Wednesday, December 20, 2023

CASE STUDY 1 & 7: EDEMA & NEAR INFRARED LASER

The following is an anecdotal performance report from an academic series of case studies of the Aspen Laser Apex Model Exploring the science of photobiomodulation therapy (PBMT).   Reports collected were from May 4-July 7, 2023 under the medical supervision of BARD DIAGNOSTIC IMAGING.  Quantitative imaging reports in this review were conducted strictly with the use of 3D Doppler Ultrasound imaging and Elastographic technology and are submitted by Dr. Robert L. Bard.


CASE STUDY #1: EDEMA / L HAND

5-23-2023   1:53:23pm   

Patient presented evidence of edema on both hands / wrists after impact. PBM light treatment occurred on left hand only and is scanned with Doppler Blood Flow and Elastography to identify edema in median nerve.

PATIENT NARRATIVE: Around 5-9, I fell down a flight of stairs and landed on my hands causing major bruising and significant inflamed swelling on both. I used ice on it frequently + 600mg ibuprofen and counted on nature to make it go away.

On 5/23, I experienced a 15 minute demo treatment of the (Aspen) laser on my left hand only. I would say like right away I noticed a difference. I had more flexibility in my wrist right away. It just continued to get better and better (from the treatment). I was able to sleep through the first night without any pain when I rolled over on my hand. The next day, the purple began to fade and it started to turn yellow- indicating recovery. The other hand (untreated) was still purple. It was interesting to see the comparison and that the hand that was treated was the worst hand. I could see the recovery on the spot! And by the second or third day, it was completely gone- and the other hand was still purple. As an athlete, I'm no stranger to bruises and bumps from things like falling off a bicycle. My one experience with this laser therapy was the fastest recovery...I would say by double, if not triple, because the purple started going away right away.    


CASE STUDY #7: DERMAL EDEMA

INITIAL NOTES from 6/21: Lymphedema in the right arm from breast cancer surgery. The patient expressed that lymph node was not painful, but that the arm felt heavy. A scan from the elbow down to the wrist indicated massive subcutaneous edema. Epidermal thickening from 0.2 millimeters to 0.9 millimeters, epidermal thickening, dermal edema from 1mm to 2mm, and the subcutaneous tissue was bulging and firm and expanded to 12mm when the normal side was three millimeters. Patient expressed improvement upon 1 (20 min) treatment/exposure to PBM light therapy.  The ultrasound imaging shows dark edematous thickening of the epidermis to three millimeters, and the elastography confirms the mean of three kpa demonstrating that this is edematous fluid. Adjacent to the edema is a scar which shows up at 4.6 kpa showing that it's harder tissue than the edema.

PHYSICIAN’S NOTES: The importance of elastography in imaging edematous tissue is to find out where the inflammatory edema or backup edema is causing a permanent fibrotic or scarring process. The last study demonstrates that fibrosis or scar formation is now beginning in the tissues of the leg. So medical attention has to be paid to this to reduce the edema that will result in scarification and fibrosis of a permanent nature.



THE PBM DEVICE UNDER REVIEW / ASSESSMENT & INITIAL STUDIES

According to the National Institutes of Health, Laser therapy has widely attracted experts’ attention in medical sciences for its proven benefits in areas including (but not limited to) regenerative medicine, cosmetic, dentistry, neurodegenerative diseases and an ever-growing list of disorders. Basic concepts and various kinds of lasers which are applied in medicine report laser therapy’s response to various fields of medicine such as pain reduction and wound healing in several other body organs at high potential for success. [1]

It is reported that the mitochondrial respiratory chain is a suitable chromophore for red to near-infrared light. It can be concluded that mitochondria are appropriate targets in laser therapy (photobiomodulation therapy). It is a well-known fact that mitochondria are the important organelles of the cells which contain critical biomolecules such as reactive oxygen species (ROS), nitric oxide (NO), adenosine triphosphate (ATP), and cyclic adenosine monophosphate (cAMP). It is proposed that laser therapy affects the production of these biomolecules, which is accompanied by the initiation of cell proliferation. This, in turn, induces the signal cascade effects. Recently, researchers have published findings of the role of LLLT in the prevention of endothelial dysfunction development in COVID-19 patients. Based on these investigations, the clinical experience of the treatment and rehabilitation of COVID-19 patients is affected by LLLT. [1]


APEX NEAR INFRARED THERAPY: Upon review of the company’s information: the Apex Laser series is the world’s first and only laser device of its kind, the Apex Tri-Wave Laser Series is changing the way health care professionals are treating pain and injuries. Uniquely featuring three wavelengths of 810nm, 980nm and 1064nm, the Apex Tri-Wave incorporates 15 watts of high power with each wavelength for a combined total output of 45 watts.  Their TRI-WAVE technology capacitates 810nm, 980nm and 1064nm wavelength. The Aspen Laser can deliver more energy than other therapy lasers. More power equates to deeper penetration, faster treatment times and delivery of the proper therapeutic dosage, an enhanced ability to treat difficult conditions, and ultimately better clinical outcomes.

