Effect of Erchonia Laser on Erectile Dysfunction

A Pilot Evaluation of the Effect of the Erchonia® HLS™ on Individuals With Erectile Dysfunction

This study is to see if applying low-level laser light can provide improvement in erectile dysfunction

The purpose of this pilot study is to determine the effectiveness of the Erchonia® HLS™, manufactured by Erchonia Corporation (the Company), in providing improvement in erectile dysfunction.

Inclusion Criteria:

• Male between 40 and 80 years old
• Known or suspected vasculogenic ED based on clinical history
• In an active sexual relationship with a minimum of 2 sexual attempts per month for at least one month prior to enrollment
• Suffering from ED for at least 6 months
• Testosterone level between 300 - 1000ng/dL within one month prior to enrollment
• Hgb A1C less than or equal to 8% within one month prior to enrollment
• Total IIEF-EF scores between 8-25
• EHS score greater than or equal to

Exclusion Criteria:

• ED due to radical prostatectomy, prior pelvic surgery, or radiation therapy to the pelvis within 12 months prior to enrollment
• Men with known neurogenic or psychogenic ED
• Anatomic malformations of the penis including Peyronie's disease
• Testosterone greater than 300ng/dL or 1000ng/dL
• Hgb A1C greater than 8%
• International Normalized Ratio greater than 2.5, and men on any blood thinners other than 81mg aspirin
• Active testicular or prostate cancer