Health Tech Reporter

Wednesday, April 17, 2024

THE “cUSBr Patch” WEARABLE ULTRASOUND: MEET THE LATEST ADVANCEMENT IN BREAST CANCER IMAGING

Report / Edited by: Roberta Kline, MD

3/18/2024‐ In a recent review on the latest medical diagnostic innovations in early detection and interventional imaging, MIT NEWS published a review on the development of the wearable breast ultrasound patch. This device is designed to be integrated into a bra for long term use, allowing for more frequent monitoring of patients at high risk for breast cancer from the convenience of their home. Dr. Tolga Ozmen, a breast cancer surgeon at Massachusetts General Hospital who is also an author of the study gave us an exclusive interview about the concepts behind this technology and his clinical involvement leading to bringing this groundbreaking diagnostic device to market.

Dr. Tolga Ozmen is a breast surgical oncologist affiliated with Mass General Hospital and is a faculty at Harvard Medical School. He highlights that the inventor of this novel wearable ultrasound device is Dr. Canan Dagdeviren and her team at the MIT Media Lab. Dr. Dagdeviren, known for her distinguished contributions to science, shares a common research interest with Dr. Ozmen which is advancing breast cancer detection and early diagnosis, which has brought their paths together.

INTERVIEW with Dr. Tolga Ozmen

As the study is still ongoing, I cannot discuss the full details‐ but I can tell you that our preliminary results were very successful. It was published in the Journal of Science Advances. Our wearable ultrasound device showed similar performance measurements as conventional ultrasound device in detecting breast lesions.

The results of our preliminary study are very compelling. In the next phase of our study, we will be exploring the performance of our device in a larger cohort of patients. Our objective is to confirm a baseline of (at least) the same performance as the conventional models – within a much larger number of patients. And if everything goes as planned, I don't see any reason why we can't hit the market in the next 10 years.

This device will contribute to breast imaging by offering a convenient method to screen women with dense breast tissue or women with high breast cancer risk. Our device is a wearable bra- shaped automated device that the patient will put on herself. The patient can do this easily and take this device home for their convenience. The images will be taken by the ultrasound patches placed on the cup‐shaped conformable device, and the data will be sent to a central unit via wifi.

Source: MIT News

Deep learning based algorithms will generate the interpretation of these images and if any concerning findings are detected, it will alert us and the patient will be recalled to a radiology unit or a breast health center for additional imaging or an additional physical exam. For this reason it has the potential to be used as the first step for screening in patient with high risk or dense breast tissue. Today's breast cancer treatment is becoming more personalized as a result of increased knowledge. We can now tailor treatments to patient demographics ( i.e. race, age) and tumor characteristics. With accumulating knowledge, we can now also extend personalized approaches to screening strategies including modalities and frequency intervals based on each woman's breast cancer risk.

The current standard in breast cancer screening for average risk women includes yearly breast exams and mammograms starting at age 40. This is an effective screening method for decreasing breast cancer mortality in average risk population, backed by numerous published research studies. But we also know that mammography has been shown to be inferior to other imaging modalities in certain cases, including women with dense breast tissue. In the presence of moderate or extreme density of breast tissue, the sensitivity of mammogram decreases significantly, reducing the ability to detect breast cancer. In these women, supplemental imaging modalities in addition to mammography are often indicated.

In some cases, there are findings on the screening that require close follow up. Especially if these women are already identified as being at higher risk, they would benefit from follow up in 3-6 months rather than the standard one year.

I think our device is the perfect solution for these and other similar scenarios because it makes the follow-up surveillance much easier for the patient and the physician. Another benefit is that our device uses an ultrasound technology which is ideal for reading dense breast tissue. Ultrasound is very efficient and is highly sensitive for detecting abnormalities in dense breast tissue, and this is especially relevant for younger patients at high risk due i.e., inherited genetic mutation, etc.. These women can be screened with this device more frequently, and this device makes it easier because they can take it home and wear it regularly rather than having to take time to go to frequent imaging appointments. This paradigm has the potential to greatly improve accessibility and increase compliance with breast cancer screening.

We potentially see patients wearing this device as often as every couple of months, enabling us to detect changes early. There are often scenarios where screening mammography and/or ultrasound may show abnormalities that aren’t concerning enough to warrant biopsy but do benefit from close follow-up. Often the patient is requested to come back in 3-6 months. Wearing this device between mammogram visits could offer new data in the form of significant changes in the size or characteristics of that abnormality. Any new images can be generated and reviewed at the central unit, and compared with previous imaging. This interventional imaging allows us to watch the changes on a particular mass or lesion more closely and intervene sooner than their regular screening schedule when warranted.

INTEGRATING WEARABLE BREAST SCANNER WITH CURRENT IMAGING SCHEDULES

I envision that insurance companies, hospitals, or imaging centers would carry our device and lend it to patients who need frequent follow-ups. If the patient has increased risk or has suspicious lesions as I described, our device may be helpful in detecting any changes or abnormalities much earlier, and then these patients can be invited back to the hospital or breast imaging center for further workup. There is also a great benefit to the patient who feels less stressed knowing that she is receiving close attention, rather than worrying until her next scheduled imaging appointment.

AFFECTING PERSONALIZED TREATMENT WITH EARLY DETECTION

I want to emphasize that every woman has different rate of risk for breast cancer. This is why it is important to personalize each woman’s screening strategy. For average risk women, starting mammograms at age 40 is the standard recommendation, but we know that doesn’t fit many women who are at higher risk and may not even know it. We also recommend that women increase their awareness of breast cancer starting at a younger age, including knowing thE signs of breast cancer and how to do their own breast exams. It’s also important that if they have any concerning findings, symptoms, or signs, they also need to know to approach their primary care physician, gynecologist or a surgeon for an exam and to discuss their concerns and feel that they are taken seriously.

