Predictmedix Announces Completion of 1600-Person Clinical Study for Safe Entry's Medical Device Regulatory Approval in Indonesia

Rhea-AI Summary

Predictmedix Inc. (CSE:PMED, OTCQB:PMEDF) has successfully completed a 1600-person clinical study at a leading Indonesian university, aimed at securing regulatory approval for its AI-powered Safe Entry screening device to be classified as a medical device. This classification is crucial for commercialization in Indonesia, which is home to over 280 million people. The study validated the effectiveness of Safe Entry, with the approval process expected to be swift due to its non-invasive nature. This advancement marks a significant milestone for Predictmedix, as it builds credibility and paves the way for future sales opportunities in the ASEAN region.

Positive

• Successful completion of a 1600-person clinical study validates Safe Entry's effectiveness.
• Safe Entry's classification as a medical device facilitates commercialization in Indonesia.
• The non-invasive nature of Safe Entry may expedite the regulatory approval process.
• Strong market potential in Indonesia and ASEAN region due to large population and demand for medical devices.

Negative

• None.

• The 1600-person study at a prestigious University in Jakarta, Indonesia prepares Predictmedix's Safe Entry for regulatory approval listed as a ‘Medical Device'
• Medical device classification allows Predictmedix to commercialize Safe Entry at scale in Indonesia
• Third-party clinical validation yet another milestone for Predictmedix's AI-Powered screening technology

TORONTO, ON / ACCESSWIRE / March 8, 2023 / Predictmedix Inc. ("Predictmedix" or the "Company") (CSE:PMED) (OTCQB:PMEDF) (FRA:3QP), an emerging provider of rapid health screening solutions powered by a proprietary artificial intelligence (AI), today announced the completion of a 1600-person clinical study taken place at a prominent University in Indonesia for the purpose of validating the company's AI-powered non-invasive screening technology in order to prepare for the regulatory approval application to classify Safe Entry as a medical device.

As the company's commercialization efforts are underway in Indonesia, having Safe Entry classified as a Medical Device is an integral step to scaling into the landscape of the Indonesian market. The third-party validation of the company's AI-powered screening technology marks yet another milestone for the efficacy of Safe Entry.

The National Agency of Drug and Food Control (NADFC) under the Indonesian Ministry of Health (MoH) regulates medical devices. The organization overseas all pre-market and post-market evaluation, standardization, legislation, and Good Manufacturing Practices (GMP) certification. All Medical Devices and IVDs (In Vitro Diagnostics) must receive a registration number and product license issued by the Ministry of Health to a local licensed distributor before import. Due to the non-invasive nature of Predictmedix's Safe Entry unit, the approval process is not expected to take a significant amount of time. The University is expected to begin the certification process within the month of March of 2023.

"The Safe Entry Station powered by artificial intelligence is a highly effective and intelligent instrument for detecting health problems and modernizing medical examinations," commented Assoc. Prof. Ts. Dr. Zulkarnain Kedah.

"AI powered screening in a quick, non-invasive, no contact methodology is the way of the future. The Safe Entry Unit has been validated by our University with demonstrated high accuracy rates for multi functional application. We look forward to getting this approved as a medical device for Indonesia and assisting with commercial deployment", commented Professor Dr. Ir. Untung Rahardja, M.T.I., MM, President at the University of Raharja.

"With Indonesia being the fourth most populous country in the world housing over 280 million people and being a part of the ASEAN group of countries with over 680 million people and more than 10 trillion dollars in GDP - the market opportunity for Safe Entry is immense, not only in Indonensia but also throughout the Asean region. There's a strong demand for various medical devices in Indoensia, and the sheer size of the population positions Predictmedix to build a lucrative sales pipeline," commented Dr. Rahul Kushwah, Chief Operating Officer at Predictmedix. "The further validation of our technology from the University adds even more credibility to Safe Entry and the work we are accomplishing at Predictmedix."

About Predictmedix Inc.
Predictmedix (CSE:PMED) (OTCQB:PMEDF) (FRA:3QP) is an emerging provider of rapid health screening and remote patient care solutions globally. The Company's Safe Entry Stations - powered by a proprietary artificial intelligence (AI) - use multispectral cameras to analyze physiological data patterns and predict a variety of health issues including infectious diseases such as COVID-19, impairment by drugs or alcohol, fatique or various mental illnesses. Predictmedix's proprietary remote patient care platform empowers medical professionals with a suite of AI-powered tools to improve patient health outcomes. To learn more, please visit our website at www.Predictmedix.com or follow us on Twitter, Instagram or LinkedIn.

Public Relations Contact
For further media information or to set up an interview, please contact:
Nelson Hudes
Hudes Communications International
(905) 660 9155
Nelson@hudescommunications.com

Dr. Rahul Kushwah
(647) 889 6916

Caution Regarding Forward-Looking Information:
This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results of the Company. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Although such statements are based on management's reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances. The Company's securities have not been registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or "U.S. Persons", as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful. Additionally, there are known and unknown risk factors which could cause the Company's actual results, performance or achievements to be materially different from any Page 4 of 4 future results, performance or achievements expressed or implied by the forward-looking information contained herein, such as, but not limited to dependence on obtaining regulatory approvals; the ability to obtain intellectual property rights related to its technology; limited operating history; general business, economic, competitive, political, regulatory and social uncertainties, and in particular, uncertainties related to COVID-19; risks related to factors beyond the control of the Company, including risks related to COVID-19; risks related to the Company's shares, including price volatility due to events that may or may not be within such party's control; reliance on management; and the emergency of additional competitors in the industry.

All forward-looking information herein is qualified in its entirety by this cautionary statement, and the Company disclaims any obligation to revise or update any such forward-looking information or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except required by law.

Disclaimer: "The Company is not making any express or implied claims that its product has the ability to diagnose, eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time."

THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

SOURCE: PredictMedix Inc.

View source version on accesswire.com:
https://www.accesswire.com/742579/Predictmedix-Announces-Completion-of-1600-Person-Clinical-Study-for-Safe-Entrys-Medical-Device-Regulatory-Approval-in-Indonesia

FAQ

What is Predictmedix's Safe Entry?

Safe Entry is an AI-powered health screening device that analyzes physiological data to predict health issues.

What is the purpose of the 1600-person clinical study for Safe Entry?

The study aimed to validate the effectiveness of Safe Entry to prepare for regulatory approval as a medical device in Indonesia.

What are the next steps for Predictmedix following the study?

The next steps include initiating the regulatory approval process to classify Safe Entry as a medical device in Indonesia.

How does Safe Entry impact the market potential for Predictmedix?

With Indonesia's large population and demand for medical devices, Safe Entry has significant market potential in Indonesia and the ASEAN region.

What regulatory body oversees medical device approval in Indonesia?

The National Agency of Drug and Food Control (NADFC) under the Ministry of Health regulates medical devices in Indonesia.