Predictmedix (PMED.C), an emerging provider of rapid health screening and remote patient care solutions, announced today that it had completed a 1,600-person clinical study at the University of 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.
With commercialization efforts underway in Indonesia, getting Safe Entry classified as a medical device would be integral to scaling up sales in the Indonesian market.
The National Agency of Drug and Food Control (NADFC) under the Indonesian Ministry of Health regulates medical devices for the country and oversees all premarket and post market evaluation, standardization, legislation and good manufacturing processes.
Since Safe Entry is non-invasive, it is expected that the approval process won’t take a significant amount of time. The University is anticipated to begin the certification process within the month.
Dr. Rahul Kushwah, CEO of Predictmedix, commented on the company’s milestone, “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 [gross domestic product] — the market opportunity for Safe Entry is immense, not only in Indonensia, but also throughout the ASEAN [Association of Southeast Asian Nations] region. There’s a strong demand for various medical devices in Indonesia and the sheer size of the population positions Predictmedix to build a lucrative sales pipeline. The further validation of our technology from the University adds even more credibility to Safe Entry and the work we are accomplishing at Predictmedix.”
Predictmedix reported $107,190 CAD in cash and cash equivalents as of October 31, 2022, with revenues totaling $3,500 for the three months ending October 31, 2022, for a total and comprehensive loss of $459,227 for the same period.
The company currently trades at $0.14 per share for a market cap of $18.20 million.