Breast cancer screening itself doesn't only include mammograms or other imaging. It also includes a patient's self‐awareness, and we recommend women start doing self breast exams by the age 20‐25 and knowing the signs, symptoms, and risk factors that increase (and decrease) breast cancer risk. This expansion of what is considered part of breast cancer screening is very important, and is why we're trying to do as much as we can in order to increase awareness.

Assessing a woman’s risk enables us to further personalize her strategies and screening schedule. High risk patients may have inherited gene mutations, a family history, or both. For these women we typically start screening them with a mammogram or MRI 10 years younger than the first family member with breast cancer. For younger women that start at age 20‐25, we typically will screen with an MRI until after age 30, when we may add mammography as per recommended guidelines.

Reference & Image Sources: https://news.mit.edu/2023/wearable‐ultrasound‐scanner‐breast‐cancer‐0728

A TRUE GAME-CHANGER IN BREAST TREATMENT MONITORING
"As Breast cancer continues to be the second leading cause of cancer death in women, the battle continues and one of our best weapons in this fight is the innovative use of technology. Screening and diagnostic protocols are a major part of imaging but so is image guidance and monitoring. This technology offers significant promise in the tracking and treatment support on a logistical level. The idea of a wearable imaging monitor gives both the patient and the physician better data as to treatment progress and/or potential malignancy. It uses remote/wifi technology in the best way- by connecting the patient directly to the central monitoring specialist in real-time, eliminating any delays and appointment waiting." - Dr. Robert L. Bard -breast cancer radiologist, NYC

A major concern is the presence of breast cancer in underserved communities, including those TOO YOUNG FOR A MAMMOGRAM. Whereby the medical community touts the recommended (and legal/billable status) of getting a mammo scan should be between 40-50, what happens to the many women who do not fit this age criteria? How would they even know to get checked without the support of their clinicians or an alarm from family history? Decades into the battle against breast cancer, clinicians and the public are much more educated about EARLY DETECTION, PREVENTION and the current protocols and modalities available to save lives. Recent headlines on DENSE BREAST and the advancements in ULTRASOUND SCANNING supports a major part of this battle. SEE COMPLETE FEATURE

2022 REVIEW ON WOMEN'S EARLY DETECTION STANDARDS

Excerpt from the 2021 NYCRA Dense Breast Diagnostic Conference By: Dr. Roberta Kline

Breast cancer is still one of the most common cancers in women, and the leading cause of cancer mortality. While mammography is considered the standard imaging for early detection, it falls short for many – including those with dense breasts. Approximately 40% of women have dense breasts, which we now know is associated with an increased risk of breast cancer. On top of this increased risk, mammogram is less sensitive for early detection – up to 50% less for women with the highest breast density. [1] As a result many women are not diagnosed until they have a much later stage cancer – and a worse prognosis. [2]

The State of Connecticut passed legislation requiring notification of breast density in 2009, after having passed legislation requiring insurance coverage for ultrasound for dense breasts in 2005. As an ObGyn physician practicing in CT at the time, I remember the discussions with colleagues and patients around this issue although at the time there were no formal efforts to raise awareness or update guidelines from our national specialty organization, the American College of Obstetricians and Gynecologists (ACOG).

PERSPECTIVE: PERSONAL FINDINGS BY A CLINICAL PROFESSIONAL

I was fortunate to have benefited personally from this effort when I had my first screening mammogram shortly after the law went into effect. The reading radiologist personally informed me of my high breast density immediately after the mammogram, and after recommending a breast ultrasound for further evaluation this was done right then and there. I walked away from my appointment feeling well informed, and any potential anxiety relieved by the prompt additional imaging and results. I also knew that I needed a different approach for my screenings going forward.

Between 2009 and 2019, 37 other states and D.C. passed legislation requiring notification of breast density, one of the last being my new home state of New Mexico. In 2019 a federal law was passed to require both clinician and patient reports contain plain language around the woman’s breast density, and to discuss with her provider. The FDA then created standard language that has now been implemented, requiring reporting on a woman’s individual breast density, and recommendation to discuss with her provider.

There is still much to be learned about what causes dense breasts and why women with dense breasts have an increased risk of breast cancer, and our ongoing study is one of many that are seeking to answer these questions at the molecular and genetic level. But the evidence that supplementing mammograms with other imaging modalities can increase the rate of early detection is substantial, and provides us with tools we can use right now to make a difference. [3,4] Despite this progress, there are still significant hurdles in changing the standard of care. A recent experience with my routine breast cancer screening highlighted the ongoing challenges. When I had asked to schedule an ultrasound with my screening mammogram, I was informed that it was not done this way – I could only get a mammogram. After my mammogram, I had to wait to receive my letter in the mail approximately one week later to be able to take any additional steps. The interpretation included a description of breast density and recommended to discuss any additional care with my physician.

See 2022 Dense Breast Ultrasound Study

When I called to schedule an ultrasound, I was told that since the radiologist did not recommend it in the report, I could not schedule it. I then had to speak with my primary care provider, educating her on dense breasts and why I needed an ultrasound. Luckily, she agreed to order one. While the radiology facility still questioned the order, eventually I was able to have this done. When the radiologist came in to discuss my results, she too was confused as to why I was having the ultrasound, and was not aware that this should be standard for women with dense breasts.

