PAIN SUFFERER'S PERSONAL LOG: TEST DRIVING PEMF

TEST DRIVING PEMF: THE FIRST 30 DAYS
By: Stephen "Mr. Pain" Signorile  | Produced by IPHA Editorial Team

I'm a man who's had an awful lot of problems. If you saw my list of surgeries, (it goes back to 1987), you'll get an idea about my relationship with PAIN.  Since the summer off 2023, I committed to a self-induced pilot study designed by the Integrative Pain Healers Alliance and HealthTech Reporter magazine to test drive a PEMF company called AuraWell. This is pulsed electromagnetic frequency therapy. It's not a silver bullet but everything I read about this science and this particular model seems to makes sense to me.  It's core effect is CELL REGENERATIVE therapy and it addresses inflammation non-invasively.  I've logged each daily use and after 2-3 weeks, I would say that my pain level has been reduced to 60% or 65%. 

MAJOR SURGERIES
I've had several orthopedic surgeries- the latest being spinal fusion surgery on my entire lumbar spine. I've had hip replacement. I've currently got problems with my left knee and both shoulders. 

DEPRESSION
One of the very important effects that it's had on me is it has greatly reduced my symptoms of depression.  I wasn't able to effectively deal with my depression, but I saw results using the P E M F device within days. I wasn't waking up in the morning, dreading the day. Now I wake up in the morning and I'm like, Hey, this is great. Another day I've got something I've gotta do and I'm gonna do it. The other thing is, I'm usually sitting with my dog on my lap, so I guess she's close to the energy field - but lately, she's been much nicer. 

WRAP UP STATEMENT
You'll like the results. I consider it to be the answer to a lot of ailments. The best thing I can say, the easiest thing is that it works. Maybe that's part of the reason why I'm, I'm not as depressed. I don't have to worry about how am I going to feel today. 

#     #     #

Sponsored AD

---

Originally published @ Journal of Modern Healing: October 18, 2022

HEALING, STRESS AND THE PARASYMPATHETIC SYSTEM 

Written by: Roberta Kline, MD

Analyzing STRESS & ANXIETY from a holistic point of view means identifying the body’s interconnected systems (ie. circulatory, cardiovascular, nervous, lymphatic, endocrine etc.) and its many touch points for stimulation.   This analysis should also offer a comprehensive breakdown of the body's HEALING capacity- which includes our hormones, digestive system, immune system, brain, heart-- all the way down to our cells and mitochondria.   

Stress is part of life, and comes in many forms including physical, emotional, mental and environmental. Foods we eat, unhealthy relationships, difficulties at work, toxins in our environment, even poor posture or lack of sunshine can all create stress on our bodies. But when stress is catastrophic or becomes chronic, it creates imbalances in this functioning that are much more likely to promote disease while at the same time preventing healing from taking place.  With people under record levels of chronic stress, it is no wonder we have an epidemic of people suffering from all sorts of health issues and chronic diseases. Heart disease, diabetes, obesity, pain, anxiety, depression, infertility, cancer, autoimmune diseases such as arthritis, neurodegenerative diseases such as Alzheimer’s …. These are just some of the many health conditions that have been linked to diet and lifestyle including chronic stress.   But how does this work? And is meditation the answer to reversing this trend? Science is revealing some interesting clues. (see original feature)

---

STUDY OF INTRACRANIAL IMPACT DISORDERS - Concussions are viewed as a mild form of traumatic brain injuries and most frequently occur following an event that involves an acceleration–deceleration mechanism without actual injury to the head, such as whiplash, or the head striking an object. As we study these, researchers and clinicians are learning that these are fairly common, but often underdiagnosed.  While the vast majority of people with concussions recover without obvious disability, people can end up with long-term cognitive, emotional and functional issues affecting quality of life – including memory issues and Alzheimer’s disease. Efforts to better predict outcome from head injuries by focusing on the age, sex, type of injury and acute assessments have led to some improvement, but still fail to predict or explain the variation in healing and outcomes. Studies in professional athletes have shown that about 80–90% are sufficiently recovered to return to playing within 7–10 days. But that means that 10-20% are not, and their recovery can take up to 3 times longer. Even taking into account variations in initial injury, this variation is difficult to explain or predict.  (see complete feature by Dr. Roberta Kline)

