An anonymous director reports
HEALTH LOGIC INTERACTIVE INC., ACQUIRES NEXT-GENERATION LAB-ON-CHIP MEDICAL DIAGNOSTIC TECHNOLOGY
Health Logic Interactive Inc.’s wholly owned operating subsidiary, My Health Logic Inc., has entered into a licence agreement with an arm’s-length third party, pursuant to which My Health Logic has a worldwide, exclusive licence to the UAL-Chip, a patent-pending lab-on-chip (LOC) technology that has the potential to be used in a smart-phone-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 health care costs for treatment of CKD in the United States exceed $120-billion 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 per cent of those afflicted by CKD do not realize they have it. The company believes 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 around the world.
The UAL-Chip technology has the potential to drive a much-needed disruption of the legacy systems used for CKD testing and accelerate the trend toward automation, digitization and personalization in the health care industry. The UAL-Chip can utilize microfluidic technology to test for the albumin levels in urine and deliver rapid results to a user’s smart phone and his or her health care practitioner. Currently, less than 50 per cent of at-risk patients are tested; the company expects 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 underrecognized. 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,” said 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,” said Dr. Francis Lin, lead inventor.
Highlights of the market:
- CKD is the eighth-leading cause of death in the United States;
- Estimated that 15 per cent of all people in the United States are at risk of CKD, yet 90 per cent 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;
- ESRD includes kidney failure, dialysis and transplant;
- American kidney health initiatives passed in 2019;
- The global POC market has been growing at a CAGR (compound annual growth rate) of 10.2 per cent and the global digital remote health market is expected to grow at a CAGR of 27.9 per cent through to 2026.
Highlights of the technology:
- Proof-of-concept trial complete in clinical setting showing successful results;
- Patent-pending technology with USTPO (U.S. Patent and Trademark Office) patent number;
- The UAL-Chip is being built so that results will connect to a user’s phone and provide feedback in less than five 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) premarket FDA submission plans — accelerated regulatory pathway;
- Planned development of urine ACR (albumin-to-creatinine ratio) and blood eGFR (estimated glomerular filtration rate), the two necessary tests needed for accurate CKD assessment);
- First-mover 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. Tangri, Dr. Komenda and Dr. Rigatto and biomedical engineering LOC expert Dr. Lin. The team of inventors are expected to play an active role in the continuing development of the lab-on-chip and MATLOC device as the company pursues regulatory approvals with Health Canada and the U.S. Food and Drug Administration through an accelerated 510K pathway. In addition to the continuing 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 licence agreement include: (a) developing, manufacturing and selling products that incorporate the licensed technology; (b) marketing licensed products in the United States and Canada within six 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 licence agreement. As consideration for the licence 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 licence maintenance fees and make certain payments upon the occurrence of milestone events in the regulatory approval process with respect to licensed products.
The company plans to conduct a non-brokered private placement for gross proceeds of up to $1.4-million, subject to approval of the TSX Venture Exchange.
About Health Logic Interactive Inc.
Health Logic Interactive, through its wholly owned operating subsidiary My Health Logic, is developing and commercializing consumer-focused hand-held, point-of-care diagnostic devices that connect to patients’ smart phones and digital continued care platforms. The company plans to use its patent pending lab-on-chip technology to provide rapid results and facilitate the transfer of that data from the diagnostic device to the patients’ smart phones. The company expects this data collection will allow it to better assess patient risk profiles and provide better patient outcomes. The company’s mission is to empower people with the ability to get early detection any time and anywhere with actionable digital management for chronic kidney disease.