2024 NON-INVASIVE RESEARCH CLINIC
Integrative Health Research Center

8/16/2023 - In great support of a the global movement of NON-INVASIVE medicine, we proudly introduce the INTEGRATIVE HEALTH RESEARCH CENTER by AngioInnovation Research (501c3). This New York city-based diagnostic imaging validation lab is established to clinically identify the efficacy, performance and supportive claims set by non-invasive therapeutics and diagnostic solutions. Co-founded by Dr. Robert L. Bard, the IHRC offers a non-profit, non-commercialized testing option for health-related innovations who seek an independent and impartial reporting through single-case pilot studies or IRB-Based clinical trials. The IHRC employs credentialed medical professionals and specialists in clinical research whose experience contributes to the unique strategic approach of each test study.

IMAGE GUIDANCE AND PERFORMANCE TESTING
Dr. Robert Bard's research reporting protocol is one that he has perfected to align with current validation standards, whereby his use of quantifiable imaging is acquired as part of clnical data when providing the effects of specific tested medical devices or serums. With his strategic use of non-invasive imaging solutions like the 3D Doppler Ultrasound (to record hemodynamic reactions of any tested product) or the Elastogram (to record tissue elasticity), we are able to record and monitor any pathological changes and effects in real-time.

The concept behind ‘CLINICAL VALIDATION’ in performance testing helps underscore the safety and performance of a certain health product (in question) “ensuring the manufacturer will consistently provide the intended benefits for its use condition. Clinical validation is usually done through a series of tests and inspections.” To conduct this medical validation officially can be offered through various protocols, an Institutional Review Board approved by the HHS and FDA regulations. One protocol that can be available for consideration by the IRB panel is the use of medical grade 3D Doppler Ultrasound imaging. The use of medical imaging technologies like an ultrasound alongside the interpretation of a certified clinical radiologist may offer biometric assessment and analyses of all scanned readings and the collection of ample data to confirm or validate a health device’s effects on the body as marketed.

VALIDATION SUPPORTS PUBLIC CLAIMS
Especially when a product is a health‐related solution, testing is an important and highly critical step from a legal standpoint. This step is directly involved in a developer’s statements and claims about the device. Before any device is to be promoted for a specific pathology, a series of formal performance exams must be conducted to suit regulatory acceptance by an outside agency or clinical team approved by a federally backed review board. Considerations for validation include: range of physiological effects, warnings about the possible hazards, physical risk to the user in regular use, adverse 2 reactions (potential side effects)‐ and all these elements are from data acquired during a validation study. To confirm (or validate) that a product is effective within the statements and claims that it provides the public, the manufacturer would need to invest in an exclusive and dedicated lab or agency that is poised to perform this level of testing. Said lab must acquire enough data (according to the IRB board) to supports the aspired claims. If/when enough data has proven the hypothesis true, this would add to the product’s marketing credence as well as confirms the device’s ability as a health or wellness product. Any other type of observational testing outside of the authority of an IRB is considered ANECDOTAL and must be established as such‐ which holds no credence as an industrywide claim whatsoever.

EVIDENCE-BASED PERFORMANCE REPORTS
The following are excerpts from actual pilot studies and performance reports of medical / therapeutic solutions:

•11/24 - Image Guided Approach to the Potency of PEMF on Prostate Hyperplasia (PDF report- official)
• 10/15 - Phase 1 Pilot Study of Exosome Topical Product (PDF report)
• 9/11/2023 - Performance Micro Study of (Aspen) Photobiomodulation (PDF report)
• 8/18 - Interventional Monitoring of Muscle Reaction to PEMF Induction (PDF official report)
• 6/1 - Mindray Sample Data/Performance logs (PDF official report)

