Product Update MATLOC 1 & Update on FDA Pre-Submission meet. CALGARY, AB, Aug. 30, 2021 /CNW/ - Health Logic Interactive Inc. ("Health Logic" or the "Company") (TSXV: CHIP.H)(OTCPK: CHYPF), is pleased to announce its second update to its digital diagnostic device MATLOC 1. MATLOC 1 is the Company's proprietary diagnostic platform technology in development for the testing of different biomarkers, with a current focus on the urine-based biomarkers albumin and creatinine for chronic kidney disease (CKD) screening and eventual diagnosis.
Current development activities continue to focus on MATLOC 1 and the Company's accompanying lab-on-chip products. MATLOC 1 is wrapping up its first phase of development, which included the building and testing of a fluid handling apparatus, the completion of a user interaction study, and initial design concepts that will lead to a functional prototype for the second phase of development. The prototype to be developed in Phase 2 is expected to be used in the Company's clinical trials, which are anticipated to commence in Q1 2022.
The Company's lab-on-chip technology is focused on achieving better detection sensitivity and shorter test times for the urine creatinine chip (uC-Chip). Recent developments in the Company's lab-on-chip technology have shown promising results in achieving these goals and advances the Company closer to an integrated urine albumin creatinine chip (uACR-Chip). The Company also continues to advance its work done on its blood based eGFR detection chip (eGFR-Chip), especially on its signal optimization to provide a more complete proof-of-concept eGFR-Chip.
The Company's United States Food and Drug Administration ("FDA") pre-submission meeting (the "Pre-Submission Meeting") that was anticipated to occur in September has been postponed by the FDA due to the FDA's necessity to allocate resources to COVID-19 related activities. It is expected that the Pre-Submission Meeting will be delayed until early in the 2022 calendar year.
The Company will continue with its current plan to complete the product development of MATLOC 1, conduct analytical validation of the product, and evaluate the product's status with the Company's FDA regulatory consultants in January 2022. At that time, Health Logic expects to either submit a pre-submission plan to the FDA or move forward with a formal FDA 510(k) application.
Update on Marizyme Transaction
The pending transaction with Marizyme to sell the Company's wholly owned operating subsidiary, My Health Logic Inc., continues to move forward as both teams finalize the deal structure, review due diligence materials, and work towards a definitive agreement.
"These are exciting developments, especially completing the first phase of product development for MATLOC 1. This is a milestone that highlights our progress and brings us closer to a functional prototype, the same functional prototype we expect to use in our clinical trials in Q1 of 2022. We continue to advance toward a complete FDA 510(k) application and look forward to updating our stakeholders again soon," stated David Barthel, CEO of Health Logic.
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 its 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
Further information regarding Health Logic Interactive Inc. and its disclosure documents are available on SEDAR at www.sedar.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.