FY24 Annual Report (June, 2024)

2024 ANNUAL REPORT

Chronic Kidney Disease Preventative Medicine

FDA De Novo Marketing Authorization.

Real World Evidence.

Increasing Reimbursement.

Index

STRATEGIC REPORT	3-19
CEO's Statement	3
Company Overview	5
Operational and Financial Highlights	6
Product Overview and Strategy	7
Financial Review	11
Risk Management Approach	13
Section 172 Statement	17
Corporate Social Responsibility Review	19
CORPORATE GOVERNANCE	20-52
Board of Directors	20
Directors' Report	22
Corporate Governance Statement	27
Directors' Remuneration Report and Policy	30
Audit Committee Report	46
Independent Auditors' Report	48
FINANCIAL STATEMENTS	53-83
Consolidated Income Statement	53
Consolidated Statement of Comprehensive Income	54
Consolidated and Company's Statements of Financial Position	55
Consolidated and Company's Statements of Cash Flows	57
Consolidated Statement of Changes in Equity	57
Company's Statement of Changes in Equity	58
Notes to the Financial Statements	60
Additional Financial Information	82

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STRATEGIC REPORT

CEO Statement

During the prior year we have taken considerable and painful steps to reorganize our Company and complete the transition from a development-phase organization to a commercial growth-phase business. With substantive reductions in operating expenses, restructuring of debt and payable obligations, and in November, the completion of a fresh institutional funding, we now believe that the company will be able to achieve profitability in 2 years.

With the positive June Medicare coverage decision, kidneyintelX.dkd has just completed the trifecta of FDA approval, insurance reimbursement and guidelines recommendation. kidneyintelX.dkd is now the only regulated and reimbursed test available for early prognosis, a cornerstone in understanding who is at risk and who to treat with lifetime drug therapy for some 14 million patients with diabetic kidney disease in the United States.

In the United States, over 80% of our $4.5 trillion national healthcare budget is spent on chronic disease. Yet the U.S. has one of the poorest life-expectancies in the developed world - a U.S. male can expect to live 10 years less than in Japan or Switzerland. Chronic kidney disease, the third fastest-growing cause of death globally, is one of the principal drivers of this unsustainable dynamic.

The great news is that new drug therapies such as SGLT2 inhibitors and GLP1 agonists are now available for individuals with diabetes and kidney disease and have dramatically changed the game. However, we simply cannot afford to blanket prescribe these expensive drugs across such large populations at costs approaching $30,000 per year for life.1

kidneyintelX.dkd opens the door to heavily vetted prognostic risk assessment to front-line doctors making critical choices during the short patient visit times allotted. Indeed, world experts, including in the 2024 clinical guidelines2, are now strongly advocating prognosis to enable a personalized approach to treatment and patient identification. And to put this in perspective, kidneyintelX.dkd prognosis can be executed for less than one month's worth of drug therapy cost.

After a multi-year process, the decision in May 2024 by Medicare contractor National Government Services to provide full coverage for kidneyintelX.dkd at $950 per reportable result, is now allowing for settlement of billed tests in under 30 days and an increase to our realized average sales price. Achieving Medicare insurance coverage represents a key commercial milestone given that Medicare and its related insurance plans make up the majority of our addressable patient market in the United States.

We are continuing to perfect the commercial implementation of kidneyintelX.dkd into doctor practice groups using the electronic medical record system to automatically identify eligible patients for testing , accompanied by a doctor best practice alert. Our sales team is now able to walk into this message-integrated environment with doctors already alerted to at-risk patients with the actionable benefits of kidneyintelX.dkd. We are seeing the benefits of this integrated approach to order generation this quarter and expect to leverage this model with additional large group practices in calendar 2025.

The Environment is Heating Up for kidneyintelX.dkd

Chronic disease and preventative medicine are now taking center stage with regard to policy on both sides of the Atlantic to address unsustainable healthcare costs.

