[DTx Era①] Digital Healthcare Established by Pandemic
Over 40 Domestic Companies Developing
Five Including 'Hi' at Confirmatory Clinical Trial Stage
Commercialization Possible as Early as This Year
HAII, a domestic digital therapeutics (DTx) development startup, has been invited to the 'Company Presentation' session at the world's largest bio expo, BIO International Convention (2022 BIO USA), held next month in San Diego, USA. This session, where companies introduce their pipelines, research and development (R&D) activities, business and investment goals on a separate podium for 13 minutes, is one of the most anticipated programs of the entire event. This indicates that DTx is gaining attention from the global bio industry.
In this presentation, HAII plans to introduce the diagnostic accuracy of its cognitive impairment DTx biomarker 'Alzguard' along with its main pipeline. Jinwoo Kim, CEO of HAII, said, "Being able to present at BIO USA itself is very encouraging," adding, "We will make it well known that Korean DTx technology has reached a considerable level."
With the COVID-19 pandemic, digital healthcare has deeply embedded itself into our daily lives. In particular, DTx, which does not require taking medicine or injections, has emerged as a new market. Since Korea has secured competitiveness in IT and BT fields, it is expected to rise as a hub for the DTx market.
According to industry sources on the 16th, about 40 companies are currently engaged in DTx development projects in Korea. Although no DTx has yet been approved by the Ministry of Food and Drug Safety, several clinical trials targeting insomnia, respiratory rehabilitation, visual impairment, generalized anxiety disorder, and others are underway. Since June 2019, a total of 10 clinical trial plans have been approved. Among them, five companies including NewNaps, LifeSemantics, AimMed, Welt, and HAII are in the confirmatory clinical trial stage in accordance with the Ministry's DTx guidelines, raising expectations that the first commercialized DTx may be launched as early as this year.
The Yoon Suk-yeol administration is aiming to become a 'global hub for bio and digital health' and is signaling a paradigm shift in the medical industry, including the introduction of DTx. The government plans to promote a cross-ministerial project to secure early-stage technologies and will undertake regulatory innovation and financial support to foster the digital healthcare industry.
Jaeyong Shin, professor at Yonsei University College of Medicine's Department of Preventive Medicine (Digital Healthcare Innovation Research Institute), said, "Domestic companies have already accumulated sufficient technological capabilities through existing wellness businesses, and the COVID-19 pandemic has significantly reduced resistance from doctors and patients toward digital health, including non-face-to-face medical care," adding, "Once government approval is obtained, it will be possible to accumulate data by applying it to actual patient treatment, and the procedures for commercialization, such as health insurance reimbursement recognition, could be completed in about three years."
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