The patent is directed to a proprietary waveguide specially designed for the transmission of shock waves used in the treatment of cardiovascular disease. It covers the Active Wire, Soundbite’s proprietary guidewire, and the rest of the company's product portfolio.
The patent is expected to expire no earlier than January 2039 and will provide key intellectual property protection for the company's technology platform.
This is the third U.S. patent to be issued around the approved Soundbite technology. A fourth U.S. patent has recently been allowed. Soundbite continues to enhance its patent portfolio with additional patent applications that will broaden and strengthen its patent protection in other key markets throughout the world.
“Building a robust patent portfolio in the US and around the world, supported with clearances by regulatory bodies in the U.S., EU, Canada and eventually Japan strengthen our position in the cardiovascular intervention market,” said Lori Chmura, president and CEO of Soundbite.
The SoundBite Crossing System – Peripheral (SCS-P) consists of the reusable SoundBite Console, a single-use sterile SoundBite Active Wire, and their respective accessories. SCS-P leverages Soundbite’s proprietary method to produce and safely deliver shock waves via guidewire platforms to selectively “micro- jackhammer” through calcified lesions.
“The cardiovascular community is primed for a new tool to help physicians treat these challenging and debilitating lesions safely and effectively,” said Dr. Martin Leon M.D., professor of Medicine at Columbia University Medical Center, director of the Center for Interventional Vascular Therapy, director of the Cardiac Catheterization Laboratories and executive board member of the Columbia New York-Presbyterian Heart Valve Center, and chair of Soundbite’s Medical Advisory Board. “The progress that Soundbite has made in its patent work, as well as its FDA clearances, is promising.”
High calcium burden is present in up to 50 percent of PAD patients with severe claudication and in >65 percent of patients with CLI, especially in difficult to treat below-the-knee (BTK) disease. CTOs are encountered in up to 50 percent of PAD and CLI patients. CLI is associated with a high risk of lower limb amputation estimated in 10 percent to 40 percent of patients at six months, especially in non-treatable patients.
Soundbite is a privately-held medical device company uniquely dedicated to developing meaningful solutions for the interventional treatment of calcific peripheral and coronary arterial diseases. Soundbite has developed and deployed a proprietary method to produce and safely deliver shock waves to calcified lesions using an array of devices to improve and transform the standard of care for treatment of patients suffering from calcified and occlusive cardiovascular disease.