Futura Medical Share Discussion Threads

[lbo] 26/10/2022 12:45

The solvent (Alcohol) just evaporates. Not even Futura are that stupid to try claim what you are claiming as it would mean it wouldn't be allowed be called a class 2 medical device anymore just like all lubricants. Same cooling effect can be replicated using any water based cooling lubricants that also evaporate or even an similar alcohol and water gels. And yes all medical device gels/water based lubricants are goopy and messy out of the tube until they evaporate.https://www.scientificamerican.com/article/chilling-science-evaporative-cooling-with-liquids/https://www.gskhealthpartner.com/content/dam/cf-consumer-healthcare/health-professionals/en_IN/pdf/article-1.pdfVoltaren vehicle gel is the carrier substance of the topical Voltaren products. This vehicle gel is especially formulated to be easily applied on the skin, while providing some sensory benefits. The present study aims to substantiate the widely perceived hydrating and cooling effect of Voltaren vehicle gel.https://en.m.wikipedia.org/wiki/Personal_lubricantBecause water-based personal lubricants absorb into the skin and evaporate, most water-based lubricants have a tendency to dry out during use

[lbo] 26/10/2022 12:37

LOL

Nothing is absorbed in Med3000 except some water! It contains no Active pharmacological ingredients. Its just a medical device and only works by mechanical rubbing! Even the claim it works by evaporative cooling is totally unproven and cannot be substantiated.




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.

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 approved. But unfortunately it does need to be proven to substantiate its marketing claims 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 medical device



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. FTC v. QT, Inc., 512 F.3d 858, 862-63 (7th Cir.

[petroc] 25/10/2022 23:01

LiarBO lying again. MED3000 has been proven to work in three trials. Just because LiarBO, a proven stock basher, says they aren't adequate, doesn't mean it's true. Those trials were 'adequate' enough to interest the EU regulators and the FDA and the scientific community. Sufficiently 'adequate' to interest both large and small investors. And, of course, 'adequate' enough to make LiarBO scuttle around like an idiot, frantically copy/pasting his stock bashing nonsense to keep his posts at the top of the pile to try and discourage ordinary, honest folk from making a few bob.

[petroc] 25/10/2022 23:00

'There are many reasons why symptoms can improve over the course of a trial, of which the placebo effect is only one.'(quoted by LiarBO) And the most obvious of those reasons is of course the product actually working, so thanks to LiarBO for pointing out the obvious - MED3000 works, in 60% of patients.

[petroc] 25/10/2022 22:58

LiarBO lying again. MED3000 has been proven to work in three trials. Just because LiarBO, a proven stock basher, says they aren't adequate, doesn't mean it's true. Those trials were 'adequate' enough to interest the EU regulators and the FDA and the scientific community. Sufficiently 'adequate' to interest both large and small investors. And, of course, 'adequate' enough to make LiarBO scuttle around like an idiot, frantically copy/pasting his stock bashing nonsense to keep his posts at the top of the pile to try and discourage ordinary, honest folk from making a few bob.

[lbo] 25/10/2022 15:00

Same applies to the the limited significance of the De No medical device registration which all that Med3000 is undergoing. Just like other medical devices for ED





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 OK

Journalists 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 devices

Ninety-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 route

For 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.



De Novo-winning devices often lack effectiveness data, analysis shows

[petroc] 25/10/2022 14:09

False. It's been proven to work in three trials. Just because LiarBO, a proven stock basher, says they aren't adequate, doesn't mean it's true. Those trials were 'adequate' enough to interest the EU regulators and the FDA and the scientific community. Sufficiently 'adequate' to interest both large and small investors. And, of course, 'adequate' enough to make LiarBO scuttle around like an idiot, frantically copy/pasting his stock bashing nonsense to keep his posts at the top of the pile to try and discourage ordinary, honest folk from making a few bob.

[lbo] 25/10/2022 13:57

False. Med3000 itself has not been proven to work in any adequately controlled study. What has been proven to work is a placebo in ED. Be it oral or a medical device gel. All the effects of Med3000 can be replicated with any arousal gel. The rubbing, the cooling and the placebo effect. Why hasn’t even a simple blind efficacy test been done against a standard cooling arousal gel/lubricant?



‘You are the active ingredient’

[lbo] 25/10/2022 13:54

Just like with Pain. ED is primarily a self-assessed condition. Amazing how its the two indications that placebo gels are being claimed to have ‘magic’ effects! It’s all about exploiting the men’s belief’s. Like in the consumer HUT. What were the participants told about MED3000? Were they told it was a clinically proven ED gel?

Clinical assessment of the therapeutic intervention is not done with a measurable laboratory value or physical finding but is derived from patient reporting and in ED indirectly from partner perception.

In the course of ED and Pain evaluation, therapy selection, and outcome assessment, the patient and physician enter into an intimate communicative relationship in which there is some element of bias. Physician bias arises from the desire to achieve an excellent response without side effects, and patient bias may occur in the additive unconscious need to please the physician. This may lead to treatment outcome inaccuracies, with an over-reporting of efficacy and an under-reporting of treatment side effects.




Percentage change from baseline has the lowest statistical power and was highly sensitive to changes in variance.

[petroc] 25/10/2022 13:49

'There are many reasons why symptoms can improve over the course of a trial, of which the placebo effect is only one.' And the most obvious of those reasons is of course the product actually working, so thanks to LiarBO for pointing out the obvious - MED3000 works, in 60% of patients.