Member Info for Muck165

Long overdue consultation I think. I know plenty of people who work at FOS and I think it’s fair to say that they’re almost as sick of spurious and generalised claims from the CMC try it on merchants as we are. Vanquis alone are suffering from the sheer number of these, so imagine the sheer amount of workload FOS will ultimately have to deal with from across the industry unless the FCA puts a formal redress scheme (which we won’t be involved in) in place.

Final one from me, but just to note that after checking it’s clear that as part of the MRHA registration process a company MUST provide a copy of its conformity assessment. So there is no doubt that Septiloop, having now been registered, must have UKCA and can now be sold in the U.K.

Also worth remembering that the Health Ombudsman published a damning report on the state of U.K. Sepsis care in the Autumn, nicely titled “TIME TO ACT Severe Sepsis: Rapid diagnosis and treatment saves lives”, and in that report identified that NHS cost savings of £196m p/a could be achieved if that were to happen.

A great time to be launching this 3x more sensitive and 10x faster diagnostic into the U.K. market, and I think a great opportunity to get in or add here if you can before formal announcements are made.

https://www.ombudsman.org.uk/sites/default/files/Time_to_act_report.pdf

Really excited by this - to give a flavour of the market you need only look at this from the U.K. Sepsis Trust

“Every 3 seconds, someone in the world dies of sepsis. In the UK alone, 245,000 people are affected by sepsis with at least 48,000 people losing their lives in sepsis-related illnesses every year. This is more than breast, bowel and prostate cancer combined. Globally, sepsis claims 11 million lives a year. Yet, for many patients, with early diagnosis it is easily treatable.”

https://sepsistrust.org/about/

On 16/3/23 Salignostics/Salistick became registered with the MRHA, leading ABDX to say in a 31/3 RNS - “ We were pleased to see Salistick™ achieve Medicines and Healthcare products Regulatory Agency (MHRA) approval in March 2023 and will therefore be available for sale in the United Kingdom and we remain on target for an exclusive launch of Salistick™ on the Abingdon Simply Test™ website and on Amazon before the end of this financial year.”

I am excited to see, therefore that on 14/3/24 Loop Diagnostics/Septiloop achieved MRHA registration, which I am VERY reasonably assuming means that Septiloop, like Salistick, has now achieved UKCA and can be sold in the U.K. market.

Neither Loop or ABDX have said anything about this yet, but I’m sure it won’t be long and I would imagine it will give a very nice little shot in the arm of the SP! Remember, Septiloop is one of the products that ABDX has taken through tech transfer, scale up, and into manufacturing.

https://pard.mhra.gov.uk/manufacturer-details/110414 ((Salistick registration)

https://pard.mhra.gov.uk/manufacturer-details/117995 (Septiloop registration)

https://www.youtube.com/watch?v=4Z32joS9aD4 (See slide at 11 mins in)

Further on this, but a week or so ago Upfront presented at the Cambridge Enterprise Venture Partners Investor showcase, and this would seem to be their full pitch presentation (which is far more detailed than anything I’ve seen before).

It makes for interesting reading!

https://www.enterprise.cam.ac.uk/wp-content/uploads/2024/03/240305-Upfront-LVOne-full-deck-1.pdf

For those interested, a bit of reading from the European Centre for Disease Control from earlier this month, highlighting the increase in STI’s (including Syphillis, one our new tests), and commenting about how early testing is crucial. Just seems to me that the “embarrassment” factor might stop many from going to the docs, another reason why discrete at home LFT testing might benefit.

https://www.ecdc.europa.eu/en/news-events/sti-cases-rise-across-europe#:~:text=In%202022%2C%20the%20number%20of,and%20chlamydia%20cases%20by%2016%25.

If these new tests are built on the Senzo ALF platform, then that might well explain Yates decision to invest because everything I’ve read suggests that historically LFT’s have struggled in the STI market because achievable sensitivity was too low and that is precisely what the ALF platform addresses.

I enjoy it Metatron - gives an old fogey something to do!

As I say, I do have a suspicion that these new tests may be built using the Senzo amplification platform. I’ve already given some reasons why in earlier posts, but another is that this lady regularly began reacting to ABDX posts from at least 4-5 months ago, and she very quickly reacted to Abingdon’s LinkedIn post about our new relationship/investment by commenting; “ Congratulations, Chris and team. Desperately needed tests for individual health and public health.”

Why is that relevant - well she is an IVD consultant who has been advising a company called Bioadvance Ventures since 2022, a VC company that counts Senzo as one of it’s investee companies.

https://www.linkedin.com/in/cfinkmdte/

https://www.bioadvance.com/portfolio/

By trawling through various US state registries I’ve now found Find Out From Home LLC, registered in Delaware on 9/8/23.

https://icis.corp.delaware.gov/Ecorp/EntitySearch/NameSearch.aspx

Morning Lucksin.- don’t get me wrong, I am still very positive about ABDX for very good reasons and, yes you’re right that getting a foothold in the US STI market when STI infection rates there are a huge and growing problem, is a boon. But whilst £500k may not be a huge sum, it does represent more than 10% of our last years total revenue and I think it only reasonable for any shareholder to want a little more comfort about the companies and people were investing in, particularly when we’ve been so focussed on getting to cash flow positive. So I was disappointed ABDX couldn’t be more forthcoming.