Fortunately all was fine, but had I not been a physician that was fully aware of this issue, I would very likely have had only a mammogram and walked away with a dangerously false sense of security. This experience highlighted for me how much still needed to be done more than 20 years after my first experience. Legislation is only part of the solution. Clinician education and public awareness are the keys to changing how the intention behind these laws gets translated into actual change in health care.

As I experienced, many clinicians are ill-informed about the nature of dense breasts, and options for adjunctive screening including ultrasound or MRI. This means that many of these reports end up being filed away with no further action being taken that could make a significant difference in early detection and saving lives.

EPILOGUE: CURRENT STANDARDS VS NEEDS
ACOG still officially does not recommend any further imaging for women with dense breasts on mammogram, despite the significant body of evidence suggesting that mammogram alone is insufficient and adjunctive imaging with ultrasound or MRI increases rate of early detection. [5] The U.S. Preventive Task Force [6] does not recommend routine adjunctive imaging for screening women with dense breasts. This leaves many healthcare practitioners, from ObGyns to other primary care providers, unprepared to discuss this with their patients or provide sound recommendations.

The American College of Radiologists, who also publishes the BIRADS standards for breast cancer screening, acknowledges awareness of breast density detection issues with mammography but stops short of recommending routine adjunctive imaging. Instead, they list ultrasound and MRI as “may be appropriate”. [7] We have enough evidence to know how to better serve women with dense breasts, and we can do better. Now we need to push for better education of all primary health care providers, including ObGyns, and continue to raise awareness for women around current knowledge and best practices.

2024 CLINICAL PROFILE OF THE DENSE BREAST PARADIGM - for the Obstetrics & Gynecology Society

Thursday, March 28, 2024

THE FUTURE OF PORTABLE ULTRASOUND- IS WEARABLE!

By: Lennard M. Goetze, Ed.D

An ever-expanding portion of the medical community recognize ultrasound advancements for its non-invasive, real-time and non-radiation safety. Since the advent of medical ultrasound for fetal imaging (in 1956), developers have propelled the global movement to advance its capacity to scan deeper & wider, to go portable and to record more biometric data.

Scientists and clinicians alike have advanced ultrasound applications to benefit a wide variety of medical applications. This includes its abilities to study: MSK/musculoskeletal injuries, breast health (screening), abnormal tissues and cancerous masses, cardiac performance (echocardiography), kidney disorders/renal blood flow monitoring and ophthalmic scanning of ocular structures.

Amidst the Covid-19 Pandemic, an astounding report from MIT NEWS (7/28/2022) reported on engineers who developed a 2x3cm postage-stamp sized wearable ultrasound Patch that can "see inside the body". This innovation offered continuous imaging of internal organs for 48 hours or longer (contingent upon the life of the rechargeable power supply).

Clinicians and researchers are impressed by the range of possibilities for the use of this innovation as the news continues to spread throughout the radiological community about this next clinical scanning "game-changer". "I learned about Dr. Zhao's work at the thick of the pandemic and the very idea of a wearable scanner clearly raises the bar in the current trend in portable ultrasound designs", says Dr. Robert L. Bard, cancer imaging radiologist and principal investigator of IHRC (Integrative Health Research Center) in NYC. "Since Covid (19), ambulance rigs, triage units and ER's took full advantage of the many hand-held ultrasounds in the market... they called it the digital stethoscope. Where conventional ultrasound allows us to detect and diagnose pathology on the examination table or during a procedure, the idea of a patient wearing the ultrasound for 48 hours marks a new era in data collecting or biometric research."

THE ULTRASOUND PATCH TECHNOLOGY (Excerpt from MIT news)

MIT engineers have developed a small ultrasound sticker that can monitor the stiffness of organs deep inside the body. The sticker, about the size of a postage stamp, can be worn on the skin and is designed to pick up on signs of disease, such as liver and kidney failure and the progression of solid tumors. [1][2]

The probe is attached to a flexible circuit, which activates the ultrasound transducers, collects the ultrasound echoes, amplifies and filters these echoes, and transmits the digitized signal to a terminal device. The entire system is powered by a commercial rechargeable lithium polymer battery.[3]

In an exclusive (3/8/2024) special interview with development team leader and senior author Dr. Xuanhe Zhao -mechanical & environmental engineer at MIT, the imaging system he aptly calls "the ultrasound patch", HealthTech Reporter presents this imaging innovation to “advance noninvasive scanning into the body’s workings in real time, providing clinicians with live & recorded images of a patient’s internal organs for up to 24 hours”.

EXCUSLIVE INTERVIEW WITH DR. ZUANHE ZHAO

The origins of this design started with a student Chonghe Wang- who got his Masters Degree from Harvard University. He joined my research and development group on a graduate level, focusing on ultrasound imaging. We worked together on this dream about a wired ultrasound device that's wearable on the body. Wang made the ultrasound probe to be soft and stretchable- so you can put on different locations on the body. Then the challenge is creating quality ultrasound imaging. Imagine the camera in your cell phone- if you stretch the camera sensor, you distort the image dramatically, degrading the image quality.

Together with my team, we came up with a fundamentally new idea- to shrink the handheld ultrasound probe to a thin, but a very rigid ultrasound probe. As probes are rigid, you cannot stretch it. We also had to figure out how to conform this rigid probe to different locations of the body. We needed to invent a bio-adhesive coupling- a gooey, jello-like adhesive to attach to different locations and skin surfaces of the body while (at the same time) adhering the ultrasound to the body for lengthy periods of time. Immediately, we realized (that) now we can have a very high quality ultrasound imaging similar to the handheld ultrasound probes.

