Futura Medical Share Discussion Threads

[2 solaris] 19/3/2024 09:06

So much for the Futura Medical thread.

[mdi] 18/3/2024 18:52

Its not even necessary to support any similar hydroalcoholic medical device gel CE mark applications with any real supporting efficacy evidence.



Researchers call for stricter rules on drug-like medical devices

More oversight is needed over products in the grey area between medical device and medication

Powders, tablets and gels used like medications but registered as medical devices the same category plasters and pacemakers fall into need tighter controls, a team of clinical researchers has concluded after studying several such materials. Products that fall into this regulatory grey zone dont need to prove their efficacy or safety in the same way pharmaceuticals do, which could be a concern for vulnerable patients

According to European regulations, medical devices are used for diagnosis, prevention or treatment of disease, but unlike drugs their primary mode of action isnt biological. The definition includes everything from medical software to wound dressings and surgical instruments

Manufacturers need to demonstrate medical devices safety and performance. An organisation called a notified body then assesses the products conformity and grants it a CE mark. But Van Winckel and her colleagues found only poor clinical evidence for the three devices they investigated. Studies were small or of low quality, often missing placebo controls. In some cases, there was no data at all, for example to show the effect

The researchers also highlighted the lack of safety information in the devices instruction leaflets. There was no or little mention of interactions with other compounds, maximum safe dose or adverse effects



Oral powders or gels, sold as medical devices in the European Union (EU), arent regulated to the same safety standards as those applied to medicines

As a result, these products, which look like medicines, can be marketed with very limited clinical data and accompanied by poor quality product information.

require only certification with a CE (quality) kitemark before the product can be marketed.

This process doesnt require evidence of efficacy or safety from high quality clinical trials, as is the case for medicines.

It also means that these products can automatically be sold without a prescription across the EU, and actively marketed to patients and clinicians.

[mdi] 18/3/2024 18:24

‘Doesn’t have to work for everyone, but if it works regularly and reliably for a good percent of people who try it, that’s a great recurring revenue stream’

If that’s the case. Then companies like Reckit who own Durex will also see it as a ‘great’ return on a very small investment too. They will all be submitting applications for similar hydroalcoholic medical device gels to market. They will also all cause evaporative cooling and can be supported by the many studies showing similar placebo gels are ‘clinically proven’ to have positive effects in many blinded ED studies and are all safer then Oral drugs..



The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process.

One of the positive sides to seeking a FDA 510K approval for a new medical product, whether tested or untested, is that if there is already a similar FDA approved product being marketed, then the FDA will have to approve any new products that are almost the same as the product that is already FDA 510 K approved and have under gone all required testing, documentation, and registration processes.

[petroc] 18/3/2024 17:59

One of the most frequent health claims made about apple cider vinegar is that it can help manage blood sugar levels.

A 2004 study published in the Journal of the American Association of Diabetes suggested consuming the vinegar as part of a meal containing carbohydrates, like potatoes or rice, may improve glucose and insulin levels after you have eaten.

This, in theory, helps combat the high blood sugar levels that can lead to issues like diabetes.

Researchers gave participants a meal of a bagel with butter and a glass of orange juice.

After the meal participants were then given 20 grams of apple cider vinegar or a placebo.

Blood glucose levels of all participants were then checked at 30 minutes and again a hour after the meal.

This showed those that had the vinegar had lower blood glucose levels.

Other studies that used humans and not just test tubes also drew similar conclusions.

But researchers in one 2016 study found the vinegar is more effective in healthy individuals rather than diabetics.

However, drinking a shot of apple cider vinegar after a meal will not take the place of diabetic medications.

Although many studies suggest there is some beneficial affect on blood glucose many of these are 'very short and often not blinded', said Professor Gunter Kuhnle an industry-recognised food scientist at the University of Reading.

