Tuesday, December 24, 2024

SMARTER SAFETY PROTOCOL: IMAGE GUIDANCE IN THE HAIR RESTORATION PROCESS (part 2)

By:  Robert L. Bard, MD  / Edited by Lennard M. Gettz, Ed.D

From the standpoint of studying hair loss or androgenetic alopecia with non-invasive imaging, there appears a sensible solution to support both the management and research in a growing number of pharmaceutical and cosmetic treatments of this condition. The sonographic pre-depiction of the presence of remaining hair follicles in the dermis within epidermal dysfunction may suggest the optimal type of medical treatment (or surgical treatment). If we start with a basic premise of an area of the scalp with no hair follicles at all, current data may suggest that surgical or transplant treatment is the only option available. 

The diagnostic use of ultrasound or high resolution sonography for hair restoration procedures has been validated with electron microscopy in various key studies. Imaging innovations allow dermatologists and hair transplant specialists to identify follicles in their biologically active present condition.  Imaging advancements help to define follicles as either dormant/inactive, intermediary or active & healthy growing. Follicles in that inactive or dormant stage may suggest a decrease in follicular health, usually suggesting a delay surgical procedures and instead application of more topical or interventional treatment options into that area to boost the production of  scalp health and cellular regeneration.   In the case of normal & healthy hair; this is ideal to proceed with ultrasound guided transplant treatment. 


LAND MINES vs. IMAGE GUIDANCE
Hair transplants are considered minimally invasive procedures which often includes bleeding (due to its engagement with large blood vessels or aberrant arteries).  Because of this, potential risks may include tapping into unsuspected skin conditions like cancers nearby or underneath- often identified with the use of clinical imaging.  The term “scan and treat” is a research term that may also apply to clinical procedures.  In the case of IMAGE GUIDANCE, the inclusion of real-time ultrasound monitoring adds a significant layer of safety and added confidence in the technician’s role-- forging a more expedient treatment pace from potential surprises. 

During the implant process, there may exist certain LAND MINES like a subcutaneous tumor or a cluster of dilated vessels called a hemangioma that can bleed profusely. Occasionally there may also exist nerves that are traversing the base of the neck or shoulders that may accidentally be damaged in a postoperative situation. Since the micro vessels in the scalp bleed profusely, the formation of a blood clot or hematoma or inflammatory process can also be imaged. 

Today, we have the availability to use adjunct ultrasound features such as elastography, which shows scarring in the skin. In other words, scar tissue is hard and it may be more difficult to put a probe through heavily scarred tissue. Oftentimes areas that scar have micro or macro calcification – aptly called “an iceberg” of calcium or a bone underneath the area where the technician may be injecting or inserting stillets.  

Additionally, inflammatory disorders like skin cancers may reside under the scalp.  Use of a thermogram is also available to detect subdermal anomalies.  Finding a mass or a fluid collection is of concern. Fluid is avascular (no blood vessels) which means no heat. A big fluid spot will show up dark on our imaging with low temperature. Inflammation will appear as a brighter hot spot because it's full of inflammatory vessels. This procedure is used internationally to locate areas of wound healing. When a wound is healing correctly, there's very low temperature, what we might consider normal healing temperature. When an area is inflamed or is infected, the temperature in that given area is elevated and the thermogram represents this temperature increase as a bright spot correlating with the degree of inflammation. 


SCANNING PROCESS & PATHOLOGY
Once we have the top half of the skin (the dermis) covered optically or photographically, we may then apply high resolution ultrasound which starts from the epidermis and goes down to hit the bone. Instead of 200 micron depth, you have a hundred times greater penetration, around 2-20 centimeters of depth depending on the ultrasound transducer (or probe). The ultrasound is adjustable for targeting the exact site, depth wise. 

Today’s ultrasound probe designs are actually quite ideal for hair transplant process. There are a variety of probes (curve, flat, square, linear etc) that are designed for a wide range of unique applications.  Similar to ultrasound guided biopsies, integrating an ultrasound probe with an active transplant needle can call for PRO GUIDES where you can attach the device either to inject or to extract to the guide more accurately.  Having a live subdermal monitor available to you allows for an added level of safety as far as what NOT to target. If there's a nerve that you're about to hit or a large vein, or (hopefully not) a larger sized artery, you can avoid it as you're doing it.  So forewarned is forearmed in this case.

Diagnostically speaking, this imaging application can be used to uncover problems that cause the hair loss before it actually happens.  There are many cases where someone with a full head of hair can have inflamed follicles. You cannot see this with the naked eye even with magnification tools - but is easily identified with  ultrasound imaging in the mid part of the dermis and lower part of the dermis (where the follicles arise from).  This inflammation offers a prediction of upcoming hair loss if unmitigated.  It is from this imaging test that we are able to caution the patient about an underlying disorder. Upon further subclinical inquiry and investigation, we find such disorders to stem from hereditary baldness due to (possible) inflammatory skin disease such as rosacea or psoriasis.

Additionally, autoimmune diseases such as lupus and sometimes certain cancers cannot be seen from the skin- even though they may manifest eventually in hair loss.  Early indicators can be itching or redness, which in itself is a cause of scalp loss and great distraction to everyday normal functioning. Further investigation of this inflammation through clinical imaging may easily show the disease, how deep the inflammatory disease is- and then how aggressive it is.  

Recognizing the condition shows that abnormal skin appears white and inflamed- whereby normal dermis is dark.  Appearance of a whitish layer to a grayer and sometimes a darker level identifies the degree of inflammation. Then, we also look at the blood flow (which the 3D Doppler function provides) whereby the more inflammatory blood flow in the area, the more aggressive the disease may be.  This is the activity visible BELOW the skin. It may show up as a little redness on top, but the “real drama” occurs below the skin, which is why it's often missed clinically.  For this reason alone, use of clinical imaging such as ultrasound technology and other optical technologies are extremely important to see what is missed by the naked eye.

