Futura Medical Share Discussion Threads

[lbo] 12/1/2023 10:42

Yet more lies from the ramper. Trinity Research even openly admitted the hypothesised effects believed to be happening by Futura are disputed. Trinity admitted no mechanism of action has to be even shown to get a medical device registered. But it does need to be shown and proven to substantiate its marketing claims of having any effect beyond a placebo or fall foul of the FTC, ASA and the Courts.

Trinity research:

Presumably the effect is comparable to the cold-induced vasodilation (CIVD) that occurs with extremities such as toes and fingers. Despite being a well-known effect, the mechanisms of CIVD are still disputed, but the pathways involved could well be similar. Interestingly, the precise mechanism of action does not need to be elucidated for the regulators to be comfortable for a product to be approved as a medical device



There is no evidence for the evaporative mode of action from the clinical trials. To show that the evaporation is what makes MED3000 work, you'd need to compare it to a non-evaporative gel.



A product that contemporary technology does not understand must establish that this magic, actually works. Proof is what separates an effect new to science from a swindle . . . . If a condition responds to treatment, then selling a placebo as if it had therapeutic effect directly injures the consumer

[lbo] 12/1/2023 10:37

Unlike the rampers. Futura has openly admitted in an RNS back in 2021 it was using the 'least burdensome' route of just a De Novo medical device registration for Med3000. A pathway with unblinded studies the same as Futura used that are 'prone to bias' results.This path only requires a low 'flimsy' threshold of effect over baseline for 'reasonable assurance' of some effect including even just placebo effect for lower class medical device registration! And it even appears as if the Med3000 trials were designed to build in even more bias due to the use of non standard inclusion criteria and allow for increased spontaneous recovery being wrongly attributed to the use of Med3000.This has allowed Futura, like other medical device manufacturers, to exploit 'the 2002 Medical Devices User Fee Act' . This act brought in via corporate lobbying by the medical device companies requires the FDA to use the least burdensome route to market for that low class device. So the FM71 study was deficient as it was an uncontrolled and an unblinded study and 'prone to bias'. So even if if Med3000 is given medical device registration. FM71 still has not met the standards of the FTC, ASA or the Courts to substantiate claims of an effect beyond a placebo. And the FTC has jurisdiction over the marketing claims of these lower class medical devices. Similar applies to FM57. It was not an adequately controlled study as it was designed to study Med2005 not the placebo MED3000 gel.https://www.healthnewsreview.org/toolkit/tips-for-understanding-studies/medical-devices/Devices are subject to weaker standards than drugs because they are regulated under a different law. The Medical Device Amendments of 1976 was intended to encourage innovation while allowing for a range of review standards based on risk, according to legal expert Richard A. Merrill. An array of corporate lobbying has since prompted Congress to ease regulations and make it easier for devices to get the FDA OKJournalists need to scrutinize the claims.Journalists have a responsibility to report this lack of evidence, but they often dont. Investigative journalist Jeanne Lenzer, who wrote a book about the under-regulated medical device industry, says more dogged reporting is needed: We really dont know what we are getting with many of these devicesNinety-nine percent of devices never have to provide clinical data, thanks in part to the 2002 Medical Devices User Fee Act, which requires the FDA to use the least burdensome routeFor the few devices subject to a scientific review, the quality standards are flimsy. Randomized controlled trials, the gold standard, are infrequent. Most studies are unblinded, and thus prone to bias. The FDA settles for loosely defined reasonable assurance that a device is safe and effective, versus its higher standard of substantial evidence for drugs, which require studies with comparison groups that didnt receive the same treatment. Thus, data that would never be sufficient to support the approval of a drug can result in the approval of a device used to treat the same condition, potentially diverting patients from effective drugs to less-effective devices.

[lbo] 11/1/2023 17:39

And how does a company expect to patent something that was clearly already described in research literature!? Whch they also admitted!



The Company has conducted initial literature and in vitro based research that has shown the cooling from the evaporation of these specific combinations of solvents



There is a risk that some claims will either be challenged in future (eg on the grounds of non-obviousness or existence of prior art) and/or that another technology may be employed to achieve a similar effect. The protracted development times mean the clock has been ticking on the original issued patents, reducing the protected commercial products




A smooth gel intended for alcohol soluble actives. Provides cooling effect upon application while leaving minimal residue




The cooling effect of a topically applied product can be evaluated using a validated handheld thermal imaging system. When the gel matrix is destroyed after application to the skin, the bound water and alcohol evaporates and a measurable cooling-effect results.


