29 Mar, 2021, 09:15 ET
CALGARY, March 29, 2021 /PRNewswire/ - Health Logic Interactive Inc. ("Health Logic" or the "Company") (TSX.V: CHIP.H), is pleased to announce its wholly owned operating subsidiary, My Health Logic Inc. ("My Health Logic"), has entered into a license agreement (the "License Agreement") with an arm's length third party (the "Licensor") pursuant to which My Health Logic has a worldwide, exclusive license to the UAL-Chip, a patent pending lab-on-chip ("LOC") technology that has the potential to be used in a smartphone connected, hand-held device to provide rapid point-of-care ("POC") diagnosis of Chronic Kidney Disease ("CKD").
CKD is a life-changing chronic condition that is harmful for patients and extremely expensive to treat unless caught early. Over 850 million people globally and 37 million people in the United States have CKD, and total healthcare costs for treatment of CKD in the US exceed $120B per year. The key to preventing the major harms from CKD, such as kidney failure, kidney dialysis, and death, is early testing and treatment; however, approximately 90% of those afflicted by CKD do not realize they have it. We believe that providing patients and caregivers a low-cost, accessible tool for early diagnosis and treatment is an opportunity to help millions of at-risk patients and start to bend the cost curve for health systems worldwide.
UAL-Chip technology has the potential to drive a much-needed disruption of the legacy systems used for CKD testing and accelerate the trend towards automation, digitization and personalization in the healthcare industry. The UAL-Chip can utilize microfluidic technology to test for the albumin levels in urine and deliver rapid results to a users' smartphone and their healthcare practitioner. Currently, <50% of at-risk patients are tested; we expect that introducing digitally connected home testing solutions would increase this number by removing one of the current barriers to testing, being attendance at a central lab, and would also provide My Health Logic with the opportunity to develop a robust platform for continuous digital patient monitoring and care for CKD of all stages.
"CKD is common, costly and harmful for patients and communities. It is also under-recognized. Bringing the CKD diagnosis into the home is a disruptive approach that could bridge the screening gap for millions of patients, allowing early detection and treatment, preventing harms for millions, and reducing health costs by billions" – Dr. Claudio Rigatto, Co-Inventor, Seven Oaks General Hospital
"Our lab-on-chip platform can give accurate results rivalling central laboratories in precision but in an accessible, low cost and rapid form usable in the home, fulfilling the dream of true point-of-care diagnosis and personalized medicine." – Dr. Francis Lin, Lead Inventor
Highlights of the Market:
- CKD is the 8th leading cause of death in the US.
- Estimated that 15% of all people in the US are at risk of CKD yet 90% are unaware they have the disease.
- Medicare spent $120 billion on all CKD related costs in 2017.
- End Stage Renal Disease (ESRD) caused by CKD led to $36 billion in Medicare-related costs in 2017.
- o ESRD includes kidney failure, dialysis, and transplant.
- American Kidney Health Initiatives passed in 2019.
- The global POC market has been growing at a CAGR of 10.2% and the global digital remote health market is expected to grow at a CAGR of 27.9% through to 2026.
- Sources: www.kidney.org, www.uofmhealth.com, www.grandviewresearch.com, www.businesswire.com
Highlights of the Technology:
- Proof of concept trial complete in clinical setting showing successful results.
- Patent pending technology with USTPO Patent number.
- The UAL-Chip is being built so that results will connect to a users' phone and provide feedback in less than 5 minutes. The plan is to collect the data through My Health Logic's MATLOC device, a hand-held POC device currently in development, and store the data on the My Health Logic continued care platform.
- 510 (k) pre-market FDA submission plans - accelerated regulatory pathway.
- Planned development of urine ACR and blood eGFR (the two necessary tests needed for accurate CKD assessment).
- First-movers advantage – there are currently no available hand-held, POC diagnostics on the market that quantitatively measure both ACR and eGFR.