We developed this patch to be a long term and continuous use for variable imaging. Similar to an EKG patch that you adhere a few patches on the body, our ultrasound patch adheres to the corresponding location of the body for long-term continuous imaging.

The core design allows you to conduct B mode imaging, Doppler mode to measure blood flow and Elasticity mode to measure the elasticity, the rigidity of the tissues in the same ultrasound sticker- at the same time! Since we first published this idea in 2022, we received incredible attention from the (medical) society to keep expanding. In addition to measuring images of deeper internal organs, continued development now allows us to also scan for blood flow (3D Doppler) and the rigidity of different organs (Elastography) with this ultrasound patch -as another variable.

Expanding the functions of our ultrasound patch to add elastography is so useful because when organs develop diseases, they usually change their stiffness. For example, tumors are usually stiffer than the surrounding soft tissues. When an organ like the liver is undergoing acute liver failure, it becomes stiffer than the healthy state. By continuously measuring the organ's rigidity, you can do early diagnosis of different types of disease. If this organ under monitoring shows change in rigidity, we can assess that maybe there's something wrong- enough to mitigate. A situation like this will be the potential impact.

IMAGE 3: Each of the dots is one PIEZOelectric transducer. When you apply voltage on it, it sends a pulse to the body. Then your organ surface will reflect that wave and it will be received by either that or other transducers on this ultrasound probe. Then we translate that electrical signal into (measurable) imaging information or doppler mode data etc.

In our current version, we have a cable connected to that sticker that's connected to a device called VERASONICS (the size of a desktop computer). So that's not a miniaturized machine that's, uh, the size of, uh, desktop computer. That demonstrate the capability of this device for hospital use. In my group, we already achieved a miniaturized version of device- sized similar to a cell phone or even smaller. You can put it in your pocket, or you can wire somewhere on the body that is a fully integrated. The battery, the imaging processing, the CPU- everything is in this package. Then this package communicates with your cell phone or with your computer via Bluetooth. It transmits the imaging data to your device.

Source: MITNews Video:

A team of engineers have designed a stamps size device that sticks to the skin and can provide continuous ultrasound imaging of internal organs for 48 hours. The current design requires connecting the stickers to instruments that translate the reflected sound waves into images. However, if the devices can be made to operate wirelessly, a goal the team is currently working toward, the ultrasound stickers could be made into wearable imaging products that patients could take home from a doctor's office or even buy at a pharmacy. The entire ultrasound sticker measures about two square centimeters across and three millimeters thick about the area of a postage stamp. The bottom elastomer layer is designed to stick to the skin while the top layer adheres to a rigid array of transducers. The team also designed and fabricated this pairing of stretchy adhesive layers with a rigid array, enables the device to conform to the skin while remaining in position to generate clear, precise images.

The device's bottom adhesive layer is made from two thin layers of elastomer that encapsulate a middle layer of solid hydrogel. The elastomer layers prevent dehydration of the hydrogel. According to the researchers. Only when hydrogel is highly hydrated can acoustic waves penetrate effectively and give high resolution imaging of internal organs. The researchers ran the ultrasound sticker through a battery of tests with healthy volunteers who wore the stickers on various parts of their bodies. The stickers stayed attached to their skin and produced clear images of underlying structures for up to 48 hours. As the researchers work to make their design completely wireless, they point out that even in their current form, an immediate application could include continuously imaging internal organs of patients in hospitals without requiring a technician to hold a probe in place for long periods of time while continuing to reapply the necessary liquid gel, which acts to transmit ultrasound waves.

CONTINUED PURSUIT OF IMAGING REVOLUTION

We continue to develop many other technologies moving this field forward. In addition to fundamental scientific research, because this technology is so promising, we receive so many requests for upgrades as well as samples for clinical use.

Our ultrasound patch is currently approved for MIT IRB for imaging healthy human subjects. We are collaborating with Harvard Medical School and Stanford Medical School to image patients in hospitals. Our next step is to undergo FDA approvals for this ultrasound patch technology- however, because this is a noninvasive imaging modality, and because the power induced by the ultrasound sticker is even lower than that of the conventional handheld ultrasound, we do not expect, too much difficulty or too many surprises in obtaining FDA approval. But we remain careful with GMP (Good Manufacturing Practices) of the whole system to earn FDA approval.

Our wearable ultrasound sticker technology will potentially impact both the healthcare by providing long-term continuous monitoring of diverse diseases. It shows promise in impacting the fundamental biological research by providing a new long-term/continuous window to image diverse organs simultaneously. We are very excited about the future of this ultrasound imaging technology.

References

1) https://news.mit.edu/2022/ultrasound-stickers-0728

2) https://news.mit.edu/2024/ultrasound-sticker-senses-changing-stiffness-deep-internal-organs-0209#:~:text=MIT%20engineers%20have%20developed%20a,the%20progression%20of%20solid%20tumors.

3) https://www.nibib.nih.gov/news-events/newsroom/wireless-wonder-wearable-ultrasound-patch-goes-completely-cable-free#:~:text=The%20probe%20is%20attached%20to,commercial%20rechargeable%20lithium%20polymer%20battery.

*All images are courtesy of MIT News and/or Dr. Xuanhe Zhao

Sunday, February 25, 2024

CHANGEMAKER OF THE MONTH: WHO IS CHARLES VORWALLER?