REFERENCES: 1) Usefulness of high-frequency ultrasonography in the assessment of alopecia areata – comparison of ultrasound images with trichoscopic images- https://pmc.ncbi.nlm.nih.gov/articles/PMC8953880/ (2) Innovative ultrasound scans to reduce hair follicle transection during follicular unit extraction for the hair transplantation- https://www.wcd2019milan-dl.org/abstract-book/documents/invited-speakers-abstracts/09-dermatological-surgery/innovative-ultrasound-scans-to-reduce-96.pdf   (3) Innovative Strategies for Hair Regrowth and Skin Visualization- https://pmc.ncbi.nlm.nih.gov/articles/PMC10141228/  (4) Images in Scalp Ultrasound Before and After Hair Transplant in Frontal Fibrosing Alopecia-  https://pubmed.ncbi.nlm.nih.gov/31725066/  (5) Transcutaneous application of ultrasound enhances the effects of finasteride in a murine model of androgenic alopecia  https://pmc.ncbi.nlm.nih.gov/articles/PMC8942741/








THE CRITICAL ROLE OF DIAGNOSTICS IN HEALTH AND WELLNESS  By: Dr. Jess Sabrowsky DNP, RN, FNP-BC

What I have learned over the years is the importance of listening to the patient, but equally, the importance of using data-driven diagnostics to make real-time decisions about care. This is not just about numbers on a chart—it is about understanding the full picture of your health, long before symptoms arise.

We need to use technology, diagnostics, and assessment techniques to gather real data. Data that can guide each patient on their unique health journey. Diagnostics help us understand the true state of a person’s health, even when they may not feel “sick.” This is where the rubber meets the road: when you find a PCP who truly understands the importance of these tools and works with you to achieve your wellness goals and who also has skills beyond the transitional medical model to help you live your best life.

Having difficult conversations is uncomfortable, but it is necessary for growth. If you want a healthcare provider who will partner with you—someone who creates a safe space, builds trust, and encourages honest dialogue to support long-term growth—then you must also be willing to put in the effort. Finding a provider who matches your commitment to your health, and one who uses diagnostics to empower you, is key to achieving your goals.


WHY DIAGNOSTICS MATTER

In short, diagnostics are essential because they offer concrete, actionable insights into your health that go beyond surface-level symptoms. They help uncover hidden health risks and enable early intervention, which can be the difference between preventing a chronic condition or managing it effectively. Diagnostics allow for personalized care tailoring interventions to meet the specific needs of the individual based on real, measurable data. I also would add that as a provider I prefer to reference functional lab ranges when reviewing results as I find that I can make small preventative recommendations and also challenge individuals and providers to think outside the box when looking to help resolve health conditions, like in the case of my daughter who otherwise would still be suffering. Let’s aim to stop the suffering and optimize wellness for all who seek it.

 





WOMEN'S HAIR LOSS EXPLORED - FROM THE GENETIC RESEARCHER'S JOURNAL  By: Roberta Kline, MD

One of the most common causes of hair loss is ANDROGENIC ALOPECIA. This is related to androgen receptors called dihydrotestosterone.  We know that this is passed down through families. There is a significant hereditary component, but as of now, I have not yet found  a good discussion on what we know about the hereditary pattern in terms of what genes are linked to hair loss.

SNPs (pronounced "snip") = Single Nucleotide Polymorphism make up our genomic blueprint, and is a variation in a DNA sequence among individuals.  I don't believe hair loss is epigenetic; I believe it's most likely due to SNPs but it doesn't appear to always relate to the levels of androgens.  So this path of logic may not necessarily involve the metabolism, per se.  

As androgens are converted, testosterone gets converted into dihydrotestosterone (DHT), which is what binds to the hair follicle. Then testosterone gets metabolized into estrogen, and I learned more recently that there is actually a pathway where estrogen gets metabolized back into testosterone. From here, one could conclude that there are SNPs on androgen receptors involved.

When we look at women who have polycystic ovarian syndrome (which is not one disease), it's a spectrum, but they tend to have hormonal imbalances, insulin resistance and issues with excess androgens and imbalances between the estrogen and the androgens. Furthermore, they tend to have androgenic hair loss much earlier-  starting around twenties and thirties. So we know that these cases are significantly related to hormones. We know the hair loss is related to insulin and other things but this is part of my research about autoimmune diseases.

Autoimmune diseases tend to have some element of a hereditary pattern in terms of their predisposition. We know that polymorphisms and various genes related to the immune system and immune response, not only can they be inherited but they are linked to autoimmune diseases.  Understanding the genetics and the genomics of various types of hair loss can potentially build a knowledge base where we can see who might be predisposed and in those people, give them the foresight to intervene and potentially modify that predisposition.  This is part of a proactive approach to identifying early signs of hair loss, which often go missed.

Nobody will dispute that stress and certain toxins can cause hair loss. Observing one's predispositions may identify teltale clues supporting hair loss as a potential reaction to these jars to the system-- and there's even less research about this scenario on women.

In the case of Diane Pinson's early surprise hair loss (where she went completely bald in three days), logic dictates that such a dramatic symptom can only come from some type of TRAUMA.  As rare as this may seem, this is not It is not a gradual interruption of the hair follicle nore is it a gradual interruption or inflammation causing such a catastrophic loss of the hair. It's not a typical process that we know about -- this loss affects the hair follicle itself. The fact that her hair was able to grow back tells me that her hair follicles were okay- it was just that hormonally (along the way) they all got the signal to shed the hair at the same time.

Hormones are the body's communicators. When we talk about hormones, we think of the sex hormones. Most often, we first recognize estrogen, testosterone and the progesterone-- the metabolites. These are affected by other hormones such as insulin, cortisol and melatonin. These are all hormones and they are part of an intricate dance that coordinates communication among all sorts of different cellular processes and systems from the genes that run them. Unfortunately, we often get focused on one set of hormones, neglecting everything else.

HAIR REGEN CONCEPTS
The idea that topical hormones, estrogen and progesterone applied to the scalp can be effective in helping to grow or regrow hair. Theoretically, this makes sense if you understand how the hormones are affecting the hair follicles.  Certainly endogenous hormones, those that people take in terms of hormone replacement are linked to hair. We know that loss of estrogen leads to loss of hair throughout a woman's life cycle. So if somebody is adding testosterone locally to the hair follicle, and it's being absorbed in stimulating the hair follicle, it stands to reason that this can stimulate the growth phase of hair.