CONCUSSION ON THE FIELD..."Miami, We Have a Problem!" OP-ED by: Dr. Michael Gruttadauria |  9/25/2022 - The Miami Dolphins prized quarterback Tua Tagovailoa sustained what was clearly a concussion.  He was dazed and in trying to walk off the field, staggered and nearly collapsed.  He was helped off the field and taken into the injury evaluation tent.  You didn’t need to be a neurologist to see that he was shaken from hitting his head on the ground.  Incredibly, the QB cleared the NFL Concussion Protocol and to everyone’s surprise, was allowed to play in the second half of the game.  Many questions were raised about the injury following the game and everyone from the Dolphins coach, to their staff to Tua himself seemed to blame the entire incident on a back injury he said he sustained earlier in the game. (see complete issue)

ON POST-CONCUSSION SYMPTOMS By: Dr. Robert L. Bard | The underreported cases of bowel permeability to toxins in concussion is likewise mostly anecdotal. The possibility of scanning the gut for increased blood flow following brain trauma may be easily performed as followed as a guideline for evaluation of concussion chronicity. As the bowel activity is regulated by the autonomic nervous system we may apply the same diagnostic endpoints as other physiologic norms.  The response of the microvasculature in the retina provides a functional guideline as to the progression of brain trauma and concussion as measured by blood flow. The application of optical devices and sensors for physical (temperature, respiration, heart rate, blood pressure) chemical (pH, pO2, glucose, lipids, oximetry) and biological (antigens, antibodies, electrolytes, enzymes, inhibitors, metabolites, proteins)  data with imaging (endoscopy, optical tomography, confocal microscopy) adds new classifications of metabolism in the altered state. 

A PARTNERSHIP WITH SPORTS MOMS  Another key launch pad to this research program is his alliance with MOMS OF ATHLETES, co-architected by Dr. Roberta Kline (Women's Diagnostic Network) and Dr. Donna Febres.  This educational advocacy group supports clinical care and preventive science to college level athletes.  This unique alliance of professionals and moms are dedicated to finding the safest options in injury and pain care - with an emphasis on new solutions for concussion research and prevention.  This includes the modern non-invasive (non-surgical) alternatives where possible.  NCMOA also teams up with the professional pain and medical associations to collaborate on latest protocols and information on ground-breaking neurostimulation, electromagnetic, holistic/full-body solutions and wearable therapeutics plus the latest in non-radiation clinical imaging validation. (see complete details)

---

USER REVIEW: POST SURGICAL RECOVERY FROM KNEE REPLACEMENT  By: Maria Errera 

I had knee replacement surgery in mid-2021 on my left knee. I understood that everyone’s recovery is different but mine seems to be more difficult than others based on other who had it done - even with all my PT and exercises.    Meanwhile, my right knee has still bone and bone and is headed for the same procedure soon. (there's no cartilage between).   I’ve been having a hard time with recovery before I started this PEMF treatment with BOTH knees. The sensitivity, the pain, the tension of the knee, the tightness of the knee, the pressure… it was just so much that even physical therapy and exercising going to the gym. It's a slow process as compared to this one. Since I went back to work seven days a week, I haven't had the time to go to the gym nor use the treadmill or whatever exercises I have. Getting in and out of the car is agonizing at times. Kneeling in church is not there yet. The tension has kept me from consistent sleep which I’m sure affected my state of mind and social interactions. This and the pain meds that the doctor keeps sending me just make me a zombie at work! And when I go upstairs, 13 flights of stair or 13 steps, the pressure and tension kept me going one step at a time on both knees, holding on to the rails with both hands to hoist my entire body with ridiculous effort. (see full story)

---

Healing Technology: "We All Began with ANIMALS!"

INSIGHT ON PEMF APPLICATIONS - AN INTERVIEW By: Kate Baccus, Occupational Therapist

I originally found out about P E M F in 2018 as a result of my horse having a non-healing wound. He had had a laceration to the back of one of his heels on a front foot and while it didn't seem to hit any important structures, we just couldn't seem to get it to close. We tried all of the traditional veterinary therapies.  He wasn't limping or anything but we could not get that wound to close. And with an open wound, he was not able to go back to being ridden. I was grasping at straws and my vet really wasn't sure what else we could do at that point. So I went searching on the internet for anything that I could find that might kind of be out of the box thinking that could help his body potentially close this wound. That's when I came across P E M F as a modality. (see complete article)

---

Wednesday, October 18, 2023

"USING ULTRASOUND TO PROVE THERAPIES WORK!"

May 4, 2023- an independent 30-day pilot study (also known as a PHASE ONE performance study) of the effects of near infrared laser therapeutic technology (also known as photobiomodulation) as was conducted by the Bard Diagnostic Imaging & Research Lab. The test drive was coordinated in part by the academic publishing and research administrators of the Integrative Health Research Center.  Defined as an anecdotal test drive and report, this expanded product review was a collaborative spearheaded and clinically supervised by Dr. Robert Bard, diagnostic imaging specialist and Sr. Research Advisor to HealthTech Reporter projects.  Dr. Bard, a seasoned radiologist supports the implementation of quantitative ULTRASOUND imaging as the key platform for reporting on the hysiological effects induced by the Photobiomodulation Therapy device model as with other health technologies under review.

