Erchonia

 

Erchonia Medical began in 1996 with the intent of becoming the “World Leader in Low Level Laser Technology™.”  We knew this was going to be an arduous task because, at the time low level laser therapy was considered experimental in the US, virtually unheard of by US healthcare professionals and experimental by the FDA.  To achieve this goal, Erchonia Medical made the commitment to do what it took to overcome the existing prejudges and controversies.  Knowing that only proven scientific data could overcome preconceived perceptions, Erchonia Medical developed a business model with the following objectives: ·  Research – Erchonia Medical committed to prove all hypothesis through clinical trial in order to ensure the governing agencies that heretofore had outlawed such devices, that Erchonia Medical’s brand of low level laser therapy (3LT™) was a viable medical modality.·  Quality – Erchonia Medical adopted the existing US and International code regulated standards for medial devices as our standards for operation, before any one or any governing agency considered them more than “alternative,” establishing manufacturing and marketing controls that would elevate product perception from “underground” to emerging technology.· Application – Erchonia Medical would apply their commitment to research and quality to all facets of the business, the business model, and the outcome.  By this, we would transform the knowledge base achieved through clinical research into trainable practical application. This bold move, coupled with the evidence of its implementation, (ref: accomplishments below), has in our twelve years in operation, earned us the goal we original set forth – World Leader in Low Level Laser Therapy (3LT™) 

 

MILESTONES:

 

1) Pioneered Low Level Lasers as a viable medical device in the US and worked with FDA representatives to champion the development of a new category for Biostimulation devices - NHN (laser Classification).

2) Granted first FDA market clearance for a low level laser in US January 17, 2002  

a) Device - Red single diode

b) Indication - Chronic neck and shoulder pain

3) Granted second FDA market clearance September 30, 2004    

a) Device - Red multi-diode   

b)Indication - Low Level Laser Assisted Liposuction and reduction of pain associated with surgery

4) Granted third FDA market clearance May 2, 2005  

a) Device - Red/Violet multi-diode  

b) Indication - Dermatological conditions, Acne Vulgaris

5) Granted fourth FDA market clearance March 1, 2007  

a) Device - Iontophoresis/Galvanic Generator   

b) Indication - Plantar/Palmer Hydrophoresis

6) Submitted for 510(k) Market Clearance - Breast Augmentation - Expected 11/07  CLINICAL RESEARCH:

 1) Chronic Neck and Shoulder Pain/Low Level Laser – 2000 - Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study  

a) Used in support of 501(k) submission

2) Chronic Neck and Shoulder Pain/Low Level Laser – 2001 - Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study  

a) Study results used to obtain FDA clearance

3) Carpal Tunnel Syndrome/Low Level Laser- 2004 - Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study  

a) IRB Approved  

b) Awaiting implementation

4) Breast Implantation/Low Level Laser – 2007 - Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study 

a)  Study completed  b) Results used in 510(k) - Submitted 8/13/07, expected market approval 11/07
5) Hair Restoration/Low Level Laser – 2008 - Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study  

a) IRB Approved  

b) Awaiting implementation
6) Burn Healing and Pain Reduction/Low Level Laser - 2005 - Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study 

a) In development 

b) FDA final evaluation completed, waiting on grant money.
7) Low Back Pain - 2008 - Sponsor and Monitor, double blind, placebo controlled, multi-site, clinical study 

a) Developing the clinical study protocol.
8) Body Contouring - Laser Scanner:  Waist, Hips, and Thighs-Pilot Study 

a) Conducted informal pilot - 2006 

b) Finalizing FDA comments 

c) Clinical Trial started - 11/ 2007 9) Hearing Laser - 2006  

a) Obtained IRB approval  

b) Started clinical trial in April 2007  

c) Study 30% complete  

d) Preliminary results - 44% difference between Real and Placebo
10) Capsular Contracture Study – James Baker, MD – To begin 2008  PATENTS:1) 6,875,186 - Pressure Activated Device 2) 6,605,079 - Laser Assisted Liposuction Application 

a) US and PCT Countries

3) 6,746,473 - Therapeutic Laser Device, Multi-diode 

a) US and PCT Countries4)Numerous Patents pending 

b) Device

c) Applicationc) US

d) PCT  UNIVERSITY RESEARCH:1. University of California - San Diego  

a. Flap Study - 10/07 - Completed  

b. Apoptosis - 04/07 - Completed   c. Mitochondria / ATP - On going - Completion in early 2008
2. Columbia University  

a. Acne - Awaiting IRB Approval - To be completed in 20083. University of Cincinnati  

a. Muscle Strength - Clinical Trial on going PUBLICATIONS:· Plastic and Reconstructive Surgery - Neira - 2001· AACS – Neira, Jackson, Dedo - 2002, 2003, 2004, Pending review for 2007· Clinics in Plastic Surgery - Neira - 2006· Aesthetic Plastic Surgery - Neira - 2003· Journal of Clinical Laser Medicine and Surgery - Al WatBan – 2004· Liposuction 2006 Neira  PRESENTATIONS

BURNS·  NABS - UCSD, Nelson, Shanks - 2002, 2003, 2004 2005, 2006, 2007· ABA - Nelson - 2004· Southwest Regional - Nelson - 2005· John Bostwick International Meeting - Nelson – 2005· Plastic and Reconstructive Surgery Meeting – 2002-2004 LIPO·  Plastic, Reconstructive and / or Cosmetic Surgery    - ASPS - Neira, Ramirez - 2001    -  AACS - Neira, Jackson, Dedo, Roche, Butter wick, Lim - 2002, 2003, 2004, 2005, 2006, 2007    -  ASAPS - Slattery - 2003    -  ADD - Slattery - 2003    -  Mexican Plastic Surgery Society - Rameriz - 2003    -  CA Plastic Surgery Society - Slattery - 2002    -  World Congress on Liposuction - Neira, Jackson, Dedo - 2002, 2003, 2004, 2005, 2006, 2007
 ·  ASLMS   - Lipo - Shanks   - Pain - Shanks WOUND HEALING· APTA - Chu, Kleinkort - 2002, 2003

 Contact :

 

Dr.Steven Shanks

President Erchonia Medical

E-mail: CShanks@erchonia.com

Debra J. Engolia

IP Manager

Erchonia Medical

214.733.5209 DR

888.242.0571 TF

972.632.6171 CL

E-mail: DEngolia@erchonia.com

Website: www.erchonia.com