Inflamed Hair Follicle
ON IMAGING
I find the idea of using ultrasound to get a different perspective on the health of the scalp, the follicles and the related blood supply is a huge untapped area. The current standard is a topographical visual inspection (with a dermatoscope or a magnifier). Rarely does somebody get a biopsy of the scalp to identify its pathology, but Dr. Bard's use of the 3D Doppler ultrasound provides so much quantifiable information on the state of health of the skin that can potentially make the correct diagnosis faster and  can also provide much faster feedback on treatment efficacy. One of the challenges with many of the hair regenerative treatments is that they take a long time to show effect. You need repeated applications for months before you know whether it's actually working (or not).  Regular ultrasound monitoring with these treatments should actually provide a better indicator as to their effectiveness and when to expect those changes to occur.






A COMMENTARY ON IMAGE GUIDANCE By: Dr. Emil Shakov

Alopecia, also known as hair loss, is a condition that affects a significant number of people, with over 80 million individuals in the United States alone experiencing its effects 1. The most prevalent form of hair loss is called Androgenetic alopecia, commonly referred to as male pattern baldness. It is important to note that this condition can affect both men and women.
As a hair restoration surgeon, I frequently encounter patients seeking solutions for this type of alopecia. The diagnosis is typically established through a thorough patient history, focusing on any scalp-related itching or burning sensations. Additionally, a visual inspection of the scalp is conducted to identify any areas of inflammation. This step is crucial in order to rule out other types of alopecia, such as alopecia areata, traction alopecia, or other inflammatory scalp conditions, which may require different treatment approaches.


Interestingly, many hair restoration and hair loss specialists rarely utilize image guidance to accurately diagnose the condition. This oversight can hinder the effectiveness of medical management, minimally invasive procedures, or hair transplant surgery.

In the article "SMARTER SAFETY PROTOCOL: IMAGE GUIDANCE IN THE HAIR RESTORATION PROCESS..." Dr. Bard presents a compelling case for using ultrasound or high-resolution sonography to improve results and identify patients who would benefit from treatments. For example, treatments such as platelet-rich plasma or PepFactor for scalp treatment would be ineffective if the diagnostic study shows no hair follicle in the treatment area. Most of these less invasive treatments require a usable hair follicle to be effective.

Furthermore, as Dr. Bard accurately points out in the article, areas of high risk such as cancers, vascular issues, or nerves can be identified prior to any intervention. Ultimately, the use of imaging techniques can lead to improved treatment outcomes by selecting the most suitable candidates for the most effective treatment.

Footnotes
1. Source: [https://my.clevelandclinic.org/health/diseases/21753-hair-loss] 


About the Author

Emil Shakov, MD
, FACS is a board certified general surgeon fellowship trained in minimally invasive surgery and bariatric surgery. He has been in active clinical practice since 2010 performing full scope of general surgical procedures, emergency general surgery, and bariatric surgery.
Dr. Shakov performs peer reviews, independent medical examinations, utilization management and utilization review, and expert witness in general surgery. He is the Founder and Medical Director of The Youth Fountain Medical Spa in Freehold, NJ. The medical spa offers services for cosmetic injections of the face, laser tattoo removal, invasive and non-invasive body contouring, non-surgical weight loss, IV therapy, and bio-identical hormone replacement. He is the owner of New Jersey Hair Restoration Center specializing in hair transplants, PRP and PepFactor for scalp. Dr. Shakov is clinical instructor in cosmetic injections with neurotoxins and dermal fillers.

Thursday, December 19, 2024

WOMEN'S HAIR LOSS & SONOGRAPHY OF SCALP AND HAIR (part 1)


DIANE PINSON, recognized expert in the hair transplant industry speaks out about her devastating surprise hair loss in her late teens and her arduous journey to find answers. Diane has been a passionate researcher for clinical answers and resources to address women's hair loss and made a career out of this mission. Today, Diane is an outspoken supporter of women's hair loss and has recently joined the IHRC research group in pursuit of technological advancements and imaging validation of subdermal disorders identifying the root causes of hair loss in women. She also maintains her professional goal as a technical trainer, sharing her expertise and helping others achieve their goals in the hair transplant industry.


WHY ADD DIAGNOSTIC IMAGING TO HAIR RESTORATION MODALITIES?

Diagnostic protocols in the hair loss & regeneration industry includes the use of microscopy and subdermal scanning. This includes the blood flow functions in 3D ultrasound, offering real-time quantitative reporting of hair follicle health and conditions. Health issues of the scalp indicate a wide range of possible disorders including Dandruff, Seborrheic Dermatitis, Fungal Infections or inflammatory conditions like Psoriasis. They may likely result in cosmetic interference and quality of life issues that may call for the need for medical surveillance or clinical intervention.

Upon review of the latest advancements in ultrasound technology, scalp pathology and cross-sectional imaging presented physicians with a new areas of pathological reporting, yielding to a more targeted way of prescribing solutions to mitigate scalp-related issues including HAIR LOSS.

(L-Image) Inflamed Hair Follicle note feeding arteries -red-/ high flow turbulence from tortuous vessels- yellow





(L-Image) Scarred hair follicle- orange outlined area shows scar formation from inflammatory fibrosis





PART 2:

Disorders of the scalp often result in severe cosmetic interference with quality of life, creating the need for optimal medical surveillance. We tested the latest generation of ultrasound machines in patients with scalp pathology and prepared a cross-sectional library encompassing a wide assortment of conditions. Normative data on the sonographic anatomy of scalp and human hair, and important methodological considerations, are also included. 


Figure 1. (a) Ultrasound of normal scalp (transverse view) shows the typical echogenicity of the different skin layers; note the oblique orientation of the hair follicles. (b) Hair follicles on three-dimensional ultrasound (asterisk; 5 sweep). bms, bony margin of the skull; d, dermis; epidermis; em, epicraneous muscle; st, subcutaneous tissue.

