FDA Approval

25 Sep 2006 07:04

Plethora Solutions Holdings PLC25 September 2006 Plethora Solutions receives 510(k) Marketing Approval from US FDA for diagnosis and evaluation of ejaculation latency using the SAM(TM) (PSD401) device. London, UK - Sept. 25 2006:- Plethora Solutions Holdings plc ("Plethora" or the"Company", AIM:PLE) announced today it has received 510(k) clearance from the USFood and Drug Administration (FDA) to market its SAM(TM) device (PSD401). Theproduct will be used for the reproducible measurement and recording ofejaculation latency time in clinical trials and in the diagnosis, evaluation andmanagement of patients with premature ejaculation. The product has alreadyreceived CE mark approval for European marketing. Ejaculation latency time is the key parameter in the measurement and managementof premature ejaculation (PE); a condition that affects up to 30% of the adultmale population. Although there is no approved pharmaceutical treatment for thecondition, there are currently several potential PE drug treatments at variousstages of clinical development. In these clinical studies, ejaculation latencytime is assessed currently via a stopwatch, which lacks consistency andaccuracy. The SAM device enables data to be captured in clinical trials ofpotential PE drugs in a more reproducible manner and the product has alreadybeen utilized in several clinical trials with some of the data reported in arecent paper in BJU Int. (2006, 98(3) 613-8). Ultimately, it is anticipated that the SAM device will be used more widely inurology clinics for the general evaluation and management of the many millionsof men suffering from PE. To pursue this objective, Plethora will continue togenerate additional clinical data over the next six months that will be used toobtain coding in the US for reimbursement as a diagnostic procedure. In the US, the device will be marketed through Plethora's subsidiary TimmMedical which successfully markets a similar device, Rigiscan(R), formeasurement of erectile function in the diagnosis of erectile dysfunction. TheSAM product also complements Plethora's therapeutic product for the treatment ofPE, PSD502, which completed a Phase II study at the end of 2005. This studyreported a statistically significant (four-fold) improvement in time toejaculation with PSD502 compared to placebo and no reported side effects. Professor Culley Carson, Rhodes Distinguished Professor and Chief of Urology atthe University of North Carolina and a past president of the Sexual MedicineSociety of North America commented: "The SAM device represents a great advancein our ability to measure ejaculation latency reproducibly. It could expeditethe development of drugs for treating premature ejaculation. Ultimately it couldform an important component of the clinical management of the many men sufferingfrom PE." Steven Powell, CEO of Plethora, commented "The marketing of the SAM device isconsistent with our objective of putting additional, complementary products intothe Timm sales force. We are confident that the fit of SAM with Timm's existingproduct portfolio will ensure timely generation of additional revenue fromexisting resources." For further information contact: Plethora Solutions Tel : 020 7269 8630Steven Powell Collins Stewart Tel : 020 7523 8350Tim Mickley City/Financial Enquiries Tel : 020 7379 5151MaitlandBrian Hudspith/Liz Morley Scientific/Trade Press Enquiries Tel : 020 7861 3838DeFacto CommunicationsRichard Anderson About Plethora Solutions: Plethora Solutions (AIM:PLE) is a rapidly growing London, UK-based specialtypharmaceutical company created in 2003 to develop and market new products todiagnose and treat urology disorders. With a proven track record for rapid andcost effective drug development, Plethora Solutions now has eight products inits clinical development pipeline with indications in sexual dysfunction,urinary incontinence and uro-gynaecology. Of these, five are in Phase IIstudies. The Company has two marketed products, Erecaid(R) and Rigiscan(R),which will soon be complemented by the SAM(TM) device. These products aredistributed via Plethora's US subsidiary, Timm Medical Technologies, Inc., whichhas a specialty urology sales force. Further information is available at:www.plethorasolutions.co.uk This information is provided by RNS The company news service from the London Stock Exchange