Futura Medical Share Discussion Threads

[glavey] 21/11/2022 16:31

"local penile burning was noted in MED3000 users"

'A slow burner', those involved know they are going to get burnt, eventually.

[petroc] 21/11/2022 14:09

LiarBO said 'The rampers feeble attempts at deflecting is so predictable every time they are proven to be wrong!' Hahaha! Not only can he barely string a few words together, he is yet to prove anyone wrong! What a fool, thinking that if he keeps repeating the word 'proven', it will make it so. Hehehe! He doesn't have a shred of proof that MED doesn't work.

[petroc] 21/11/2022 14:08

'The efficacy of Eroxon® is remarkable and has been shown to deliver clinically meaningful benefits to most sufferers with erectile dysfunction in two Phase 3 studies but with significantly lower adverse events than current first line therapy. With topical application, it will be of particular appeal to mild to moderate ED patients who want a fast onset of action. Lack of drug interactions with prescription products will enable the product to be used with other medications such as nitrates and other cardiovascular drugs. As such the product will be of great interest to the medical community' - Prof David Ralph

[petroc] 21/11/2022 14:07

MED3000 was approved in April 2021 as a medical device in the EU and becomes the first clinically proven, pan-European OTC topical treatment for erectile dysfunction available without a doctor’s prescription. In April 2022 Futura also received approval for a UKCA mark.

The CE mark approval of MED3000 from the EU Notified Body 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.

MED3000 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 patient severities and recently approved in the EU as a medical device with potential over the counter peak sales of US$650 million

[petroc] 21/11/2022 13:10

Safety profile
MED3000 was shown to be an effective treatment for ED in both the FM57 and FM71 Phase 3 studies and demonstrated a highly statistically significant improvement across all ED patient severities than before treatment along with an excellent safety profile. In addition, adverse events were substantially lower than typically seen with oral ED treatments

[lbo] 21/11/2022 09:56

Oh and there are Carbopol alternatives on the market so a competitor can still create a cooling gel similar to Med3000 with all the same ingredients of water, alcohol, gycol and carbopol.







177 days is all it will take to a have similar product on the market via the 510k pathway. No clinical studies required for similar alcohol, water and glycol gels claiming to treat ED with evaporative cooling. And remember Futura still haven’t even shown that evaporative cooling or needing a cabopol excipient to make the gel feel nicer is what is having any effect! LOL



‘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’



‘This 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’

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

[c140] 21/11/2022 07:38

lbo - thank you for the links. However re: 'Go to 6 min 45sec in and you will hear him say many couples use lubrication and its not too much different from that' Not really sure he's saying that - wasn't he commenting on lubrication in foreplay and you are correct, our product is not too much different when utilised in foreplay activity. ED sufferers will buy our product and see if it works for them.

[lbo] 20/11/2022 20:49

David Ralph also made some interesting comments about MED2005 in this chat in Feb 2019. Before Med2005 failed in its Phase 3 drug trial. And Futura’s hand was forced to go down the route of getting the placebo Med3000 gel approved as a Medical device.

Go to 6 min 45sec in and you will hear him say many couples use lubrication and its not too much different from that. But he could say that with MED2005 as it still contained GTN and had not yet failed so it was different. But now MED3000 with no drug is just rubbing on a cooling lubricant/arousal gel made just of alcohol, water and glycol that the man believes is an effective treatment for ED.





GSK also knew it was just a lubricant having placebo effects all along. Even before it failed phase 3. And now with the GTN ‘penile enhancer’ action removed after the phase 3 failure of Med2005/2002. Med3000 is nothing more then a lubricant with placebo effects when users are led to believe ˜it works’ to treat ED.



No Goopy ED Gel in GSKs Futura



After Phase III Failure, UK Firm Pushes Placebo to Treat Erectile Dysfunction