Futura Medical Share Discussion Threads

[lbo] 15/8/2022 11:59

Especially as there is no patent stopping anyone from making a similar alcohol and water gel that also supposedly works by evaporative cooling!



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.

Voltaren vehicle gel application resulted in a rapid reduction of skin surface temperature by 5.1°C after only 3 min



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

[lbo] 15/8/2022 11:56

A much bigger issue for Futura is if Med3000 does get registered as a De Novo device. Then anyone eg Reckitt can do the same if they believe there actually is a genuine market for just an alcohol and water placebo gel for Erectile Dysfunction.



The FDA reviewed the One Male Condom through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for devices of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA 510(k) pathway, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The average length of time for clearance under the traditional 510(k) pathway is 177 days,



a company must compare their product to one already cleared by the FDA and provide evidence that their product is substantially equivalent to the previously cleared (legally marketed) device. To be substantially equivalent, the product must meet criteria for the same intended use, have the same technology or (slightly) different technology but produces similar end results, and be safe and effective. Once pre-market clearance is received from the FDA the device can be distributed commercially immediately.

[lbo] 15/8/2022 10:50

According to the rampers the EU courts are liars!?'there is consistent case-law on the (limited) significance of CE markings'https://buse.de/en/insights/ce-marking-is-no-excuse-for-uncorroborated-claims-of-efficacy/CE-marking is no excuse for uncorroborated claims of efficacy. The successful CE certification of a medical device or remedy does not release companies from the obligation to prove the correctness of advertising statementsThe court did not concur with the defendant's arguments. It stated that the CE conformity assessment is neither an official approval procedure nor an administrative legal act. The so-called "notified bodies" which carry out conformity checks and award the CE-certificates are private companies. The tests carried out by these companies therefore rather amount to plausibility checks, which, moreover, only concern individual aspects, for example, of a production process. A product's (alleged) therapeutic effectiveness is not (necessarily) examined.

[j777j] 15/8/2022 08:20

Trial has completed and results any moment now folks



The US remains the largest market opportunity globally for ED treatments OTC and the Company is making steady progress towards completing US Food and Drug Administration ("FDA") regulatory submission for MED3000.

Patient recruitment for the FM71 study (a confirmatory study stipulated by the FDA) completed at the end of 2021 and the clinical study, including patient follow-up, is drawing to a close. The Company remains on track to be able to disclose the results in early September

[glavey] 13/8/2022 05:26

How can there be a "short squeeze" if there are no significant short positions?

[lbo] 12/8/2022 20:11

The vanishing FAQ

Even looking at the change vs. baseline, the improvement in the placebo (MED3000) group was actually very modest in the first trial. In response to the question "Has the treatment you have been taking improved your erectile function?", only 26% of patients answered "yes" for the placebo (MED3000).

In the second trial, MED3000 seemed to do a lot better. Why is this? Well, Futura themselves offered some interesting answers to this question on their FAQ.

Futura emphasized that the second study had a longer treatment period ("The study ran for 12 weeks versus 4 weeks where we noticed improvement in efficacy between 4 and 12 weeks.") They also pointed to "very strict compliance to the inclusion and exclusion criteria" and "greater emphasis on patient training and therefore compliance to the treatment regimen" in the second trial.



the main outcome measure is always a subjective patient-reported outcome expressed through validated questionnaires The use of patient-reported outcomes means that the potential for placebo responses is high, so randomized trials are needed

[lbo] 12/8/2022 20:02

Futura said themselves MED3000 was the Placebo in FM57 and then that a placebo is a sham in FM71.



PLO = Placebo (identical gel to MED2005 but without the active pharmaceutical ingredient glyceryl trinitrate)



’placebo (sham) cohort’



Just like in the failed IDEA-033 studies in which Flexiseq gel was the placebo which were then relied on to get it also approved as a class 2b medical device gel. Med3000 had been used as the placebo sham treatment in the FM57 study on Med2005. Therefore the researcher ie Futura had initially believed Med3000 had no therapeutic effect. The FM57 trial did not set out to measure the efficacy of Med3000. therefore, the ASA will consider that its reported effectiveness by the advertiser was a post-hoc finding

The ASA will also be concerned that there was not an adequate placebo control for Med3000 in the trial. therefore, considering that the study did not provide adequate evidence for the claim clinically proven. Its all very Deja vu!



One specialist commentator felt that the clinical effectiveness has not been demonstrated. The absence of an adequate placebo (an inactive topical gel) for highlighted as a limitation by 3 commentators. One commentator said that without it, the clinical effectiveness could be attributed to the placebo effect of rubbing a gel



What happened next gets to the FTCs allegation that the respondents, in effect, deceptively sliced and diced the data in search of a positive marketing message. According to the complaint, the respondents subjected the data to post hoc analyses of different subgroups of test subjects. (The complaint describes a post hoc analysis as statistical analysis conducted after the data have been collected in hopes of discovering statistical relationships that suggest cause and effect.) The FTC concern is that unplanned, post hoc subgroup analyses pose a high risk of generating spurious findings.

[petroc] 12/8/2022 17:17

The placebo effect in RCT of iPDE5 for ED occurs at a rate as high as 50%, does it, LiarBO? Well, MED3000 can trump that figure that you've grasped from somewhere obscure. 'Data analysed was positive on measures of clinically meaningful benefit which physicians, patients and regulators view as increasingly important. MED3000 had a significant clinically meaningful effect in 60% of patients as calculated using the Rosen and Araujo statistical methods, standard assessment techniques for measuring Patient Reported Outcomes recognised and accepted by leading ED experts.' So keep digging for some actual evidence that MED3000 doesn't work, LiarBO, because all you're doing at the moment is proving my case for me and making yourself look like the idiot that you are.

[lbo] 12/8/2022 16:20

Yes the placebo effect is ‘remarkable’ in ED. And whats even more ‘remarkable’ is that it’s known that sham medical devices like Med3000 have enhanced placebo effects. Pity Futura wont even try to prove that their ‘magic’ placebo gel is any better then any other placebo gel! I wonder what they are afraid of? LOL



˜the placebo effect in RCT of iPDE5 for ED occurs at a rate as high as 50%



Recent research has shown that the placebo effect is not only similar for medical devices to medical trials; it is considerably larger – the effect of a sham device is almost three times that of an oral placebo.



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.



In order to truly determine the efficacy of this non-medicated gel in treating ED, researchers would need to design a new study with a different control such as an oral placebo pill and demonstrate that the gel showed benefits beyond the other placebo method. Until then, this gel will likely remain just as it initially seems: too good to be true.