The retuof a Trump Administration has already brought the discussion on chronic disease management policy to the forefront. U.S. Health and Human Services Secretary nominee Robert Kennedy has pledged to "end the chronic disease epidemic in the country". The KidneyIntelX prognostic program benefited greatly from the previous Trump Administration's chronic disease regulatory and insurance policy environment. We also note a parallel policy discussion emerging in the United Kingdom with Health Secretary, Wes Streeting's chronic disease platform for revival of NHS. We would expect kidneyintelX.dkd, to have renewed opportunities to support both governments' preventative medicine goals.

1. Clinical practice is moving towards the "four pillars" of diabetic kidney disease therapeutic management which includes combination use of ACEi/ARB, SGLT2 Inhibitors, Finerenone and GLP1 RAs. Estimated cost of SGLT2 Inhibitors, Finerenone and GLP1 RA are $12k, $7.9K and $11.6K annually.
2. https://kdigo.org/wp-content/uploads/2024/03/KDIGO-2024-CKD-Guideline.pdf

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Also, of strategic importance to the kidneyintelX.dkd top line was New York Governor Kathy Hochul's signing into law of Senate Bill1196a/Assembly Bill 1673a (https://www.governor.ny.gov/news/governor-hochul-takes-action-protect-public- health-signs- legislative-package-support-patients) which requires all insurance companies, including state Medicaid, to cover comprehensive diagnostic biomarker testing for patients beginning January 1st, 2025. While we will remain cautious about actual government implementation dates, this type of legislation has received broad bi-partisan support and can have a significant positive impact on kidneyintelX.dkd adoption, average testing sales price and revenue recognition. Other states in our commercial focus are also in process of enacting similar legislation and we will provide updates as they become available.

Reorganized for Expense Reduction and Commercial Execution

In Fiscal year 2024, we completed a substantial reorganization of our business and raised enough money to secure the run through profitability. Our execution was painful, wholly necessary and only available to us now that we have achieved the regulatory, outcomes data and reimbursement trifecta. The Company is now devoting the significant majority of resources to our sales program with much less cash required to operate. Two big moves below have allowed us to target a cash burate of £560,000 or less per month by the end of FY25 (June).

• Debt and Payables Reduction
  Post year end, we have successfully renegotiated the terms of our £8.7 million amortizing senior convertible loan notes. We have improved our accounts payable situation and negotiated with other accounts payable creditors to reduce or write- off their balances. The various actions that we've taken will substantially reduce the Company's monthly cash buand we estimate that this will remove more than 80% of the total forecasted cash obligations of the Company over the next three years (approximately £485,000 per month).
• Transfer of U.S. Trading to OTCQB and Re-qualification of Foreign Private Issuer Status
  Having considered the benefits versus the costs of maintaining the Nasdaq listing, we have decided to transition U.S. trading of our ADS securities to the OTCQB ® Venture Market, which is operated by OTC Markets Group, from the NASDAQ Global Market on October 7th. In addition, at our next testing date for Foreign Private Issuer ("FPI") status, the Company expects to qualify as an FPI. We anticipate that transferring the trading to OTCQB and re-acquisition of FPI status will provide significant savings of up to £1.9 million p.a.

Financing

Post year end, the Company raised an additional £11.9 million gross with strong institutional demand that exceeded our initial funding target. Inside management was an important investment player, and we received long-term cornerstones from both large UK and US institutions.

Board Changes

It is with great pleasure that Renalytix has secured Julian Baines MBE as our new Executive Chairman. Julian was formerly the Non-Executive Chairman of Renalytix from March 2018 to June 2020. I am also delighted Christopher Mills, our long- serving Chairman will continue on the Board as a Non-Executive Director of the Company.

Thank you for your continued confidence.

James R. McCullough

Chief Executive Officer

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Company Overview

PIONEERING NEXT-GENERATION TECHNOLOGY SOLUTIONS FOR KIDNEY HEALTH

Renalytix is the global founder and leader in the new field of bioprognosis™ for kidney health. The Company has engineered a new solution that enables early-stage chronic kidney disease progression risk assessment. The Company's lead service, kidneyintelX.dkd, has been granted Breakthrough Designation by the U.S. Food and Drug Administration (FDA) and is designed to help make significant improvements in kidney disease prognosis, transplant management, clinical care, patient stratification for drug clinical trials, and drug target discovery.