But strangely, it’s Yates willingness to make this play when break even is so paramount that gives me the most comfort. I just can’t see him doing it unless he was forced to (and if that were so I’d have thought he’d drives much better deal), or that he sees huge potential.

https://www.nbcnews.com/health/sexual-health/sexually-transmitted-infection-rates-rose-older-people-cdc-rcna145332

For info, I wrote to ABDX For more info about Devyn, FOFM, or Yannick Namia given none appear to have much, if any, online presence. Disappointingly, ABDX simply replied to say that parties they’ve contacted with are registered in the USA - they gave no other pointers or comfort, despite our potentially waiving £500k in fees to acquire equity.

From what I’ve been able to ascertain from my own searches, Yannick Namia is a bit of a serial entrepreneur in the health and well-being space, who says his businesses have turned over €100m. He had a business, Devyn LLC, registered in Austria which he voluntarily liquidated last year - it apparently had €710k capital assets on liquidation. During Covid he ran a home testing service company in California, and now runs business promoting sexual education and health. He also has a business, Devyn Inc registered in Florida, which became Devyn LLC in 2022. I am assuming this is who ABDX contracted with. I can find nothing about FOFH.

So, it looks to me like we’ve been developing tests for a serial entrepreneur about which I can find little, and are intending to spunk £500k fees for equity in his business. I still think these tests might well have something to do with Senzo, and very much hope that Yates sees significant potential for a £500k fee waiver, but I have to say that Abingdon have been extremely poor when responding to my simple requests for comfort and clarification in this respect.

Comments made about FOS Fee consultation. For those unaware this might be useful

Basically a proposal to charge CMC's the fee, given the account for 20% of cases brought but over 50% of cases not upheld.

https://www.financial-ombudsman.org.uk/news/financial-ombudsman-service-reports-performance-improvements-consults-plans-reduce-costs-businesses

He's an impressive speaker and so far I'm seeing a lot of competence, planning and passion.

Thank you both!

Please forgive me, but I can't find out how to watch the seminar this afternoon. I am assuming there is a registration link somewhere - could anyone help?

Easy solution - any claim brought by a CMC to FOS that they lose, make them pay the admin fee. At the moment they do little work apart from put together some generic standard paras and market themselves to public on the promise of "what have I got to lose". Putting that at risk for spurious claims would reduce the number!

Right, so ABDX finally put a media post out

https://www.linkedin.com/posts/abingdon-health_london-stock-exchange-london-stock-exchange-activity-7178041844059021313-DZLH?utm_source=share&utm_medium=member_desktop

Liked by Yannick Namia, CEO of our new investment

https://www.linkedin.com/in/yannick-namia/

Thanks Ant, but nobody should look to me. I just post stuff I find, and my own thoughts, much of which may be irrelevant or rubbish!

But in that vein. and in the short term..

IMO this is being held back because the market is concerned about a raise. Regardless of what I think about that, a Director buy would help massively. It would show confidence in the business and indicate that no discounted raise in which they might otherwise participate is on the horizon.

Salistick FDA approval would spark interest from the many out there who think that is our one and only product.

I think we will be launching another test in boots in the pretty near future (weeks according to Crest Medical)

PW - thanks for posting the article, which helps describe the scale of the STI problem.

I haven't been able to shake the thought that somehow these new partners might have come through Senzo. This latest RNS says we have been working with them for 12 months, we announced the Senzo partnership almost 12 months ago to the day, and both the new partners and Senzo are based in the US.

https://www.senzo.com/newsroom/senzo-and-abingdon-health-enter-into-strategic-partnership

So this might also be interesting. Its a blog from Senzo about STI's which again details the scale of the problem and highlights that getting LFT sensitivity levels up when looking at STI conditions has been the main headwind in development. Of course, the whole point of Senzo is to increase sensitivity to PCR levels through its ALF tech.

https://static1.squarespace.com/static/63174674e5302f1a8f9e9dbc/t/659ae1c8fc1f77528ed44d4b/1704649165514/FDX+-+STI%28s%29.pdf

It does worry me that I can't find anything about our new partners, and nor have ABDX put out anything on their media feeds about this news so they're not screaming it from the rooftops - I have written to ABDX to see if they can give me anything more. But if we are looking at an LFT for STI's that meets required sensitivity thresholds then the market looks massive. And of course, by buying into a US based company we are getting a foothold in that jurisdiction.