Written by: Lennard Goetze, Ed.D
An Interview with CHARLES VORWALLER

Since 2021, I collaborated on a publishing project with Dr. Robert L. Bard (diagnostic imaging specialist) to conduct a tech performance review about AxioBionics wearable therapeutic device. This was the impetus to our advocacy group and educational initiative aptly called HEALTH TECH REPORTER whose goals are to seek out and test drive the latest in non-invasive therapeutic solutions and publish reports on the validity of their claims and health advantages.

In early 2023, we launched an event series called HEALTH TECH DEMO DAY in Dr. Bard's diagnostic imaging practice in NYC. This became the central ground for hosting manufacturers showcase of their latest devices where they provide actual case demonstrations directly to our reporters and Dr. Bard's patients.

Our 2023 search brought us together with a remarkable advancement in red light therapy by a company called Aspen Laser (See event report on March 7, 2023) where a Demo Day with their rep was a great success. Shortly after the event, a heartfelt thanks and congratulatory letter was sent to CEO and founder Mr. Charles Vorwaller for a fantastic product. A stunning surprise was granted us directly by Mr. Vorwaller who immediately booked a flight to NYC to see us. With a growing set of clues about the strength behind this company (and their truly fearless leader), his energy and enthusiasm to connect aligned with the INC5000 list of fastest growing privately owned companies in 2020. Headlines reported Aspen Laser was the only medical laser company on the list. In 202I, it received a five-year GSA contract to sell to VA hospitals. [1]

Setting the industry standard, the TheraLight 360 uses patent pending technologies that ensure tissue saturation regardless of skin color or body type. He brought major spotlight to the scientific term (and treatment modality) "Photobiomodulation Therapy" - the application of Red and Near Infrared light to tissue that is injured, sick or degenerating to increase circulation, increase cellular energy production, reduce inflammation and reduce Oxidative Stress. His original vision that began in 1988 over 35 years ago was to redefine Pain Management and Recovery that resulted in the startup in 2014 for a new company called ASPEN LASER. It grew to become a leading edge nonpharmacologic technology and research based products that make a difference in the lives of individuals (including animals) suffering from pain and injury. Mr. Vorwaller's initial focus to accomplish this was through innovative development and breakthrough advancement with lasers providing High Intensity Laser Therapy, incorporating technologies with multiple power levels, multiple wavelengths and multiple operating modes.

We had the distinct pleasure of collaborating with Mr. Vorwaller at Dr. Bard's "MedTech Research Lab". We also enjoyed sharing Dr. Bard's arsenal of diagnostic imaging devices used for clinically validating biometric response as part of our Medtech device testing.

We found the exchange with Mr. Vorwaller to be both highly educational and inspiring for our continued research work. He mentioned feeling right at home in deep discussions about exploring the future of therapeutics - aligning with his first passion as a "Technology Tinkerer'. Dr. Bard and I gained so much from his generosity by the way of endless notes on laser and light technology as well as a front row seat to the entire medical device industry. With decades of relentless R&D on expanding therapeutic light penetration and engineering, Charles was not shy to describe his process.

In addition, he also shared impressive insight about other non-invasive cell-regenerative modalities including PEMF, SHOCKWAVE, RT THERAPY, NEUROSTIMULATION, TRANSILLUMINATION and BIOFEEDBACK (to name but a few). He claimed this is all part of his "required reading" as part of identifying the entire pain-healing science. As an inventor, he also looks at the many potential integration opportunities or "stacking" of existing technologies to form the next generation of products.

"Since our company began, our focus has been on developing leading-edge technology in laser therapy," said Mr. Vorwaller. "Our medical lasers represent a number of technological developments that are significantly different than other lasers and light therapy products in the market... which we found to not be very effective". The result of his passion and never-ending pursuit for optimal outcomes has resulted in products delivering new treatment options providing higher dosages, more treatment areas and overall faster treatment times and accelerated healing and recovery.

HUMBLE BEGINNINGS INSPIRED BY HIS GREATEST HERO
In an exclusive interview with Mr. Vorwaller, he shared a candid look at where it all began for him. The roots to all of his work was heavily inspired by his Dad (Charles J. Vorwaller, LCSW), a 60+ year veteran and recognized visionary leader in the non profit mental health industry.

As a young boy, Charles witnessed firsthand the individuals that were undergoing treatment. They were sufferers of mental diseases and all the challenges that come from that. He witnessed his father develop and pursue forward thinking strategies and programs including therapeutic treatments and modalities beyond the traditional and limited drug-focused programs and protocols, with the incorporation of newer standards, including non-pharmaceutical and non-invasive based treatments and interventions. This humbled him greatly to see that his dad explored all options to help the sufferers when no one could help them. Charles grew up wanting to help the underserved and built this road in health technology. Looking back, Charles Vorwaller is convinced that his laser and red light therapy innovations contributed to mobilizing the science of patient care and impacted others by offering improved quality of life and in some cases, giving people a new chance at life."

References:

1) https://theceoviews.com/aspen-laser-revolutionizing-pain-management-with-drug-free-photobiomodulation-2/

Special thanks to ASPEN LASER and THERALIGHT for allowing us to interview CEO Charles Vorwaller - tech innovator and role model to the global community of entrepreneurs! Innovators of today's therapeutic technology are a rare and respected breed. Their life's work is dedicated to offering improved change to the current trends by exploring and introducing safer and more effective ways to resolve health issues both large and small. The success of their work adds to the definition of the future of functional and regenerative medicine. In search of these pathfinders, IPHA celebrates some of the top role models of our day! These solutionists are the next modelers of the non-invasive movement in integrative healthcare. One such visionary is Mr. CHARLES VORWALLER, American Health Innovator and the brainsmith behind Aspen Laser and the Theralight series.

