ALESI SURGICAL SECURES FDA CLEARANCE FOR ITS REVOLUTIONARY OPEN SURGERY DEVICE.

19th September, 2024

Cardiff, United Kingdom

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Alesi Surgical Limited, a leading innovator of minimally invasive surgery technologies, has secured United States FDA 510k clearance for the latest product to incorporate its Ultravision technology platform, the IonPencil.

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The IonPencil integrates the company’s proprietary surgical smoke management technology with a lightweight, easy-to-use, silent, and ergonomic electrosurgery device. Used with Alesi’s recently FDA-cleared Ultravision2 System, it is the company’s first product for use in open surgery procedures. The Ultravision2 system is now cleared for use in all open, laparoscopic, and robotic procedures that create surgical smoke in the US and other countries where FDA clearance is accepted.? There are over 20 million such procedures that take place in the US annually.

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Surgeons are increasingly required to use smoke management in their daily procedures because of concerns over the risks of infection and toxicity associated with long-term exposure.? The adoption of legislation in the US mandating the use of preventative measures in all surgical procedures that create smoke has grown dramatically, rising from one state in 2018 to 18 states in 2024, with a further four states where legislation is pending.? Before the clearance of the IonPencil, the only alternative to manage surgical smoke in open surgery was to use suction-based smoke evacuators and electrosurgery “smoke pencils”, which have received generally negative feedback from surgeons.

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Independent research has already demonstrated that Ultravision technology is 23 times better than alternative solutions at minimising surgical smoke release into the operating room during laparoscopic surgery.? In addition, Ultravision’s unique mode of action captures and reduces the infectivity of aerosolised viruses.? The slimline, tubing-free, and silent IonPencil now brings the performance of the Ultravision technology to open surgery, helping to overcome the limitations that have hindered smoke management adoption.

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In parallel to achieving FDA clearance, the company has successfully raised a further ￡5m in funding from both new and existing investors. Mercia Ventures, a leading provider of financing to innovative, fast-growing companies in the fields of healthcare and life sciences in Europe and the US, joined existing investors IP Group PLC and Panakes Partners in providing this package of growth capital to the Company. Mercia joins Alesi’s existing UK and European investors, who also include Earlybird and Development Bank of Wales, who have all recognised the potential of the technology to revolutionise surgical smoke management globally.? The capital will primarily be deployed to fund the commercialisation of the IonPencil, Ultravision2 system and its other accessories in the US; as well as to secure MDR and PMDA clearance of the system in Europe and Japan, respectively.

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Dominic Griffiths, CEO of Alesi Surgical, commented: “We have been overwhelmed with the positive surgeon feedback we have received during the development of the IonPencil.? The hazards of surgical smoke in the operating room are increasingly recognised, and we are delighted to be able to offer US surgeons and nurses this new, unique, and innovative way of addressing the problem.? Surgeons have been vociferous in their reluctance to adopt current smoke pencils. ?We believe that offering them such a simple, effective, and ergonomic device will greatly improve compliance with the increasing legislation being introduced across the US.? We are thrilled to welcome Mercia Ventures as an investor in Alesi Surgical. Alongside our other supportive investor base, we are eager to put the capital to work and fuel our future growth.”

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Robert Hornby, Investor Director at Mercia Ventures, commented “The introduction of new regulations will drive uptake of smoke management solutions in the years ahead. Alesi’s technology offers many advantages over current systems. The company has already established a name for itself with its laparoscopy systems but the introduction of the IonPencil will open up a much wider market. We look forward to supporting Dominic and the team in this new chapter in the company’s growth”.

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About Ultravision

The UltravisionTM system is the world’s first use of electrostatic technology to manage the vapour and particulate matter – so called “surgical smoke” – generated by modern surgical cutting instruments during surgery. It is cleared for use in laparoscopic surgery in the USA, Europe, and Japan – and for open surgery in the USA. The revolutionary medical device produces a low-energy electrostatic charge that eliminates surgical smoke from the atmosphere as it is created by the cutting instrument. Minimising healthcare professionals’ exposure to surgical smoke is increasingly important worldwide because of concerns over the risks of infection and long-term exposure toxicity. The technology also benefits the patient as it can minimise the pressure, flow rate and volume of cold, dry carbon dioxide gas that a patient is exposed to during laparoscopic and robotic surgery. Excessive use of carbon dioxide, which is used to create a working space inside the abdomen, contributes to cardiovascular problems, complications in anaesthesia, post-surgical pain, and longer recovery time for the patient.

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Notes to editors:

For more information, please contact Alesi Surgical on +44 (0) 29 2029 1022.

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1. Alesi Surgical develops and commercialises products that improve the safety, efficiency, and outcomes of advanced surgical procedures. ?With headquarters in Cardiff, UK, the company was founded in 2009 as a spin-out from Cardiff University.? The Company’s wholly owned subsidiary, Alesi Surgical Technologies Inc, oversees its US operations.

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2. About IP Group. IP Group accelerates the impact of science for a better future. As the most active UK based, early stage science investor, we develop and support some of the world’s most exciting businesses in deeptech, life sciences and cleantech (led by Kiko Ventures). Through Parkwalk, the UK's largest growth EIS fund manager, we also back world-changing innovation emerging in leading universities and research institutions. Our specialist investment team combines sector expertise with an international approach. Together we have a strong track record of success, having backed high-profile companies including Oxford Nanopore Technologies plc, First Light Fusion, Hysata, and Oxa. IP Group is listed on the Main Market of the London Stock Exchange under the code IPO. For more information, please visit our website at www.ipgroupplc.com.

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3. About Panakès Partners. Panakès Partners is a Venture Capital firm, based in Milan, which invests in the most ambitious companies and teams, developing revolutionary technologies and products, in the field of life sciences, aiming to improve the lives of people around the world. Panakès, founded in 2015 by Fabrizio Landi, Alessio Beverina and Diana Saraceni, has €250 million under management. www.panakes.it.

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4. About Mercia Ventures. Mercia Ventures is a proactive venture capital investor focused on being the first-choice partner for growth. Mercia Ventures makes equity investments of up to ￡10million across all sectors, with specialisms in Software, Consumer, Healthcare and Deep Tech.?? Mercia Ventures is a trading name of investment funds managed by Mercia Fund Management Limited and Mercia Regional Ventures Limited, part of the Mercia Asset Management PLC Group, and sits alongside the Group’s wider private equity, debt and proprietary balance sheet operations. The Group has 11 offices in the UK, and Mercia Ventures’ national footprint and 48 strong investment team draws on their experiences as founders, PhD scientists, software engineers, corporate financiers, and management consultants to help our partner companies successfully achieve their ambitions. As of 30 September 2023, Mercia Asset Management PLC has c.￡1.5billion of assets under management. Mercia Asset Management PLC is quoted on AIM with the epic "MERC". www.mercia.co.uk.

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