Health Logic Interactive Provides Update on Anticipated Pre-Submission Meeting with FDA for MATLOC 1
Health Logic Interactive Inc. (TSXV: CHIP.H; OTCPK: CHYPF) announced progress towards a Pre-Submission Meeting with the FDA for its MATLOC 1 diagnostic device, scheduled for September 2021. This meeting aims to obtain guidance on device classification, predicate devices, and necessary clinical data for FDA submission. The company will work with Reveles Clinical Service for regulatory strategy and clinical trial management. CEO David Barthel expressed optimism about this step, viewing it as crucial for de-risking the FDA application process and advancing towards approval.
- Progress towards FDA Pre-Submission Meeting for MATLOC 1 device.
- Collaboration with Reveles Clinical Service for regulatory guidance.
- Potential clarity on FDA submission pathway through guidance.
- None.
TSXV: CHIP.H
CALGARY, AB, July 12, 2021 /PRNewswire/ - Health Logic Interactive Inc. ("Health Logic" or the "Company") (TSXV: CHIP.H) (OTCPK: CHYPF), is pleased to announce its continued progress towards an 510(k) pre-submission meeting with the United States Food and Drug Administration (the "FDA") for its diagnostic screening device MATLOC 1 that is anticipated to occur in September 2021 (the "Pre-Submission Meeting"). An FDA 510(k) pre-submission meeting is a method for a company like Health Logic to receive feedback and guidance from the FDA on its potential FDA 510(k) submission plan.
The Company has engaged Reveles Clinical Service, a specialty Contract Research Organization (Southlake, TX), to provide regulatory strategy and clinical trial management, to assist the Company with the necessary documentation and clinical plan in preparation for the Pre-Submission Meeting.
The Company intends to obtain the following guidance from the FDA at the Pre-Submission Meeting:
- Guidance for a predicate device;
- Guidance for a potential Class 2 Medical Device Designation; and
- Guidance on potential clinical data to support an indication for use.
"We are excited to be making this progress towards an FDA 510(k) pre-submission meeting and believe this will be an important step in our progression toward FDA 510(K) approval. We expect that the results of the Pre-Submission Meeting should help de-risk the pathway and provide the clarity necessary for a successful 510(k) application," stated David Barthel, CEO of Health Logic Interactive.
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.
Cautionary Notes
Certain statements contained in this press release constitute "forward-looking statements". All statements other than statements of historical fact contained in this press release, including, without limitation, those regarding the guidance the Company anticipates receiving from the FDA in the pre-submission meeting, the anticipated timing of the pre-submission meeting, the likelihood that the FDA application will be successful, and the Company's strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words "believe", "expect", "aim", "intend", "plan", "continue", "will", "may", "would", "anticipate", "estimate", "forecast", "predict", "project", "seek", "should" or similar expressions or the negative thereof, are forward-looking statements. These statements are not historical facts but instead represent only the Company's expectations, estimates and projections regarding future events. These statements are not guarantees of future performance and involve assumptions, risks and uncertainties that are difficult to predict. Therefore, actual results may differ materially from what is expressed, implied or forecasted in such forward-looking statements. Additional factors that could cause actual results, performance or achievements to differ materially include, but are not limited to the risk factors discussed in the Company's Management's Discussion and Analysis for the year ended December 31, 2020. Management provides forward-looking statements because it believes they provide useful information to investors when considering their investment objectives and cautions investors not to place undue reliance on forward-looking information. Consequently, all of the forward-looking statements made in this press release are qualified by these cautionary statements and other cautionary statements or factors contained herein, and there can be no assurance that the actual results or developments will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, the Company. These forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update or revise them to reflect subsequent information, events or circumstances or otherwise, except as required by law.
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SOURCE Health Logic Interactive Inc.
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