Galway-based VERSONO Medical is celebrating the success of a new pilot study which found its FastWire intravascular medical device to be hugely effective at enabling the treatment of the worst type of arterial blockages, reducing amputation in vulnerable patients threatened by sepsis caused by vascular disease.
Professor Craig Walker, MD, a world-leading vascular specialist and member of VERSONO Medical’s Clinical Advisory Board, presented the results of the FREEFLOW pilot study to the New Cardio Vascular Horizons meeting in Chicago on September 23.
VERSONO Medical’s FastWire device uses ultrasonic technology to cross through complex blockages in patients with Critical Limb Threatening Ischemia (CLTI ), the most severe and advanced form of peripheral vascular disease (PAD ).
CLTI affects eight million people in United States and accounts for 90% of lower limb amputations. More than 30% of CLTI patients will have a limb amputated withing the first year of diagnosis and 60% will die within the five years of diagnosis.
Established therapies have had limited success in treating severe blockages in CLTI patients because clinicians cannot get these to cross the blockage, increasing the probability of an amputation. Some 91% of lower limb amputations in Europe and the US each year are a result of CLTI.
VERSONO Medical’s compact device’s flexible FastWire follows the curvature of arteries, carrying ultrasonic waves to the tip of the wire which then crosses through calcified lesions allowing blood flow to be restored in the affected limb.
Prof. Walker told the conference of specialists in peripheral vascular medicine that the patients who were treated using VERSONO Medical’s FastWire device had presented with very severe blockages. Two-thirds of study cohort had already undergone a previous amputation in the opposite limb to the one being treated.
The conference heard that the FREEFLOW pilot study was successful with no adverse events reported. The restoration of the blood flow, Prof. Walker said, would likely prevent further amputations in these patients.
The company is now preparing for a larger pivotal study in the USA of the FastWire device in 2024 before bringing the product to market.
VERSONO Medical has raised more than €12m to date, some €6.7m of which came following a second funding round in December 2021. The funds were raised from existing investors, including DHKN, BVP and private investors from the medical device sector, as well as State investors Western Development Commission and Enterprise Ireland.
Earlier this year VERSONO Medical was recognised and awarded two Research and Development grants. The first came from the European Innovation Council to finalise and commercialise FastWire. The second was from the Department of Enterprise Trade and Employment and Enterprise Ireland’s Disruptive Technology Innovation Fund to develop the company’s product portfolio.
It has been a productive year Versono. The company, which is based in Parkmore West in Galway, was awarded its ISO 13485 quality management certificate in May this year. It now employs 22 staff in full and part-time roles and has advanced its technology to meet the needs of the global vascular market.
Peripheral Artery Disease (PAD ) is on the rise globally. It is estimated that more than 230 million people, aged 25 or older, are living with PAD. The prevalence of PAD in the general population increases exponentially with age, with more than 18% of those aged 70-75 afflicted with the disease.
The rate of CLTI is rising rapidly. It mostly affects the lower extremities, legs and feet where arterial blockages prevent blood flow to the limb, which raises the risk of necrosis, sepsis, amputation and death.
Current endovascular treatments can re-establish blood flow to the affected areas. However, the arterial blockages in these patients with CLTI are an average length of c.22cm and composed of complex calcified tissue which makes it very technically difficult to cross them and deliver an endovascular therapy to restore blood flow.
The four main risk factors for PAD include smoking, hypertension, diabetes and high cholesterol.
Versono CEO Finbar Dolan said the VERSONO Medical FREEFLOW pilot study represents another positive step on the journey to bringing Versono Medical’s FREEFLOW medical device to market. We are honoured and delighted that Professor Craig Walker presented the findings of the study to the New Cardio Vascular Horizons meeting in Chicago. Inviting scrutiny of our FastWire technology by some of the world’s leading medical experts is an important step in building confidence that FastWire can transform the treatment of vascular disease in patients across the world.”
Versono CTO Hugh O’Donoghue said VERSONO Medical’s mission is to transform the treatment of complex vascular disease. Our unique and revolutionary FastWire technology has the potential to make a life-saving difference to people suffering from complex blockages due to Critical Limb Threatening Ischemia (CLTI ). The FREEFLOW pilot study is an important step in demonstrating this.