[mdi] 18/3/2024 17:33

Voltaren vehicle gel application resulted in a rapid reduction of skin surface temperature by 5.1°C after only 3 min with an average maximum reduction of 5.8°C after 10 min. The cooling effect was experienced by 94% subjects



Voltaren® Gel also contains
carbomer
isopropyl alcohol,
propylene glycol,
purified water,

[petroc] 18/3/2024 16:28

Keir Starmer has praised Sadiq Khan's ULEZ expansion saying he did not want his children to 'breathe dirty air'.

The Labour leader offered backing to the controversial policy at the official launch for the London Mayor's reelection campaign.

Sir Keir previously sat on the fence after the spread of the £12.50-a-day charging zone was blamed for his party losing the Uxbridge & South Ruislip by-election in July.

But at the joint event this morning, he insisted he supports 'everything Sadiq is doing' on clean air.

'I say to people who challenge me on clean air. I say I've got two kids. They're 15 they're 13 and I don't give them dirty water to drink and I wouldn't want them to breathe in dirty air,' Sir Keir said.

Mr Khan, who is hot favourite to beat Tory Susan Hall and secure a third term in City Hall, also took a swipe at critics.

Speaking to reporters, the London mayor said of the scheme: 'When we first planned to bring it in in central London, there were people who were hostile and anti. It came in and the sky didn't collapse.

'We then expanded it to inner London, lots of complaints and concerns and by the way the Tories have been consistent in opposing it at all levels, the sky didn't fall in.

Keir Starmer offered backing to the ULEZ policy at the official launch for Sadiq Khan's (left) re-election campaign.

Sir Keir previously sat on the fence after the spread of the £12.50-a-day charging zone was blamed for his party losing the Uxbridge & South Ruislip by-election in July

'We then expanded it to outer London and here's the great news – 19 out of 20 cars seen travelling on an average day are compliant… they don't pay a penny more.'

Mr Khan said he would have gone 'further and faster' if he was not being 'held back' by a Tory government.

Despite polls indicating he is on track for a big win on May 2, Mr Khan said the contest would be a 'two-horse' race and the 'closest' ever between himself and Ms Hall.

He said: 'It's a choice that will determine if London's brightest days are ahead of us or behind us, and if the next generation of young Londoners will be better off than the last.

[mdi] 18/3/2024 14:48

Does any similar non medicated placebo hydroalcoholic gel ‘meet criteria for same intended use’ Yes. As proven in all the Libigel/ Tadalafil/Testosterone gel studies. Has ˜slightly different technology but produces similar end results. Yes. All hydroalcoholic gels are made of the same main solvents that also cause temperature changes by evaporative cooling. And are all ‘safe and effective. Yes. The hydroalcoholic gels are already fully FDA approved and been on market for years delivering drugs.




˜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



‘De Novo authorization will also allow subsequent devices of the same type and intended use to come to the market through the 510k pathway, which could enable the devices to get on the market faster’



the average time to issue a decision in 2021 was 147 days according to FDA data.

For the year up to the end of September 2022, 85 percent of 510(k) applications were issued with a Substantially Equivalent decision from the FDA. A Substantially Equivalent decision means the product has regulatory approval to be sold in the US market.

[mdi] 18/3/2024 10:26

Auxilium Pharmaceuticals can also get their non medicated placebo hydroalcoholic gel cleared via the 510k pathway as a ‘clinically proven’ medical device.





Researchers found that, over 14 weeks, men who were randomly assigned to take Viagra plus testosterone gel did no better than those given the drug plus a hormone-free placebo gel.

Overall, men in both groups responded to the drug, Spitzer said.