IMAGING PARADIGM: 3D DOPPLER AND ELASTOGRAPHY

For this research project, the research imaging director opted to advance the quantitative data gathering by employing the elastogram feature of the ultrasound system.  Dr. Bard recognized the capacity of a certain model- the MINDRAY™ RESONA 7 to be the ideal 'workhorse' of choice. In pursuit of physiological reactions to the PBMT energy induction, "we may anticipate fibrosis or hardness or stiffness... scan ning musculature enables us to capture measurable effects of the light/energy induction in the form of abnormal color which tracks with the value of the hardness or physical elastic change in the muscle fibers. The elastography scale (upper left of screen) from 100 represents very hard tissue or muscle spasm or fibrosis down to zero, indicating fat or soft tissue.  From this test, the elastogram reading allows for additional comparative studies alongside standard ultrasound and 3D Doppler Blood Flow biometric readings. (see complete test drive)

Disclaimer & Copyright Notice: The materials provided on this web-based newsletter are copyrighted 2023 and the intellectual property of the publishers/producers (IntermediaWorx inc and the AngioFoundation (501c3). It is provided publicly strictly for informational purposes within non-commercial use and not for purposes of resale, distribution, public display or performance. Unless otherwise indicated on this web based page, sharing, re-posting, re-publishing of this work is strictly prohibited without due permission from the publishers.  Also, certain content may be licensed from third-parties. The licenses for some of this content may contain additional terms. When such Content licenses contain additional terms, we will make these terms available to you on those pages (which his incorporated herein by reference). This feature content and the digital platforms this resides in does not support, endorse or recommend any specific products, tests, physicians, procedures, treatment opinions or other information that may be mentioned on this site. Referencing any content or information seen, published or shared by other individuals is solely at your own risk. The publishers/producers of this article reserves the right, at its sole discretion, to modify, disable access to, or discontinue, temporarily or permanently, all or any part of this Internet web site or any information contained thereon without liability or notice to you.

---

IMAGING REVIEW: TEST DRIVE OF THE MINDRAY™ RESONA 7 IN A PHASE 1 PILOT STUDY

INTRODUCTION

May 4, 2023- an independent 30-day pilot study (also known as a PHASE ONE performance study) of the effects of near infrared laser therapeutic technology (also known as photobiomodulation) as was conducted by the Bard Diagnostic Imaging & Research Lab.  Candidly known in their clinical circles as "SCAN & TREAT", this performance study design conforms to the real-time use of ultrasound technology for base-line data gathering, treatment process monitoring and post-treatment reporting of the health/medical device under review.

The test drive was coordinated in part by the academic publishing and research administrators of the Integrative Health Research Center.  Defined as an anecdotal test drive and report, this expanded product review was a collaborative spearheaded and clinically supervised by Dr. Robert Bard, diagnostic imaging specialist and Sr. Research Advisor to HealthTech Reporter projects.  Dr. Bard, a seasoned radiologist supports the implementation of quantitative ULTRASOUND imaging as the key platform for reporting on the hysiological effects induced by the Photobiomodulation Therapy device model as with other health technologies under review.

IMAGING PARADIGM: 3D DOPPLER AND ELASTOGRAPHY
For this research project, the research imaging director opted to advance the quantitative data gathering by employing the elastogram feature of the ultrasound system.  Dr. Bard recognized the capacity of a certain model- the MINDRAY™ RESONA 7 to be the ideal 'workhorse' of choice. In pursuit of physiological reactions to the PBMT energy induction, "we may anticipate fibrosis or hardness or stiffness... scan ning musculature enables us to capture measurable effects of the light/energy induction in the form of abnormal color which tracks with the value of the hardness or physical elastic change in the muscle fibers. The elastography scale (upper left of screen) from 100 represents very hard tissue or muscle spasm or fibrosis down to zero, indicating fat or soft tissue.  From this test, the elastogram reading allows for additional comparative studies alongside standard ultrasound and 3D Doppler Blood Flow biometric readings.

---

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]

TESTING THE ASPEN LASER APEX NEAR INFRARED THERAPY
Since inception, our research group launched a commitment to support non-invasive therapeutic solutions and the movement to advance a non-surgical medical future. 

