UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of July 2023
Commission File Number: 001-41089
Advanced Health Intelligence Ltd
(Translation of registrant’s name into English)
71-73 South Perth Esplanade, Unit 5
South Perth, WA 6151
Australia
(Address of principal executive offices)
Indicate by check mark whether
the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form
40-F ☐
INFORMATION CONTAINED IN THIS FORM 6-K REPORT
Attached as Exhibits 99.1 to this Report on Form 6-K is a copy of the
press release of Advanced Health Intelligence Ltd, dated July 5, 2023: Advanced Health Intelligence Ltd Shareholder update - FDA and Stellenbosch
Study.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
ADVANCED HEALTH INTELLIGENCE LTD |
|
|
|
Date: July 5, 2023 |
By: |
/s/ Scott Montgomery |
|
|
Name: |
Scott Montgomery |
|
|
Title: |
Chief Executive Officer |
2
Exhibit 99.1
Company
Announcement
July
5, 2023 |
|
Advanced
Health Intelligence Ltd
Shareholder
update - FDA and Stellenbosch Study
South
Perth, Australia – July 5, 2023 - Advanced Health Intelligence Ltd (ASX/NASDAQ: AHI) (“Advanced Health Intelligence”,
“AHI” or the “Company”) shareholder update regarding technology progress and Stellenbosch University study.
We
are delighted to provide a comprehensive update on the latest developments at Advanced Health Intelligence, specifically focusing on
our ground-breaking smartphone-based biometric health assessment (BHA). This shareholder update aims to offer a detailed insight into
our ongoing development, launch and release of the BHA and the actions the company is taking to launch its robust, peer reviewed and
validated technology with a study, enabled by Stellenbosch University. In working with Stellenbosch University AHI seek to validate the
purpose and significance of its biometric health assessment, and in doing so, demonstrate AHI’s traction to academic, clinical
and commercial communities of our commitment to supporting the innovation in global healthcare.
Study
and the Role of Stellenbosch University:
AHI
is committed to ensuring the effectiveness and accuracy of our proprietary multi-sensor data set captured via our BHA, which will be
demonstrated by the initiation of a joint study with globally respected Stellenbosch University. The current phase of the study is designed
to rigorously test and evaluate the capabilities of AHI’s BHA, which encompasses a contactless method using only a smartphone and
multi-sensor method to create an impressive 61 health outputs, resulting in 41 biometric captures across five significant health and
disease categories – cardio-respiratory, body composition, estimated blood biomarkers, metabolic health and mental health.
To
undertake this crucial process, AHI has selected Stellenbosch University, renowned for its exceptional research history and extensive
expertise in healthcare. The University’s sterling reputation and scientific rigor make them an ideal collaborator for this and future
studies. With their profound knowledge and commitment to excellence, Stellenbosch University brings invaluable insights and a meticulous
approach to the verification of our biometrically driven outputs which have been captured and computed using four sensors exclusively
on a smartphone – no additional equipment or medical professional required.
We
are pleased to share that significant progress has already been made in the initial phase of the study. In fact, the initial phase involved
testing AHI’s BHA on the first 20 subjects, yielding some highly valuable correlative biometric data sets and promising results.
Across the 20 subjects, 18 of which, we have observed clinical relevance, affirming the efficacy and accuracy of our technology in stratifying
biometric health risk utilising a completely non-invasive and contactless method.
This
remarkable achievement underscores the robustness and reliability of our sensor set, and it reinforces our confidence in the transformative
potential of our smartphone-based biometric health assessment. The relationship with Stellenbosch University further strengthens the
credibility and reliability of our technology, instilling confidence in the broader healthcare community.
As
the study progresses, we remain committed to ensuring the highest standards of scientific rigor and meticulousness. By subjecting our
multi-sensor capture to rigorous testing and evaluation, we aim to establish a solid foundation for its widespread implementation and
adoption globally. This collaborative effort will contribute to shaping the future of healthcare and reinforce our position as a trusted
provider of cutting-edge health technology solutions.
FDA
Submissions Underway
AHI
has made an initial submission to the FDA by section 513(g). The purpose of a Section 513(g) submission is to obtain clarification on
the regulatory pathway for a medical device. This will provide AHI with the appropriate guidance from the FDA before submitting a formal
application. The FDA is currently reviewing the request and AHI is awaiting written feedback.
| Advanced Health Intelligence Ltd | 1 |
| ACN 602 111 115 | |
| Postal Address: PO Box 190, South Perth WA 6951 | |
| Email: investors@ahi.tech | |
Company
Announcement
July
5, 2023 |
|
The
current submission is seeking categorisation of the AHI BodyScan to be specifically used in the identification and tracking of obesity.