REGULATORY APPROVED TECHNOLOGY
Since the early 1970s, lasers have been categorized in four classes with two subclasses based on a laser’s wavelength and maximum output of power. The classes group lasers according to their ability to produce damage in exposed people, from class 1 (no hazard during normal use) to class 4 (severe hazard for eyes and skin). [Sourced from AspenLaser.com] HealthTech Reporter™ offers performance reviews of health technologies that received regulatory approvals.  Our diagnostic test drivers have assessed the Apex laser system’s documentation to meet FDA clearance as a Class II Medical Device and a Class IV Laser (CDRH). 



EFFICACY REVIEW 

Since march of 2023, Dr. Robert Bard initiated a multi-pathology study of pulsed bioenergy treatments. This specific study is a clinical evaluation of treatments volunteers @ the Bard Diagnostic facility at 121 E. 60th St. NYC. In pursuit of the many reports of success in inflammation reduction, applying the effects of the cellular regenerative properties of photobiomodulation (near infrared) field directly on various pre-confirmed disorders. Supervised exposure shall be provided by Dr. Bard and his research team through the use of real-time 3D Doppler Ultrasound and other non-invasive imaging devices. The initial (Image Guided) treatment shall be conducted @ the NYC clinic where Dr. Bard established base line studies and immediately after, PBM treatments and ultrasound scans under periodical comparative imaging. Dr. Bard recorded any and all progress within the time allotted- collecting any/all quantifiable data about the state of the volunteer’s pathology. Any progress is identified by quantitative blood flow scans or elasographic (tissue elasticity) scans. This information is often collected by the diagnostic imaging technologies selected for this study at Dr. Bard’s scanning devices. 

3D DOPPLER ULTRASOUND: A MAJOR ASSET TO RESEARCH  
From simple case studies to double blind clinical trials, the many benefits of non‐invasive imaging offers visual proof of treatment  efficacy.    Ultrasound  in  particular  is  more  widely  used  to  collect  a  patient's  biometric  data  safely  and efficiently, thanks to its vastly improved quantitative reporting capacity.   Under exploratory device tech reviews, this video shows the effects of electromagnetic pulse wave stimulation and the induction of therapeutic lasers on the body are  just  some  of  the  noninvasive  modalities  that  are  easily  monitored  with  an  ultrasound  scan.  In  the  case  of 
electromagnetic devices, the involuntary muscle contraction is evidence of the electrical changes in the targeted muscle developers of this technology continue to find new evidence, supporting its ability to recover the body's process through cellular regeneration on a preliminary study, quantitative measurement that the regenerative timeline through the use of  a  neurostimulator  through  a  simple  before  and  after  comparison  can  easily  show  the  body's  reaction  to  the 
therapeutic device. 

MANUFACTURER'S OVERVIEW:

The Mindray Resona 7 platform begins with proprietary and industry-first virtual beam-formation technology, ZONE Sonography® Technology+. The acquisition of larger and more robust acoustic data sets coupled with proprietary, industry-first virtual beamforming methods and innovative signal processing techniques translates into a number of unique imaging advantages. These include extremely fast image processing and display for noticeably improved temporal resolution; exceptional image uniformity throughout the field of view with improved spatial and contrast resolution. ZST+ also has the ability to generate novel and exclusive advanced diagnostic applications while improving the performance of established imaging technologies. Virtual beam formation will continue to shape the future of ultrasound imaging in impactful ways, allowing for more powerful technology, improved workflow tools, and the inclusion of more AI-based advancements. ZST+ has paved the way for the future of ultrasound.

Mindray’s High Fame Rate Sound Touch Elastography utilizes the advantages of ZST+ with smoother transition times and faster refresh rates for more consistent acquisition and assessment during live 2D shear wave imaging allowing for more rapid, reliable, and reproducible quantitative results.  

Advantages include:
- Patented ultra-wide beam tracking technology improves penetration, especially for stiff tumors, fatty livers, and obese patients
- Rapid acquisition with high reliability for improved efficiency and throughput
- Consistent results with high reproducibility
- Four quality measures for improved inter-operator variability and diagnostic confidence: motion stability, tissue homogeneity, reliability map, and reliability overlay visualization
- Continuous-fire STQ acquisition methods for more results in less time, enhancing the patient experience
- Combination STE and STQ mode for continuous-fire point measurement with the added advantage of quality maps 

For complete information on this technology, visit: www.MindrayNorthAmerica.com


SPECIAL THANKS

The producers of this exploratory performance test (HealthTech Reporter) wishes to thank Dr. Robert Bard for his innovative vision to convert his clinical diagnostic ultrasound imaging facility into a research validation lab for academic and scientific advancement of non-invasive technologies.  Accordingly, we also express our deepest gratitude to Charles Vorwaller, CEO/Founder of Aspen Laser and Mark Murdoch (demo/training advisor) for their vast insight and technical participation and for the generous loan of the Apex Laser model. Further thanks goes to Michelle and Frank marcantonio of Mindray NA for their unending and gracious support and for the loan of the Mindray Resona 7- without whose help this study would not have been made possible.

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