In our continued search for the next voice in support of Integrative and Functional wellness, our editors opted to follow the trail of innovative (or "alternative") healing technologies to the doorsteps of those who truly believe in their benefits. In this case, an early report featuring Dr. Jennifer Stagg and her use of the THERALIGHT 360 prompted us to meet other therapists to get more insight in its clinical uses.

VISIONARY SPOTLIGHT: Dr. Scott Schaeffer (Mt. Kisco, NY)

His treatment approach, in addition to spinal manipulation includes a wide array of modalities and physiotherapy. In our discussion about the Theralight 360 device (and other near-infrared technologies), we covered his holistic and integrative approach to bringing full-body wellness to his patients. Dr. Schaeffer identified his commitment to researching for the latest proven innovations to address soft-tissue injuries, musculoskeletal dysfunction and other inflammatory conditions that his patients commonly present with. "There's so much out there", he started. Learning about these new healing concepts, "whatever I can use within my scope of practice to help people safely and

non-invasively... I'm going to find it!" (Visit Dr. Schaeffer's full feature)

FROM THE BRAIN HEALTH COLLABORATIVE

11/18/2022- RED LIGHT THERAPY FOR TBI (By: Jennifer Stagg, ND) Within the past decade, ads for Red Light Therapy (RLT) devices have exponentially appeared in the health, wellness and commercial markets- drawing significant attention to their claims and challenging their efficacy. As with all technologies, many variables are to be considered as far as concluding on their proposed health benefits. Published reports from clinical (valid) studies detailing the utility of RLT in human health. Encouraging reviews indicate that there is a growing body of evidence for the use of RLT in traumatic brain injury (TBI) and neurodegenerative processes, including Stroke and Parkinson’s disease.

PHILOSOPHY BEHIND RED LASER THERAPY

Photobiomodulation is what we're actually doing when we look at red and near infrared light. (it’s different from far infrared-that's a sauna creating deep heating in the tissue and sweating out toxins). Photobiomodulation is the application of red and near infrared light to tissue where there is disease or dysfunction. The mechanism of action of light is very simple. It doesn't treat any specific disease or diagnosis, but it treats the underlying cause of all dysfunction in the body (all disease) and that is cellular health and wellness.

Within the cell, oxygen is supposed to flow into the mitochondria, which is the powerhouse of the cell, and that's supposed to produce adenosine triphosphate or ATP. This is what every cell in the body uses for energy. Due to exposure to via environmental toxins, lack of sleep, stress, injury and disease, lack of exercise, too much exercise, not enough sunlight, poor nutrition etc. oxygen flows in the cell and then it's bound by nitric oxide. That binding of nitric oxide with oxygen forms a deadly particle called a free radical. This causes two problems: #1- that oxygen is now not free to go into the mitochondria- so our ATP production in the body drops. #2- there's the abundance of free radicals is the root of every disease. It's the gene expression for things like cancer, heart disease and diabetes. So what light does very simply is when we shine light in and we can get light into the cell at the right wavelength, dosage and power density, it simply unbinds the oxygen particle and the nitric oxide particle and the free radical is dissipated into the blood vessel walls. So now we have removed free radicals and inflammation inside the cell. Also, the oxygen respiratory chain starts up again and that oxygen particle is allowed to flow into the mitochondria, and the ATP now goes through the roof and rises again the body.

# # #

RELATED ARTICLES

RED LIGHT THERAPY FOR TBI: by Dr. Jennifer Stagg
’Infrared’ refers to a type of light that is below the spectrum of visible light. The naked eye cannot see this type of light. Light is measured in wavelengths, and to further define infrared, there are near infrared (NIR) and far infrared (FIR) wavelengths. FIR is what is typically found in many of the devices sold to the general public like infrared blankets and saunas. (Although, saunas, combine heat with light so the effects of FIR are not comparable.) FIR offers some mild effects, but it doesn’t penetrate the body as much as NIR. As a result, most clinical research published to date is on visible red/NIR because these have been shown to be more effective. (See full review)

DEMO DAY WITH ASPEN LASER - PHOTOBIOMODULATION THERAPY: IPHA NEWS and HEALTH TECH REPORTER covers DEMO DAY at the Bard Diagnostic Imaging Center in NYC @ March 7, 2023. National clinical trainer Mark Murdoch speaks in an interview about the Aspen Laser technology while he treats registered patients suffering from various chronic disorders (including a rotator cuff tear & other MSK joint injuries, psoriatic arthritis and psoriasis on the skin. (See full review)

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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 waves neurostimulat stimulation and the induction of cold laser 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.