Figure 2. Hair growth cycle. (a) Schematic representation. (b) Ultrasound; note the progressive dermal penetration of the hair follicle, from the telogen phase

(inactive and resting phase with the hair bulb in a subepidermal location) to the anagen phase (active growth phase with the hair follicle reaching the bottom of the dermis)

Figure 3 (R). Estimation of scalp follicular population. Density gradient ultrasound depicting variation in hair follicle number (arrows).


TRAUMA & TOXINS (and Non-Invasive Treatments) - Written By: Robert Bard MD

The human body is continually assaulted by harmful forces which may be obvious-trauma and burns-or dismissed as the “flu or nerves”-chronic poisoning and delayed hidden scarring. However, in the unregulated world of fillers, patients and physicians often encounter unexpected findings and potential complication medicolegal traps. One picture is worth a thousand words and one image may launch a thousand lawsuits while possibly giving birth to a new medical image guided treatment paradigm. (Fig 1)

TRAUMA: Soft tissue trauma causes a black and blue area but subcutaneous pathology is best imaged by ultrasound FIG 2 The normal dermal layer is light gray on scans while inflammation is dark gray and fluid (blood) is black. Dermal ultrasound has been used for 30+ years to find skin cancer and guide scar treatment so the use in subacute trauma victims is a logical progression of this portable and non invasive technology.

Foreign bodies such as glass and splinters are easily visible as bright white areas so the surgeon is directed to the exact removal site under ultrasound guidance with minimal tissue “exploration” Fillers have characteristic echo pattern where HA products appear as black globules when they coalesce.  Often the HA injected aliquot disperses immediately leaving a diffuse hazy picture. Complications of fillers are well described in recent textbooks. A special case is free silicone having specific “snowstorm” pattern that is commonly seen in breast imaging of ruptured implants. The theoretical possibility of immune system compromise by free silicone is still being studied.

FIBROTIC SCARRING: Elastography shows scar tissue quantitatively in the liver parenchyma but also in traumatized skin, muscles and tendons. The “elastic” properties of tissue are used worldwide for cancer diagnostics because malignant tumors are rock hard and “gritty” has we feel with the needle biopsy while benign lumps are soft. Ultrasound maps tissue signatures to that free silicone has a MG value 35-40.



A COMMENTARY ON WOMEN'S HAIR LOSS
By: Gina Adams, CEO Wareologie and Health Tech Advocate


Diane’s journey and the integration of diagnostic tools like subdermal scanning offer invaluable insights into the complexity of hair loss. This condition is inherently multifaceted, often influenced by overlapping factors such as hormonal changes, stress, genetics, and overall health. Like many women, I initially attributed my hair loss to menopause and stress—both significant contributors—but I now recognize the importance of investigating other underlying causes.

I’ve recently begun exploring hormone replacement therapy (HRT) to evaluate estrogen and progesterone levels, which could provide clarity on potential hormonal imbalances contributing to hair thinning. Stress management has been another area of focus, though as we know, it’s impossible to eliminate stress entirely. Despite consistent use of supplements over the years, I’ve found the results underwhelming, which emphasizes the need for more evidence-based solutions.

In the meantime, I’ve resorted to temporary aesthetic measures, such as hairpieces, to manage the emotional impact of hair loss while avoiding interventions like weaving, which might exacerbate strain on existing hair. I look forward to Part 2 of this discussion to uncover innovative, research-backed solutions that could benefit women navigating similar challenges.

It’s particularly striking that alopecia affects nearly 50% of women, yet much of the focus remains on male-pattern baldness. This research fills a critical gap, and I deeply appreciate the efforts of the Women’s Health Collaboration in addressing this disparity. Such resources are a beacon of hope for women seeking personalized, effective care.


ABOUT THE AUTHOR

GINA ADAMS, MBA
Wareologie Founder and CEO | HealthTech Advocate
Gina is a problem-solving entrepreneur with 20+ years in product development management. She transforms ideas into commercialized products and penetrate markets through multifaceted, strategic partnerships. While acquiring her MBA, Gina launched her certified Woman Owned Small Business called Wareologie where she develops intuitive, innovative products through user-experience collaborations to enable independence and self-care to improve people's quality of life.



Wednesday, December 4, 2024

QUICKIPEDIA: INTRODUCING THE HEARTREADER (short & friendly version)

 

In October 12/13, 2024, HealthTech Reporter met with Dr. Sándor Kulin (developer of the HEARTREADER from Budapest, Hungary) at the Holistic Health Educational Expo in North Bergen, NJ. (see expo group). In this issue of HealthTech Reporter, we feature the concept behind of Dr. Kulin's innovation as a medical-grade scanning solution designed to generate reports and scores to support treatment response and estimating cardiovascular age. 





Functions on-demand of the HeartReader 

By: Dr. Sándor Kulin

Source: HeartReader marketing

Peripheral pulse wave analysis is a well-established scientific method for evaluating an individual's hemodynamic status. However, transforming this methodology into a clinically applicable tool requires innovation and dedication. This is precisely the mission at HeartReader™: to develop and implement a robust system that bridges the gap between foundational research and practical healthcare applications.

HeartReader’s Core System and Scoring

HeartReader is built on more than 30 parameters derived from scientific literature, alongside a composite Total Score that provides an overall evaluation of cardiovascular health and risk levels. As noted by Professor Sengupta of Rutgers University, cardiovascular disorders remain the leading cause of death globally, emphasizing the urgent need for reliable tools to assess individual risk. Esteemed cardiologists and specialists acknowledge that HeartReader may be the first system to meet this critical need effectively.

In addition to the Total Score, HeartReader offers a series of specialized subscores, each targeting specific aspects of cardiovascular and overall health:

    Cardiovascular Health Score
Assesses the aging speed of the arterial system and the heart, offering insights into vascular health over time.

    Blood Pressure Score
Similar to HbA1c for blood sugar, this score identifies potential blood pressure issues over recent months rather than providing real-time measurements. A high score suggests lower cardiovascular risk, while a low score indicates potential concerns.

