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Another observation, this time just a post from Upfront.
https://www.linkedin.com/posts/upfrontdiagnostics_timeislife-activity-7188440790136676352-hZJU?utm_source=share&utm_medium=member_desktop
Upfront have been working with North East NHS Hospitals since 2018 and, as you can see from the post, that means they have built a product that not only works, but has been made specifically for use in the NHS. Its little wonder they were selected for the IDAP scheme and their LVOne test is, for my money, destined for widespread NHS adoption. The next I think we will hear from Upfront, which I suspect will come pretty shortly, is a successful latest funding round. Then it will be UKCA this quarter and then very quick NHS adoption and ergo manufacturing requirements.
Worth noting again that Upfront have been telling people that they can manufacture at scale. Well, we are their only manufacturing partner as far as I can tell.
Another observation…
It would appear that Salignostics have become a client of Sheng Enterprises, a Chinese company helping Israeli companies get a foothold in the Chinese market. More detail can be found here under the March 24 event “ The Israel Medical Device Special Matchmaking Event” - https://www.sheng-cn.com.cn/events-meetings/.
More on Sheng generally here - https://www.sheng-cn.com.cn/
More for awareness really
Just another little observation….
ABDX latest blog was about security of supply chain, written by our COO Mark Jones - https://www.abingdonhealth.com/ensuring-your-critical-components-are-protected-the-importance-of-supply-agreements/
Whist this is undated, it appears to me to be a new news release from a company called Rosti, who have partnered with is for injection moulding.
https://rosti.com/rosti-uk-secures-exciting-new-project-with-abingdon-health/
Just interesting that focus lately has been on supply and security of manufacturing components.
This is worth a listen to - yes, its about the Helix IPO but it all adds to knowledge!
Of particular interest to me was at about 59 seconds in, when the interviewer commented how the Helix IPO raise suddenly went from Lukewarm to hot, with an original intent to raise £3-4m but ending up with about £20m of demand.
Georgina are looking to raise £3m, using the same broker as Helix.
https://www.youtube.com/watch?v=2uIlWZKSvYY
Positives for me are
1) Can’t see him doing that interview if he had concerns about EP145
2) He didn’t express any concern about the deal completing
3) he again confirmed works were progressing pending approval
Not the most forthcoming or energetic person in interview, but a solid experienced guy.
I see that under the “Reports” section of its website, Georgina are including MMM RNS announcements. Just wondering, but is this a new development, or have they been doing it for a while? Just seems a little odd to be doing this unless confidence deal completion is high.
https://www.georginaenergy.com/about/reports/
They also say “ Georgina Energy is seeking to raise GBP 3 Million to complete a Reverse take over on the London Stock Exhange/LSE with re admission in Q2 2024, subject to shareholder and regulatory approvals.”
https://www.georginaenergy.com/about/georginas-journey/
Apologies for any ignorance or repetition of what’s known! I just don’t follow this one as closely as others.
Hi Wyn
Agree - getting regulatory approval is like wading through treacle and all sorts of extra requests can delay things. But the point still remains valid - it’s reasonable to think we’re entering a time window when a decision might be made.
And the Times of Israel quoted Krieff last month as saying Salistick is currently being “positioned” in the States.
How approval might directly affect ABDX I don’t know - we’re unlikely to be a US distributor (although that would be amazing!), but we will still be manufacturing.
Just another small observation…
We know that Salignostics got UKCA approval in March 23, and that they also have CE. We also know they had initial meetings with the FDA by at least November 21.
Now, I’m not entirely sure what FDA approval pathway they’d have to follow, and so what additional requirements the FDA might have over and above conformity assessments in the U.K/EU
What I do know is that for a De Novo application, being the pathway for a device with no existing substantial equivalent, the FDA aim to give a decision within 150 days of having all necessary information.
So if we got UKCA in March 23, I think it’s reasonable to think an FDA decision can’t be too far away (assuming there’s been no hiccups!)
1. Boots have little pop up that tells you how many times an item has been viewed, and how many times its been added to basket in the last 24 hours. I've been watching this daily (sad I know) since our Vit D and Iron tests launched, and we are consistently ahead of the MHC equivalents, despite no price differential. Boots are selling between 25 and 50 of each product each day, online only.
