LPG’s Cellu M6 Keymodule Gets FDA Clearance for Treating Lymphedema

Miami, FL (November 17, 2008) – According to the World Health Organization, Lymphedema afflicts hundreds of millions worldwide. Of these, the US Department of Health and Human Services estimates more than 300 million are American. Various forms of massage are used to treat this painful condition, but none really have enough consistency or depth-of-action to produce results. But now one does. The Food and Drug Administration (FDA), has just given the Class 1 Cellu M6 Keymodule, manufactured by LPG, Inc. (a medical device company renowned as the world leader in connective tissue technology), full FDA clearance for Lymphedema. The new claims are as follows:

• Reduction of secondary Lymphedema of the arm (SLA) post mastectomy (RX only)
• Improvement of secondary Lymphedema (RX only)
• Improvement of lymphatic circulation in the treated area (RX only)

For this FDA clearance, LPG presented well-documented, scientifically proven clinical results showing the Technology’s efficacy on the body’s circulatory, anti-edematous and dermatrophic systems. Along with these published studies, multimodal clinical studies examining the efficacy and durability of the traditional Manual Lymphatic Drainage (MLD) and Compression Bandaging (CB) versus the non-invasive LPG Treatment were conducted by Neil Piller, M.D., Professor for Lymphology at the Lymphedema Assessment Clinic of Flinders University Medical Center in South Australia.

Michel Van Welden, the Chief Executive Officer of Techno-Derm (LPG’s exclusive US distributor), explains, "Dr. Piller’s research demonstrates that LPG Technology offers an all-inclusive, standardized therapy for SLA pathology – with greater consistency, efficacy and faster results than MLD – which confirms that LPG devices are essential for treating patients with Lymphedema.”

The study included 45 patients with a Lymphedema volume difference of > 200 ML who had had a mastectomy and auxiliary clearance with SLA within at least 31 mo. (post-chemo and/or radiotherapy). The 24 in the LPG test group completed 16 sessions for anastomosis mobilization and drainage (4 times a week over 4 weeks) for 25 minutes (duration/session). The 21 in the MLD Control Group completed 16 sessions on the unaffected and affected arms, neck, back, upper am and torso (4 times a week over 4 weeks) for 45 minutes (duration/session).

Participants were required to have not had active arm or LPG Treatment prior to entry. Evaluation criteria included perometry imaging device for volume and cutaneous skinfold circumference measurements, tonometry for bio-impedance measurements, lymphoscintigraphy for functional modifications, echography for tissue thickness and structural modifications and self questionnaires of QDV impact on pain, hardness, and heaviness.

The research concluded that the LPG Treatment showed significant decreases in perometry (18%), bio-impedance (23.5%), and tissue softening in half the time as the MLD control group and with a sustained effect. What’s that mean? That LPG’s FDA cleared Cellu M6 Keymodule presents a lastingly effective solution for millions of Lymphedema sufferers around the world. Lymphedema occurs whenever lymph nodes have been damaged - so although this study examines the Cellu M6 Keymodule’s treatment of breast cancer mastectomy Lymphedema – it’s also ideal for Lymphedemas resulting from lumpectomies, radiation treatments and many other procedures.

Study Information:
Professor Neil Piller, MD is a lymphologist and the Team Leader of the Lymphedema Assessment Clinic at Flinders Surgical Oncology. He is a professor at the Flinders University Medical Center in South Australia and co-author of The Lymphedema Handbook: Causes, Effects and Management, 2002.

Company Information:
LPG Technology is marketed and distributed by Techno-Derm, LLC, (DBA: LPG America), 10800 Biscayne Blvd., Ste. 850 in Miami, Florida. For more on LPG treatments and LPG’s FDA-cleared medical devices, visit www.cellum6.com.

Contact Information:
To view a copy of Piller’s study, learn more about LPG’s FDA Lymphedema claims or schedule an interview with a Company representative, please contact Rebecca Hausen at 305-335-8696 or by email revcom.group@gmail.com.