The ASPEN LASER APEX series rose to our short list of intriguing reports as one of the predominant High Intensity Class IV therapy laser on the market.  For the treatment of pain and injuries, the company's design focus claims to advance the science of the 'cold laser' paradigm, uniquely featuring three wavelengths of 810nm, 980nm and 1064nm for  more strategic applications and controllable depths of penetration.  Engineering spec sheets detail the Apex Tri-Wave  to incorporate 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]. 

MAINTAINING SAFETY COMPLIANCE
Our research group selected the Aspen Laser device based on its claimed effects and advancements.  We have confirmed the Apex laser system to meet FDA clearance as a Class II Medical Device and a Class IV Laser (CDRH) and has been determined to meet market standards as a clinically safe and approved device.  

This performance review as conducted by Bard Diagnostics and IHRC (as well as all reviews of this kind) is an anecdotal test drive of non-invasive health technologies that have successfully acquired regulatory approvals for public use.  Its main objective is to publish reports supportive of our clinical findings for public access to the professional communities and is distributed for informational use only.  The use of the aforementioned device under this performance study formally complies to the regulatory approved uses of this device and the Aspen Laser certified training course.  Each treatment is supervised by a board-certified medical professional within a state licensed medical practice, thus did not require the need for IRB approval (Institutional Review Board)  and applications undergone in this test. 

---

CASE STUDY #7: PSORIASIS  / FOOT & ELBOW

FOOT:  laser compare 3-11-23.  Hx: Right foot pain  Sonofluoroscopy of the plantar and hallux tissues was performed in multiple scan planes with 18 and 20 MHz transducer frequencies.  Power and spectral Doppler was performed. Mild tendinitis unchanged.

3D DOPPLER: Normal posterior tibial and pedal arterial Doppler flows. No regional hyperemia. Triphasic waveforms. Peak vel 11cm/s. Hyperemia decreased to the dip joint. 3D shows abnormal dermis decreased from 2.1mm to 15mm.

ELASTOGRAM: Decreased edema psoriatic plaque (light blue) with early fibrosis of talar ligament (yellow). 

IMPRESSION:

- Decreased Dermal Inflammation

- Mild Ligament Fibrosis And 

-Tendinitis  

PATIENT NARRATIVE
“I have been suffering from PSORIASIS since I was 25. Periodically my psoriasis gets inflamed and gets very scaly and very itchy. (When I scratch, which is often it gets worse). I received my first treatment with the (Aspen) Laser back in March, 2023 and I received various treatments afterward. I continue to have this laser treatment on my right foot, which is the worst and on my right elbow.  Lately, the scaling seems much flatter.  I don't know whether it's the laser or some of the other home treatments I'm doing for myself… but it seems to be quite a bit improved”.

---

CASE STUDY #9: 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".

---

CONCLUSION STATEMENTS:

Written by the IHRC Testing Team

IHRC acquired several technologies to fulfill this study; the Aspen Laser near infrared light therapy for the performance test drive, and the Mindray™ Resona 7 Ultrasound system as the imaging solution.  Both offered significant findings on their own merit.

As it stands today, the use of ultrasound in research studies continue to bring consistent real-time scans and recordings.  From the establishment of a base line to all stages of treatment progress, ultrasound scans provide safe multi-scanning options with an expanded set of custom probes for specific organs studied. Notably, ultrasound, doppler imaging and the elastography feature all succeeded in their abilities to provide measurable validation reports of treatment reactions (in their own way) while offering an intelligent and cost-effective imaging option for this exact type of research.

Throughout this series of performance test drives, the Aspen Laser provided surprisingly high marks from the vast majority of test subjects who received its treatments. Both the patients and the ultrasound scans reported close-to-immediate (positive) response for their disorders.  With over 75 volunteer test subjects, a significant percentage stated remarkable improvement and recovery (of their disorders) within the time of the treatment and/or days thereafter.  

As originally conceived, use of ultrasound and elastography function allowed our research team to visually identify the Aspen laser's efficacy.  Moreover, this review gave us the opportunity to explore the wide range of scanning and investigative capabilities of the elastographic paradigm under the studies of musculoskeletal and inflammatory disorders.  Additional case studies under this performance test is available in upcoming IHRC reports.

#     #     #

---

SPECIAL THANKS
IHRC, Health Tech Reporter and the Bard Diagnostic Imaging team wish to give special thanks to all the clinical technicians and volunteers who offered their time and support in completing this performance test study.  We further express our deep appreciation to the generosity and innovative vision of Aspen Laser CEO & President, Charles Vorwaller for donating the Aspen Laser Apex device to this study.  Further special thanks also belong to Michelle Carter, Frank Marcantonio and the entire team at Mindray NA for their endless support in the facilitation and use of their remarkable imaging technology and further education in ultrasound advancement. Additional thanks belong to Abdellatif Zerzif (ultrasound & laser tech) for his stellar professional performance in managing both technologies and patient care.  Also, extended thanks belong to research advisors Lennard Gettz, Dr. Noelle Cutter, Dr. Roberta Kline and Dr. Leslie Valle-Montoya for their support throughout the coordination and execution of this project, including the development of its final reports. 