AHI’s long-term strategy to seek FDA approval for the BHA under a 510K software as a medical device category. The Stellenbosch
study will provide valuable data that will form part of these submissions.
The
following link provides a sanitized real-time BHA report: BHA Report
- Health Risk Assessment
Why
AHI developed the Biometric Health Assessment (BHA):
The
biometric health assessment (BHA) serves as a powerful solution and aid for healthcare professionals, insurers and governments, offering
a transformative approach to patient-care. Anchored by decades of medical, scientific literature and studies, AHI has meticulously identified
and digitized known health indicators that medical practitioners rely upon in their day-to-day consultations.
This
transformative approach to digitizing health marker captures substantially minimizes the propensity for human error. This innovation
paves the way for the delivery of accurate, low cost and reliable data grounded on trusted and validated principles to be accessed by
most of the world’s smartphone users.
Early
identification and intervention in chronic diseases have immense significance for both individuals and the healthcare system. Chronic
diseases, such as cardiovascular conditions, diabetes, respiratory disorders, sleep apnea and mental health disorders, pose a significant
burden on individuals’ health and well-being and due to current physician-led screening and monitoring methods for those conditions,
further reduces timely access to already over-burdened health professionals. Moreover, they result in substantial financial strain on
healthcare payors, including both private and public entities.
By
facilitating earlier detection of chronic disease risk, the BHA can play a pivotal role in improving patient outcomes and help alleviate
the economic burden associated with an increasing need to screen and monitor these chronic conditions. By capturing and analysing a comprehensive
set of biometric data, including but not limited to vital signs, body fat percentages and estimated blood lipid profiles, the BHA enables
healthcare professionals to identify early warning signs and indicators of chronic diseases, even before the onset of visible symptoms.
Earlier
identification promotes timely interventions, such as lifestyle modifications, targeted treatments, and preventive measures, which can
significantly slow the progression of chronic diseases. This proactive approach not only improves individual health outcomes but also
results in substantial cost savings for private and public payors of healthcare.
The
financial implications of early identification and intervention in chronic diseases are far-reaching. By identifying earlier intervention
opportunities, the BHA has the potential to save billions of dollars in healthcare costs. It reduces the need for expensive hospitalizations,
emergency room visits, and complex treatments associated with advanced stages of chronic diseases. Instead, resources can be allocated
towards preventive care, patient education, and community health initiatives, fostering a more sustainable and cost-effective healthcare
system.
The
intension of the BHA developed by AHI is to offer healthcare professionals an invaluable tool to aid in the early identification and
intervention of chronic disease risk. By digitizing known health indicators, grounded in proven scientific principles, the BHA will substantially
mitigate human error and delivers accurate and reliable data that otherwise would require a series of health professional consults or
multiple pieces of expensive medical equipment to obtain. This access via smartphone offers early detection of chronic disease risk which
not only improves patient outcomes but also results in substantial cost savings for both private and public payors of healthcare. The
BHA is poised to revolutionize patient care and contribute to a more sustainable and efficient healthcare system for all stakeholders
involved.
Utilizing
a Proprietary Cross Combination of Sensor Sets for Causal Analysis:
Innovation
is key to driving advancements in healthcare and achieving better health outcomes. Advanced Health Intelligence recognizes the critical
importance of focusing on causation, particularly in the context of chronic diseases. To address this challenge, we have developed a
proprietary combination of multiple sensor sets integrated within the smartphone interface, enabling a comprehensive and holistic approach
to health assessment.
| Advanced Health Intelligence Ltd | 2 |
| ACN 602 111 115 | |
| Postal Address: PO Box 190, South Perth WA 6951 | |
| Email: investors@ahi.tech | |
Company
Announcement
July
5, 2023 |
|
Our
commitment to innovation is rooted in a deep understanding that identifying causation is vital for effective disease management and prevention.
By leveraging our unique sensor set captures and meticulously correlating numerous calculations across the human form, our technology
can estimate with a higher degree of relevance, clinical signs and indicators of chronic diseases at an early stage. By utilizing our
proprietary combination of sensor sets, we augment healthcare rather than disrupt it.
We
firmly believe that any technology introduced in the healthcare space should work in harmony with existing care providers and systems.