Renalytix is focused on optimizing clinical management of kidney disease to drive improved patient outcomes and lower healthcare costs. KidneyIntelX, our first-in-class in vitro diagnostic platform, employs a proprietary algorithm that combines diverse data inputs, including validated blood-based biomarkers, inherited genetics and personalized patient data from electronic health record, or EHR, systems, to generate a unique patient risk score. This patient risk score enables prediction of rapid progressive kidney function decline in chronic kidney disease, or CKD, allowing physicians and healthcare systems to optimize the allocation of treatments and clinical resources to patients at highest risk.

ON A MISSION TO COMBAT A DEVASTATING AND COSTLY DISEASE

Kidney disease is a public health epidemic affecting over 850 million people globally. Managing a CKD population of this scale and the associated healthcare spending presents a unique healthcare system challenge, requiring a solution that provides a clearer understanding of clinical risk tied to specific guideline-driven clinical recommendations. The ability to predict which patients will experience progressive kidney function decline, which includes rapid kidney function decline, or RKFD, sustained significant decline in kidney function, kidney failure, initiation of long-term dialysis or kidney transplant, is critical to changing patient outcomes and health economics. Current methods for risk stratification of patients with CKD lack sufficient precision in predicting progressive kidney function decline, especially at earlier stages of the disease. This can exacerbate the occurrence of unexpected and expensive clinical events. In fact, up to 38% of patients with CKD initiate dialysis with little or no prior clinical specialist consultation, and up to 63% of patients with CKD initiate dialysis in an unplanned fashion with a central venous catheter and/or during emergency hospitalization, which we refer to as "dialysis crash." This highlights the need for an early mechanism to identify potential instances of rapidly progressing CKD before it becomes critical to the patient's health and costly to healthcare providers.

We have now validated KidneyIntelX in multiple distinct studies, involving specimens from thousands of patients with DKD. In all studies, KidneyIntelX has demonstrated the ability to more accurately identify which patients would experience rapid progressive kidney function decline over current clinical practice. We believe early risk stratification, using advanced technology implemented in partnership with healthcare systems and insurance payors, can help support a fundamental shift towards optimal treatment for the over 850 million people suffering from kidney disease worldwide.

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Operational and Financial Highlights

Including post-period events

COMMERCIAL HIGHLIGHTS

Business refocused to deliver commercial sales growth

• New leadership with a track record of commercial success
• Revamped sales and customer service strategy and implementation of a scalable sales-force-led or "direct-to- doctor" strategy
• Now demonstrating quarter-over-quarter sales growth and repeat doctor testing
• 400 direct-to-doctor orders received from 125 doctors in calendar Q3 2024, with the number of ordering doctors expected to increase to 225 in calendar Q4 2024
• Significant expansion in patient blood draw options with Quest Dx and Exam One, a simplified test order requisition form to reduce doctor workload and a market-informed Customer Services and Billing offering to improve end-to-end user experiences
• Rollout to a major New York-based physician group practice, with potential to access up to 10,000 eligible patients and 140 new ordering doctors starting in September 2024
• Target to achieve 1% US market penetration in 3-4 years
• Guidance on potential revenue generation: c. US$3.2 million in FY25, $8.5 million in FY26 and $17.5 million in FY27