IMAGING REVIEW OF SERUM PERFORMANCE CASE STUDY: EXOSOMES TOPICAL PRODUCT (part 2)

INTRODUCTION:

Sept 8, 2023- an independent single-case evaluation study (also known as a PHASE ONE performance study) of the effects of a commercial skin topical product conducted by the Bard Diagnostic Imaging & Research Lab. The test drive was coordinated in part by the academic publishing and research administrators of the Integrative Health Research Center.  

DISCLAIMER: This study is conducted as an impartial anecdotal test drive and report for public information.  This product review was designed as an academic review of imaging technologies and the effect of the exosome-based product clinically supervised by Dr. Robert Bard (diagnostic imaging specialist and Sr. Research Advisor to HealthTech Reporter projects).   This study is not in any way a commercial or marketing effort for the product(s) or technologies presented in this report.  As an unbised/impartial review, it supports the implementation of quantitative imaging as the key platform for reporting on the physiological effects as induced.

---

COMPREHENSIVE PERFORMANCE REPORT OF A TOPICAL SKIN CONDITIONING PRODUCT 

The  following is an anecdotal  performance  report  from a  single academic  case  study  to  represent  the effects of an exosome‐based topical product.  Process and reaction reports collected were from the durations of July 25‐August 21 under the strict medical supervision of IHRC/ Bard Diagnostic Imaging Center.  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. 

TOPICAL SERUM EFFICACY PERFORMANCE – RESEARCHER’S LOG 

OVERVIEW:
Case study 1 of 1: the test subject is also a professional dermatologist who clinically identified disorders in the glabellar region (the smooth  part  of  the  forehead  above  and  between  the  eyebrows)  with  skin  roughness,  itchiness  and  pigmented protrusions.   Our research team established a base line with a sonogram scan labeled “DAY 1” at high resolution. The two short arrows point to the thickened epidermis, which is normally 200 microns and it is thickened to between 300 and 500 microns‐ as indicated by the arrows and the circle. Upon review, the tissue appears to be considerably swollen between the epidermis and the bone, and the inhomogeneous echo pattern is filled with dilated subdermal glands. The significance of this is that the surface of a skin lesion in inflammatory diseases is dependent upon  the  subsurface or subcutaneous pathology, which is often not visible with the naked eye.   

In this case, after 27 days of using the product three times a day, we noticed that the arrow at day 27 points to the 200 micron  epidermis  and  the  swelling  has  greatly  reduced,  and  the  internal  subcutaneous  echo  pattern  is  more homogeneous with fewer dilated glandular regions.   From the user’s perspective, the volunteer expressed significant satisfaction after one month of progress and is now continuing use of the product with a 2nd bottle. 

ABSTRACT: Stem cells, just like every other cell in the human body, release exosomes to communicate with each other. Exosomes are membrane-bound vesicles with a diameter of about 40–160 nm, which are released from cells by an endosomal pathway. In June of 2023, the IHRC research team was introduced to the Exosome-based skin conditioning products.  They promoted topical product lines marketed to the aesthetics community as a “rejuvenating serum for at-home daily use, combining nano-encapsulated stem cell growth factors, powerful peptides, and the highest quality skincare ingredients available to support skin health and rejuvenation”. The product was also described to offer faster recovery after skin procedures. 

Global interest in the advancement of Exosomes continues to raise significant interest in the research community to explore and confirm findings about this technology as has been raised since the advent of stem cell research (early 1980’s).  Dr. Robert Bard initiated this “test drive” employing an IMAGE-GUIDED approach to monitor, track and report his findings through the use of advanced ultrasound scanning modalities.

IMAGING TRANSDUCER/PROBE TECHNOLOGY & SCAN INTERPRETATION:  On day #1, we used a 33MHz ultra‐high resolution probe. On day #27, because the roughness and puffiness of the skin had reduced, we use a 20MHz probe. What's important is the dermis is clearly seen to have two layers; one is a dark gray layer which is represented by the single arrow that points to the epidermis.  Below that is a white layer‐  which is the  bottom layer  of  the epidermis. This is indicative  of a  collagen  disease  or inflammatory  disease  process and  the epidermis,  which  still  continues,  but  the  irregularity  in  the  epidermis  and  the  dilated  inflammatory  glands  have decreased dramatically. 

