Cocoa Beach, Florida: Ward Photonics has announced today the opening of enrollment in a clinical study for photobiomodulation for Lung Inflammation in patients recovering from pulmonary inflammation. This study will evaluate the use of red light to relieve inflammation and resulting respiratory distress in patients with ongoing symptoms after infection with COVID-19.

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Research

IRB Clinical Trials: Fat Reduction

In 2018 multi-site clinical trials (NCT02867150 at ClinicalTrials.gov), researchers documented that UltraSlim® Professional provides the results that so many of your patients want:

Immediate Results. All patients lost fat immediately -- without dieting, exercise, drugs, or surgery.

Dramatic Fat Loss At Each Visit. Patients lost an average of 1,580cc of fat in just 32 minutes (3.5" combined waist, hips, and thighs). During one visit!

Works For Everyone. Every patient had clinically significant losses at each visit, ranging from 717cc to 4,608cc (1 5/8" to 10" from the waist, hips, and thighs).

Durability. Patients seen at follow-up had lost an additional 1 1/8" of fat during the week following treatment. With UltraSlim®, patients lose the fat permanently through a natural bodily function known as "lipolysis", whereby the contents of their fat cells are excreted primarily in their waste.

IRB Clinical Trials: Cellulite and Fat Reduction

In 2018 multi-site clinical trials (NCT03647748 at ClinicalTrials.gov), researchers documented that UltraSmooth® is second only to UltraSlim® Professional for fat reduction (average losses of 3.9" 14 days post-treatment) and UltraSmooth® also significantly improves the appearance of cellulite noninvasively.

IRB Clinical Trials: Effects of a Red/Gold/IR LED Combination Light on Reduction of Fat

We are currently sponsoring clinical trials (NCT04525573 at ClinicalTrials.gov) as an open-label evaluation of the effects of a red/gold/IR LED combination light on the reduction of fat. The results shall be compared to previous results from a comparator UltraSlim® device utilizing only red LED monotherapy for the non-invasive reduction in fat layer for body contouring.

IRB Clinical Trials: Treatment of Lung Inflammation

We are currently sponsoring clinical trials (NCT04524715 at ClinicalTrials.gov) to determine if a reduction of pneumonic inflammation occurs after treatment with our investigational device applying red-light technology in the respiratory system of patients suffering from acute viral pneumonia.

The United States Patent and Trademark Office has also accepted our U.S. Patent Application No.: 63/074,790 for the treatment of respiratory diseases and more generally a utility patent for RESPIRATORY TREATMENT DEVICE AND METHOD UTILIZING OPTICAL EMITTERS, as invented by our COO Terry "Judson"Ward II and CEO Terry J. Ward, Sr., M.H.A.

Other Clinical Studies

Listed below are studies demonstrating the power, penetration, and efficacy of UltraSlim®, along with blood chemistry studies which find no increase in serum triglycerides or cholesterol:

• Intra-Surgical Study of Fat Reduction In Vivo


• Trials by Robert H. Burke, MD, MS, DDS, FACS, FICS


• Blood Chemistry Studies by Drs. Ruth and Olaf Rustad


• IRB Clinical Trials NCT02867150 at ClinicalTrials.gov


• Comparison of UltraSlim® and Laser Transmission Through Skin and Fat


• UltraSmooth^® Clinical Trials 2020

Other novel research currently includes the treatment of lymphedema by vascular surgeon Michael Romberg, MD, FACS and the treatment of surgical wounds by investigator Robert H. Burke, MD, MS, DDS, FACS, FICS.

Accreditations

Independent laboratory testing, bench testing, animal testing, international standards accreditations, and U.S. patents awarded for the UltraSlim® Professional and UltraSmooth® include:

• IEC 60601-1:2012 reprint Medical Electrical Equipment - Part 1 General Requirements for Basic Safety and Essential Performance.
  
  
• IEC 60601-1-2:2007 Medical electrical equipment. General re-quirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests.
  
  
• IEC 60601-2-57:2011, Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetics.
  
  
• ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 - Part 1 General Requirements for Basic Safety and Essential Performance.
  
  
• IEC 62471:2006 Photobiological safety of lamps and lamp systems.
  
  
• ISTA 3A Shipping & Handling (ASTM) testing.
  
  
• Toxikon Animal Testing 14-00947-N1 Non-GLP Report.
  
  
• FDA Good Manufacturing Practices.
  
  
• FDA Clearances K160880, K150336, and K180338.
  
  
• Manufactured subject to US Patents No. 9,044,595, 9,498,641, and 9,808,314.
  
  

Patents and Trademarks

The United States Patent and Trademark Office has awarded our inventors U.S. Patents No.: 9,044,595, 9,498,641, and 9,808,314 and has accepted our pending U.S. Patent Application No.: 63/074,790 for respiratory treatments.

We also have patents issued or pending in 146 other countries.

The United States Patent and Trademark Office has also awarded several registered trademarks, including UltraSlim^®.

Our patents, trademarks, and other intellectual property are held by Blue Water Innovations, LLC.

MDSAP certification

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