Continue to Part 2: VALIDATION TESTING

2023 Research: Exploratory Use of Extracellular Vesicles for CHRONIC Disorders
4/12/2023 - Dr. Paul Dreschnack, NY-based surgeon and biochemical researcher announced in a medical partnership for a new set of Extracellular Vesicles (EVs) research protocols. His research proposals are aimed to addressing some of the most highly challenging chronic disorders including PTSD, PSORIATIC ARTHRITIS, DIABETES, ALZHEIMER'S DISEASE, and AMYHOTROPHIC LATERAL SCLEROSIS. Advancements in areas of cell regenerative solutions include concepts in Extracellular Vesicles therapy which are now being explored for its potential as a natural product of our stem cells. Various in vitro studies have exhibited these nanoparticles or Extracellular Vesicles to contain advanced numbers of proteins, mRNA and lipids - all working to safely and effectively address the progression of specific given diseases. Though (at the time) no FDA regulatory clearances have been granted to the wide clinical use of EVs, continued research and clinical trials are underway to collect more data on EV applications and show substantial promise as novel treatment strategies for diseases. Launch plans for mid-2023 include IRB proposals, a national fundraising campaign and the submission to partner with specific development labs to conduct multi-validation medical studies of EVs. His new research A-team includes leaderships from the medical community including senior diagnostic imaging expert, Dr. Robert Bard (NYC), epigenetics and genomics expert Dr. Roberta Kline (NM), clinical psychiatrist Dr. Janice Greene (NYC), researcher Dr. Noelle Cutter and functional medicine practitioner Dr. Leslie Valle-Montoya (CA). - see complete article

WAGING "WAR AGAINST INFLAMMATION"
6/1/2023 - One of the most comprehensive ways to confirm the results of any treatment is by clinically tracking the body's physiological response from underneath the skin. Diagnostic imaging captures measurable data about the injured or inflamed area, allowing both clinicians and patients the ability to identify therapeutic progress in real time. AngioFoundation researchers have united with innovators in the science of PHOTOBIOMODULATION (PBM) and PULSED NEUROMAGNETIC technologies to form this unique Image Guided protocol. Candidly called "Scan & Treat", imaging specialists may have finally closed the gap between non-surgical regenerative technologies and the real-time monitoring of its effects on the body. To collect quantitative biometrics through ultrasound and elastography is now available at one of our collaborative DEMO DAYS at the AngioFoundation headquarters (Soon to be erected as Bard Diagnostics Lab).

Refs: • Demo Day 1 (ASPEN LASER) | • Science behind THERALIGHT? | • PEMF 101

"SEEING IS BELIEVING": Advantages of Imaging in Research Studies

QUANTIFIABLE DETECTION OF THERAPY RESPONSE
MEDICAL IMAGING refers to the set of FDA approved modalities that are used to view the human body in order to diagnose and monitor medical conditions or the response of its treatments. The types of common modalities include X-rays, MRI (magnetic resonance imaging), Ultrasound, CT scan (computed tomography scan) and Nuclear medicine imaging including Positron Emission Tomography (PET) [1][2]
Ultrasound imaging (sonography) uses high-frequency sound waves to view inside the body. Because ultrasound images are captured in real-time, they can also show movement of the body's internal organs as well as blood flowing through the blood vessels. Unlike X-ray imaging, Ultrasound uses NO ionizing radiation exposure whatsoever.[3] This modality (sometimes referred to as "the orthopedic stethoscope"), offers easy access, portability, affordability and real-time monitoring and is safe for all patients, including those with cardiac pacemakers and metal implants, without any contraindications.

TRACKING THERAPEUTIC EFFECTS THROUGH BLOOD FLOW REACTIONS
To date, the ultrasound's ability to evaluate abnormalities within the soft tissue such as cysts, tumors and inflammation is used to help identify an expanded set of pathologies in the body.  Since the early 1970's, Dr. Robert L. Bard (NYC Cancer Radiologist) has used diagnostic imaging for pre and post procedural guidance, and diagnostic care (screening and monitoring) of his patients.  Dr. Bard is also recognized for his use of ultrasound in pharmaceutical research and clinical trials, where his leadership in analytical interpretation is sought after worldwide for identifying markers and therapeutic efficacy. 

