Alesi Surgical pioneering surgical device gains United States FDA approval

Alesi Surgical Limited, the leading innovator of minimally invasive surgery technologies has successfully secured FDA (Food and Drug Administration) approval for its Ultravision™ system.

The Ultravision™ system is a world first that clears the vapour and particulate matter generated by modern surgical cutting instruments during abdominal keyhole (laparoscopic) surgery through the use of electrostatic technology. The technology dramatically and effortlessly improves visibility for surgeons that is otherwise rapidly obscured by this “plume” or “surgical smoke”.

“We are thrilled to have gained FDA approval for our Ultravision™ system that will now allow us to enter the US market. Commercially the US represents approximately fifty per cent of the global medical device market and so it is difficult to overstate the importance of this for the company,” said Dr Dominic Griffiths, Managing Director of Alesi Surgical.

Alesi Surgical becomes a member of a select group of only 26 medical device companies worldwide in the last 12 months that have successfully navigated the FDA De Novo regulatory review process.

The Ultravision™ system, which produces a small, low-energy electrostatic charge similar to the principal of static electricity, is able to greatly improve visibility for surgeons by actively getting rid of surgical ‘smoke’.

The technology also benefits the patient as it minimises the amount of cold, dry carbon dioxide gas – used to create a working space inside the abdomen – which a patient is exposed to during the keyhole procedure. It is not uncommon for abdominal keyhole procedures to require several hundred litres of this gas to clear the visual field throughout the procedure. Excessive use of carbon dioxide contributes to post-surgical pain and prolongs recovery time for the patient.

FDA approval is a significant milestone on the road to the company gaining traction in a global market worth an estimated £800m per year and forms part of the strategic growth of the business that has also seen the appointment of a UK national sales team.

Dr Griffiths said: “Gaining FDA approval for Ultravision™ allows us to continue the progress and development in the US market. This is the next step after launching our new Ultravision Trocar product in Europe which integrates the benefits of Ultravision™ into a pen-like access device, used in over seven million abdominal keyhole procedures performed annually, worldwide. The combination of these two major achievements places us in a strong position to enter 2017 with confidence.”

Alesi Surgical launched in 2009 as a spin out from the internationally recognised Welsh Institute of Minimally Invasive Surgery, part of Cardiff University.  To date, Alesi has secured £6.1m worth of venture capital funding, principally from its lead investors IP Group PLC and Finance Wales Limited.

Phil Barnes of Finance Wales said, “We are delighted with the progress Alesi is making and gaining this FDA clearance provides a cornerstone for their future success. We are pleased to support Alesi as they enter the US market and look forward to further growth of this innovative Welsh company.”

 

 

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  1. Alesi Surgical develops and commercialises products that improve the safety, efficiency and outcomes of advanced surgical procedures.
  1. The company was founded in 2009 as a spin-out from the Welsh Institute for Minimal Access Therapy (WIMAT), with the vision of becoming a world leader in surgical devices. Part of Cardiff University, WIMAT runs multi-disciplinary training courses across a range of surgical and medical specialties and is the busiest multi-disciplinary training centre in the United Kingdom.
  1. For more information, visit alesi-surgical.com
  1. Alesi Surgical is based at Cardiff Medicentre,the dedicated medical, healthcare, and life sciences business incubator located on the University Hospital of Wales campus. The latter is also home to Cardiff University’s School of Medicine.  Cardiff University is Wales’s leading Higher Education Institution for innovation, ranked 7th in the UK and 45th in Europe for innovation by Thomson Reuters. 
  1. Finance Wales was established by the Welsh Government in 2001 and provides commercial funding to small and medium-sized businesses throughout Wales to enable them to realise their potential for innovation and growth. The company is part of the Finance Wales Group and in 2015-16 the Group invested £63 million through 268 debt-equity investments in growing businesses. The Finance Wales Group, one of the UK’s largest SME investors, has in excess of £990 million of funds under management across all SME investment fund and the Help to Buy – Wales scheme. The Group has invested more than £484 million through more than 4,018 investments.
  1. IP Group is a leading intellectual property commercialisation company which focuses on evolving great ideas, mainly from its partner universities, into world-changing businesses. The Group has pioneered a unique approach to developing these ideas and the resulting businesses by providing access to business building expertise, capital (through its 100%-owned FCA-authorised subsidiary IP Capital), networks, recruitment and business support. IP Group has a strong track record of success and its portfolio comprises holdings in approximately 80 early-stage to mature businesses across four main sectors — Biotech, Cleantech, Healthcare and Technology. The Company 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.

 

Alesi Surgical Announces Japanese Regulatory Approval for Ultravision and Exclusive Agreement with Adachi Co., Ltd.

Alesi Surgical, a leading innovator of advanced minimally invasive surgery technologies, and Adachi Co., Ltd. today announce regulatory approval of the Ultravision™ visual field clearing system by the Japanese Ministry of Health, Labour and Welfare and an exclusive agreement in Japan.

Adachi Co., Ltd. was founded as a family-owned medical and scientific products distributor in 1931.  It has since grown into a leading distributor of innovative medical devices with sales, marketing and services capabilities throughout Japan.  Adachi has successfully established relationships with leading hospitals and medical organizations across the country and has deep expertise in the field of laparoscopic surgery gained through previous and current distribution of products for leading companies such as Olympus and Intuitive Surgical.

