This time our spotlight is on Edward Cappabianca, CEO of Ingenion Medical Ltd. Ed is an experienced Medtech CEO who also has significant prior experience as an investment banker advising early-stage and listed Medtech and Life Science companies in the UK, USA and Europe. Ed was previously CEO of Biocontrol Ltd, which he merged with a US-listed company to form AmpliPhi Biosciences Corporation. He was also the founder and first CEO of EnXray Limited and has previously worked as a senior investment banker, and raised over US$2 billion in capital, including both public and private equity, as well as grant funding and private debt capital.

1. What attracted you to join Ingenion?

    I was approached by our then Chairman, Alistair Taylor, with whom I had worked very closely as an advisor to Lombard Medical PLC. Ingenion was at an important inflection point, with its lead product in a stage of final development before being ready for submission for CE Marking. I was very impressed with the novel approach of the technology to a problem that has not really seen much significant innovation for many decades. Last, but not least, the nature of the business model is really compelling, which unlike many other medical devices is expected to create a strong recurring revenue base, while also significantly improving the lives of the patients.

2. What is the story behind Ingenion developing bladder management solutions – a market opportunity, problem identified, personal?

    The initial idea and technology were developed by Philip Davis, the brother-in-law of our current Interim Chairman, Dr. Sergio Rothstein. Unfortunately, Phil had an accident while hiking on a holiday in South East Asia, and fell down a cliff, which left him a paraplegic, and he was having to catheterise himself multiple times each day when he needed to pee. He found the experience very inconvenient and dehumanising. Fortunately, as he also happened to be trained as an engineer at MIT, he decided to solve his problem and developed the first generation of the CymActive bladder management system, even testing the first prototypes on himself.
    On a personal note, a very dear friend of mine suffered from progressive MS for many years. Shortly before I joined Ingenion, he passed away from pneumonia, which had progressed from persistent UTIs that were caused by his long-term catheter use. I feel confident that if Ingenion’s device were available, both his quality of life and life expectancy would have been significantly improved. I am motivated to ensure that our products can improve patients’ lives, as something like a urinary tract infection can have serious knock-on effects for people with conditions such as MS, Parkinson’s Disease, Alzheimer’s, and other similar conditions.

3. Who are your biggest competitors and how do you differentiate yourself from them?

    The urinary catheter market is a large, global industry that is dominated by many large medical device companies, including Coloplast, B Braun, Teleflex, Becton Dickinson, Boston Scientific, Convatec PLC.
    • There are several significant differentiators between Ingenion’s approach and the existing alternatives. One of the most obvious is that

our device does not extend outside the body

    • , and as such is intended to work with the body’s own natural defence against infection, as catheter-associated urinary tract infections are a major cost to healthcare systems worldwide. Coloplast’s website states that long-term catheter users can expect to experience 2.7 CAUTIs every year. Our devices also work to

give patients complete control over where & when they urinate

    • , which

restores patient dignity

    • and is expected to

encourage higher levels of mobility and activity

    • , while also encouraging better hydration, which is extremely important to overall health. The anchoring device that Ingenion has developed is also more elegant than the fluid-filled balloons used in current indwelling catheters. Our device ensures that

the patient can achieve a completed bladder voiding

    , which should prevent biofilms and encrustations from developing in the bladder, which is a major cause of blockages.
    There are also some other small competitors in the market, some of whom are also trying to solve some of the problems that exist with the current alternatives in the market. If we were trying to solve a problem that no one else was concerned about, then we might be doing something that the market does not need, but that is definitely not the case.

4. What does success look like for the company?

    We would like to create a growing base of patients who continue to use our devices. Over time, we would like to see our devices move from being a niche product to becoming the new standard type of catheter used around the world.

5. What sets you apart as a management team?

    The core members of the team all worked closely with Alistair Taylor, and he was instrumental in bringing us together. Each of us has a different set of complementary skills, including finance, business development, and product development, which are combined to bring Ingenion to the next level. We are also collectively very resourceful and agile in terms of being able to find creative ways of solving issues, which is essential for an early-stage company. We also happen to be pretty good at writing (and winning) grants, which is a great source of non-dilutive capital.

6. How do you intend to market your business?

    Our primary route to market will be working with key distributors in national or regional markets, who understand the local market requirements and are close to the urologists, and importantly, the urological nurses in those regions. We also plan to promote awareness of our products through conferences, such as the British Association of Urological Surgeons, the British Association of Urological Nurses, the International Continence Society, and many others. We are also planning clinical marketing studies, the results of which will be published in journals and online to raise awareness more broadly about Ingenion’s innovative products.

7. Where will this round of investment take you?

    Raising our goal of £2 million will enable the company to fully commercialise our lead product in several key markets in the UK and Europe, as well as Argentina, and later in the USA. We will also be able to fully develop and bring to the market our next two devices, which are currently in development with the support of two recent grant awards from Innovate UK and the NIHR’s i4i Connect program.
    We expect to be able to reach a cash-flow break-even or even profitability by the end of 2023 if we raise the full amount now. If we only reach our minimum, we will be able to commercialise our lead device and achieve other important milestones, but the timetable may be longer with fewer financial resources available.

8. What was your experience doing the Investor Readiness Program with Stakeholderz?

    Working closely with Megan and Graham at Stakeholderz was a really good experience. They were extremely supportive as well as very efficient. Graham helped to put us in contact with a group who really helped us with our company presentation, and we now feel that it tells our story in a strong and compelling way.

9. Would you recommend it to other Entrepreneurs?

    Yes, the process was very helpful to ensure that all of our information is up to date and in a single place to make it easily accessible for potential investors.

10. What fundraising advice would you give other Founders?

    Have a strong and supportive Board who will not only challenge you, but also roll up their sleeves and pitch in to support the company.
    Make sure that the amount of funding that you raise is enough to carry you through at least 2 or 3 key milestones, as you will need “gas in the tank” and need to be able to show achievement of milestones while raising your next round.
    Be able to articulate clearly to investors why the problem that you are solving is one for which people will be willing to pay, and have a clear idea about how you will navigate the path to those eventual sales orders. In medical devices, the issue is a complex one; however, our team understands it well, and there is clear value for every part of the decision process, including patients, urologists, nurses and very importantly, the healthcare system as a whole.

11. What’s next on the horizon for Ingenion?

    We are very focused on bringing our lead product to market later this year, as we are establishing important distributor relationships in all of our key markets. At the same time, we are working hard on the product development for our next two devices to treat chronic severe incontinence in women and men. We are looking forward to later this year being able to attend various urology conferences, which will allow us to raise awareness about our products. The small amount of opportunity we have had to expose clinicians and patients to our device during the past two years has confirmed to us that what we have developed and will be able to offer is a real game-changer for the industry.


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