Giovanna Forte, Chief Executive Officer of award-winning specimen collection company Forte Medical expresses exasperation with the challenges of raising secure investment to turn innovative medical device concepts into widely-adopted practice in the NHS.
In the early 2000s, I met Marc Koska, inventor of the novel and highly successful K1 auto-disable single-use syringe. He advised very gently that it takes at least seven years for an innovation to reach market and that still doesn’t mean it gathers traction or adoption. That can take a lot longer. Be prepared.
Having been told then, and am still told today, that our evidence-based innovation Peezy Midstream is a no brainer, of course I didn’t believe him. This excited start-upper believed that it would be different for us.
A 2011 paper by Morris, Wooding and Grant cites a 17-year lag between MedTech invention and adoption and this remains closer to reality. What investor is going to wait this long for their money to flourish? It is a miracle that anyone with start-up ambitions even starts the up.
Peezy Midstream is the first case study to feature in the 2017 book Managing Innovation in Healthcare, by Professor James Barlow. For a number of years, James invited me to present to his Masters Students at the Imperial College Business School because our journey had been fraught with challenges. Our innovation had been so persistently overlooked, misunderstood, and ignored by healthcare providers that he found it a valuable, if forbidding tale for his post-grad students.
Between 2006 and 2019, I raised £4.25m for Forte Medical, starting with Government-backed London Development Agency investment and extending into friends, family and industry partners. This financed 10 years of R&D and three design iterations, each of which was subsequently tested, evaluated and trialled. The prototype Peezy Midstream won prizes including an early NHS Innovation Award, Certificate for which was signed by the then Secretary of State for Health, Andy Burnham.
Which brings us to it has taken too long.
By March 2020 Peezy Midstream was scaling into maternity services. The work undertaken to ensure clinical and cost value is not an overnight process but we achieved 10,000 units/month, and rising. We were on the way, or so we thought. And then Covid.
I vividly remember realising the implication of the news announcement that point of care testing was being suspended. Our growing sales and revenue ceased overnight. The investment syndicate with which we were negotiating £1m funding, pointed to our freshly acquired £0 turnover and walked away.
Walk away, was the subsequent advice given to me by industry advocates, shareholders, friends and family. Forte Medical isn’t going anywhere. This, I could not do. Firstly, urine-based diagnostics still needed precision collection to make it the best it can be: my own no-brainer. Secondly, abandoning the people who invested into Forte Medical with their hard-earned money, would keep me awake at night. Thirdly, I still had ambitions for Forte Medical.
Then, slowly but surely, the tide began to turn. Watching Covid tests being rolled out through pop-up diagnostic points with face to face instructions and witnessing its full integration into our everyday lives I realised that our future lay in home testing. GP and Laboratory services were overburdened then and remain so today. Our simple analogue tech could introduce dramatic cuts to waiting lists by reducing re-tests and false positives, something our extensive clinical evaluations, cost-benefit analyses and patient feedback proved we could achieve.
A fresh business plan was developed for a pathway that joined the dots between a home-collected midstream specimen and fast, targeted prescribing, targeting also the risk of Antimicrobial Resistance (AMR) being fuelled in women through empirical prescribing guidelines; 50% of the global rise of AMR has been attributed to urinary sources.
Let me take you back to 2023 when point of care testing resumed in earnest. Our remaining stock was too short date to sell. We needed to manufacture afresh but finding traditional investment routes reluctant to support us, in early 2024 we Crowdfunded raising a net £209,000. Visiting our manufacturing partner Boddingtons in June, we agreed a run of 50,000 Peezy Midstream devices for relaunch.
On 1st July an email landed; Boddingtons had been taken into Administration by their private equity owners. Now we had no investment, no sales, no revenue, no stock … and no manufacturing partner.
But … as the song says: from the ashes of disaster come the roses of success.
It has been hard work and we are making again, generating outstanding, fresh evidence to add to our portfolio of excellent data. We have a female-founded, female-focused sales and distribution partner in Una Health and the roses of revenue are beginning to bloom again.
Happily, our home and remote testing ambitions are about to come to fruition with flatpack Peezy Midstream launching early 2027. We are generating recognition from healthcare decision makers, and demand from maternity clinics. Having previously sold into the US Military and others, a return to the USA is planned for next year. Meanwhile due diligence is being carried out on enquiries from distribution partners from the Middle East and South America.
Embarking afresh on fundraising in January of this year, it has become clear that investors are focused on female health conditions with greater media exposure, especially those supported by Digital and AI services. While our proven analogue solution tackles at source a condition that impacts 1 in 3 women, UTI remains stubbornly under the radar; as far as the media is concerned, wee is not sexy.
With insolvencies in the life science, biomedical and MedTech sectors reaching a peak in 2023, Forte Medical is still here with sleeves rolled up, people to see and places to go. At last, our work in wee is validated by a cluster of start-ups that also struggle to gain investment: talk to Extracted whose home UTI test under their Utee brand, will launch next year with Llusern Scientific.
The average return on a MedTech investment is estimated to be x7 – x10, our minimum ambition. Over the next 18 months we will have three devices, each focused around urine specimen specificity for precision diagnostics. To my knowledge, there is no other business focusing on the need for the accurate urine specimens fundamental to so much diagnostic medicine.
Regrettably, our opportunity presented to prospective investors has been repeatedly rejected; they cite length of time and insufficient revenue. An unavoidable reality is that less than 2% of investment comes to female-led and female-founded businesses, making the funding struggle far harder.
Fortunately, we have shareholders who believe in our vision and have kept us alive which, together with tough bootstrapping, means Forte Medical has survived these bleak and thin years. Had we achieved the £1m funding years ago, we would be in an entirely different position today.
Not only have we survived, revived and embraced the home testing zeitgeist with globally unique devices, we are poised to achieve success . Our future is bright. An EIS raise will simulate growth, transformation of women’s urological and prenatal health, reduce demand on antenatal clinics, GP surgeries, hospitals and community setting, whilst generating healthy revenues and profit, a reward for 20 years graft.
Our success will support British manufacture, employment and export. It will support our new precision diagnostic device pipeline designed to underpin early stage cancer testing, sports dope and evidential forensic urine screening. Huge global markets set to deliver significant returns for investors.
To our shareholders of 20, 10 and five and less years, thank you. To future investors, our work is de-risked. Join us, because the hard yards are done, we’re ready for rapid international growth.
It’s been a long time coming.
Any questions about or comments upon this article can be shared with the author at giovanna.forte@forte-medical.com.