Loop - - their CEO has been heavily publicising a speaking session he is delivering at the EIT Health Summit on 18-19 April. Perhaps we might get a UKCA announcement before then?
As I say, just little observations...
More good news from the Upfront CEO today
https://www.linkedin.com/posts/gonzaloladreda_timeislife-activity-7183373180240019457-NJE-?utm_source=share&utm_medium=member_desktop
Final one from me, but I came across this pitch update because a company called Odelle posted this on LinkedIn (which Yates liked)
https://www.linkedin.com/posts/odelle-technology_excellence-diagnostics-activity-7183021230294192129-2eH9?utm_source=share&utm_medium=member_desktop
So it’s interesting to see what Odelle do, and the companies they’ve worked with
https://odelletechnology.com/about-us/
Overall it’s really obvious that Upfront have a very well planned and professional roadmap to market, involving professional and experienced consultants and with support of regulatory health powers that be. Great customer for us.
Also worth noting again that one of the benefits of IDAP is the potential for “Exceptional Use Authorisation” from the MRHA, which could come sooner than anyone expects.
https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase
Hi Apre
Everything you note is certainly relatable, but it’s the numbers in this latest update to their pitch that excite me, forecasts though they are.
And yes, whilst the trials are important and will take a little more time, it doesn’t appear to delay UKCA or CE applications which, according to this and prior versions of the pitch (see earlier in the thread) will be done this quarter. And then of course there’s IDAP, so at least in respect of UKCA I think we can expect a fast track approach to approval, fully supported by all the heavyweight national health bodies.
But like you, I’m no accountant and would love it if someone could shed more insight on the forecasts as they might relate to us.
So, it would appear that Upfront have again updated their pitch deck.
I would encourage anyone here to read it, because this is the first time they have put forward financial projections - see page 22 of the report. I'd really appreciate comment anyone might have.
Apart from the size of the numbers, the one thing that stood out for me is that they are quoting "net revenue" figures, which they say are quoted after 30-40% distributor fees. No guarantees of course, but I would imagine we would be one of those distributors, as well as a manufacturer. Give the size of the numbers, those fees could be very significant indeed and, as Yates has said, recur year on year.
Upfront are very clearly on a funding drive at the moment to raise £3m., having been pitching all over the place. It will be interesting to see if they get it away, although I have little doubt they will.
https://media.licdn.com/dms/document/media/D4E1FAQGlCe3DkrR-fA/feedshare-document-pdf-analyzed/0/1712565286749?e=1713398400&v=beta&t=aihEAC-lBZsZNPQoOSlPvZgOm_-z5Pc44_JfLj2ALKs
Just one of the horses we will soon have running, and certainly one of my favourites.
Just say it as I see it Invwell!
The really key things for me are diversification of business risk, growing number of developers, lack of CDMO/CRO competitors, growing need and demand for product, high automated manufacturing capability, prudent management, and solid and growing customer base.
Could things go wrong - of course! But I think that prospect is far far lower here than in many other AIM stocks.
Loop also filed for a U.K. trademark to cover Septiloop on 30/10/23, which was granted on 19/1/24.
Getting their ducks in a row..
https://trademarks.ipo.gov.uk/ipo-tmcase/page/Results/1/UK00003973303
Further on this, I note that since Friday (when I last checked), Loop have updated the project time line on their website to confirm the following achievements;
1) Clinical trial results in Q4 23
2) Clinical trial publications in Q4 23 (I haven’t been able to find these yet).
3) Technical file submitted for CE marking in Q1 24
4 UKCA mark Q1 24
They are now also signposting first U.K. sales in Q2 24, ie in the next 3 months.
To be honest, I’m surprised they haven’t yet made an announcement about UKCA. Perhaps this recent site update signals they’re about to, maybe alongside some other announcement?
Anyone wanting to compare old to new, here is a snapshot of the timeline on 25 March (best I could get)
https://web.archive.org/web/20240325163648/https://loopdx.com/
and here it is now
https://loopdx.com/