The brokers also admit they are assuming the original Med2002/2005 patents which expire in 2025 in EU and USA in 2028 will provide some protection to Med3000 until then. Thats a big assumption as the original patent was an umbrella patent covering Dermasys with GTN. Med3000 is just Dermasys on its own and now just a medical device delivering only a cooling sensation via ‘evaporative cooling’



intellectual property protection is limited to use patents for the individual products and umbrella patents for the technology. There is a risk that some claims will either be challenged in future (eg on the grounds of non-obviousness or existence of prior art) and/or that another technology may be employed to achieve a similar effect.
The protracted development times mean the clock has been ticking on the original issued patents, reducing the protected commercial product


So no enforceable additional patent has still been granted. Its even questionable if that application protects Med3000 as its all about ‘methods of measuring the cooling abaility of a topical composition’. Presumably because GSK used a handheld device thermal device to measure the cooling of their alcohol and water gel so Futura have to make their patent look different! LOL

And Dermasys on its own has no patent anymore as Dermasys itself dates back to 2002.

[lbo] 11/1/2023 12:58

All Futura have done with MED3000 is open the door for Reckitt to sell similar lubricants/arousal gels as medical device placebo treatments for ED. And report Med3000 to the ASA, FTC etc for being misleading if it does not inform consumers that MED3000 itself has no proven effect in ED beyond a placebo. It has never proven efficacy in an adequate placebo controlled study or even against any standard cooling lubricant/arousal gels in an ED study.



‘You are the active ingredient’

Even the analysis on market forecasts knows Reckitt who is the market leader in lubricants will be only one to gain from marketing lubricants as placebo treatments for Erectile Dysfunction




Reckitt Benckiser was the defined leader and the ultimate four Personal lubricant vendors with leading brands such as Durex Play and K-Y Jelly.

KEY GROWTH FACTORS

Increasing prevalence of erectile dysfunction

9 Market Growth Enablers
9.1 Increasing Prevalence of Erectile Dysfunction

[j777j] 11/1/2023 11:37

Any day now folks :-)

[lbo] 07/1/2023 20:13

A Viagra study also showed using a placebo was also just as likely to harm you. It compared some 4,500 patients taking the drug to about 3,100 on placebo. So based on that study Med3000 even as a placebo is just as likely to harm you as viagra.

There was only 96 men in FM71 so less then 50 men actually used MED3000. There was also burning reported by some of the men and women in FM57 and there was also adverse events reported in 18.5% of the placebo gel users in FM53.

Yet millions and millions of men have used Viagra safely over many many years. So thats billions of doses taken yet its only linked to a few deaths. More men die from deaths associated with alcohol ingestion and medical devices per year. And even placebo gels like MED3000 claiming to be a treatment for ED with no appropriate assessment will be associated with deaths and thousands of reports of side effects if it ever manages to be used by enough men over time.

The objective data over many years of use. After appropriate assessment and correct use has proven Viagra to be effective and safe. Viagra has a well-established efficacy and tolerability profile. From its introduction in 1998 to 2016, over 64m men worldwide were treated with sildenafil citrate. 'The safety profile of sildenafil citrate is based on over 9,570 patients in 74 double blind placebo-controlled clinical studies as well as postmarketing surveillance that has been gathered over 10 years.' And correlation is not causation. Meanwhile there is no medium and long term safety data on Med3000 use in the real world.

Viagra studies have even showed men taking it live longer.



With many millions of men taking erection erection drugs. Lots of men with heart disease will die from that heart disease whether or not they take erection medication. That is all it is, an association. There’s no proof of cause and effect. And the data actually shows men with CVS disease who take viagra live longer.

[lbo] 07/1/2023 20:00

So you are now also accusing the FDA of telling lies? And openly accusing the them on a public bulletin board of covering up data related to Viagra? Hope you have the evidence to substantiate your libellous accusations against the FDA that ‘ many Viagra deaths there have been - conveniently covered up’.


According to data from the U.S. Food & Drug Administration (FDA), more than 80,000 deaths and 1.7 million injuries have been linked to medical devices in the past decade.