Throughout his career, Dr. Bard has employed this imaging strategy to detect, track and confirm the body's reaction to a variety of therapeutic interventions. He has conducted medical center based double-blinded, corporate sponsored and private studies reviewing the effects of injectable therapies (PRP, Stem Cell therapies, etc) as well as non-invasive therapeutic interventions in studies of neuro-stimulation, electrostimulation and electromagnetic field treatments.  His approach involves the comparative study of measurable scanning data or quantitative ultrasound (QUS) which aims at recording interactions between the behavior and activity of biological tissue microstructure and ultrasound waves [5][6]. From a time-based comparative study of the treated area (before and after studies), Dr. Bard applies the use of blood flow detection technology or hemodynamic data gathering protocols, document specific objective and quantifiable biological responses to therapeutic treatments.

Ref:
1) Medical Imaging/FDA: https://www.fda.gov/radiation-emitting-products/radiation-emitting-products-and-procedures/medical-imaging#:~:text=Medical%20imaging%20refers%20to%20several,monitor%2C%20or%20treat%20medical%20conditions.
2) https://sonosimaging.com/press-corner/understanding-the-different-types-of-imaging/
3) https://www.fda.gov/radiation-emitting-products/medical-imaging/ultrasound-imaging
4) Diagnostic imaging to detect and evaluate response to therapy in bone metastases from prostate cancer: current modalities and new horizons https://pubmed.ncbi.nlm.nih.gov/26956538/

"Before & After" Studies

The most sensible and logical way to identify the results of any treatment is by tracking the body's response to it. Controlled testing must show the patient's condition PRE and POST effects, where true data-finding is collecting the necessary EVIDENCE of its claims. The investigator can pull a significant amount of data from this form of oberservational testing and recording: including stage-by-stage bodily response to future projections of possible side effects. Recording of any and all psysiological response means the researchers are counting on the patient's body to tell us what it is undergoing during the testing phase. To prevent mis-reading and erroneous reports, trials tend to work with a large number of test patients (commonly 50-100) and may also employ redundancies like undergoing multiple testing protocols for a second or even third opinion. To capture the benefits of a BEFORE AND AFTER review, Imaging is often used as a standard screening solution for the response of most of the major organs.

From Local to Global:
ENTER THE AGE OF REMOTE MEDICAL ACCESS

The subdermal ultrasonic technology has become a powerful new standard in diagnosing and treating patients. The movement to "go digital' also brings significant advantages between clinicians in different locations by allowing them to share patient scans and test images in real time. This benefit is also greatly used in clinical trials from multiple locations. Working with a team is no longer limited to localized personnel; today's medical project allows complete working access to the most credentialed experts from any part of the globe. Dr. Bard has proven this work paradigm throughout his career -having partnered with countless clinical teams and research groups in European medical centers who sought his specific experience and diagnostic talents. Thanks to the use of the latest CLOUD-BASED imaging programs, trial projects can easily acquire, host, transfer and securely deliver any and all 3D/4D subdermal imaging of a patient (or test case) via REMOTE ACCESS. This innovation significantly adds a new level of efficiency and performance to any research project while greatly reducing trial costs and delays.

Contributing to the evolution of SCIENCE

by: Dr. Robert L. Bard

I welcome all solutionists and innovators who support the healing arts community. I have devoted my specialized work to pursue the advancement of MEDICAL RESEARCH with NON-INVASIVE SURROGATE ENDPOINTS with the hopes of contributing my talents to the performance of your current and future projects. With over 45 years in the field of advanced diagnostic science, my life's work has been about the clinical examination and targeted analyses of all subdermal disorders using the latest quantifiable digital imaging innovations. I have established an entire foundation dedicated to Medical Research committed originally to the exploratory studies of all cancer treatment proctocols. Alongside this, I have also been most active in collaboration with some of the top treatment strategists, health centers, clinical labs, experimental / alternative treatment professionals and medical device manufacturers. I have earned a reputation for my investigative approach within various examination paradigms including progress monitoring and surveillance.

