FastSize® Extender: Non-Surgical Treatement for Peyronie's Disease

Leading Researcher to Test European Peyronie's Device

FOR IMMEDIATE RELEASE | UROLOGY SPECIALISTS | 5/04/2006 | Aliso Viejo, Ca. Leading American Urologist Dr. Laurence Levine, of Urology Associates in Chicago, is about to embark upon a “proof of concept” medical trial to investigate the use of traction therapy in the treatment of Peyronie’s Disease. The disease results in unnatural bends in penile tissues that can range from mild to totally debilitating. It affects an estimated 9-12 percent of all American males.

The therapy is already widely used in Europe where studies and published papers have shown excellent success rates. Medical traction devices designed to deliver this therapy have been “CE” marked in Europe - a standard of manufacture and performance that meets government approval.

Levine, recognized as an authority on Peyronie’s Disease, has followed the development of traction therapy treatment in Europe and late last year decided to see if European trial results could be duplicated in the US. Levine obtained sponsorship for the study from FastSIZE LLC, a California-based manufacturer of the European style traction therapy device. Called the FastSize© Extender, the device can also be used as a non-surgical treatment for penile enlargement. As a result, Levine has organized a pilot study that is now about to get under way. The study will be a formal clinical trial under Institutional Review Board guidelines and may be the precursor to a larger trial next year.

The study will make its results known later this year through medical publications and via FastSize© website. Until the introduction of the FastSize© Extender into the US last year, there were few treatments available for Peyronie’s Disease. Promising results have been obtained from the off-label use of a three-cylinder vacuum therapy device designed for the treatment of erectile dysfunction (ED). Now the Extender, especially with its successful history in Europe, provides another option to patients with the debilitating disease.

Dr. Levine is scheduled to make introductory remarks about the trial at lectures to be delivered at the annual convention of the American Urological Association late in May of this year in Altanta, Ga.

Leading Urologist Expresses Interest in Traction Device for Peyronie's Patients

FOR IMMEDIATE RELEASE | UROLOGY SPECIALISTS | 6/29/2006 | Aliso Viejo, Ca. Dr. Laurence A. Levine of Urology Specialists of Chicago, Ill is predicting wider availability of new Peyronie’s Disease treatments from the medical profession following meetings at the annual American Urology Association last week.

Peyronie’s Disease is caused by the build up of scar tissue in the penis. The scar tissue or “plaque” prevents expansion of the tissue of the penis to which it is attached during the erection process resulting in narrowing, shortening, and most commonly unnatural bending in the penile shaft. The disease affects as many as 10-12 percent of American males. Mechanical traction devices have been used in Europe for a number of years to stretch the penile tissues and straighten them over time. Levine’s research will seek to reproduce and study this process in the U.S.

“I have had discussions with other researchers about the use of drugs such as Verapamil, which is injected into the scar tissue to modify the abnormal scarring process. There was a great deal of interest in use of the FastSize© Extender as a splint, which could be used to remodel the scar tissue by stretching the penile tissue,” said Levine.

“Penile traction devices, vacuum therapy devices, both with and without the use of drugs such as Verapamil and Interferon are holding out the promise of significant correction of penile deformity caused by Peyronie’s Disease. We believe that viable treatment modalities that can become standards of care for this problem are now on the horizon for American patients,” Levine added.

Levine is a leading American thought leader in urology research and practice. He is currently heading up trials on the FastSize© Extender from FastSize LLC to further establish the efficacy of this device as a treatment for Peyronie’s Disease. The device is an American-made version of similar devices used for several years in Europe. The trial, which is now under way in Chicago, will report its results later this year.

“We are very happy to note that the medical profession is taking an interest in our Extender device and the many contributions it can make to the treatment of Peyronie’s,” said FastSize© President Brian Walter.

Significant Peyronie's Curvature Correction Achieved in IRB Trial with Penile Traction Device

FOR IMMEDIATE RELEASE | UROLOGY SPECIALISTS | 5/21/2006 | Aliso Viejo, Ca. fsPhysioMed, a Division of FastSize, LLC., announced today that its mechanical penile traction device, the Extender, has been demonstrated to produce from 10 degree to 45 degree improvements in Peyronie's curvatures for study patients. The device also produced up to a 2 cm increase in length with accompanying increases in girth.

The trial was conducted as a controlled study by Dr. Laurence Levine, of Chicago IL. Dr. Levine, a leading researcher and author in the field of Peyronie's Disease, said, "This was a small, proof of concept trial and the preliminary results are very encouraging indeed. Penile traction appears to offer an effective, non-invasive, and non-surgical treatment option for Peyronie's Disease. This is the first treatment option of its kind that has undergone clinical trials. The most exciting result is that every patient had some degree of measured improvement in their penile deformity. The data will no doubt be the basis of larger, multi-center trials in the future. For now, it is a reliable indication that mechanical penile traction can offer a significant degree of relief for sufferers of this condition."

The recently completed trial will be the subject of professional articles and presentations by Dr. Levine.

"We will now work to get this information to physicians and specialists so that they can inform patients of this new treatment option," said Mike Hays, Vice President of fsPhysioMed. "This is a debilitating condition that affects many men. Now physicians can offer their patients a safe, effective, and tested alternative to surgery and other invasive treatments."

Peyronie's Disease results in an unnatural curvature of the penis caused by scarring within the penile tissue. Research has yet to identify a specific cause, or cure for the disease.