PART 2: A supplemental test is to expand this line of research to detect and measure the vascular effects of the inflammation with  the  3D  Doppler  histogram  technology.  This  ultrasound  feature  is  often  used  to  quantify  the  inflammatory vascularity. In this case study, we are able to detect intradermal hyperemia and inflammatory vascularity. 

STRATEGIC  TARGETING OF INFLAMMATION
Most inflammatory diseases are  subdermal  or  dermal and are not visually evident with the unaided eye. Use of the sonogram clearly shows measurable  epidermal thickening  and  irregularity.  Our  diagnostic  scanning indicated  subdermal  dilated glands  and  cystic  areas which  are  related  to  the  inflammatory  process.  While  quantitative  imaging helps  us  identify  the cosmetic  effects  of exosomes with this product, confirming  this  with  the patient’s reported reduction of  itching  (or  pruritus reduction) aligns with the product’s anti‐inflammatory effect.  This is a conceivable indicator of the depth of penetration of this product from the surface to the subcutaneous tissues, offering potential validation of the therapeutic effects of this product. 

#     #     #

---

IMAGING MODEL USED IN THIS STUDY: THE CANON APLIO i800 (3D DOPPLER AND ELASTOGRAPHY)
For this research project, the research imaging director opted to advance the quantitative data gathering by employing the elastogram feature of the ultrasound system.  Dr. Bard's research sought the functionality of the CANON APLIO i800.  Thanks to Canon's expansive collection of transducers (probes), scanning the epidermal area was made possible in pursuit of physiological reactions to the patient's exposure to the topical exosome serum. 

PHYSICIAN'S NARRATIVE REPORT

By: Dr. Robert Bard

There are quite a few advantages to the multiple probes of the Canon Aplio i800 package, starting with the "hockey stick" probe at 22 MHz which provides focused small point resolution of a dermatologic target lesion. The fact that the probe has doppler as well is useful. The next probe in the system would be a 24 MHz pro, which has doppler imaging and elastography.  This will offer a broader view, but also show the high resolution microvascular flow in the system. Microvascular flow is different from Doppler because it shows the tiny low velocity vessels that are very important in inflammatory and malignant disease processes. Moverover, the system carries a 33MHz probe, which is essential for aesthetic use because plastic surgeons now need resolution from 500 microns. That's 0.5 millimeters to image the depth of five millimeters of dermal thickness, including the epidermal layers. The multiple functions in one readily available unit makes this device applicable for advanced, yet rapid image guided diagnostics with treatment applications based on the imaging findings.

The visual quality of the large high resolution screen was superb and  and offered a useful view to the technician and the patient who are observing the investigational use of this advanced device. The advantage of having a high resolution 33 MHz probe, which is priced competitively with the more expensive and higher resolutions, 70 MHz probes from other units make this a commercially viable office-based product. 

For complete information on the Canon Aplio i800 series, visit Canon's product site (LINK)

---

SPECIAL THANKS

IHRC and Health Tech Reporter wish to give special thanks to all the clinical technicians and volunteers who offered their time and support in completing this performance test study.  We also express our deep appreciation to the generosity and innovative brilliance of Dr. Jordan R. Plews, Co-founder & CEO of ELEVAI Labs, Inc. for his remarkable product(s), his clinical guidance and his scientific tour of the ELEVAI product development which greatly inspired the strategic planning behind this phase 1 study.  Further thanks to Mr. Michael Wetter, Ultrasound Regional Business Manager of Canon Medical Systems USA, Inc. for their professional support in the facilitation and use of their imaging technology and further education in ultrasound advancement. Additional thanks belong to Abdellatif Zerzif (ultrasound & laser tech) for his stellar professional performance in managing both technologies and patient care.  Major thanks belong to clinical and diagnostic talents of Dr. Robert Bard as well as reporters Lennard Gettz, Dr. Noelle Cutter, Dr. Roberta Kline and Dr. Leslie Valle-Montoya for their research structure and coordination throughout the execution of this project, including the development of this final report. 

---

FOR IMMEDIATE RELEASE

10/25 - Dr. Robert Bard's presentation has been approved for the Inflammatory Skin Disease Summit 2023 in Vienna from November 15-18, 2023. The conference will be accommodated at the Austrian Academy of Sciences (Aula der Wissenschaften).  This world conference welcomes experts in the medical community to discuss new concepts and new developments in the field of inflammatory skin diseases and to devise and explore new therapeutic strategies. The ISDS is promoted by the ESDR- European Society for Dermatological Research, an institute committed to the education and training of the next generation of skin researchers and to promote the highest quality skin research. The expertise that resides within the ESDR community is immense from skin research centers to individuals. 