As a CO-INVESTIGATOR, I have the greatest interest in supporting all entities committed to contributing technical innovations and new advancements in treatment solutions for our medical community. By this, I wish to build a partnership with establishing research teams to conduct clinical test projects where my talents to support visual reporting through imaging to be a priceless benefit to your overall objectives. Most research sponsors and medical developers' testing and tracking needs often fall into one of a number of common task categories- all within the objectives of public health, safety and healthcare support. I look forward to learning about your project with the hopes of supporting your needs and objectives.

Research & Educational PROGRAMS
The AngioFoundation has been recognized worldwide by official medical organizations and peer reviews for its work in FIVE MAIN focal topics and class divisions. We continually maintain and update research works in these categories to support the advancement of these disciplines as part of The AngioFoundation's commitment to the scientific community. Below is a selected examples of medical reseearch projects:

• Efficacy of Injected Hyaluronidase Filler Reduction Dept Dermatology Mt Sinai
Marmur E  HS#14-00291 | Icahn School of Medicine 2015

• Photoacoustic and Optical Imaging
Bard R, Krueger L, Rasmussen S Rockefeller University 2013-2014

• Doppler Evaluation of Radiation Treatment Response
Bard R, Kaplan A 2013-2014 NY Medical College

• 3D Doppler Sonography of Malignant Melanoma 
Bard R, Lefkovitz A In conjunction with Mt Sinai Medical Center New York, NY 2013-2014

• 3D Imaging of Psoriasis
Bard R, Lebwohl M, Wortsman X In conjunction with Mt. Sinai Med Ctr New York, NY 2012

• Doppler Vessel Density in Melanoma
Morton D, Bard R in conjunction with John Wayne Cancer Institute Santa Monica 2009-2010

•  Prostatic Volume Reduction Implementing Radiotherapy Treatment Application
Rotman M, Bard R.  Applications in Prostate Cancer Patients 2006-2008
In conjunction with Downstate Medical Center Brooklyn, NY

• Ultrasonography of the Spine in Rheumatoid Arthritis
Smith M, Bard R | Dept Rheumatology St. Vincents Hospital New York 2000-2001
in conjunction with New York Medical College Valhalla, NY

• Ultrasound Evaluation of the Patient with Rheumatoid Arthritis
Smith M, Prashad R, Bard R et al | Dept Rheumatology St. Vincents Hospital New York 1997-1998 in conjunction with New York Medical College Valhalla, NY

Click HERE at pgs 19-21 for a complete list of Research Projects

Scientific PUBLICATIONS
A significant asset to the medical community is publishing our research studies for complete academic access through medical journals and through full-text distribution with Springer Publishing Inc. Publishing all findings of our research reports maintains the tradition of supporting the growth of current and future generations of clinicians and for the expansion of the vast majority of relevant audiences who benefit from our discoveries. Under the authorship of Dr. Robert Bard, we have amassed over 18 combined years of research and generated countless articles, over 22 scientific textbooks with various topics and hundreds of presentations to the medical community worldwide.

(see Pg. 6-19 books published & international presentations)

Recent & Innovative PROJECTS
Within the past decade, the world of medicine has witnessed (and achieved) a significant amount of success with STEM CELL therapies managing a wide range of disorders. There are 2 main types of stem cell transplant processes- AUTOLOGOUS (source of harvested cells are the same as the recipient) and ALLOGENIC (sourced from a matching donor). Concentrates of regenerative cells can be extracted from bone marrow, unbillical cord (newborns) or fat (adipose) cells & bloodstream. Patients are (now) recognized to receive treatments for a growing list of isses such as ORTHOPEDIC damage (bone and joint injuries) and AUTO-IMMUME DISORDERS (lupus, arthritis, diabetes ). NEUROLOGICAL ISSUES are also now being addressed by stem cell treatments whereby research and testing for treatment efficacy relating to the Nervous System is also in full swing within the clinical community.