Our goal is to support care providers, with the ease of use and valuable information the BHA delivers, our technology can become a valuable
tool in their hands and most importantly in the hands of their patients. The integration of our sensor sets within the mobile phone interface
allows for seamless and convenient health assessing, screening and monitoring, augmenting the capabilities of healthcare professionals
rather than replacing them.
It
is essential to emphasize that our technology does not aim to replace medical practitioners or act as a substitute for their expertise.
Rather, we seek to empower healthcare providers with accurate and comprehensive data, enabling them to make more informed decisions and
deliver personalized care based on the individual needs of each patient.
Our
technology acts as an additional layer of support, providing healthcare professionals with vital insights and actionable information
that can enhance diagnosis, treatment planning, and ongoing monitoring. By offering a patient the ability to stratify their biometric
risk anytime they choose, or are advised to, we are able to bring more accessibility to biometric markers which underpins a more modern
method of health management.
AHI’s
dedication to augmenting healthcare by enabling ubiquitous access through innovative sensor combinations is driven by our commitment
to improving health outcomes and delivering value to patients, care providers, and healthcare systems at large. We recognize that collaboration
and integration are crucial for success, and we are actively engaged in fostering partnerships with healthcare providers to ensure our
technology seamlessly integrates into existing care frameworks as well as become a foundation function into the digital future of personalised
healthcare.
AHI’s
proprietary technology represents a significant leap forward in the early detection and management of care. By leveraging our innovative
technology, we empower healthcare professionals with actionable insights and timely interventions, leading to improved health outcomes
for patients. We firmly believe that by augmenting healthcare and collaborating with care providers, we can collectively achieve the
goal of delivering better, more personalized care while driving positive change in the healthcare landscape.
Vlado
Bosanac Founder and Head of Strategy at AHI said:
“AHI’s
role is to assist health professionals, insurers, and governments, by providing essential information, for the facilitation of ongoing
health monitoring, and empowering healthcare professionals to make more informed decisions enhancing patient care. Through collaboration
and the utilization of our technology, we strive to shape a future where healthcare is accessible, personalized, and with trusted data-driven
insights.
Enhancing
the accessibility and affordability of care is of paramount importance. We want to deliver risk assessment on a global scale, which is
why we have embraced smartphone technology as the delivery tool. The compute power of these devices allows for the seamless delivery
and implementation of our proprietary AI and machine learning models which are at the foundation of our technology. The value of this
approach is now being realized as we roll our technology out to our partners effectively and economically at scale”.
Scott
Montgomery CEO of Advanced Health Intelligence said:
“We
are dedicated to enhancing healthcare outcomes on a global scale. By empowering individuals with ever-present access to biometric health
insights we in turn provide healthcare professionals with accurate and more timely data, and therefore enable early detection of health
conditions, preventive interventions, and personalized treatment plans. This holistic approach leads to better patient outcomes, reduced
healthcare costs, and improved population health. At AHI the transformative impact we can make together with our partners and stakeholders,
through harnessing advanced technology and fostering collaboration, we are revolutionizing healthcare and creating a brighter, healthier
future for individuals and communities worldwide.”
| Advanced Health Intelligence Ltd | 3 |
| ACN 602 111 115 | |
| Postal Address: PO Box 190, South Perth WA 6951 | |
| Email: investors@ahi.tech | |
Company
Announcement
July
5, 2023 |
|
Our
Mission
Supporting
Informed Decision-Making:
AHI
recognizes that healthcare professionals possess invaluable expertise and insights. Our role is to provide accurate and timely data that
complements their knowledge, allowing them to make informed decisions regarding patient care. By harnessing advanced technology and data-driven
solutions, we enhance the capabilities of healthcare providers and enable them to deliver more personalized, evidence-based care.
Facilitating
Ongoing Health Monitoring:
Our
unique digitized interface enables continuous health monitoring within communities, even, and more importantly when individuals are not
physically present at medical facilities. By utilizing the capabilities of mobile phones and other digital devices, we create opportunities
for remote patient monitoring, preventive care, and early intervention. This approach not only improves accessibility to healthcare but
also fosters a more proactive and patient-centric model of care.
Identifying
the Right Patients at the Right Time:
Accurate
and timely information is vital for effective healthcare delivery. AHI’s technology equips healthcare providers with the tools to identify
the right patients who require immediate attention or targeted interventions. By leveraging data analytics and our digitized interface,
healthcare professionals can optimize their resources to identify and address needs proactively, to facilitate earlier intervention and
enhanced care for those most at risk.
