Minimally invasive access and aspiration of circulating lymphocytes from the thoracic duct

Building on a half-century of innovation in transvascular access and ultrasound image guidance, LXS has developed a novel catheter device and venous access procedure to cannulate and aspirate the thoracic duct under ultrasound guidance. The company has successfully completed Phase I and II of the NIH’s SBIR program and is applying for a Commercialization Readiness Pilot (CRP) award to complete development, prepare and submit for FDA clearance, ramp manufacturing, and develop critical sales and marketing strategies in anticipation of commercial use. This CRP program has four Specific Aims to be completed over three years. With interest in cell-based therapies for a variety of disease states is at an all-time high, access to large numbers of substrate cells remains a significant obstacle. Harvesting rare cell types from peripheral blood is costly and time consuming. At present, development of lymphocyte-focused therapies depends on cells collected from peripheral blood where lymphocytes make up less than 3% of circulating cells. The low number of desirable cells makes ex-vivo expansion and manipulation impossible in a point-of-care setting. Over a quarter century of research has significantly improved our understanding of the circulating cardiovascular system and its cellular components. However, study of the parallel lymphatic system has lagged far behind, limiting our understanding of this complex and potentially clinical beneficial network. The lymphatic system is comprised of an extensive network of vessels and nodes that parallel the venous vasculature. Peripheral lymphatic channels combine to form a single thoracic duct that enters the venous system at the confluence of the left internal jugular and subclavian veins. The lymphatic system plays a number of critical roles in pathophysiological conditions such as diabetes, heart failure, cancer, and autoimmune disorders. In Phase I, we designed and tested a proof-of-concept device capable of accessing the thoracic duct from a left subclavian vein approach. In Phase II, the company further refined our approach and validated pre - clinical devices in a large animal study and a unique perfused cadaver model. Outside of NIH-funded efforts, the company conducted a successful first-in-human study, grew our IP portfolio to 10 applications and issued patents, and attracted additional funding and resources from the Wellcome Trust, AmFAR, and J&J. Completion of this CRP program will place the company in a position to launch sales with an FDA cleared device as a direct competitor to plasmapheresis and the only transvascular access device for lymphocyte collection and depletion. Next, through collaborations and partnerships with leaders in basic science and clinical medicine, we plan to implement a range of studies and applications to expand the therapeutic role for large-scale lymphocyte collection and manipulation. Data from post-market clinical studies in CAR T-cell production, infectious disease, heart failure, and autoimmune disorders will lead to additional indication-specific clearances.