Dr. Bard's 4D Doppler capabilities have become the preferred non-invasive solution with research programs to seek out treatment testing or application performance tracking for this exact type of exploratory testing. Dr. Bard has the capacity to identify and track prestroke vasospasms, any increase in intracranial pressure, brain aneurysms and many degenerative disorders. (See related article)

Early collaboration with technological FRONTIERSHIP

In 1976, during Dr. Bard's days as a young radiologist, he was approached by Dr. Henry Leis Jr., the pioneer doctor who wrote the very first text on breast cancer and developed mammography 18- a means of early diagnosis and instrumental in the use of many of the less invasive procedures used in the treatment of breast cancer today. He confessed with great concern that he had all these patients with lumpy or cystic breasts developing tumors that he could clearly feel but the mammogram kept missing it. Seeking Dr. Bard's help through sonogram technology, they worked on his patients together and the sonogram clearly identified and quickly diagnosed a mass as either a cancer or a benign cyst, in a dense, lumpy breast. Since then, the sonogram became incorporated in high-risk patients’ regimen every six months religiously because it finds tumors while they're small and “lumpectomy” surgery is curative if the mass is less than 1 cm. This is alongside doing mammograms once a year in women over 50 or unless they have a history of cancer- at which case, we do it starting at age 45.

Research Support and Fundraising EVENTS

May 10, 2018- NYC; The LOTOS CLUB hosted the 2018 speaker series with Dr. Robert Bard's opening presentation on Early Detection & Prevention by NYCRA (New York Cancer Resource Alliance) and endorsed Dr. Bard to launch this theme because of his expanded knowledge in today's modern diagnostic technologies and non-invasive applications including the 4D Doppler ultrasound technology - much of which has been driven by European medical influence for the cancer treatment community. Dr. Bard is an internationally recognized leading expert in the use of this process for the screening, scanning and pre/post procedural monitoring of Breast, Prostate & Skin Cancers. He is also known for his public mission to replace surgical analysis of tumors with his coined "digital biopsies". Dr. Bard gave the standing-room only audience at the LOTOS CLUB an astounding look at the effectiveness of his imaging process to the surgical chain. He shared images of actual patient cases including the study of blood flow in tumors, behaviors of cysts, foreign bodies in trauma cases, fracture analysis and proven ways that cancers can be safely detected, studied and even treated with the use of non-surgical means. The high accuracy of 3D-4D Histogram analysis allows cancer treatment to be implemented without invasive biopsies that may spread tumor cells. (full article)

Research results in APPLIED SCIENCE

IMAGING ASSISTS SURGICAL PLANNING OF INDICATED BIOPSIES

In my extensive career as the medical director of an advanced imaging diagnostics practice, I have provided great assistance to many surgeons with my work using advanced Doppler Scanning of Tumors and Cosmetic Disorders. I have uncovered countless dermal and subcutaneous issues that would have otherwise gone undetected with less effective technologies, leading to potential complications in the surgical procedure and patient recovery. The advancement in this innovation empowers upcoming surgical procedures with remarkable confidence of a safer end result. Where biopsies are becoming a thing of the past, our non-invasive 4D Digital imaging replaces weeks of lab work and radiologic tests and often provides more useful information.

DIGITAL BIOPSY CASES: WHAT ARE YOU ABOUT TO BIOPSY? WHAT HAPPENS AFTER THE NEEDLE INSERTS? Here we have 2 subdermal masses which are non tender and firm with no history of trauma. Case A: The oval mass (dark echoes=suspicious) with irregular vessels (red) was referred as a probable cyst or lipoma. The tumor is highly vascular and connected from the aorta by way of the subclavian feeding artery. Liposuction could result in massive hemorrhage and spread of tumor cells into the circulation.

Case B: The ovoid white region (bright echoes=benign) is ossified as confirmed by the CT scan of the coccyx. The sonogram allows you to reassure the patient it is NOT CANCER. It prompts one to avoid a standard needle that could bend, crack or dislodge into the soft tissues requiring further exploration to locate/retrieve the broken metal fragment.