2022 Events Courtesy of Bardvideos.com

Since the inception of his profound career in cancer research and advanced diagnostic imaging, Dr. Bard has been a staunch supporter of non-invasive imaging technologies that has proven to offer significant quantitative biometrics for a wide range of clinical uses. From pre and post-op scanning, clinical research validation and 2nd opinion scans, Dr. Bard's mission as a medical educator is to mobilize more effective strategies in pathology reporting and data gathering through the use of ultrasound functions.  He is globally recognized in conferences and throughout the medical media for his informative presentations and published textbooks on diagnostic imaging science- including his  highly referenced IMAGE GUIDED PROCEDURES series.

Dr. Bard's latest presentation to be delivered at the ISDS conference is the "ABSCOPAL EFFECTS OF IMAGE GUIDED PULSED BIOENERGY TREATMENT WITH VIRTUAL BIOPSY".  His report explores adjuvant treatment effects of modern and non-invasive therapeutic solutions such as pulsed near infrared laser and pulsed electromagnetic therapy irradiation (PEMF) and their potential in invoking an “abscopal effect,” which occurs when the primary site is irradiated, and regression of non-irradiated sites are observed. 

 ABOUT THE ESDR
The European Society for Dermatological Research (ESDR), founded in 1970, is a non-profit organization promoting basic and clinical science related to dermatology. The ESDR is the largest investigative dermatology society in Europe with a current membership of about 1100. By supporting investigative dermatology and skin research, the ESDR contributes to in-depth understanding of skin homeostasis and towards improving the health of patients suffering from skin and venereal disease, infectious diseases and immune-mediated and inflammatory disorders. Applications of recent scientific advances have produced diagnostic and therapeutic innovations in dermatological practice, particularly in genetics, skin cancer, allergic skin disease, infectious disease and autoimmune diseases.

---

Health Tech Reporter: Performance Micro Study of PBM (Photobiomodulation) part 1

May 4, 2023- an independent 30-day pilot study (also known as a PHASE ONE performance study) of the effects of near infrared laser therapeutic technology (also known as photobiomodulation) as was conducted by the Bard Diagnostic Imaging & Research Lab.  Candidly known in their clinical circles as "SCAN & TREAT", this performance study design conforms to the real-time use of ultrasound technology for base-line data gathering, treatment process monitoring and post-treatment reporting of the health/medical device under review.

The test drive was coordinated in part by the academic publishing and research administrators of the Integrative Health Research Center.  Defined as an anecdotal test drive and report, this expanded product review was a collaborative spearheaded and clinically supervised by Dr. Robert Bard, diagnostic imaging specialist and Sr. Research Advisor to HealthTech Reporter projects.  Dr. Bard, a seasoned radiologist supports the implementation of quantitative imaging as the key platform for reporting on the physiological effects induced by the ASPEN LASER™ APEX model as with other health technologies 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]

TESTING THE ASPEN LASER™ APEX NEAR INFRARED THERAPY

Since inception, our research group launched a commitment to support non-invasive therapeutic solutions and the movement to advance a non-surgical medical future. 

The ASPEN LASER™ APEX series rose to our short list of intriguing reports as one of the predominant High Intensity Class IV therapy laser on the market.  For the treatment of pain and injuries, the company's design focus claims to advance the science of the 'cold laser' paradigm, uniquely featuring three wavelengths of 810nm, 980nm and 1064nm for  more strategic applications and controllable depths of penetration.  Engineering spec sheets detail the Apex Tri-Wave  to incorporate 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]. 

MAINTAINING SAFETY COMPLIANCE
Our research group selected the Aspen Laser device based on its claimed effects and advancements.  We have confirmed the Apex laser system to meet FDA clearance as a Class II Medical Device and a Class IV Laser (CDRH) and has been determined to meet market standards as a clinically safe and approved device.  

This performance review as conducted by Bard Diagnostics and IHRC (as well as all reviews of this kind) is an anecdotal test drive of non-invasive health technologies that have successfully acquired regulatory approvals for public use.  Its main objective is to publish reports supportive of our clinical findings for public access to the professional communities and is distributed for informational use only.  The use of the aforementioned device under this performance study formally complies to the regulatory approved uses of this device and the Aspen Laser certified training course.  Each treatment is supervised by a board-certified medical professional within a state licensed medical practice, thus did not require the need for IRB approval (Institutional Review Board)  and applications undergone in this test. 

