Updated: Mar 9, 2020
November 14, 2019
New Britain, PA (November 14, 2019)- Thrombolex Inc. executives joined State Senators Pat Browne (R-16 District) and Steve Santarsiero (D-10 District) to announce a $1 million state grant awarded to Thrombolex. The state funding will support clinical trials for Thrombolex’s BASHIR family of catheters, new breakthrough medical technology designed to better combat deep vein thrombosis (DVT) and pulmonary embolism (PE).
Pulmonary Embolism is the third leading cause of cardiovascular death in the United States.
The BASHIR catheters’ design allows physicians to more effectively treat and break up large blood clots associated with deep vein thrombosis and pulmonary embolism. The device is threaded through a vein to the site of the blood clot, where a uniquely designed “infusion basket” near the tip of the catheter is expanded in the blood clot to rapidly restore blood flow. This also allows for substances in the patient’s own blood to begin to break down the blood clot. Small doses of clot-dissolving drugs can then be infused through 48 holes in the six limbs of the infusion basket to further dissolve the clot safely and effectively.
The unique pharmaco-mechanical mode of action of the BASHIR Endovascular Catheter not only greatly reduces the clot burden but also does so with minimal risk of bleeding complications. This is because a very low dose of clot-dissolving drug is administered directly into the clot rather than the large doses that are infused into a peripheral vein according to the FDA labeling, with the attendant risk of bleeding complications.
In an early feasibility study of patients with PE, this new device produces a more than three times greater reduction in clot burden than other infusion catheters.
“DVT can be a very debilitating condition for many patients, and may lead to a PE if the blood clot breaks off and travels to the lungs. Thrombolex is absolutely delighted with the support we have received from the Commonwealth of Pennsylvania in recognition of our very exciting technology that can benefit so many patients. The funding will help us to provide the necessary clinical data to the FDA to advance this form of therapy,” said Marvin Woodall, CEO and Chairman, Thrombolex.
Successful clinical trials are the next step required by the Food and Drug Administration (FDA) before the FDA will grant approval to use the BASHIR catheters for treating patients with PE.
“Thrombolex is a prime example of a homegrown company whose successes continue to position Pennsylvania as a leader in advancements in medicine and puts the Commonwealth on the forefront of innovative medical technologies,” said Senator Browne. “The products that Thrombolex are developing have the potential to revolutionize how deep vein thrombosis and pulmonary embolisms are treated, creating better and safer outcomes and saving lives.”
The grant was secured by Senator Browne through the Department of Health and supported by Senator Santarsiero. “The innovative technology being developed by Thrombolex has the potential to revolutionize patient care and save thousands of lives,” Sen. Santarsiero said. “As Thrombolex continues to develop breakthrough technology, I will continue to lend my support for their research and development goals.”
Founded in 2016, Thrombolex, Inc., a Pennsylvania company, is engaged in the design, development, manufacture and distribution of innovative endovascular catheters used in interventional procedures, particularly in catheter-directed thrombolysis (CDT) of large thrombus, in patients affected by acute venous thromboembolic (VTE) conditions. It has secured clearance from the FDA to market three different catheters for the treatment of peripheral vascular diseases and is currently seeking to obtain FDA clearance for four more devices that are specifically designed to treat severe DVTs up to 50 cm in length, namely, ones that extend from the knee to the pelvis. The company is currently completing an early feasibility and safety clinical study for the treatment of acute PE to be followed by a large pivotal trial.