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THE SCIENCE OF ENERGY HEALING & THE BIOFIELD -

By: Roberta Kline, MD

Everything is energy. Quantum physics has demonstrated that everything exists as a vibrational energy. Some forms of energy have a frequency low enough to make the object solid and therefore visible and physically tangible, such as concrete, trees, mountains, and the human body. Others, such as sound, light, heat and gravity are invisible – but they are no less real. The Biofield is a relatively new term developed in 1992 to describe the concept of energy in a more unified way, integrating knowledge gained from traditional practices with that of modern science. Three of the main scientific principles underlying our current understanding of the Biofield energy are thermodynamics, physics and quantum physics. (See complete feature article)

"GETTING MY LIFE BACK FROM CHRONIC FATIGUE SYNDROME" 2/15/2022- Mrs. Suzanne Wheeler of Minneapolis, Minnesota is celebrated as IPHA NEWS' Researcher of the Month. After years of suffering a life-altering disorder that currently continues to challenge the scientific community of its root causes, Mrs. Wheeler explored “outside the conventional box” of opioid prescriptions, uncovering alternative solutions that got her back on her feet and joining life again. Invoking CHANGE against all odds by diligently searching for what’s beyond the convenient takes courage and conviction. It is this level of academic strength and strategic leadership that comprises the Alternative Health and Wellness community. (see full feature on Mrs. Wheeler's PEMF review)

BRAIN HEALTH REVIEW [Part 3]:
POST-COVID BRAIN FOG & WORK PERFORMANCE

Written by: Marilyn Abrahamson, MA,CCC-SLP - CBHC

For some, Post-Covid brain fog can cause everyday cognitive tasks to be more difficult, causing the thought of returning to work to become daunting. Among the many symptoms of Long Covid, one study suggests that up to 80% of Covid-19 survivors suffer from neuropsychological symptoms such as memory impairment, attention deficit, executive dysfunction, difficulty with word finding, multitasking, and impaired visual/spatial skills. These are skills people need to properly perform their jobs, and without these skills, people can become overwhelmed by the smallest tasks.

CONTRIBUTORS

MARILYN ABRAHAMSON, MA, CCC-SLP : As a Brain Health Education Specialist at Ceresti Health, Marilyn offers initiatives that supports education and empowerment of family caregivers. She also writes for and edits the Ceresti’s monthly newsletter and produces all brain health education and brain-health coaching programs for caregivers. Marilyn's prior work is as a NJ Licensed Speech-Language Pathologist since 1987 and is an Amen Clinics Certified Brain Health Coach.

SORAYA BEHZADI is an aspiring medical student and researcher in neurological studies focusing on holistic practice to help alleviate mental health, like generalized anxiety disorder. She received a bachelor's degree in clinical psychology with a minor in biological sciences from Hunter College. Aside from being a medical assistant at local urgent cares, her current field placement under affiliations with the Integrative Pain Healers Alliance/Brain Health Collective fuels her interests in brain health initiatives from imaging to holistic perspectives.

ROBERTA KLINE, MD (Educational Dir. /Women's Diagnostic Group) is a board-certified ObGyn physician, Integrative Personalized Medicine expert, consultant, author, and educator whose mission is to change how we approach health and deliver healthcare. She helped to create the Integrative & Functional Medicine program for a family practice residency, has consulted with Sodexo to implement the first personalized nutrition menu for healthcare facilities, and serves as Education Director for several organizations including the Women’s Diagnostic Health Network, Mommies on a Mission. Learn more at https://robertaklinemd.com/

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Tuesday, January 23, 2024

Epigenetic Research Notes: Profiling the Dense Breast Paradigm

A Clinical Report by: Dr. Roberta Kline

As an Ob-Gyn physician and genomics specialist, I have spent the better part of 10 years translating research in the genomic and gene expression areas into clinically usable information for healthcare professionals. One of the biggest challenges we face when connecting research with patient care is the long delay in the translation process and dissemination of the information. It often takes 10 to 20 years for information (validated findings) that comes out of research to be applied in clinical practice. These delays result in many lost opportunities to provide better care for our patients. This is one of the reasons why I'm really passionate about accelerating this process and making it easier for clinicians and their patients to take advantage of cutting-edge information and new technologies.

(See complete feature)

ACADEMIC PREFLIGHT STUDY OF ULTRASOUND SCREENING APPLICATIONS FOR DENSE BREAST CASES

Transcript by: Noelle Cutter, Ph.D.
Edited by: Roberta Kline, MD and Lennard M. Goetze, Ed.D

We started working with the Terason 3200t Ultrasound (hereinafter shall be referred to as the Terason) in the summer of 2022. The goal of the project was to be able to scan a limited number of younger premenopausal women under the age of 40 who are more likely to have dense breasts based on their status as being endurance based athletes. We have been exclusively using the Terason based on the recommendation of our lead radiologist Dr. Robert Bard. The Terason became our lab scanner of choice to conduct the screening of 10 individuals in the lab on a voluntary basis to get a readout for their breast density. Endurance athletes are more prone to dense breast tissue, especially athletes under the age of 40. Mammographic density is the strongest risk factor for non-familial breast cancer among women, especially those under the age of 40. Metastasis, tumor relapse, and resistance to therapy remain the principal causes of death for breast cancer patients and the lack of effective therapies calls for an improved understanding of the molecular mechanisms driving breast cancer progression. Early identification of mammographic density is an essential step in preventative health.

REMOTE COLLABORATIVE TEAM

The Dense Breast paradigm continues to plague our population of the underdiagnosed and underserved women. uniting with public advocates and legislative change makers like the ARE YOU DENSE? FOUNDATION raises significant public awareness in both the clinical and patient communities (see news feature). Meanwhile, this cohort study received great support from the medical research and diagnostic society whereby scientific leaders like Dr. Robert L. Bard (diagnostic imaging specialist) and Dr. Roberta Kline (epigenetics expert in women's health) helped to spearhead their own respective areas of study to help offer new insight and data in support of the launch of this field research program.