FINANANCIAL & OPERATIONAL HIGHLIGHTS

Restructuring to accelerate path to profitability

• Successful renegotiation of existing senior convertible loan note terms, improved accounts payable situation and agreed with other creditors to reduce or write-off balances - removing more than 80% of cash obligations over next three years (£485,000 per month)
• Nasdaq delisting with American Depository Shares ("ADSs") now quoted on the OTCQB® Venture Market under symbol (OTCQB: RNLXY), and anticipated move to Foreign Private Issuer ("FPI") status to provide significant savings of up to £1.9m annually
• Over-allcash buto be reduced to £560,000 or less per month by the end of FY25
• Over-subscribedequity capital Fundraise to raise approximately £11.9 million, with strong demand exceeding our initial funding target of £10 million that targeted along with reduction in expenses and anticipated revenue growth are expected to allow the Company to achieve break-even in approximately two years
• Board changes - Julian Baines, MBE, an experienced executive within the life science industry and former Renalytix Non-Executive Chairman of the Company from March 2018 to June 2020 reappointed as Executive Chairman; additionally, Daniel Levangie announced his resignation from the Board of Directors effective October 31, 2024

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Product Overview and Strategy

THE KIDNEYINTELX MODEL

At the core of our approach is an artificial intelligence-enabled algorithm capable of synthesizing a set of current and diverse data inputs, such as biomarkers, EHR data, genomics, patient-generated digital data, environmental information, clinical utility, and actuarial and clinical compliance information.

Proprietary blood-based biomarkers

Blood-based biomarkers are typically genes or proteins that indicate the existence and severity of certain conditions (such as kidney disease) and can be measured from a simple blood sample. KidneyIntelX includes inputs from three specific blood- based biomarkers that have previously been examined in several academic and clinical study settings as reported in scientific publications. These publications support consistent associations of soluble Tumor Necrosis Factor Receptor (sTNFR) 1 and 2 and plasma Kidney Injury Molecule-1 ("KIM-1"), with reliable independent predictive signals for kidney disease progression in DKD patients. We licensed the patented sTNFR1 and sTNFR2 biomarkers from the Joslin Diabetes Center of Harvard University because of this evidence of their predictive capabilities. KidneyintelX.dkd measures these biomarkers using a proprietary, analytically validated multiplex format with reliable inter- and intra-assay results. We are exploring additional biomarkers, including both proteomic and genomic based, from blood, urine and other biological samples for subsequent KidneyIntelX technology platform service offerings that could support enhanced predictive performance and expand indicated uses.

Electronic health records data harmonization, adjudication and machine learning

The use of EHRs has been adopted broadly by hospital systems in the United States, the United Kingdom, the European Union and other developed countries. EHR data are generally collected during routine clinical encounters and contain detailed information on disease and treatment patterns. When assessed in the aggregate, EHR data can provide insights into disease progression and clinical management strategies across diverse populations. EHR factors may include items such as current or past therapeutic regimes, diagnostic results, weight, age, geographic location, physician visiting habits and physician annotations. Additional data factors can be added to the KidneyIntelX technology algorithms to address different target populations.

Through experience with our clinical study work, we have developed proprietary data processing methods that enables us to analyze patient data collected during clinical encounters by a diverse set of physicians in different clinical environments and still ensure that the data used by the KidneyIntelX technology platform to support product development and clinical testing is consistent and falls within specific quality control metrics. We have tested this capability in our clinical validation studies involving stored specimens from over 2000 patients with DKD from the Mount Sinai Health System and University of Pennsylvania Health System biobanks.

• EHR Data Harmonization. EHR data from different institutions can be entered and stored in different formats. To overcome this significant limitation, we have developed proprietary algorithms to convert the diverse data (specifically laboratory values and medication names) and map to a standardized template.
• Clinical Adjudication. Kidney function can fluctuate over time and can vary in different clinical scenarios. In the clinical validation studies, to ensure that the kidney disease outcomes for kidneyintelX.dkd and future service offerings were accurately classified and did not represent random non-disease variation, all kidney function changes over time and all clinical outcomes were adjudicated by examining the trajectory of kidney function over their longitudinal course of treatment to the outcome. This adjudication and knowledge base has been codified into the overall workflow for KidneyIntelX technology versioning and validation.
• Machine Learning. We use a proprietary machine learning-enabled algorithm to integrate the diverse inputs from biomarker data and harmonized EHR data to achieve increased predictive performance over the current metrics for prediction of kidney disease progression.

