Futura Medical Share Discussion Threads

[petroc] 15/3/2024 16:39

MDI/LBO etc bleated in his semi-literate fashion, with extra full stops:

'Well if it works regularly and reliably for a good percent of people who try it and it is such a great recurring revenue stream. Then everyone and anyone will launch their own similar placebo non-medicated hydroalcoholic gels.'

Yeah, and be 3 years behind the curve. Good luck with that one, stock basher.

[mdi] 15/3/2024 15:01

Well if it works regularly and reliably for a good percent of people who try it and it is such a great recurring revenue stream. Then everyone and anyone will launch their own similar placebo non-medicated hydroalcoholic gels

No evidence exists from any double blind study that the non medicated ˜Dermasys’ hydroalcoholic gel works any better then just using any other similar non medicated hydroalcoholic gel. Others have already shown that it was proven years ago any non medicated placebo hydroalcoholic gel can have similar effects on erectile function ˜progressively improved over a period of at least 12 weeks’



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

[heialex1] 15/3/2024 14:57

Thousands a month sold on Amazon and very visible in Boots and other pharmacies zDoesn'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.Just seen it next to Durex in a Boots

[mdi] 15/3/2024 10:42

Unlike Futura’s pain gel products based on its Dermasys system which have never made it to market.



‘Licensees also market an ibuprofen gel using Antares Pharma’s ATD™ technology in several major European countries’



‘Its ATD (advanced transdermal delivery) system containing ibuprofen is being sold in several foreign countries for treating pain’

[mdi] 15/3/2024 10:12

Does the non medicated placebo hydroalcoholic ATD gel technology ‘meet criteria for same intended use’. Yes. As proven in the Libigel studies. Has ‘slightly different technology but produces similar end results’. Yes. Its made of similar solvents and also causes temperature changes by evaporative cooling. And is ‘safe and effective’. Yes. Its already on the market in gels 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’

[2 solaris] 15/3/2024 10:01

Balmy posts here all the time now as idiots respond to trolls when they could easily use the filter button. Post your drivel elsewhere please.

[onedayrodders] 15/3/2024 08:15

Nice tennis match going on here

:O(

[petroc] 14/3/2024 18:35

Tsk tsk. You managed to reply in six minutes, but the correct response should have been 'How high?'

[mdi] 14/3/2024 15:59

No evidence exists from any double blind study that the non medicated ‘Dermasys’ hydroalcoholic gel works any better then just using any other similar non medicated hydroalcoholic gel. Others have already shown that it was proven years ago any non medicated placebo hydroalcoholic gel can have similar effects on erectile function ‘progressively improved over a period of at least 12 weeks’



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

[petroc] 14/3/2024 15:52

Eroxon is approved as a medical device in the EU and was launched in March and April 2023 in certain countries in Europe with more countries to follow. It becomes the first clinically proven, pan-European OTC topical treatment for erectile dysfunction available without a doctor’s prescription.

The EU authorisation paves the way for approval in many countries around the world, including in Latin America, the Middle East, Africa and the Far East regions, with many countries considering “fast-track" review based on recognition of the EU CE mark. Marketing authorisation has now been received in five Middle Eastern countries with more to follow.

Eroxon is a unique and highly differentiated easy to use topical gel for erectile dysfunction which has Phase 3 clinical data demonstrating highly statistically significant improvement across all ED severities.

[mdi] 14/3/2024 14:14

Eroxon is not ‘clinically proven’ to have any effect beyond a similar placebo gel in any double blind study



Eroxon ‘is a placebo’



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.