* See: Intl. Cancer Research Summit 2023@ Multi-Expert Presentation Panel

* See: Epigenetic Research Notes: Profiling the Dense Breast Paradigm

DENSE BREAST CASES

We assembled 10 volunteers for our initial review. These subjects were all selected from the triathlete community who recently either participated in the full distance 140.6 Ironman or the half distance 70.3 Ironman in 2022. From Molloy University (base 1 of our research), I recruited from our student population who also worked in the lab- as well as from my professional contacts in the endurance world.

To note, out of our select volunteers, three have been clinically diagnosed with breast cancer within the last five years. I would say that out of the two women who had cancer, both had dense breasts, and both were Ironman athletes under the age of 40 when they were diagnosed. They're both over the age of 40 now. So, they knew that already going into our scanning. I am glad to also report that both cases remain in remission. Noting these cases, we did not consider using them as a control by any means, only that this is part of the data that we are collecting as additional considerations that relate to our survey for tissue density, as a means of comparison.

The other eight subjects were young women all under the age of 35- and none of them had any idea about breast density. They've never had any breast screenings in their life besides self-breast examinations- hence, they had no idea about density. Furthermore, they had no idea of how mammographic density is really one of the strongest risk factors for non-familial breast cancer among women and especially among younger women. Undergoing our 'simple' screening session gave them the beginnings of a sense of personal ownership and advocacy about their health. Perhaps this experience (for them) could lead to proactive steps that they need to take- the next time they visit with either their OBGYN or their general physician. They now have an idea about the types of tests to request to be proactive about their health They also have some clarity about mammographic density in their breasts.

PORTABLE, HOSPITAL GRADE AND FIELD FRIENDLY

My technicians and I found the Terason to be "super portable" and upon scanning our first few subjects, we immediately understood why Dr. Bard suggested this brand and model. The picture quality and imaging system is very clear and the user interface is very easy to read. For someone who is not experienced or well trained in using an ultrasound, with one or two training sessions I was able to easily use the machine to work with our volunteer subjects.

An underlying test is the feasibility of using the Terason itself in actual field work. The portability is astounding (to me). This means we can pack it up. I don't even need any sort of a car. I could throw it on my back and get on a bicycle and bring it to a, uh, a destination. As far as its' performance, my group and I did our own homework about its accuracy and reliability and what we often found was the common statement about it being "battle-tested"- in the EMS world). Targeting the triathlete community, all these features are critical advantages to roadside screening! It's easy to use and even easier to train other research assistants in the lab to use it. And with Dr. Bard (and his expert interpretation) on the receiving end of our scans, that is the ultimate peace of mind and a COMPLETE tele-health scanning paradigm.

To note, our research concept focused on using the ultrasound because it is completely safe and effective at scanning for (something like) image breast density. Particularly for our research, it's portable in the field, so we can bring it to the race locations. I can bring it into the lab, I can bring it into my office. I can really package it up in a small briefcase sized bag, and it can come with me and travel with me anywhere I need to go.

*** SEE COMPLETE IMAGING INTERPRETATION REPORTS by Dr. R. Bard

REMOTE ULTRASOUND TRAINER

Working with Mike (Terason virtual trainer) was surprisingly easy, and he thoroughly guided me over the phone and via the device itself which is also a computer. He gave us such a comprehensive tour on all of the different probes but of course, we were focused on the one (L20) probe that was suited for of screening of breast density. We found the device itself to cover the most common demands of a hospital-grade or field-grade ultrasound including the ability to capture measurements of critical data like blood flow and density. Recalling my initial training session with Dr. Bard (at his office) aligned with everything because as a field/remote ultrasound tech, I am literally capturing all images for him (our in-house radiologist). This Terason model truly enables this remote scanning paradigm between the field screening tech in communication with the central radiologist- making for a truly ideal and real time professional collaboration!

VITAL RESEARCH IN SUPPORT OF EARLY DETECTION

I believe that because our focus was on women with dense breasts and the fact that this issue is now showing escalating rates, the urgency for this project also aligns with an increased likelihood of developing cancer within their lifetime. We also know that women, especially pre-menopausal women, are often not sent for imaging unless they have a family history. But we know only about five to 10% of breast cancers occur because of an inherited or genetic variant. So the likelihood that we're missing a lot of women (especially young women) who may have an early stage of breast cancer is the big concern.

This project was developed out of the need for a safe, effective, and affordable screening alternative. We wanted to explore and possibly attest to the higher benefits of this modern (and field-friendly) alternative vs. the existing "gold standards" which are far more inaccessible, expensive and potentially invasive- as far contrast or radiation. I appreciate my understanding of ultrasound as a fully safe and effective imaging modality - and one that we can use and easily can be accessed in any physician's office or anywhere else.

After our dedicated training course, the roll-out to being a stage 1 ultrasound technician was very comfortable and truly supportive of our goals about ultrasound as the path to the future and "the better way".

As far as goals, our main objectives are (of course) advocacy and to identify women younger using a more safe and effective screening method. Another goal that we found of great interest in enabling ACCESS to women have dense breasts; we wanted to explore ways that we can get them screened sooner. We can have them checked out to make sure that there are no early cancers that are being missed through other tools and techniques that we can use. In addition to this, we can start looking at how density correlates to cancer. Our early studies indicate that many of the pathways enriched in patients with higher mammographic density are targetable, raising the possibility of developing prevention strategies for mitigating density-associated breast cancer risk. We hope to further elucidate those molecular changes and those genetic signatures that may be common in women with dense breasts. Our overall goal is to increase survivability and offer targetable outcomes for the patient.