NorthStar Medical Technologies Expands Portfolio with Exclusive, Worldwide Licensing of Investigational Fibrin-targeted Cardiac Diagnostic Imaging Agent

• Acquisition of technetium-99m (Tc-99m) SPECT agent expands company portfolio as strategic complement to commercially available RadioGenix^® System
• Builds on NorthStar’s leadership expertise in development and commercialization of novel radiopharmaceuticals
• Exploratory Phase 1 study planned to investigate FibroScint (Tc-99m F4A) use in identifying thrombus in heart failure patients with assisted devices; potential for additional indications

BELOIT, Wis.--(BUSINESS WIRE)-- NorthStar Medical Technologies, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, today announced that it has entered into a worldwide, exclusive licensing agreement with Capella Imaging, LLC, a BioGenerator company focused on the development of diagnostic imaging agents to support unmet medical needs. Under the agreement, NorthStar has licensed exclusive rights to a fibrin-targeted diagnostic imaging agent for cardiac imaging. FibroScint (Tc-99m F4A) is a fibrin-targeted, peptide compound labeled with the radioisotope technetium-99m (Tc-99m) for SPECT imaging. If successfully developed and approved, it may have potential applications across multiple cardiovascular conditions such as thrombus (blood clots) associated with left ventricular assist devices (LVADs), deep vein thrombosis, pulmonary embolism and acute coronary syndrome. Initial clinical investigation of FibroScint will be an exploratory Phase 1 study for its potential use in identifying thrombus in patients with serious heart failure who use an LVAD. It is anticipated that the first indication for FibroScint will receive an Orphan Drug designation.

“This agreement aligns with NorthStar’s strategic focus and further advances our mission to develop and commercialize radioisotope products to meet the needs of patients and advance clinical research,” said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Technologies. “FibroScint is a unique diagnostic agent and an ideal addition to our portfolio which complements the commercially available RadioGenix^® System (technetium Tc 99m generator). NorthStar intends to use Tc-99m produced by RadioGenix Systems in the planned clinical studies of FibroScint. We look forward to collaborating with Capella Imaging on further early development of this agent.”

Under terms of the agreement, NorthStar will invest $1 million in Capella equity in conjunction with Capella seeking federal funding grants, both of which will be used for completion of Phase 1 clinical development through an exploratory Investigational New Drug application (eIND) for the LVAD indication. NorthStar has the option to make additional equity investment in support of future clinical trials and would make additional success payments to Capella contingent upon completion of certain regulatory and revenue milestones, with royalties payable upon commercialization of the product in each of three potential diagnostic indications. Further terms of the agreement were not disclosed.

“Options for patients with severe heart failure are limited to heart transplantation, LVADs or hospice care,” said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar. “While LVADs significantly improve a patient’s survival and quality of life, they are also associated with complications such as thromboembolic events and gastrointestinal bleeding, and anticoagulation therapies may further exacerbate these bleeding events. There is a need for diagnostic imaging tools that can inform clinical management and monitoring of heart failure patients using LVADs, with the aim of reducing some of these complications, and NorthStar plans to investigate FibroScint to help meet this need.”

“We are pleased to enter into this license agreement with NorthStar Medical Technologies, and we believe that the company’s proven experience in the development and commercialization of innovative technologies will be useful in advancing further development of FibroScint,” said James Blackledge, PhD, President, Capella Imaging. “Fibroscint has shown potential in numerous indications, and preclinical studies have been encouraging and merit formal clinical assessment through an exploratory Phase 1 study.”

About FibroScint (Tc-99m F4A)
FibroScint (Tc-99m F4A) consists of a fibrin-targeted, peptide compound labeled with the radioisotope technetium-99m (Tc-99m) for SPECT imaging. It was invented by researchers at the Washington University School of Medicine, St. Louis, Mo., and exclusively licensed by NorthStar Medical Technologies in 2020. If successfully developed and approved, FibroScint may have potential applications across multiple cardiovascular conditions such as thrombi (blood clots) associated with left ventricular assist devices (LVADs), deep vein thrombosis, pulmonary embolism and acute coronary syndrome. NorthStar is initially investigating FibroScint in a planned exploratory Phase 1 study for use in identifying thrombus in patients with serious heart failure who use a left ventricular assist device (LVAD). FibroScint has not received regulatory approval.

About Heart Failure and Left Ventricular Assist Devices (LVADs)
Heart failure affects an estimated 6.2 million Americans annually and its incidence continues to grow. More than 80,000 patients die of severe heart failure per year in the United States, yet only 2,500 – 3,000 donor hearts become available. Options for patients with severe heart failure include heart transplantation, mechanical circulatory support such as a left ventricular assist device (LVAD) or hospice care. LVADs significantly improve survival and quality of life. However, they are associated with complications such as thromboembolic events, gastrointestinal bleeding and infection, and despite the use of anticoagulation therapies, LVAD-associated thrombi develop over time. Current diagnostic imaging techniques are limited in their ability to detect thrombus in the high flow conditions and anticoagulated environment of LVADs.

About Capella Imaging, LLC
Capella Imaging, based in St. Louis, Mo., is a BioGenerator company focused on the development of diagnostic imaging agents to support unmet medical needs.

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 therapeutic purposes. 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 (technetium Tc 99m generator), 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: http://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

• 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.

• Discard the first eluate from every new Potassium Molybdate Mo 99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186.

• 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 kit/packs, 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/2019/08/radiogenix-system-pi-july2019.pdf.

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