CHAPEL
HILL, N.C., May 2, 2024
/PRNewswire/ -- 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.
"We are excited to partner with SonoVascular
to extend our microbubble franchise into a
novel treatment for VTE," said Etienne Montagut, Chief
Business Officer
of Lantheus. "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."
About Venous Thromboembolism
Venous thromboembolism is a condition that occurs when a
blood clot forms in a vein. As many as 900,000 VTE events occur
each year in the United
States.1 VTE includes DVT and PE. DVT occurs when
a blood clot forms in a deep vein, usually in the lower leg, thigh
or pelvis. The most serious complication of DVT happens when a part
of the clot breaks off and travels through the bloodstream to the
lungs, causing a blockage called PE. If the clot is large, it can
stop blood from reaching the lungs and can be fatal. One-third to
one-half of people who have a DVT will have long-term complications
caused by damage to the valves in the vein called post-thrombotic
syndrome (PTS).2 In some cases, PTS symptoms can be so
severe that a person becomes disabled. PE can be life-threatening,
with 10-30% of individuals dying within one month of
diagnosis.3
About SonoVascular, Inc.
SonoVascular designs and develops innovative therapeutic
ultrasound-based medical devices for treating vascular disease.
Founded in 2018 with exclusively licensed technology developed by
scientists at the Joint Department of Biomedical Engineering
between the University of North Carolina at
Chapel Hill and North Carolina State
University, SonoVascular developed the SonoThrombectomy
System, a novel pharmaco-mechanical ultrasound facilitated
thrombectomy system for VTE that utilizes microbubble-mediated
cavitation as a core enabling mechanism of action to more
effectively remove VTE blood clots. The system uniquely combines:
(i) ultrasound, (ii) microbubbles, (iii) low dose thrombolytic
drug, and (iv) mechanical retrieval or aspiration, delivered via an
integrated intravascular catheter system. 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 ICU. SonoVascular is headquartered in
Chapel Hill, NC.
1 Gregson J, Kaptoge S, Bolton T, et al.
Cardiovascular Risk Factors Associated With Venous Thromboembolism.
JAMA Cardiol. 2019;4(2):163–173.
doi:10.1001/jamacardio.2018.4537.
2 Wendelboe AM, Campbell J, McCumber M; Bratzler D;
Ding K, Beckman M, Reyes N; Raskob G. The Design and Implementation
of a New Surveillance System for Venous Thromboembolism using
Combined Active and Passive Methods. American Heart Journal.
2015.
3 American Lung Association;
https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism#:~:text=Pulmonary%20embolism%20affects%20around%20900%2C000,that%20travel%20to%20the%20lungs
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SOURCE SonoVascular, Inc.