Periodic Reporting for period 2 - FASTWIRE (Transformational crossing system to prevent amputation and treat complex chronic total occlusions in critical limb ischemia)
Reporting period: 2024-01-01 to 2025-03-31
Peripheral artery disease (PAD) affects more than 200 million patients worldwide. Its global prevalence has increased between 13% and 27% in the past decade. As the population continues to age and obesity, diabetes, and tobacco use remain uncontrolled, the prevalence of PAD and critical limb threatening ischemia (CLTI) will increase exponentially. Although PAD can be asymptomatic and subclinical, it is associated with reduced functional capacity and quality of life when symptomatic and is a major cause of limb amputation in its most severe form. The prognosis for patients diagnosed with CLTI is devastating and worse than most cancers - 25% of patients will have passed away and 30% will have an amputation in the first year following treatment.
The major technical challenge for endovascular surgeons, and the reason many patients are amputated/treated with open surgery is getting across the blockage with a guidewire to be able to treat and open the blockage with therapeutic devices. However, although the number of major amputations has been reduced there has been a rapid rise in the number of minor amputations which is also demonstrated in data from Malta. The trend in Malta is representative of the increase in minor amputations throughout the rest of the world where it is cited that 10% of the population have diabetes and 500 amputations annually. These minor amputations are associated with more below-the-knee and smaller arteries that have more severely calcified total occlusions. German data shows that the prevalence of PAD increased from 1.85% in 2009 to 3.14% in 2018, affecting 2.3 million patients in 2018 and more males (55%) than females (45%). These results show that the prevalence of PAD in Germany, as assessed by outpatient PAD documentation, is increasing and PAD patients are underutilizing specialized vascular care.
Our proposed solution is a crossing system that transforms the paradigm of the treatment of CLTI patients. Versono’s device differentiates itself from existing CLTI strategies by providing the physician with an easy-to-use tool to quickly and reliably cross these complex blockages even in smaller arteries. The ease of use of the FastWire is a critical differentiator as it will enable less experienced physicians to safely and quickly cross the CTO, providing more patients with the option of endovascular therapy to treat their CTO and CLTI.
With current gold standard devices and techniques, clinicians can struggle for 30-60 minutes to cross a lesion. Reducing crossing times up to 80-90% (5-10 minutes) provides a major advance in the reliable prediction of treatment volumes and capacity planning. Versono’s endovascular-first approach to treating CLTI patients makes treatment more affordable and safer for the patient, provides vascular surgeons with a reliable, quick method for crossing CTOs, and significantly reduces costs to payers. FastWire is the only crossing system offering a console-free approach to penetrating CTOs and enabling the delivery of highly efficacious vascular therapies. Versono’s FastWire will enable patients with severe Critical Limb Threatening Ischemia (CLTI) to be successfully treated using minimally invasive technique and reduce or avoid amputations, open surgeries. The Fastwire technology is designed to conform easily to tortuous arterial anatomies, in both large and small vessels, and its ultrasonic actuated wire can cross all complex and calcified Chronic Total Occlusions (CTO's) to safely deliver follow-on therapies. It will enable almost all patients, including undertreated cohorts, to be treated using endovascular treatments. All CLTI patients will benefit from maintaining or improving QoL (Quality of Life), reduced recovery time (from 30 days after an amputation to 1-3 days) and resume normal life activities and exercise faster. FastWire’s ability to penetrate through the CTO, apply other treatments to unblock the vessel, and restore blood flow to the tissue downstream will improve patient outcomes and significantly reduce the need for post-operative follow up required with alternative surgical techniques.
“Versono's FastWire falls under the ‘new disruptive’ technology [category] due to its mechanism of action which allows the wire to cross with extreme efficiency, safety, in any hostile terrain of severely calcified and tortuous arteries.” –Dr Jihad Mustapha, convenor of the Amputation Prevention Symposium (AMP) conference, a world leader in CLTI treatment, and clinical advisor to Versono.
“If you make this happen it will revolutionise the market and drastically improve treatment options for patients”, “I would use in 80 % of my cases with CTO’s” Dr Thomas Zeller, Director Department Angiology at the Universitaets – Herzzentrum Freiburg, Bad Krozingen, Germany.
The major technical challenge for endovascular surgeons, and the reason many patients are amputated/treated with open surgery is getting across the blockage with a guidewire to be able to treat and open the blockage with therapeutic devices. However, although the number of major amputations has been reduced there has been a rapid rise in the number of minor amputations which is also demonstrated in data from Malta. The trend in Malta is representative of the increase in minor amputations throughout the rest of the world where it is cited that 10% of the population have diabetes and 500 amputations annually. These minor amputations are associated with more below-the-knee and smaller arteries that have more severely calcified total occlusions. German data shows that the prevalence of PAD increased from 1.85% in 2009 to 3.14% in 2018, affecting 2.3 million patients in 2018 and more males (55%) than females (45%). These results show that the prevalence of PAD in Germany, as assessed by outpatient PAD documentation, is increasing and PAD patients are underutilizing specialized vascular care.
Our proposed solution is a crossing system that transforms the paradigm of the treatment of CLTI patients. Versono’s device differentiates itself from existing CLTI strategies by providing the physician with an easy-to-use tool to quickly and reliably cross these complex blockages even in smaller arteries. The ease of use of the FastWire is a critical differentiator as it will enable less experienced physicians to safely and quickly cross the CTO, providing more patients with the option of endovascular therapy to treat their CTO and CLTI.