Enhancing
Healthcare Outcomes:
Through
our collaborative efforts with healthcare providers and other large stakeholders in the healthcare ecosystem, AHI aims to improve healthcare
outcomes on a global scale.
By
empowering healthcare professionals with accurate and timely data, we enable early detection of health conditions, preventive interventions,
and personalized treatment plans. This holistic approach leads to better patient outcomes, reduced healthcare costs, and improved overall
population health.
Embracing
Global Health Community:
AHI
is committed to embracing the global health community and collaborating with stakeholders to drive positive change. We are actively seeking
more partnerships to extend our diversity of data with healthcare organizations, research institutions, and industry leaders to foster
innovation, share knowledge, and work collectively towards enhancing healthcare systems worldwide. By engaging in these collaborations,
we contribute to the advancement of healthcare as a collective effort.
*The
Board of Advanced Health Intelligence Ltd has approved this announcement.
For
more information, contact:
Scott
Montgomery
Chief Executive Officer
Advanced Health Intelligence Ltd
E: admin@ahi.tech |
Vlado
Bosanac
Founder/Head of Strategy
Advanced Health Intelligence Ltd
E: admin@ahi.tech |
| Advanced Health Intelligence Ltd | 4 |
| ACN 602 111 115 | |
| Postal Address: PO Box 190, South Perth WA 6951 | |
| Email: investors@ahi.tech | |
Company
Announcement
July
5, 2023 |
|
About
Advanced Health Intelligence Ltd
Advanced
Health Intelligence Ltd (‘AHI’) is dedicated to global healthcare transformation, providing scalable health assessment, risk
stratification, and digital triage capabilities to healthcare providers, insurers, employers, and government agencies worldwide. Through
our proprietary technology and processes, we deliver innovative solutions that revolutionize healthcare.
Since
2014, AHI has been at the forefront of Health-tech innovation, leveraging smartphones to empower individuals with personalized health
insights. We began with the world’s first on-device body dimensioning capability and have since developed a suite of componentized solutions
that epitomize the next frontier in digitizing healthcare. These capabilities include:
| ● | Body
dimension and composition assessment: Our technology enables accurate measurement and assessment
of body dimension and composition, aiding in the identification of comorbidities associated
with obesity, such as estimating the risk of diabetes. |
| ● | Blood
biomarker prediction: We employ advanced algorithms to predict blood biomarkers, including
HbA1C, HDL, LDL, and 10-year mortality risk. This predictive capability helps identify potential
health risks and allows for proactive intervention. |
| ● | Transdermal
Optical Imaging: Through non-invasive transdermal optical imaging, we provide vital signs
and estimate the risk of cardiovascular disease. This cutting-edge technology enhances early
detection and facilitates timely interventions. |
| ● | Dermatological
skin identification: Our on-device dermatological skin identification capabilities cover
588 skin conditions across 133 categories, including melanoma. This empowers users and healthcare
professionals to assess and monitor skin health more effectively. |
| ● | Assisting
partners in delivering personalised therapeutic and non-therapeutic health coaching to improve
daily habits and build health literacy. |
At
AHI, our world-class team comprises subject matter experts in machine learning, AI, computer vision, and medically trained data scientists.
Their expertise ensures that our technology remains at the forefront of innovation, meeting the evolving needs of our consumers and partners.
With
a resolute focus on achieving impact at scale, AHI is proud to mark this milestone in digital healthcare transformation. Our biometrically
derived triage solution, accessible on smartphones and beyond, allows our partners to identify risks among their consumers and guide
them into the appropriate care pathways for proactive health management on a population scale.
By
harnessing the power of advanced technologies, AHI is driving positive change in the healthcare landscape, empowering individuals, and
transforming the way healthcare is delivered and experienced globally.
For
more information, please visit: www.ahi.tech
AHI
has been intricately involved in the integration of AI and machine learning into our operations. We recognized the significance of these
advanced capabilities early on in the development of our technology, understanding that their adoption was crucial to delivering care
on a large scale.
|
Advanced Health Intelligence Ltd |
5 |
|
ACN 602 111 115 |
|
|
Postal Address: PO Box 190, South Perth WA 6951 |
|
|
Email: investors@ahi.tech |
|
Advanced Health Intellig... (NASDAQ:AHI)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
Advanced Health Intellig... (NASDAQ:AHI)
Historical Stock Chart
Von Mai 2023 bis Mai 2024