Plethora Solutions Holdings Plc Regulatory News (PLE)

14 Nov 2008 07:00



Embargoed Release: 07:00hrs Friday 14 November 2008

Plethora Solutions Holdings plc

New Study Confirms the Role of ErecAid® as First Line Treatment for Erectile Dysfunction

Plethora Solutions Holdings PLC ("Plethora", AIM : PLE), the specialist developer of products for the treatment and management of urological disorders, announces results of a study confirming the role of its product, ErecAid®, as supplemental first line treatment for erectile dysfunction (ED). ErecAid® is marketed through Plethora's US subsidiary, Timm Medical Technologies, Inc.

The phosphodiesterase five inhibitors (PDE5i) such as Viagra® and Cialis® have become a major resource in the management of ED. Unfortunately, 30-50% of men report inadequate results with these oral medications. When patients fail to respond to the oral medications, physicians are often forced to consider more invasive and more complicated second line agents such as penile injections or urethral suppositories.

New data from a multi-center clinical trial led by investigators at Johns Hopkins School of Medicine demonstrate that use of the ErecAid® vacuum erection device to augment PDE5i therapy can greatly improve patient satisfaction. Results of the study were presented at a recent North Central Sectional meeting of the American Urological Association.

Investigators at four separate study sites evaluated 69 men aged 36 to 82 with ED of diverse etiology who had responded inadequately to PDE5i therapy. Study subjects were allowed to continue use of PDE5i's but were instructed to use the ErecAid® device as an adjunct to their current oral medication. Study subjects were assessed using three validated measurements of erectile function and sexual satisfaction: the International Index of Erectile Function (IIEF-5), the Sexual Encounter Profile (SEP-2 and SEP-3) and the Global Patient Assessment Scale (GAPS). 

After 4 weeks of supplemental treatment with ErecAid®, the IIEF-5 score improved substantially from a baseline of 9.0 to 17.6 (pthe addition of ErecAid® (pi at baseline (GAPS responses of "not at all" or "slightly"), 31 (74%) reported moderate or great improvement (GAPS responses of "moderately" or "greatly") at the end of the 4 week study (p

According to Dr. Arthur Burnett, Professor of Urology at Johns Hopkins School of Medicine and the lead investigator of this trial, "This study confirms an earlier trial that many patients can achieve excellent results using ErecAid® as an addition to oral PDE5i therapy. Based upon these results, I would encourage physicians treating ED to consider the importance of this approach in their treatment protocols and to discuss this option with their patients".

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About Plethora:

Plethora is focused on the development and marketing of products for the treatment of urological disorders. The Company has products in clinical development for the treatment of overactive bladder, stress urinary incontinence, interstitial cystitis, gynaecological pain, erectile dysfunction and premature ejaculation. In January 2006, Plethora acquired Minneapolis (Mn) based Timm Medical Technologies Inc., which markets products for the treatment of erectile dysfunction (ED) to urology clinics through a US-based specialty sales team. The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM:PLE) 

Further information is available at www.plethorasolutions.co.uk