    Heart Fitness Score
Evaluates physical capacity and cardiovascular exercise tolerance, reflecting an individual’s ability to endure physical activity.

    Metabolic Fitness Score
Offers insights into cellular health, focusing on mitochondrial function. Through collaborations with experts in deutenomics (the study of deuterium content in mitochondria), this score provides an indicator of mitochondrial health and energy production efficiency.

    Cardiac Stability Score
Measures the likelihood of irregular heart rhythms or arrhythmias. A high score suggests stability, while a low score indicates potential risks.

    Autonomic Integrity Score
Evaluates the overall activity and the balance between sympathetic and parasympathetic nervous system activity at the time of measurement, providing a snapshot of autonomic function.

Source: HeartReader marketing

Quick, Non-Invasive Measurements
All these insights are derived from a simple, non-invasive, two-minute measurement. HeartReader delivers a comprehensive evaluation that goes far beyond what is typically expected from such a straightforward process, empowering both clinicians and individuals to better understand and manage cardiovascular health.

To make the data easy to interpret for both professionals and laypeople, the 30 parameters are summarized into a simplified metric called Scores. These scores not only reflect potential medical conditions but also provide valuable insights into the individual's overall health level.

Based on a database of 150,000 measurements, we developed the HeartReader Health Map™, which benchmarks health levels for individuals aged 15 to 85. This map assigns a health score on an absolute scale from 0 to 100, where higher numbers indicate better health. Additionally, it uses a relative scale, which compares an individual's health to others in the same age group, similar to percentile rankings in other medical assessments.

This dual-scale approach offers professionals a powerful diagnostic tool while also serving as an accessible screening resource for non-experts, providing a comprehensive understanding of an individual's health status.

Our long-term vision is to integrate HeartReader into medical practice as a prescription-based service. General practitioners, cardiologists, rehabilitation specialists, and obstetricians can invite their patients to use this advanced physiological monitoring and data collection system.


Study 1: Pulse Wave Morphology Analysis
The first study focused on the repeatability and accuracy of pulse morphology analysis. Our primary goal was to determine whether variations in measurements were due to device inaccuracy or the inherent dynamism of human physiology. To address this, we conducted tests using a pulse wave generator, a device that produces a consistent pulse wave regardless of timing or settings.

Results demonstrated that when the HeartReader receives the same input signal, its output remains consistent, proving the system’s high level of accuracy in capturing and analyzing data.

Source: HeartReader marketing












Source: HeartReader marketing

Study 2: Heart Rate Variability (HRV) and Pulse Rate Variability (PRV) Analysis
The second publication examined the system's capability in heart rate variability (HRV) analysis, comparing it to the gold-standard software, KubiosQBS, widely used for HRV research.

     When the same input data was analyzed by both KubiosQBS and HeartReader, the results showed a 99% agreement, affirming that HeartReader's HRV engine is as accurate as (or potentially even slightly more accurate than) KubiosQBS.

     Additionally, we compared ECG-based HRV with HeartReader's peripheral pulse-based pulse rate variability (PRV). The correlation between the two methods aligned closely with existing medical literature, further validating the system's precision and applicability.


Key Findings
These studies confirm that:

  1. Pulse Morphology Analysis is highly accurate and repeatable, reliably capturing physiological signals for preclinical use.
  2. HRV and PRV Analysis delivers results comparable to established gold-standard systems, making HeartReader a robust tool for understanding cardiovascular and autonomic nervous system dynamics.

HeartReader is proven to offer accurate readings in Pulse Morphology, HRV and PRV Analysis.  It works ideally for the support of function/ personalized health monitoring and clinical support. This validation sets the stage for its successful integration into medical practice.


Evaluating System Performance in Clinical Contexts
The next critical question is: How does the HeartReader system perform under specific clinical conditions? While there is no universally accepted gold standard for peripheral pulse wave monitoring, our extensive dataset offers compelling insights into its reliability and clinical relevance.


Large-Scale Data Validation
With over 150,000 measurements collected from more than 8,000 individuals aged 15 to 85, our analysis revealed a strong correlation between many of the 30 calculated parameters and age. Since physiological and hemodynamic functions naturally evolve with age, this alignment with well-documented aging patterns serves as a robust internal validation of the system. The fact that HeartReader accurately reflects these age-related changes, recognized as "normal" by cardiologists and the broader medical community, reinforces the system’s credibility and precision.

Highlighting Individual Variability
In addition to reflecting typical aging trends, HeartReader uncovers individual differences in aging rates and cardiovascular health. Some individuals demonstrate faster or slower aging patterns, with corresponding variations in cardiovascular risks and conditions. This variability underscores the system's ability to go beyond averages and offer personalized insights. By identifying where a person falls relative to their age group, HeartReader provides a detailed picture of individual cardiovascular health, making it a powerful tool for early detection and intervention.

Establishing Age-Based Averages
Despite individual differences, the extensive data pool has enabled us to establish clear averages for each age group. These benchmarks further validate the system's capacity to serve as a precise and personalized monitoring tool, offering healthcare providers a reliable means of assessing cardiovascular health and guiding patient care.

HeartReader's combination of large-scale validation, individual variability analysis, and alignment with established medical norms positions it as a cutting-edge system for clinical and personalized health applications.

 

About the Author/Developer:

Dr. Sándor Kulin graduated as a medical doctor in 1990 at Semmelweis University, Budapest, and became an obstetrician and gynecologist at Imre Haynal University of Health Sciences in 1994.   He has special interest in maternal and fetal health, human physiology, cell physiology, hypoxia, malignant transformation, and therapy monitoring. Having almost 20 years of experience in non-invasive cardiovascular monitoring in 2018 he became a Co-founder and CEO of E-Med4All Europe Ltd, a Hungarian digital health startup, aiming to help the transformation towards a more data driven and personalized medicine and to be part of the shift of today’s medicine from disease management to prevention.