Under the terms of the agreement, which were not disclosed, Adachi will be responsible for the sales, marketing and distribution of the UltravisionTM system across Japan.  Adachi officially launched Ultravision at the The 29th Annual Meeting of the Japan Society for Endoscopic Surgery, which was held between December 8th and 10th 2016 at Yokohama, Japan.

“We are delighted to have obtained approval for the Ultravision system in Japan and entered into this comprehensive distribution partnership with Adachi Co., Ltd.” said Dominic Griffiths, Managing Director of Alesi Surgical. “Adachi has proven to be exceptionally adept at selling laparoscopic surgery products in Japan and it has a long history of success with cutting-edge technology.  We look forward to a highly successful partnership.”

“Japanese physicians and hospitals have embraced cutting-edge technologies to improve patient care and healthcare economics,” said Mr. Saburo Adachi, President and CEO of Adachi Co., Ltd.  “Ultravision’s unique mode of action effortlessly and unobtrusively eliminates surgical smoke particles from the operative visual field without the need for carbon dioxide exchange.”

Alesi Surgical Ltd at the 2016 ALSGBI Annual Scientific Meeting from Thursday 10th November until Friday 11th November – Come and meet us on Stand 5

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Cardiff surgical company showcases UK healthcare innovation in Texas

abhiA spin-out medical device company from a leading surgical training institute at Cardiff University is one of 12 UK companies representing the country’s health and life science industry in Texas next week (15th to 21st October 2016).Alesi Surgical, developer of the revolutionary Ultravision system, which manages surgical smoke during laparoscopic keyhole surgery, will form part of a delegation consisting of innovative medical device companies.

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New global market for Alesi Surgical

Alesi Surgical Limited, the advanced minimally invasive surgery medical device manufacturer, has announced its entry into the lucrative trocar market estimated to be worth $800 million per year, globally.

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Alesi Surgical announces key appointment to strengthen sales and marketing for its lead product, Ultravision™

Alesi Surgical the medical device company developing novel technologies to enhance outcomes in minimally invasive surgery, announced the appointment of Marcus Dyer as International Sales and Marketing Manager.

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Alesi Surgical has announced that it will be sponsoring the 23rd European Association for Endoscopic Surgery (EAES) Congress, Bucharest, 3–6 June 2015.

The company will be demonstrating its lead product, Ultravision™ which eliminates surgical smoke during laparoscopic (keyhole) surgery and provides a continuously clear visual field for the operating surgeon.

Ultravision uses electrostatic precipitation, a proven method of clearing vapour and particulate matter, which otherwise would be released into the operating room.

Dr Dominic Griffiths, Managing Director and James Cutlan, Clinical Specialist will be attending the Congress and Ultravision can be seen in action on Booth 18-20.

 

 

 

 

 

 

Alesi Surgical secures £2.1m funding to drive commercialisation of Ultravision Funding to drive adoption via new distributor network

Alesi Surgical secures £2.1m funding to drive commercialisation of Ultravision Funding to drive adoption via new distributor network

Alesi Surgical (formerly Asalus Medical Instruments Limited) announced today that it has secured additional funding of £2.1 million to drive the further commercialisation of its lead product, UltravisionTM, which was developed from concept to CE-marked device with backing from IP Group and Finance Wales.

The funding comes at an important inflection point for the Company. In 2014, Ultravision was awarded a CE mark, and the company appointed distributors in 25 countries. The new investment provides capital to drive adoption of Ultravision, which has already been trialled across a spectrum of the most commonly performed laparoscopic procedures in gastrointestinal, gynaecological, urological and colorectal surgery.

Ultravision is a substantial advance on current vacuum based systems, which have been poorly adopted because of their inefficiency. Ultravision uses electrostatic precipitation, a proven method of clearing vapour and particulate matter in industrial settings, which had not previously been used in surgical applications. Last year the product was awarded the prestigious Cutler Prize, which is granted by the Royal College of Surgeons for innovations in surgical technology. Ultravision is compatible with all major electrosurgical instruments.

“We have developed a simple, hands-free device that is unobtrusive in the operating room and delivers highly effective resolution of the issue of surgical smoke. Surgical teams involved in Ultravision trials were overwhelmingly positive, and the vast majority wanted to carry on using it after the trial ended,” said Dr Dominic Griffiths, Managing Director of Alesi Surgical.

Peter Grant, Head of Healthcare at IP Group plc, said: “We have supported Alesi Surgical since inception, both directly and via our co-investment agreement with Fusion IP plc, which is now part of the Group. Over that period, we have been pleased with the progress that Alesi Surgical has made as Ultravision gains momentum and receives the interest and recognition it deserves from the surgical community. This next round of funding will allow the team at Alesi Surgical to further strengthen its sales and marketing activities as it seeks to take the product to market.”

Finance Wales has made six investments in Alesi Surgical, alongside IP Group plc and the former Fusion IP plc. Ann Casey, Investment Executive at Finance Wales, commented: “Finance Wales has invested in Alesi, supporting it from its early stage research and development through to international market entry. The company continues to go from strength to strength. It has recruited a number of new staff at its Cardiff headquarters and is also making excellent progress establishing worldwide distribution networks. Ultravision has received some excellent reviews from senior clinicians and we’re pleased to invest in this latest round. We look forward to seeing Alesi achieve a profitable trading position.”

In parallel with the funding, the Company has changed its name from Asalus Medical Instruments to Alesi Surgical. Derived from “arloesi” the Welsh word for innovation, the change of name represents a statement of intent by the Company to continue innovation in surgical devices that improve patient outcomes and simplify complex surgical procedures.