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Dear Fellow Practitioner,

There's been some exciting news this week! Erchonia has announced that the FDA has granted Erchonia clearance to market its FX 635 low level laser for the temporary relief of chronic, nociceptive musculoskeletal pain. This is amazing news! Now even more patients can be helped with the incredible technology of low level laser therapy! Scroll down to see the full press release.

We want to help you deliver the best results to your patients using the FX 635. To this end we are happy to announce the release of our brand new FX 635 A-Z Laser Protocol Manual! This is available as a web based tool or in a printed version.

Please check out our newly redesigned online store at shop-performancepractic.com. You'll find a vast selection of tools and training to help you enhance your clinical practice.

Dr. Jerome

FX 635 Manual Now Available!

Dr. Jerome Rerucha's popular FX 635 Manual is now available as an online, web based, interactive tool. This online version allows you as the practitioner to easily reference any of the 370+ protocols (and categories) and get instant information to treat your patient. No more flipping through a book with your patient watching. 

This tool works great from any browser - whether it's on your computer, tablet or even your mobile phone.

This online version will evolve over time. Dr. Jerome will be adding additional protocols, information and even instructional videos.

Topics Include:

*Online subscription at $9.99/month is for a minimum of 1 year term.

Please watch this video explaining how our Online A-Z Manuals work.

The FX 635 manual is also available in print.

PRESS RELEASE:

FDA Clears Erchonia's FX 635 for Relief of Chronic Musculoskeletal Pain

MELBOURNE, Fla., July 17, 2019 /PRNewswire/

Erchonia Corporation, the global leader in the manufacturing and development of low level laser therapy technology ("3LT"), today announces that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its FX 635 low level laser for the temporary relief of chronic, nociceptive musculoskeletal pain.

Erchonia received FDA clearance after submitting results from double-blind and placebo-controlled clinical trials with 255 patients. Those treated with the FX 635 documented a 49% average pain reduction post treatment protocol. No other therapies were used in conjunction with the laser treatment.

For comparison, the SPACE randomized clinical trial1 published in JAMA 2018 compared using opioids and non-opioids to treat overall chronic musculoskeletal pain. In the study, 119 patients were treated with opioids, and 119 patients were treated with non-opioids. At three months, results showed a reduction in pain of only 20% with opioids and 26% with non-opioids, mainly NSAIDS. This study also implemented many adjunctive therapies such as exercise, physical therapy and chiropractic care.

"While our previous clearances from the FDA have already set us apart from the rest of the therapeutic laser industry, until now, they have all been limited to specific areas of the body," comments Charlie Shanks, VP of Erchonia. "Now Erchonia has the only whole-body indication based on Level 1 clinical data. Based on these results, the fact that there are no known negative side effects, and that it's non-addictive, our low-level laser technology should be considered first. It's more effective than opioids or NSAIDS when treating chronic musculoskeletal pain when you compare the SPACE study results with those Erchonia submitted to the FDA."

Although this new 510(k) is not limited to one specific area of the body, market clearance was also based on Erchonia's previous Level 1 blinded and controlled clinical trials on chronic neck and shoulder pain in 2002; plantar fasciitis, or heel pain, in 2014; and low back pain in 2018. Erchonia's other 510(k) market clearances for post-surgical pain in 2004 and 2008 were not part of this FDA submission as they were acute pain studies, not chronic pain.