MORE HEALTHTECH NEWS





Tuesday, December 3, 2024

HEALTHTECH INTERNATIONAL FEATURE: INTRODUCING THE HEARTREADER™



INTRODUCTION
In October 12/13, 2024, HealthTech Reporter met with Dr. Sándor Kulin (developer of the HEARTREADER from Budapest, Hungary) at the Holistic Health Educational Expo in North Bergen, NJ. (see expo group). Dr. Kulin was part of an impressive lineup of unique health and medical speakers who presented (both in the venue and online) an array of important health topics and compelling lessons in health and longevity.  This educational event drew in crowds from every form of health disciplines including the conventional to functional, integrative to holistic and beyond.  

In this issue of HealthTech Reporter, we feature the concept behind of Dr. Kulin's innovation as a medical-grade scanning solution designed to generate reports and scores to support treatment response and estimating cardiovascular age. His HeartReader promotes the ability to generate reports and SCORES for physiological health such as Cardiovascular Health, Blood Pressure, Heart Fitness, Cardiac Stability and Autonomic Integrity.  The ultimate pursuit of the device was to mitigate the need to accurately identify these readings in support of monitoring heart health --for the detection of cardiovascular disorders, the leading cause of death globally. 

Photo by: Dr. Robert Bard
According to his interview in 11/22 Dr. Kulin, an integrative and holistic OB/GYN (obstetrician-gynecologist) originally founded this technology 
as a telemetry system for monitoring health levels for women under pregnancy as part of regular monitoring of their cardiac health called PregnaScan. Pregnancy involves profound physiological changes, including a remarkable 35% average increase in left ventricular mass. In a 2021 feature on HealthCare Outlook magazine, Dr. Kulin stated that after the launch of this first model- “...our aim is to serve even the non-medical entities with very reliable physiology data and help them improve their clients’ health. For example, trained fitness coaches and dietitians can analyze the  (recorded) parameters ...both the end-users and healthcare providers can easily deduce whether or not the prescribed advice is working for them".


MEDTECH EFFICACY CHALLENGE
Currently, the HTR publishing team and medical group is undergoing a series of performance testing sessions of the HeartReader™ in support of non-invasive health and medical solutions.  Dr. Robert Bard (of IHRC) & BardDiagnostics.com) spearheaded this TechReport project inspired by his commitment to explore innovations from the international health society.  

Source: www.BardDiagnostics.com
Additionally, in November of 2024, a collaborative  multi-modality program has been drafted to engage various heart rate variability and cardiovascular scanners to explore their strategies and data points, validating and confirming their effects as health screening technologies as part of HTR's SCAN & TREAT series.  "I am proud of the engineers, developers and medical conceptualists for their individual pursuits to advance the bar of personalized health and data gathering. SCREENING solutions in support of DIAGNOSTIC SCIENCE, especially in the realm of heart health is critically important in our medical community, offering an intelligent base line for a full array of testing. Meanwhile, as the pursuit for gold standards for 'Better Aging', prevention, early detection strategies wage on, these innovations (and the development leaders who promote them) hold a  powerful place in our international scientific, academic and medical communities as future luminaries", says Dr. Bard.


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Disclaimer:  HealthTech Reporter is an impartial technology news agency, and is not a marketing partner of our subjects featured in any way. Our supporters and affiliates do not confirm or endorse the material enclosed, including any data or submitted statements by individuals presented.  The following feature is written solely by Dr. Sandor Kulin, E-med4all Europe, Ltd. whereby all statements, concepts, technical reports, claims and visual representation about said product is published 
without any intent of marketing or commercial support  for its claims of the product's actual performance or efficacy.  Identified as a foreign device, HealthTech Reporter conditionally shares the contents of this feature as a strictly informational resource as part of our HTR "International Health Innovations".  This HealthTech segment is published with the full understanding of its status (as un-established) with US regulatory agencies, reflecting on its commercial access within the US medical device markets.


Bridging Science and Clinical Application: HeartReader’s Role By: Dr. Sándor Kulin

Source: HeartReader marketing

Peripheral pulse wave analysis is a well-established scientific method for evaluating an individual's hemodynamic status. However, transforming this methodology into a clinically applicable tool requires innovation and dedication. This is precisely the mission at HeartReader™: to develop and implement a robust system that bridges the gap between foundational research and practical healthcare applications.

HeartReader’s Core System and Scoring

HeartReader is built on more than 30 parameters derived from scientific literature, alongside a composite Total Score that provides an overall evaluation of cardiovascular health and risk levels. As noted by Professor Sengupta of Rutgers University, cardiovascular disorders remain the leading cause of death globally, emphasizing the urgent need for reliable tools to assess individual risk. Esteemed cardiologists and specialists acknowledge that HeartReader may be the first system to meet this critical need effectively.

In addition to the Total Score, HeartReader offers a series of specialized subscores, each targeting specific aspects of cardiovascular and overall health:

    Cardiovascular Health Score
Assesses the aging speed of the arterial system and the heart, offering insights into vascular health over time.

    Blood Pressure Score
Similar to HbA1c for blood sugar, this score identifies potential blood pressure issues over recent months rather than providing real-time measurements. A high score suggests lower cardiovascular risk, while a low score indicates potential concerns.

    Heart Fitness Score
Evaluates physical capacity and cardiovascular exercise tolerance, reflecting an individual’s ability to endure physical activity.

    Metabolic Fitness Score
Offers insights into cellular health, focusing on mitochondrial function. Through collaborations with experts in deutenomics (the study of deuterium content in mitochondria), we have increasing understanding how this score might be a potential indicator of mitochondrial health and energy production efficiency.

    Cardiac Stability Score
Measures the likelihood of irregular heart rhythms or arrhythmias. A high score suggests stability, while a low score indicates potential risks.

    Autonomic Integrity Score
Evaluates the overall activity and the balance between sympathetic and parasympathetic nervous system activity at the time of measurement, providing a snapshot of autonomic function.


Validated Insights from Real-World Data
While ongoing and planned clinical trials across Europe will further validate HeartReader, its current foundation is strong. Analysis of over 150,000 pulse wave recordings from more than 8,000 users confirms the system’s ability to translate traditional pulse wave parameters into clinically actionable insights.