In addition, the KidneyIntelX technology risk score may, at the sole discretion of the clinical user, be tied to specific clinical guideline recommendations developed by the healthcare system, health insurance providers or practice groups. This care pathway is expected to include elements such as targets for clinician visits and referrals, blood pressure control, diabetes control

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and prescription of specific medications, as well as patient behavior, such as appropriate diet, exercise, weight loss, medication adherence, to provide immediate and actionable steps related to kidney health. We also plan to link reportable results to educational modules on kidney disease for patients to improve awareness and influence lifestyle practices.

Seamless integration with electronic health record systems for test ordering and reporting results

KidneyIntelX is designed to interface with EHR systems in order to securely access the information required for each ordered test, which is then combined with biomarker data to generate the risk score and test report. The test result is reported directly to the ordering physician through the EHR system.

In this way, the treating physician can have all of the relevant information pertinent to the patient's care delivered to them at the time of the clinical encounter and can trigger care pathways directly from the EHR interface, with the goal of driving a virtuous cycle in which patients and clinicians have increased visibility and awareness changes in care management and patient behavior on kidney health.

All personal health information captured by the kidneyintelX.dkd application is at all times stored in secure Microsoft Azure- supported cloud infrastructure and is encrypted using Advanced Encryption Standard. All transfers of data and reports through firewalls of the health system are executed using secure transfer protocols in accordance with internationally accepted Transport Layer Security versions 1.2 and 1.3. Security components also include rigid authentication and authorization of all users, a continuous monitoring tool, intrusion detection system and periodic penetration testing to mitigate risks of cyber-attacks.

At the core of our approach is an artificial intelligence-enabled algorithm capable of synthesizing a set of current and diverse data inputs, such as biomarkers, EHR data, genomics, patient-generated digital data, environmental information, clinical utility, and actuarial and clinical compliance information.

Proprietary blood-based biomarkers

Blood-based biomarkers are typically genes or proteins that indicate the existence and severity of certain conditions (such as kidney disease) and can be measured from a simple blood sample. KidneyIntelX includes inputs from three specific blood- based biomarkers that have previously been examined in several academic and clinical study settings as reported in scientific publications. These publications support consistent associations of soluble Tumor Necrosis Factor Receptor (sTNFR) 1 and 2 and plasma Kidney Injury Molecule-1 ("KIM-1"), with reliable independent predictive signals for kidney disease progression in DKD patients. We licensed the patented sTNFR1 and sTNFR2 biomarkers from the Joslin Diabetes Center of Harvard University because of this evidence of their predictive capabilities. KidneyintelX.dkd measures these biomarkers using a proprietary, analytically validated multiplex format with reliable inter- and intra-assay results. We are exploring additional biomarkers, including both proteomic and genomic based, from blood, urine and other biological samples for subsequent KidneyIntelX technology platform service offerings that could support enhanced predictive performance and expand indicated uses.

OUR STRATEGY

Our goal is to lower healthcare costs and improve patient quality of life by transforming the paradigm for kidney disease risk assessment and clinical management through our KidneyIntelX platform technology and the now FDA authorized kidneyintelX.dkd. Core strategy elements to achieve this goal include the following:

• Continue to Build Integrated Partnerships with Healthcare Systems on a Population Health Basis. We are focused on building partnerships with healthcare systems and the engagement and support of their clinical leadership teams, which will enable us to efficiently initiate and deploy our solution to patient populations with DKD. A key aspect of this is technical integration of the KidneyIntelX technology software platform with healthcare systems' EHR systems and clinical workflow. In September 2020, we announced the initiation of patient testing with Mount Sinai Health System. Integrated partnerships such as this are designed to allow KidneyIntelX technology to be deployed directly to patient populations and their treating clinicians in a cost-efficient and timely manner. We are engaging with multiple healthcare institutions and national payors regarding additional partnership opportunities.
• Further Expand Insurance Payor Coverage. We continue to successfully build pathways for payment for KidneyIntelX technology across a range of insurance payors in multiple states including from Blue Cross Blue Shield, Medicaid, Medicare, Medicare Advantage and other private insurance companies. We believe we are reaching critical scale of insurance payment in several key markets including in Illinois, New York, Texas, Florida and North Carolina.

