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Bucks business awarded $1 million grant for medical device research

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New Britain-based Thrombolex Inc. has been awarded a $1 million state grant to support clinical trials for new breakthrough medical technology designed to better combat deep vein thrombosis (DVT) and pulmonary embolism (PE).

Thrombolex Inc. executives joined state Senators Pat Browne (R-16) and Steve Santarsiero (D-10) to announce the grant Nov. 14, at the company’s offices on Britain Drive. The state funding will support clinical trials for Thrombolex’s BASHIR family of catheters, named for Dr. Riyaz Bashir, the company’s ex-officio chief medical consultant.

The BASHIR catheters’ design allows physicians to more effectively treat and break up large blood clots associated with deep vein thrombosis and pulmonary embolism. Pulmonary embolism is the third leading cause of cardiovascular death in the United States.

Marvin Woodall, chairman and CEO of Thrombolex, said the funding from the state Department of Health would be used for clinical trials, one of which is already underway.

In that early feasibility study of patients with PE, the company said, the new device produces a more than three times greater reduction in clot burden than other infusion catheters.

“We’re elated at the results,” said Woodall, former president of Johnson and Johnson’s Interventional systems.

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 company said.

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,” according to Thrombolex.

“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.”

That reduction in the amount of clot-dissolving drugs could also lead to a vast reduction in medication costs, Woodall said, citing per dosage costs of as much as $10,000 for thrombolytic drugs used in traditional treatment.

“This is an investment by the state that’s going to help a local company grow and also have the potential to help save lives and our health-care dollars,” Santarsiero said. “This is a product poised to impact our local economy and the health of people around the world.”

According to Woodall, “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.”

He said the funding would help Thrombolex “provide the necessary clinical data to the FDA to advance this form of therapy.”

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.

Browne, who secured the state grant with the support of Santarsiero, said, “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. The products that Thrombolex (is) developing have the potential to revolutionize how deep vein thrombosis and pulmonary embolisms are treated, creating better and safer outcomes and saving lives.”

Founded in 2016, Thrombolex, Inc., 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.

jarthur@buckscountyherald.com


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