AVS Partners with the Jacobs Institute to Expedite Clinical Trials for Coronary and Carotid Indications
August 20 2024 - 7:58AM
Business Wire
Company’s agreement with the JI demonstrates
progress toward commercialization of Pulse IVL™ Intravascular
Lithotripsy System
Amplitude Vascular Systems (AVS), a medical device company
focused on safely and effectively treating severely calcified
arterial disease with its Pulse Intravascular Lithotripsy platform,
today announced it has entered into a strategic agreement with the
Jacobs Institute, a nonprofit medical device innovation center in
Buffalo, N.Y., led by Adnan Siddiqui, M.D. The partnership will
execute clinical studies evaluating the Pulse IVL™ System in both
Coronary and Carotid vasculatures and aims to expand clinical
indications for the Pulse IVL System.
Pulse IVL™ is an Intravascular Lithotripsy device that uses
high-frequency pressure waves to fracture calcium with a
non-compliant balloon to expand the vessel. This partnership
combines the clinical and regulatory capabilities of the Jacobs
Institute with the novel lithotripsy technology from AVS to
potentially expedite the time to market for coronary and carotid
indications of the Pulse IVL System.
“The Jacobs Institute and Dr. Siddiqui are well positioned to
assist companies in the regulatory approval journey,” said Mark
Toland, Chairman of the Board of AVS. “Dr. Siddiqui and the team at
the JI are committed to bringing novel technologies to market
through their vertically aligned infrastructure which accelerates
the pathway from development to clinical trials to
commercialization. We are excited to partner with the JI on
expanding the use of the Pulse IVL System in Coronary and Carotid
lesions.”
There are approximately six million interventional procedures
done each year for patients with Coronary Artery Disease, and
conservatively, one-third of them present with calcific challenges.
Carotid Artery Disease impacts about 800,000 people in the U.S.
every year and causes up to one-third of all strokes, but no IVL
devices have received FDA approval for treating Carotid Artery
Disease. The joint effort between AVS and the Jacobs Institute will
strive to create a new treatment option for stroke patients and
potentially lighten the burden of death and disability caused by
stroke.
“We believe the Pulse IVL System is the perfect fit for the
structure we’ve built at the Jacobs Institute,” said Dr. Siddiqui.
“By fostering an environment that nurtures innovation, the JI will
help to bring this technology to patients sooner, ultimately
providing better treatment options for patients with Coronary and
Carotid artery diseases. We are especially excited about studying
the Pulse IVL system in Carotids to improve stroke care. We believe
its unique mechanism of action may be an important solution for the
diffuse and eccentric nature of many of our Carotid disease
patients.”
AVS recently received approval from the FDA to start a U.S. IDE
peripheral vascular clinical trial for Intravascular Lithotripsy.
The POWER-PAD-II trial is expected to start enrollment in the
coming weeks at up to 20 U.S. centers.
To learn more about AVS and the PULSE IVL™ System, please visit:
www.avspulse.com.
About AVS
Amplitude Vascular Systems (AVS) is a medical device company
based in Boston, MA, focused on safely and effectively treating
severely calcified arterial disease. AVS is backed by global
investors including BioStar Capital, Cue Growth Partners, and
others. To learn more about pulsatile intravascular lithotripsy,
visit www.avspulse.com. The Pulse IVL™ System is an investigational
device and not yet cleared for commercial distribution within or
outside the United States.
About the Jacobs Institute
The Jacobs Institute is a non-profit organization whose mission
is to accelerate the development of next-generation technologies
for vascular and neurologic diseases through collisions of
physicians, engineers, entrepreneurs, and industry. The JI’s vision
is to improve the treatment of vascular and neurologic disease in
Western New York and the world, while fostering local economic
development. The JI fosters medical collaboration and innovation
through partnerships with the University at Buffalo (UB), Kaleida
Health, and industry to be a fitting tribute to the work and memory
of Lawrence D. Jacobs, MD. Additionally, the JI’s i2R, or Idea to
Reality Center, is taking ideas for vascular and neurologic medical
devices and moving them through the proof-of-concept process.
Finally, the JI also increases physician and industry knowledge of
vascular and neurologic diseases through clinical education
programs.
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Media: Matter Health for AVS Dan Ventresca T: 617-874-5488
AVSPulse@matternow.com Investor Relations: Susie McAfee VP of
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