With current gold standard devices and techniques, clinicians can struggle for 30-60 minutes to cross a lesion. Reducing crossing times up to 80-90% (5-10 minutes) provides a major advance in the reliable prediction of treatment volumes and capacity planning. Versono’s endovascular-first approach to treating CLTI patients makes treatment more affordable and safer for the patient, provides vascular surgeons with a reliable, quick method for crossing CTOs, and significantly reduces costs to payers. FastWire is the only crossing system offering a console-free approach to penetrating CTOs and enabling the delivery of highly efficacious vascular therapies. Versono’s FastWire will enable patients with severe Critical Limb Threatening Ischemia (CLTI) to be successfully treated using minimally invasive technique and reduce or avoid amputations, open surgeries. The Fastwire technology is designed to conform easily to tortuous arterial anatomies, in both large and small vessels, and its ultrasonic actuated wire can cross all complex and calcified Chronic Total Occlusions (CTO's) to safely deliver follow-on therapies. It will enable almost all patients, including undertreated cohorts, to be treated using endovascular treatments. All CLTI patients will benefit from maintaining or improving QoL (Quality of Life), reduced recovery time (from 30 days after an amputation to 1-3 days) and resume normal life activities and exercise faster. FastWire’s ability to penetrate through the CTO, apply other treatments to unblock the vessel, and restore blood flow to the tissue downstream will improve patient outcomes and significantly reduce the need for post-operative follow up required with alternative surgical techniques.
“Versono's FastWire falls under the ‘new disruptive’ technology [category] due to its mechanism of action which allows the wire to cross with extreme efficiency, safety, in any hostile terrain of severely calcified and tortuous arteries.” –Dr Jihad Mustapha, convenor of the Amputation Prevention Symposium (AMP) conference, a world leader in CLTI treatment, and clinical advisor to Versono.
“If you make this happen it will revolutionise the market and drastically improve treatment options for patients”, “I would use in 80 % of my cases with CTO’s” Dr Thomas Zeller, Director Department Angiology at the Universitaets – Herzzentrum Freiburg, Bad Krozingen, Germany.
Versono has developed an intravascular ultrasonic platform technology, to transform endovascular treatment of complex calcified lesions. Working closely with world leading clinicians, Versono’s engineers have made several significant discoveries which have been patented, integrated and developed into a new technology platform.
Versono’s technology is designed to cross severe occlusions in the peripheral vasculature, which presents one of the most challenging unmet needs in peripheral endovascular surgery. The technology enables the device treat smaller arteries that have more severely calcified total occlusions.
Versono’s technology will support existing therapeutic products and technologies, making them available to a greater number of clinicians, to assist in providing treatments to more patients.
Versono’s technology is designed to cross severe occlusions in the peripheral vasculature, which presents one of the most challenging unmet needs in peripheral endovascular surgery. The technology enables the device treat smaller arteries that have more severely calcified total occlusions.
Versono’s technology will support existing therapeutic products and technologies, making them available to a greater number of clinicians, to assist in providing treatments to more patients.
The technology has demonstrated its effectiveness through a safety and efficacy study which was conducted by Dr Jihad Mustahpa through the FREEFLOW study with very impressive results. The study results were presented by Dr Craig M. Walker at the New Cardiovascular Horizons Conference in Chicago on 23rd September 2023.
The study demonstrated the Fastwires’ effectiveness in below-the-knee and smaller arteries that have more severely calcified total occlusions which is an area of increasing treatment need. The study showed that the system can be used in “above the knee” and “below the knee” procedures where the system effectively assisted restoring blood flow by crossing lesions from 60 to 500mm in length, average lesion length being 233mm for the cohort of patients treated as part of the study. In conclusion, the FastWire System can beneficially impact the treatment of patients with CTOs in the peripheral vasculature without any additional risks having been identified. The Fastwire platform enables the physician to treat patients with severe conditions which will result in fewer amputations and a better quality of life.
There is a clear European and worldwide need for the product based on the evidential increasing prevalence of CLTI which requires treatment. Based on the success of the FREEFLOW pilot study, a further study, the FREEFLOW pivotal study is merited. It will investigate the FastWire System in a statistically significant sample to examine if these early results apply to the general population. Versono aims to be the solution of choice for physicians globally in the treatment of CLTI patients.
The study demonstrated the Fastwires’ effectiveness in below-the-knee and smaller arteries that have more severely calcified total occlusions which is an area of increasing treatment need. The study showed that the system can be used in “above the knee” and “below the knee” procedures where the system effectively assisted restoring blood flow by crossing lesions from 60 to 500mm in length, average lesion length being 233mm for the cohort of patients treated as part of the study. In conclusion, the FastWire System can beneficially impact the treatment of patients with CTOs in the peripheral vasculature without any additional risks having been identified. The Fastwire platform enables the physician to treat patients with severe conditions which will result in fewer amputations and a better quality of life.
There is a clear European and worldwide need for the product based on the evidential increasing prevalence of CLTI which requires treatment. Based on the success of the FREEFLOW pilot study, a further study, the FREEFLOW pivotal study is merited. It will investigate the FastWire System in a statistically significant sample to examine if these early results apply to the general population. Versono aims to be the solution of choice for physicians globally in the treatment of CLTI patients.