- Co-founders and inventors of the technology plan to join My Health Logic in key leadership positions and continue to advance development, including:
- Dr. Francis Lin
- Dr. Claudio Rigatto
- Dr. Paul Komenda
- Dr. Navdeep Tangri
The Technology was invented by the world-renowned team of nephrologists at Seven Oaks General Hospital including Dr. Navdeep Tangri, Dr. Paul Komenda, and Dr. Claudio Rigatto, and biomedical engineering LOC expert Dr. Francis Lin. The team of inventors are expected to play an active role in the ongoing development of the lab-on-chips, and MATLOC device as we pursue regulatory approvals with Health Canada and the US Food and Drug Administration ("FDA") via an accelerated 510K pathway. In addition to the ongoing guidance from the inventors, the Company plans to on board and engage strategic industry thought leaders and experts to best guide My Health Logic through the development process to successful commercialization, for which there is no guarantee.
My Health Logic's obligations under the License Agreement include: (a) developing, manufacturing and selling products that incorporate the licensed technology ("Licensed Products"); (b) marketing Licensed Products in the US and Canada within 6 months of receiving regulatory approval; (c) reasonably filling market demand for Licensed Products following marketing; (d) obtaining all necessary governmental approvals for the activities in (a); and (e) spending at least $650,000 on the development of Licensed Products during the first four years of the License Agreement. As consideration for the license and other rights under the License Agreement, My Health Logic will pay Licensor annual royalties on net sales of Licensed Products, cover past patent costs, pay annual license maintenance fees and make certain payments upon the occurrence of milestone events in the regulatory approval process with respect to Licensed Products.
The Company is also pleased to announce that it plans to conduct a non-brokered private placement for gross proceeds of up to $1.4M, subject to approval of the TSX Venture Exchange.
About the Company
Health Logic Interactive, through its wholly owned operating subsidiary My Health Logic, is developing and commercializing consumer focused handheld point-of-care diagnostic devices that connect to patient's smartphones and digital continued care platforms. The Company plans to use their patent pending lab-on-chip technology to provide rapid results and facilitate the transfer of that data from the diagnostic device to the patient's smartphone. The Company expects this data collection will allow it to better assess patient risk profiles and provide better patient outcomes. Our mission is to empower people with the ability to get early detection anytime, anywhere with actionable digital management for chronic kidney disease. For more information visit us at: www.healthlogicinteractive.com
Neither the TSX Venture Exchange nor its regulation services provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward Looking Statements
Cautionary Note Regarding Forward-Looking Statements: This release includes certain statements and information that may constitute forward-looking information within the meaning of applicable Canadian securities laws. Forward-looking statements relate to future events or future performance and reflect the expectations or beliefs of management of the Company regarding future events. Generally, forward-looking statements and information can be identified by the use of forward-looking terminology such as "intends" or "anticipates", or variations of such words and phrases or statements that certain actions, events or results "may", "could", "should", "would" or "occur". This information and these statements, referred to herein as "forward–looking statements", are not historical facts, are made as of the date of this news release and include without limitation, statements regarding discussions of future plans, estimates and forecasts and statements as to management's expectations and intentions with respect to, among other things: development, manufacture and sale of Licensed Products; performance of obligations under the License Agreement; plans to engage the inventors and other experts to assist with regulatory approval and commercialization of Licensed Products; plans for and expected benefits of the licensed technology; and the Offering.
These forward–looking statements involve numerous risks and uncertainties and actual results might differ materially from results suggested in any forward-looking statements. These risks and uncertainties include, among other things: My Health Logic's ability to develop, manufacture and sell the Licensed Products, perform its obligations under the License Agreement and otherwise implement its business strategies; My Health Logic's ability to obtain regulatory approval of Licensed Products; and the Company's ability to obtain regulatory approval of the Offering and complete the Offering on the proposed terms.
In making the forward looking statements in this news release, the Company has applied several material assumptions, including without limitation, that: My Health Logic will be able to develop, manufacture and sell the Licensed Products, perform its obligations under the License Agreement and otherwise implement its business strategies; My Health Logic will be able to obtain all necessary regulatory approvals with respect to Licensed Products; and the Company will be able to obtain all necessary regulatory approvals with respect to the Offering, and the Company will be able to complete the Offering on the proposed terms.
Although management of the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Readers are cautioned that reliance on such information may not be appropriate for other purposes. The Company does not undertake to update any forward-looking statement, forward-looking information or financial out-look that are incorporated by reference herein, except in accordance with applicable securities laws. We seek safe harbor.
SOURCE Health Logic Interactive Inc.
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