IDP.L Regulatory News (IDP)

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InnovaDerma PLC

Launch of ProlongTM, the world's only FDA-cleared medical device for premature ejaculation in the United States and Australia

Launch of smilingdick.com, a 'sex positive' platform for men that aims to de-stigmatise male sexual health issues

InnovaDerma (LSE: IDP), a UK developer of life sciences, beauty and personal care products, is pleased to provide the following update:

As outlined in the Company's interim results in January, the Company has now launched ProlongTM * -- the world's only FDA-cleared medical device for premature ejaculation in the United States and Australia. The launch is being supported by a highly creative marketing campaign including a website smilingdick.com, a new, first of its kind, ground-breaking sex-positive platform with the aim to normalise and de-stigmatise discussions around sexual health and wellbeing for men.

InnovaDerma conducted in-depth research with 4,000 men and women across Australia and the United States and the findings form the basis of the launch of Prolong and smilingdick.com. Most revealing findings were one in two men in the United States believe they suffer from premature ejaculation and in Australia, one in three.

The Company is seeking CE Mark regulatory approval for Prolong and once obtained, the device will be launched in the UK and Europe.

Haris Chaudhry, Executive Chairman said: "I am delighted to be launching ProlongTM, the world's only FDA-cleared medical device for premature ejaculation in the United States and Australia together with smilingdick.com. Sexual health issues have been considered a taboo subject for far too long, igniting shame and embarrassment in sufferers, which can manifest in various negative ways -- impacting mental wellbeing and relationships. Through Prolong and Smiling Dick, we aim to provide a non-prescription solution with long term benefits and a platform to help people feel open and supported in what should be a healthy and normal dialogue."

Dr Andy Zamar, Medical Director, Consultant Psychiatrist, Founder of The London Psychiatry Centre, and Creator of Prolong Device said: "A loss of sexual confidence can have a huge impact on mental wellbeing, being linked to increased mental health issues as well as substance and alcohol abuse. For lifelong sufferers of premature ejaculation, finding a permanent solution has previously been hugely costly and time consuming, with treatments limited to techniques like cognitive behavioural therapy. This has meant that many men have not been able to seek support, and have been left feeling isolated. Through this program, we're able to offer men a cost effective, permanent solution -- with no side effects -- which they can use in the privacy of their own home."

About InnovaDerma

InnovaDerma PLC (LSE: IDP) specializes in the research, manufacture and marketing of clinically proven products in life sciences, beauty and personal care products. InnovaDerma has presence in Europe, US, Australasia, Asia and Africa. 

To find out more about Smiling Dick and the Prolong Device and Climax Control Training Program, visit smilingdick.com.

*About the Prolong Device and Climax Control Training Program

· ProlongTM is a Class II vibrating medical device as classified by the FDA and used as part of a climax control program for males who suffer from premature ejaculation. It is designed to increase the time between arousal and ejaculation through the use of the training sessions using the stimulating vibratory effects of the device on the penis as part of the "Start-Stop" technique. Prolong offers an affordable, pain-free, one-off, or long-term treatment option with no side effects. The ProlongTM prototype delivered efficacy 338% above the combination of the Start-Stop technique with behaviour therapy alone, which is the current gold standard treatment for premature ejaculation. In a clinical trial in Finland which featured a group of lifelong sufferers of premature ejaculation, 70% of patients who failed on all known treatments including drug treatment, improved after being treated with ProlongTM and the improvement was either sustained or improved six months after completion of the treatment.

About smilingdick.com 

Smilingdick.com is a first-of-its-kind 'sex positive' platform for men, which hosts a range of sexual health content providing information and tips delivered through a positive, progressive, and inclusive lens. So why does Prolong want to help dicks smile? Sexual health issues like premature ejaculation have been considered taboo for far too long, igniting shame and embarrassment amongst sufferers, which can negatively impact not only relationships, but mental wellbeing as well. Through smilingdick.com, Prolong aims to pioneer a more progressive and positive discussion, and help people feel open, supported, and comfortable in what we think should be a healthy and normal dialogue.