40.1% of the reports for patients deaths
were for class 2 devices (the same class as Med3000)

mikethebike4 - 11 Apr 2018 - 14:35:10 - 4072 of 11141

Having had similar waffling, 'smoke-screen' answers from Mr Barder over the years which have turned out to end in exactly nothing I am loathe to give any credence to virtually everything he says

mikethebike4 - 11 Apr 2018 - 15:58:28 - 4091 of 11141

Company is massively over valued if you go by 'concrete' results !

mikethebike4 - 11 Apr 2018 - 15:14:56 - 4082 of 11141

I only try and bring some sort of balance into the equation to help the gullible not get carried away with fanciful future projections.
I would like nothing better than to be proved wrong about Mr Barder (our CEO since 2001) and to sale away into the sunset grasping 5 times as many £s in my fist as I paid for the shares
Unfortunately for people like J7J, Mr Barder has been through this advisors process before - with CSD500 - and look where we've got in 17 years - sales of the product did not even equal the money we paid him to be our CEO for 2017 !

mikethebike4 - 06 Dec 2017 - 10:32:27 - 3468 of 10591

"A couple of decent deals and will be back off to the races."
Do you have any idea of how long shareholders have been using these words

mikethebike4 - 23 Mar 2017 - 09:52:33 - 2560 of 10591

As someone who has been invested for many years and who attended an AGM years ago and complained to Barder about the very slow progress, I am very frustrated.
All the time the Board are drawing good salaries off the backs of shareholders money they have very little incentive to get off their backsides and get 'selling' - thats what running a company is all about at the end of the day!

mikethebike4 - 24 Feb 2020 - 09:11:58 - 7290 of 9713

why should it be any different this time when you've still got the same useless lot running the show

mikethebike4 - 07 Jan 2019 - 11:22:52 - 4692 of 9641

I repeat I very much hope you are right - no one would be happier than me if you are - however I stupidly (in hindsight) bought in when everything looked really rosy - we were told there were loads of 'distributors' all 'champing at the bit to get selling a wonderful industry disruptive product (which it still is incidentally) once the 2 year shelf-life problem was fixed. This was despite the fact that the Holland/Belgium distributor was quite happy and successful selling them with the original 18 months shelf-life
And where are we now years later - one tiny distributor from which Futura receives a total sales income only just about covering Mr Barders employment remuneration
I just hope this MED/TPR situation is not just a repeat of CSD. As to why I don't just sell up, well my shareholding is worth such a tiny proportion of what I paid for it I might just as well hang on in the hope that new shareholders getting in now are luckier than I was and I can get some of my money back - I think what we need is Mr Barders retirement - that should give the share price a kick

[j777j] 07/1/2023 10:32

From LSE


Looking over the FDA submission

1) Highly positive FM71 Phase 3 Study Results with all primary and secondary endpoints achieved

2)FDA agreed co-primary endpoints met at 24 weeks, demonstrating a statistically significant improvement in erectile function compared to baseline, as well as achieving a clinically important improvement in erectile function at 24 weeksSecondary endpoint met demonstrating a 10-minute onset of action, which was demonstrably faster than the well-known prescription oral medication
3) The trial design and clinical endpoints were agreed with the FDA as a confirmatory clinical trial for the US regulatory dossier for MED3000
4) Co-primary endpoints pre-determined with the FDA were achieved for MED3000. The first showed a highly statistically significant improvement
5) The second primary endpoint, again using the IIEF-EF scale, showed that on average patients experienced a 5.73 unit change in IIEF-EF score versus baseline at 24 weeks exceeding the 4-unit difference agreed with the FDA and defined as the Minimal Clinical Important Difference ("MCID").
6) FM71 also included FDA agreed criteria for proving a rapid onset of action. Data demonstrated a highly statistically significant improvement
7) Safety and tolerability data were also highly positive, with no serious adverse events recorded in any patients on MED3000 with a highly favourable overall side-effect profile. Of particular note is that 19.1% of tadalafil users experienced a headache on at least one occasion whilst using the product versus 4.3% of MED3000 users.






Hahahahaha hows the short going?

[broomrigg] 07/1/2023 06:11

FUM to hit 60p next week?That was Zak Mir's recent target so if we move through it we can expect an update from him, likely a much higher target. That's without taking into account what news is in the pipeline that could easily send us over 100p. Significant updates expected this quarter.Nice to be holding this one.