On average, the men's score on a standard set of erectile dysfunction questions increased by about 8 points removing them up to the "mild" erectile dysfunction category. And there was no substantial difference between men who used the testosterone gel and those who used the placebo



Testim® (testosterone gel) is a clear to translucent hydroalcoholic topical gel

Inactive ingredients in Testim are purified water, pentadecalactone, carbopol, acrylates, propylene glycol, glycerin, polyethylene glycol, ethanol (74%), and tromethamine

[glavey] 18/3/2024 05:55

Erexon: 335 out of 429 (78%) reviewers recommend this product

Eroxon: 342 out of 456 (75%) reviewers don't recommend this product

[mdi] 17/3/2024 19:14

Any similar Hydroalcoholic gel made of the same main ingredients as Eroxon. Alcohol, water and glycol causes evaporative cooling. And other placebo hydroalcoholic gels have already been ‘clinically proven’ to work in many other ED studies. So they can all now seek marketing clearance via the 510k pathway as similar equivalent non medicated class 2 medical device gel treatments for ED.



‘In hydroalcoholic gels, the solvent evaporates quickly’



Preferred solvents in use in ATD technology are alcohols, glycols and glycol ethers.

Following evaporation of the solvents, thermodynamic activity in the residual vehicle (glycols, glycol ethers and water) is increased



Men were first treated with tadalafil 10 mg once a day (OAD) for 4 weeks; if not successful, they were randomized in a double-blind, placebo-controlled design to receive placebo or a 1% hydroalcoholic T gel (50 mg/5 g gel)

Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment groups

[mdi] 17/3/2024 17:43

‘a non-medicated hydro-alcoholic gel indicated for treatment of erectile dysfunction in adult males aged 22 years and over. Upon application, the volatile components of the formulation (alcohol and water) evaporate’

‘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 immediatelyââ

[mdi] 17/3/2024 17:14

Besins too can submit to get the pharmacologically inactive ingredients of their hydroalcoholic gel cleared in a matter of days via the 510k pathway as an equivalent non medicated evaporative cooling medical device gel ‘clinically proven’ to treat ED. Its already FDA approved delivering Testosterone.





Manufactured by Laboratoires Besins Iscovesco

AndroGel (testosterone gel) 1% is a clear, colorless hydroalcoholic gel containing testosterone.

Pharmacologically inactive ingredients in AndroGel 1% are carbomer 980, ethanol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active.



Researchers found that, over 14 weeks, men who were randomly assigned to take Viagra plus testosterone gel did no better than those given the drug plus a hormone-free placebo gel.

Overall, men in both groups responded to the drug, Spitzer said.

On average, the men's score on a standard set of erectile dysfunction questions increased by about 8 points “moving them up to the "mild" erectile dysfunction category. And there was no substantial difference between men who used the testosterone gel and those who used the placebo.

[mdi] 17/3/2024 16:08

Another similar hydroalcoholic gel vehicle from Besins Healthcare. It too can now be cleared via the 510k pathway as a ‘clinically proven’ non medicated placebo medical device for ED







‘In hydroalcoholic gels, the solvent evaporates quickly’

[broomrigg] 17/3/2024 15:44

MDI - 09 Sep 2016 - 12:08:41 - 832 of 13278........

"What a week it has been for Futura Medical, which has more than tripled in value after unveiling some quite impressive results for a new gel it has developed for erectile dysfunction (see I got all the way through that sentence without a schoolboy pun).

It now has a product that can challenge pill-based treatments such as Viagra and Cialis in this $5billion a year market.

Crucially, Futura's gel, to be branded Eroxon, acts in as little as five minutes, where the little blue pill might take up to half an hour."

[broomrigg] 17/3/2024 15:43

MDI 26 Feb '15 - 08:41 - 46 of 13267........

"Yeah and the systemic side effects of Viagra are very mild!? Dry mouth, facial flushing etc. never mind the new cancer concerns associated with Viagra. And it's definitely a drug your doctor would not advise you take OTC and buy online. Just hope you don't get sent the ones with rat poison mixed into them from some back street factory. But if you are willing to use rubber bands to get an erection then I am sure a bit of blue rat poison won't hurt either? Maybe it will kill the STDs from also not using a condom!"