Quick, Non-Invasive Measurements
All these insights are derived from a simple, non-invasive, two-minute measurement. HeartReader delivers a comprehensive evaluation that goes far beyond what is typically expected from such a straightforward process, empowering both clinicians and individuals to better understand and manage cardiovascular health.

HeartReader is at the forefront of innovation, providing healthcare professionals with reliable, personalized tools to assess and address cardiovascular and overall health effectively. The system collects data from a sensitive  HeartReader sensor connecting to a smartphone which is then sent to the cloud for real-time processing and storage.  (using the internet)


To make the data easy to interpret for both professionals and laypeople, the 30 parameters are summarized into a simplified metric called Scores. These scores not only reflect potential medical conditions but also provide valuable insights into the individual's overall health level.

Based on a database of 150,000 measurements, we developed the HeartReader Health Map™, which benchmarks health levels for individuals aged 15 to 85. This map assigns a health score on an absolute scale from 0 to 100, where higher numbers indicate better health. Additionally, it uses a relative scale, which compares an individual's health to others in the same age group, similar to percentile rankings in other medical assessments.

This dual-scale approach offers professionals a powerful diagnostic tool while also serving as an accessible screening resource for non-experts, providing a comprehensive understanding of an individual's health status.

Our long-term vision is to integrate HeartReader into medical practice as a prescription-based service. General practitioners, cardiologists, rehabilitation specialists, and obstetricians can invite their patients to use this advanced physiological monitoring and data collection system.

- To Be Continued -



SMARTER AGING: "RESETTING YOUR FUTURE"

By: Dr. Roberta Kline / Women's Health Digest

AGING is a natural process that is associated with biological changes that lead to a progressive decline in physiological functioning. Additionally, the risk of HEART DISEASE increases with 
age and irresponsibility where changes start as early as the mid-20's, accelerating in the mid-40's and again at around age 60. While aging is inevitable, the rate at which it occurs can be faster or slower depending on multiple factors, including the interactions of genetics with diet, lifestyle, environment, and stress. It is also impacted by resilience.

Without a doubt, everyone will experience aging. It’s a biological process that begins at birth, and it is inevitable. But how we age is not. We are redefining aging, celebrating it as a time of new opportunities, deeper connections, and ongoing learning. It’s a time where we are actively engaging life with joy and purpose.  Healthy aging is not just about keeping disease and disability at bay. While we’d all like to stay as healthy and functional as possible, we can age successfully and gracefully even with less-than-optimal  health. 

RESILIENCE
is the ability to “bounce back” from an adverse event or experience, large or small. This is influenced by biological factors (including genetics) as well as psychological ones, and both forms of resilience can be cultivated. As people with higher levels of biological and psychological resilience tend to experience improved health and quality of life as they age, this heightens its importance for better aging.

Health is created from physical, emotional, mental, spiritual, and energetic balance. But balance is not static. It requires constant adjustment in response to changes and challenges in your inner and outer worlds - and often changes throughout your lifetime. Resilience helps you bounce back and regain balance.  Here are 8 simple strategies to help you cultivate resilience so you can handle whatever challenges come your way in a way that helps you thrive. (See complete report)




Continued: Introducing THE HEART READER


But how do obstetricians fit alongside specialists dealing with heart-related conditions? Pregnancy involves profound physiological changes, including a remarkable 40% average increase in left ventricular mass—greater than the changes seen in professional athletes after a year of intensive training. Maternal adaptation to these increased cardiovascular demands is essential for preventing pregnancy-related complications such as preeclampsia, gestational hypertension, and intrauterine growth restriction.

With daily monitoring through HeartReader, early signs of cardiovascular decompensation can be identified, enabling healthcare providers to intervene promptly and improve outcomes. HeartReader’s flexibility allows patients across all user groups to take measurements as often as recommended by their healthcare provider. The system’s ability to track hemodynamics and physiological trends over time provides critical insights, empowering clinicians to make informed decisions and deliver better care.


Practical Use of Data – Overview

Source: HeartReader marketing
Your blood sugar, blood pressure, and pulse rate each behave independently, and our analysis captures a range of values that can indicate areas of higher or lower health status. Over time, trends begin to emerge. By collecting data for at least two consecutive weeks, a clear average for key parameters can be established, providing a reliable baseline for assessing overall health. This allows us to offer more personalized and actionable advice to clients.

For physicians, this continuous data collection offers invaluable insights into how a patient’s physiology responds to prescribed medications, enabling more precise therapy adjustments and improved monitoring of medication adherence.

Currently, HeartReader is designed to become a prescription-based system ("RX"), primarily to support physicians in optimizing treatment regimens. However, its applications extend beyond traditional medical use. Lifestyle coaches, fitness trainers, and non-medical health counselors are increasingly utilizing the device to help their clients track health improvements and achieve longevity or lifestyle goals.

Given its versatility, the HeartReader system has the potential to expand into the over-the-counter (OTC) market, making it accessible to a broader audience for personal health tracking and long-term wellness management.


We met Dr. Kulin HERE...


Personalized Testing & Validation for Launch

We have two published medical studies confirming the reliability and accuracy of the HeartReader system. These publications provide a solid foundation for the product's launch, showcasing its ability to deliver consistent and actionable insights into physiological health.


Study 1: Pulse Wave Morphology Analysis
The first study focused on the repeatability and accuracy of pulse morphology analysis. Our primary goal was to determine whether variations in measurements were due to device inaccuracy or the inherent dynamism of human physiology. To address this, we conducted tests using a pulse wave generator, a device that produces a consistent pulse wave regardless of timing or settings.

Results demonstrated that when the HeartReader receives the same input signal, its output remains consistent, proving the system’s high level of accuracy in capturing and analyzing data.












However, physiological variations were observed in real-world testing on individuals. These variations stem from the body's dynamic nature, influenced by factors as subtle as thoughts, consuming a cup of coffee, or taking a brief walk. This highlights a key insight: while HeartReader reliably tracks physiological changes, the dynamism of human physiology introduces natural variability. This contrasts with the "single-measurement" approach often used in conventional medical systems, which can overlook this dynamic nature.