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• Continue to Pursue Permanent Medicare Coverage through a National Coverage Determination (NCD), following the Company having achieved a Local Coverage Determination (LCD), which became effective 1 August 2024. We achieved our first payments from National Government Services (NGS), a Medicare Administrative Contractor ("MAC"), in October 2022. Along with achieving the LCD, we are pursuing additional coverage from other MACs in other jurisdictions. We are also simultaneously pursuing a National coverage determination directly from the Centers for Medicare & Medicaid Services ("CMS"). FDA and CMS have proposed a new Transitional Coverage for Emerging Technologies (TCET) program to support Medicare coverage on the national level for innovative diagnostic devices that service an urgent clinical need.
• Build Substantial Repository of Kidney Disease-Related Data. We are building a repository of kidney disease-related data for the development of progressive KidneyIntelX product versions and additional artificial intelligence-powered clinical applications. We are designing applications to examine disease patterns in large patient populations and to optimize clinical care navigation and management effectiveness. These developments are underpinned by the goals of driving patient and physician behavior changes and ultimately improving patient outcomes. Access to current and historical patient data, combined with the ability to analytically and clinically validate study results in a quality- controlled framework, provides us with a powerful product development platform. Moreover, the depth, specificity and quality of data is of paramount importance to developing solutions with demonstrated clinical utility across a range of practice specialties and patient demographics, and securing access to this data is central to our strategy of demonstrating both short- and long-term impact on patient outcomes and health economics.
• Expand Our Product Portfolio. We believe there are significant opportunities to expand our platform through incremental version releases of KidneyIntelX technology as well as through extending the KidneyIntelX platform into new applications for CKD patients beyond those with diabetes, including repeat testing to monitor changes in risk and therapeutic response and other CKD subtypes. We also intend to develop solutions for use in other large chronic disease patient populations, like CKD associated cardiovascular disease. KidneyIntelX technology has been designed within a quality controlled environment with regulatory approval process to allow us to take advantage of the dynamic nature of machine learning to improve product performance through a sequence of controlled version releases. We believe that our product development approach, which is based on a quality systems framework following FDA's Quality System Regulations and the ISO guidelines applicable to medical devices, will enable our KidneyIntelX platform to take advantage of exponential data growth and new clinical use cases, with a clearer path to achieving additional products and services.
• Real World Evidence Program. We have invested heavily over the past several years in developing a comprehensive portfolio of both real-world evidence outcomes and utility data. We have published and presented this data in various formats including in peer-reviewed publications and at major medical conferences. We believe the data released to date has largely satisfied the primary objective of demonstrating the clinical and economic impact of KidneyIntelX technology informed care management in large populations as has been evidenced by our regulatory, reimbursement and adoption achievements. We expect to continue to pursue real-world evidence generation in the future for KidneyIntelX platform products over time.
• Launch in Major International Markets. With FDA De Novo authorization for kidneyintelX.dkd, we have seen an increase in in-bound inquiries for international licensing and distribution opportunities. Kidney disease poses an increasing threat globally and we believe there will be a number of opportunities to partner with third-party entities to carry KidneyIntelX technology internationally through license.

We believe KidneyIntelX technology produces early, actionable prognosis that can support clinical pathways to slow the progression of kidney disease and potentially prevent the occurrence of progressive kidney function decline such as kidney failure and the need for long-term dialysis or kidney transplant. We have built a comprehensive body of published evidence through clinical validation studies and patient data generation to demonstrate that accurate and early identification of high-risk patients, coupled with guidelines-driven clinical recommendations designed to maximize patient treatment and compliance, can have a measurable positive impact on patient quality of life and significantly lower healthcare costs. By involving a broad range of expert clinical opinions, testing a growing number of patient samples, consulting closely with clinical society and patient advocacy organizations, partnering with healthcare systems and payors and developing a detailed understanding of the clinical practice environment, we believe successful use of KidneyIntelX technology will help ease suffering and improve outcomes for patients living with DKD.

