Medical device company Amplitude Vascular Systems (AVS) announced the completion of a $36m Series B financing round to support the peripheral commercial launch of its Pulse intravascular lithotripsy (IVL) device in the US.
The funds will also be utilised to support the US coronary and carotid investigational device exemption (IDE) trials of the device.
The POWER PAD II US IDE trial, which began patient enrolment in October 2024, is a single-arm, prospective, multi-centre study.
It assesses the clinical and technical achievements of the system in treating subjects with calcific femoropopliteal arteries.
Up to 120 subjects will be enrolled in the study across 20 sites in the US, with completion anticipated by the middle of this year.
Additionally, the funding will aid the company’s coronary US IDE study, and the carotid IDE trial, as part of a collaboration with the Jacobs Institute in Buffalo, New York. This trial is led by Dr Adnan Siddiqui.
AVS board chairman Mark Toland said: “We are pleased to see strong, sustained investor excitement around this technology. Intravascular lithotripsy now represents a large and well-proven therapy that demands new solutions for patients with severely calcified arterial disease.
“This investor confidence reflects accelerated execution of critical company milestones in 2024, including the initiation of our US peripheral IDE.”
Pulse IVL’s mechanism of action leverages ‘high frequency’ pulsatile pressure waves for fracturing arterial calcium.
The system operates by converting ‘pressurised’ CO₂ into pulsatile energy waves at a rate of 15 per second.
These waves uniformly and multi-directionally radiate along the complete balloon length, fracturing calcium and causing vessel expansion.
Designed for increased blood flow and improved mobility in individuals, the Pulse IVL is touted as a new treatment alternative for calcified arterial disease. It remains an investigational device and is not yet approved for commercial distribution within or outside the country.
AVS is supported by investors such as Cue Growth Partners and BioStar Capital.
