"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."
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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.