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OUR COMPETITIVE STRENGTHS

The KidneyIntelX platform has the following key strengths:

• Novel Bioprognostic™ Platform Incorporating Biomarkers and Health Record Features Analyzed with a Machine Learning Enabled Algorithm to Assess the Risk for Kidney Disease Progression. KidneyIntelX technology has produced the first machine learning enabled in vitro prognostic device with the ability to identify patients at risk of progressive kidney function decline while in the earlier stages of DKD, when costs and outcomes can be better controlled.
• Large and Growing Addressable Market. CKD affects over 850 million people worldwide, including approximately 35.5 million people in the United States. The NKF estimates that one third of adults in the United States are at risk of developing kidney disease. Type 2 diabetes is one of the most significant risk factors for developing CKD and obesity is believed to account for 80% to 85% of the risk of developing type 2 diabetes. It is estimated that there are approximately 14 million adults with DKD in the United States. Published data suggests that the DKD population will continue to grow along with the anticipated increase in the occurrence of type 2 diabetes and obesity. One study estimates that by 2060, the number of adults in the United States diagnosed with diabetes will reach 60 million. Further, according to a 2019 study from the Harvard T.H. Chan School of Public Health, by 2030, about half of the adult U.S. population will be obese and about a quarter will be severely obese.
• Achievements in Reimbursement and Coverage. We have received Medicare payment, Medicare national payment rate and multiple private insurance coverage determinations to date. We believe these positive outcomes are the result of several factors: (1) our rigorous approach to a product development and the market access process, (2) significant changes in U.S. reimbursement law with the full implementation of the Protecting Access to Medicare Act, and (3) global improvements in kidney disease policy management, including the U.S. Presidential Executive Order on Advancing American Kidney Health issued in July 2019.
• Economic Health Benefits. KidneyIntelX technology was designed to provide accurate, real-time, actionable results for patients and physicians while reducing costs and promoting improved health economics for patients, physicians, healthcare systems and payors. Health economic benefits are projected to be derived from three key areas: (1) slowing progression to the next stage of CKD, (2) delaying or preventing progression to ESKD and the need for dialysis or kidney transplant and (3) avoiding dialysis crashes. By deploying our proprietary artificial intelligence-enabled algorithm in a regulated, clinically validated, in vitro diagnostic test, kidneyintelX.dkd is able to help predict which patients will experience progressive kidney function decline from early stage disease (Stage 1-3b) within a five-year timeframe, equipping physicians with the information they need to understand risk in their patients. According to a study conducted by BHA, based on the Medicare price of $950 per reportable test, KidneyIntelX technology would generate a positive retufor health insurers in 12-24 months and deliver a cost savings of up to $1.3 billion over five years per 100,000 patients with DKD. We believe successive and broad insurance coverage decisions have validated this health economics value proposition.
• Partnered Business Model at Population Health Level. We have begun to deploy KidneyIntelX technology in the form of the KidneyIntelX laboratory developed service through partnerships with healthcare systems (including Mount Sinai Health System, and Atrium Health/Wake Forest Baptist Health) and insurance payors that provide coverage to certain healthcare systems' patients. We expect to transition these deployments and new deployments to our now FDA authorized kidneyintelX.dkd beginning early in calendar 2024. As we have demonstrated with the KidneyIntelX laboratory developed service, we believe an EHR integrated kidneyintelX.dkd with population health support will be able to potentially benefit significant patient populations without employing a large, traditional sales force on a provider-level basis at those health systems. In addition, integration of the kidneyintelX.dkd software platform with healthcare providers' EHR systems enables seamless electronic test ordering and score reporting.
• Kidney Disease Data Repository. As a result of our partnered business model at a population health level, we anticipate that we will have the opportunity to build the most comprehensive de-identified kidney disease data repository geared toward early identification of high-risk patients and optimization of care pathways. Further, our partnerships with relevant insurance payors increases the visibility and the potential cost/benefit economics of KidneyIntelX technology.

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