SonoVascular, Inc., a private medical device company focused on the development of its SonoThrombectomy™ System, a novel pharmaco-mechanical ultrasound facilitated thrombectomy system that utilizes microbubble-mediated cavitation as a core enabling mechanism of action to treat patients with venous thromboembolism (VTE), has executed an exclusive clinical supply agreement with Lantheus Holdings, Inc. (Lantheus) to use Lantheus’ microbubbles in combination with SonoVascular’s SonoThrombectomy System to treat deep vein thrombosis (DVT) and pulmonary embolism (PE).
VTE is a condition that occurs when a blood clot forms in a deep vein, resulting in DVT. One of the most serious complications of DVT happens when a part of the clot breaks off and travels through the bloodstream to the lungs, causing a PE. SonoThrombectomy uniquely combines ultrasound, microbubbles, low dose thrombolytic drug, and mechanical retrieval or aspiration, delivered via an integrated intravascular catheter system to treat DVT and PE more effectively and safely.
The microbubbles are activated by intravascular ultrasound and will be investigated in ongoing pre-clinical and upcoming clinical studies. The SonoThrombectomy System has been engineered to address and overcome the deficiencies and limitations of current interventional devices. It is a catheterization laboratory-based solution that has been designed to maximize the reduction in clot burden, reduce the dose and duration as well as enhance the delivery of thrombolytics to levels that optimize safety and effectiveness, and eliminate the need for patients to be treated in the intensive care unit. SonoVascular’s SonoThrombectomy System has been successfully evaluated in in vitro and in vivo preclinical studies and is now poised to initiate first-in-human (FIH) studies in 2024 in partnership with Lantheus to evaluate safety and feasibility of the SonoThrombectomy System for treatment of DVT and PE prior to moving forward with pivotal studies in the U.S. for both indications.
Lantheus will supply its microbubbles and activation devices, while SonoVascular will be responsible for executing clinical studies and future regulatory submissions and commercialization. Additionally, upon completion of a FIH study, SonoVascular has an option to enter into a long-term exclusive commercial supply agreement with Lantheus.
Etienne Montagut, Chief Business Officer of Lantheus
“We are excited to partner with SonoVascular to extend our microbubble franchise into a novel treatment for VTE. Our collaboration with SonoVascular leverages both companies’ strengths to help change the paradigm in the treatment of venous disease – a large and growing clinical condition.”
“SonoVascular is honored to have the opportunity to partner with Lantheus, a leader in microbubble development,” said Daniel Estay, Founder and Chief Executive Officer of SonoVascular. “Our SonoThrombectomy System, combined with Lantheus’ microbubbles, is designed to provide a true, next-generation solution for the treatment of DVT and PE that overcomes the drawbacks associated with catheter-based thrombectomy and thrombolysis devices.”