Estrem, CPA, as Senior Vice President and Chief Financial Officer
BELOIT, Wis. – December 18, 2018 –NorthStar Medical Technologies, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, today announced the appointment of Paul Estrem, CPA, as Senior Vice President and Chief Financial Officer. Mr. Estrem holds financial responsibility for the operations of company, reporting to President and Chief Executive Officer Stephen Merrick. Mr. Estrem, former Chief Financial Officer at Melinta Therapeutics, Inc., brings to NorthStar more than 30 years of relevant financial experience in the life science and medical technology industries.
“Paul’s strong combination of leadership and financial experience in growing successful organizations should serve NorthStar well as we continue building a fully sustainable company,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “With the RadioGenix® System on the market, NorthStar has commercialized the first innovative technology for production of domestic Mo-99 in more than 30 years, and we look forward to benefitting from Paul’s experience. We anticipate that his skills will be a valuable resource in financial management as we advance our plans for additional RadioGenix enhancements and expanded production capacity of non-uranium based Mo-99.”
“I’m excited to be part of NorthStar, which is clearly driven in its mission to deliver novel technologies to produce medical radioisotopes critical for U.S. healthcare,” said Mr. Estrem. “NorthStar faces a pivotal stage of growth and development as it continues its maturation process, and I’m eager that I can contribute my financial experience in working with this dedicated team at an important inflection point in the company’s growth.”
Prior to joining NorthStar, Mr. Estrem served as CFO at Melinta Therapeutics, Inc., a company focused on the discovery, development and commercialization of novel antibiotics. During his five-year tenure there, Paul guided the company in converting from a private to public enterprise, raised more than $500 million in support of the company, assisted in the acquisition of products from other companies, facilitated a merger and supported the commercial launch of multiple products. Previously, he was with Baxter International, Inc. for more than 20 years, where he held both financial and non-financial positions of increasing responsibility. During his tenure at Baxter, his experiences included divisional CFO for various divisions of Baxter, CFO of Baxter’s operations in Japan and serving as the Vice-President of Integration for a large acquisition. Prior to Baxter, Paul was a public accountant with Arthur Andersen & Co.
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
• 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 Technologies, LLC (NorthStar)
NorthStar Medical Radioisotopes is a global innovator in the production and distribution of radioisotopes used for medical imaging. Founded in 2006 and based in Beloit, Wis., 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