Medistim launches clinical study on TTFM and HFUS in Vascular surgery

14 Nov 2024 14:13 CET

(Oslo, 14 November 2024) Medistim ASA (OSE: MEDI) is a niche market leader
within ultrasound technology with headquarters in Oslo, Norway. Medistim
develops and commercializes medical equipment for use within cardiac, vascular
and transplant surgery.

Today, the company announces the launch of the PATENT study, an open,
prospective, multicenter trial aimed at evaluating the immediate clinical
benefits and long-term prognostic value of intraoperative completion control
using transit time flow measurement (TTFM) and high-frequency ultrasound (HFUS)
imaging. The study focuses on patients undergoing bypass surgery for Critical
Limb Threatening Ischemia (CLTI) below the knee.

Medistim is a global market leader in intraoperative quality assessment and
surgical guidance in Cardiac surgery, serving 37% of the worldwide coronary
artery bypass graft (CABG) market, which comprises over 700,000 procedures
annually. The company continues to expand its presence in this field. As part of
its growth strategy, Medistim aims to establish an equally strong position in
Vascular surgery, with peripheral bypass surgery identified as a particularly
promising target segment.

In 2010, estimates suggested that >200 million people worldwide were living with
peripheral artery disease (PAD)1. Accurate data on the number of patients who
have CLTI is lacking but a large study from the U.S. found that 11% of PAD
patients developed CLTI2. The rapidly increasing worldwide prevalence of type 2
diabetes is likely to have a significant impact on the future incidence and
prevalence of PAD and CLTI, as well as their morbid end points.

When PAD develops into CLTI, the patient will need immediate revascularization
to reduce the risk of limb amputation as well as cerebrovascular and
cardiovascular complications. Peripheral bypass surgery is one of the treatment
alternatives, in addition to endovascular interventions. According to recent
market research3, over 500,000 peripheral bypass surgeries are performed
annually. In some countries, vascular surgeons already utilize TTFM and
ultrasound for intraoperative completion control. Insights from the University
of Helsinki4 have played a key role in shaping the design of the PATENT clinical
study.

The PATENT study seeks to evaluate the immediate intraoperative clinical
benefits of using TTFM and HFUS during peripheral bypass surgery in patients
with CLTI. Additionally, the study aims to assess the prognostic value of TTFM
and HFUS in predicting one-year clinical outcomes, helping to distinguish
patients at high risk of graft failure from those at low risk.

The PATENT study will enroll approximately 450 patients across 15 sites in the
USA, Europe, and Asia, with enrollment set to begin by the end of 2024.
Recruitment is expected to take around two years, with each patient being
followed for 12 months. Medistim anticipates study-related costs of
approximately MNOK 25, spread over a period of 3-4 years. The return on
investment is tied to the anticipated ability to demonstrate improved clinical
outcomes through the use of TTFM and HFUS. This will drive adoption and enhance
competitiveness compared to existing technologies like Doppler ultrasound and
angiography. Medistim’s value proposition lies in offering a more comprehensive,
reliable, and user-friendly alternative to these traditional methods.

The study will be led by Professor Michael Conte of the University of
California, San Francisco, USA, who is the lead author of the Global Guidelines
on the Management of CLTI. “I was intrigued by the solid experience and
compelling data collected at the University of Helsinki, which demonstrated a
clear correlation between graft flow values and graft failure,” said Professor
Conte. “I am excited to take part in this project to provide further clinical
evidence. I believe the PATENT clinical trial has the potential to becoming a
landmark study with impact on clinical practice, to the benefit of CLTI patients
worldwide.”

“We have been preparing for this study for quite some time and are eagerly
anticipating the enrollment of the first patient,” said Kari E. Krogstad,
President and CEO of Medistim. “This study has the potential to be a
game-changer for Medistim, much like how the REQUEST study was transformative
for the adoption of HFUS in CABG surgery. A trial of this caliber will not only
generate significant attention but also spark interest among surgeons to
evaluate and adopt our MiraQ devices, which are already approved for vascular
applications. I am especially proud to announce a team of world-renowned
investigators in vascular surgery leading this effort, including:

• Prof. Maarit Venermo, University of Helsinki, Finland; the Secretary General
of the European Society of
Vascular Surgery (ESVS),
• Prof. Joseph L. Mills, Baylor College of Medicine, Houston, USA; the past
President of the US Society of
Vascular Surgery (SVS),
• Prof. Nobuyoshi Azuma, Asahikawa Medical University, Japan; the President of
the Japanese Society of
Vascular Surgery (JSVS), in addition to
• Prof. Michael Conte as previously introduced. ”

References:
1) 2019 Global Vascular Guidance on the Management of Chronic Limb-Threatening
Ischemia
2) Nehler et al. Epidemiology of peripheral arterial disease and critical limb
ischemia in an insured national population. J Vasc Surg.2014
3) Market research performed by MindGap on assignment from Medistim, 2023
4) Maarit Venermo et al, Unpublished data from the University of Helsinki

About Medistim:
Medistim was established in 1984 and has a track record of profitable growth
over the past 20 years. The company is a pioneer within its segment and
continues to invest in new product development. Medistim has wholly owned
subsidiaries with sales organizations in the USA, Canada, China, Germany, UK,
Spain, Denmark, Sweden and Norway, in addition to more than 60 distributors in
Europe, Asia, Middle East, Africa, and South America. For more information,
visit the Medistim home page: www.medistim.com

For more information, contact:

President and CEO, Kari E. Krogstad, Medistim ASA
Tel: + 47 918 38 110
Email: kari.krogstad@medistim.com

CFO, Thomas Jakobsen, Medistim ASA
Tel: + 47 906 59 940
Email: thomas.jakobsen@medistim.com

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