IMAGING PARADIGM: 3D DOPPLER AND ELASTOGRAPHY
For this research project, the research imaging director opted to advance the quantitative data gathering by employing the elastogram feature of the ultrasound system.  Dr. Bard recognized the capacity of a certain model- the MINDRAY™ RESONA 7 to be the ideal 'workhorse' of choice. In pursuit of physiological reactions to the PBMT energy induction, "we may anticipate fibrosis or hardness or stiffness... scan ning musculature enables us to capture measurable effects of the light/energy induction in the form of abnormal color which tracks with the value of the hardness or physical elastic change in the muscle fibers. The elastography scale (upper left of screen) from 100 represents very hard tissue or muscle spasm or fibrosis down to zero, indicating fat or soft tissue.  From this test, the elastogram reading allows for additional comparative studies alongside standard ultrasound and 3D Doppler Blood Flow biometric readings.

---

CASE STUDY #7: PSORIASIS  / FOOT & ELBOW

FOOT:  laser compare 3-11-23.  Hx: Right foot pain  Sonofluoroscopy of the plantar and hallux tissues was performed in multiple scan planes with 18 and 20 MHz transducer frequencies.  Power and spectral Doppler was performed. Mild tendinitis unchanged.

3D DOPPLER: Normal posterior tibial and pedal arterial Doppler flows. No regional hyperemia. Triphasic waveforms. Peak vel 11cm/s. Hyperemia decreased to the dip joint. 3D shows abnormal dermis decreased from 2.1mm to 15mm.

ELASTOGRAM: Decreased edema psoriatic plaque (light blue) with early fibrosis of talar ligament (yellow). 

IMPRESSION:

- Decreased Dermal Inflammation

- Mild Ligament Fibrosis And 

-Tendinitis  

PATIENT NARRATIVE
“I have been suffering from PSORIASIS since I was 25. Periodically my psoriasis gets inflamed and gets very scaly and very itchy. (When I scratch, which is often it gets worse). I received my first treatment with the (Aspen) Laser back in March, 2023 and I received various treatments afterward. I continue to have this laser treatment on my right foot, which is the worst and on my right elbow.  Lately, the scaling seems much flatter.  I don't know whether it's the laser or some of the other home treatments I'm doing for myself… but it seems to be quite a bit improved”.

---

CASE STUDY #9: 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".

---

CONCLUSION STATEMENTS:

Written by the IHRC Testing Team

IHRC acquired several technologies to fulfill this study; the Aspen Laser™ near infrared light therapy for the performance test drive, and the Mindray™ Resona 7 Ultrasound system as the imaging solution.  Both offered significant findings on their own merit.

As it stands today, the use of ultrasound in research studies continue to bring consistent real-time scans and recordings.  From the establishment of a base line to all stages of treatment progress, ultrasound scans provide safe multi-scanning options with an expanded set of custom probes for specific organs studied. Notably, ultrasound, doppler imaging and the elastography feature all succeeded in their abilities to provide measurable validation reports of treatment reactions (in their own way) while offering an intelligent and cost-effective imaging option for this exact type of research.

Throughout this series of performance test drives, the Aspen Laser provided surprisingly high marks from the vast majority of test subjects who received its treatments. Both the patients and the ultrasound scans reported close-to-immediate (positive) response for their disorders.  With over 75 volunteer test subjects, a significant percentage stated remarkable improvement and recovery (of their disorders) within the time of the treatment and/or days thereafter.  

As originally conceived, use of ultrasound and elastography function allowed our research team to visually identify the Aspen laser's efficacy.  Moreover, this review gave us the opportunity to explore the wide range of scanning and investigative capabilities of the elastographic paradigm under the studies of musculoskeletal and inflammatory disorders.  Additional case studies under this performance test is available in upcoming IHRC reports.

#     #     #

---

SPECIAL THANKS

IHRC, Health Tech Reporter and the Bard Diagnostic Imaging team wish to give special thanks to all the clinical technicians and volunteers who offered their time and support in completing this performance test study.  We further express our deep appreciation to the generosity and innovative vision of Aspen Laser CEO & President, Charles Vorwaller for donating the Aspen Laser Apex device to this study.  Further special thanks also belong to Michelle Carter, Frank Marcantonio and the entire team at Mindray NA for their endless support in the facilitation and use of their remarkable imaging technology and further education in ultrasound advancement. Additional thanks belong to Abdellatif Zerzif (ultrasound & laser tech) for his stellar professional performance in managing both technologies and patient care.  Also, extended thanks belong to research advisors Lennard Gettz, Dr. Noelle Cutter, Dr. Roberta Kline and Dr. Leslie Valle-Montoya for their support throughout the coordination and execution of this project, including the development of its final reports.