Study 2: Heart Rate Variability (HRV) and Pulse Rate Variability (PRV) Analysis
The second publication examined the system's capability in heart rate variability (HRV) analysis, comparing it to the gold-standard software, Kubios, widely used for HRV research.

     When the same input data was analyzed by both Kubios and HeartReader, the results showed a 99% agreement, affirming that HeartReader's HRV engine is as accurate as (or potentially even slightly more accurate than) Kubios.

     Additionally, we compared ECG-based HRV with HeartReader's peripheral pulse-based pulse rate variability (PRV). The correlation between the two methods aligned closely with existing medical literature, further validating the system's precision and applicability.


Key Findings
These studies confirm that:

  1. Pulse Morphology Analysis is highly accurate and repeatable, reliably capturing physiological signals for preclinical use.
  2. HRV and PRV Analysis delivers results comparable to established gold-standard systems, making HeartReader a robust tool for understanding cardiovascular and autonomic nervous system dynamics.

HeartReader is not only accurate but also embraces the dynamic nature of human physiology, making it a revolutionary tool for personalized health monitoring and clinical support.  These studies pave the way forward towards the next steps to successfully integrate HeartReader into medical practice.

- To Be Continued -



PEDIATRIC MYOCARDITIS & NATIONAL DETECTION MOVEMENT

Since the advent of Covid-19 Long Haul studies in 2021, the medical diagnostic community shifted into overdrive- seeking out all available screening and examination protocols to assess health problems called POST-ACUTE SEQUELAE (PASC). One of the recent Covid-19 related headliners is the rise in cases of MYOCARDITIS in children 16 years and under. CDC Reports link the pathological impact with covid infection since it is proven that Viral infections are a common cause of myocarditis. 
Between early 2020–2021, patients with Covid-19 had nearly 16 times the risk for myocarditis[1]. According to the CDC, in a study of myocarditis cases, 2,116 (41.7%) had a history of Covid-19.  In addition, cases of myocarditis reported to the Vaccine Adverse Event Reporting System (VAERS) indicated links between Myocarditis and Pericarditis to come from the mRNA Covid-19 vaccination (especially in male adolescents and young adults) more often after the second dose.[2].

Myocarditis is defined as an inflammatory disorder of the heart muscle (myocardium) leading to cardiac dysfunction. It is also recognized as myocardial cell death [3]. Checkups for this also reviews for PERICARDITIS (the inflammation of the outer lining of the heart). Various causes of myocarditis includes: Viral Infectious including adenoviruses, echoviruses, enteroviruses like the coxsackie viruses. In addition, predisposition can occur from those with Autoimmune diseases such as Celiac disease, Churg-Strauss syndrome, Crohn disease, Kawasaki disease, lupus, rheumatoid arthritis, sarcoidosis etc. (See NIH chart for full list of causes- [4])

STANDARDIZED DIAGNOSTICS
As with any critical disorder, detecting early stages of myocarditis allows for a higher opportunity to treat and even eliminate the health risk.  In children, symptoms include: Fever, Fainting, Breathing difficulties, Rapid breathing, Chest pain and Rapid or irregular heart rhythms [5]. In adults, symptoms range from chest pain, shortness of breath, at rest or during activity and fluid buildup with swelling of the legs, ankles and feet. To prevent possible heart damage, a cardiologist may order one of a number of imaging options:
▪ Electrocardiogram (ECG or EKG)
▪ Chest X-Ray
▪ Heart MRI
▪ Blood Tests
▪ Doppler Ultrasound for Acute Myocarditis
▪ Cardiovascular MR Elastography (MRE)
▪ Ultrasound Elastography

See expanded details on diagnostic protocols, visit:  http://pediatricscan.com/myocarditis.html





Continued: Introducing THE HEART READER

Evaluating System Performance in Clinical Contexts
The next critical question is: How does the HeartReader system perform under specific clinical conditions? While there is no universally accepted gold standard for peripheral pulse wave monitoring, our extensive dataset offers compelling insights into its reliability and clinical relevance.


Large-Scale Data Validation
With over 150,000 measurements collected from more than 8,000 individuals aged 15 to 85, our analysis revealed a strong correlation between many of the 30 calculated parameters and age. Since physiological and hemodynamic functions naturally evolve with age, this alignment with well-documented aging patterns serves as a robust internal validation of the system. The fact that HeartReader accurately reflects these age-related changes, recognized as "normal" by cardiologists and the broader medical community, reinforces the system’s credibility and precision.

Highlighting Individual Variability
In addition to reflecting typical aging trends, HeartReader uncovers individual differences in aging rates and cardiovascular health. Some individuals demonstrate faster or slower aging patterns, with corresponding variations in cardiovascular risks and conditions. This variability underscores the system's ability to go beyond averages and offer personalized insights. By identifying where a person falls relative to their age group, HeartReader provides a detailed picture of individual cardiovascular health, making it a powerful tool for early detection and intervention.

Establishing Age-Based Averages
Despite individual differences, the extensive data pool has enabled us to establish clear averages for each age group. These benchmarks further validate the system's capacity to serve as a precise and personalized monitoring tool, offering healthcare providers a reliable means of assessing cardiovascular health and guiding patient care.

HeartReader's combination of large-scale validation, individual variability analysis, and alignment with established medical norms positions it as a cutting-edge system for clinical and personalized health applications.

 

About the Author/Developer:

Dr. Sándor Kulin graduated as a medical doctor in 1990 at Semmelweis University, Budapest, and became an obstetrician and gynecologist at Imre Haynal University of Health Sciences in 1994.   He has special interest in maternal and fetal health, human physiology, cell physiology, hypoxia, malignant transformation, and therapy monitoring. Having almost 20 years of experience in non-invasive cardiovascular monitoring in 2018 he became a Co-founder and CEO of E-Med4All Europe Ltd, a Hungarian digital health startup, aiming to help the transformation towards a more data driven and personalized medicine and to be part of the shift of today’s medicine from disease management to prevention.



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