[Issue] Treating Illness with Digital Therapeutics Instead of Medications... Consumer Commercialization Approaches

[오늘경제 = Reporter Kim Min-seong]

 

The era of treating diseases with oral medications is fading. Now, digital therapeutics are emerging as a replacement for traditional pills. Following the first-generation synthetic drugs and second-generation biopharmaceuticals, digital therapeutics are becoming a new trend in treatment. South Korea is on the brink of commercializing these digital solutions.

 

Digital therapeutics are software-based medical devices designed to prevent, manage, or treat medical conditions or diseases based on clinical evidence. Unlike traditional pills or injections, they utilize apps, games, and other software for treatment. The COVID-19 pandemic has increased demand for remote consultations, personalized healthcare services, and real-time patient monitoring, thereby boosting the digital therapeutics market.

 

Traditionally, a patient suffering from insomnia would visit a doctor and receive a prescription for sleeping pills. However, now patients can be recommended 'digital therapeutics' instead. An application designed to help with insomnia has recently completed clinical trials and has been designated as an innovative medical device by the Ministry of Food and Drug Safety (MFDS).

 

On the 11th, the MFDS announced that "Wellt's 'PillowRx' and Aimmed's 'SOMZ', software for treating insomnia, are currently undergoing the critical technical document review for medical device approval." This indicates that the software is likely to be commercialized soon.

 

On the 13th, the MFDS released the status of clinical trial approvals for digital therapeutics and other software medical devices in 2022. The number of approved clinical trials for software medical devices has steadily increased over the past five years, with a significant rise from 6 cases in 2018 to 49 cases last year.

 

Approval numbers by category are as follows: ▲ AI-based software for diagnostic assistance and prediction (31 cases) ▲ Digital therapeutics (DTx) for treatment and relief (17 cases) ▲ AR-based surgical assistance software (1 case). The majority of approvals were for diagnostic assistance and prediction.

 

In the digital therapeutics and assistive device sector, there were 9 clinical trial approvals for 8 diseases in 2021, and 17 approvals for 12 diseases in the previous year.

 

Digital therapeutics startup Hippo T&C is set to expand its supply this year following the completion of clinical trials for its digital therapies, including those for ADHD, depression, and diabetic foot.

 

Hippo T&C's digital therapeutics include: ▲ ADHD diagnosis and treatment 'AttnKare' ▲ Depression treatment 'BlueKare' ▲ Diabetic foot treatment 'DfuKare'. Among these, AttnKare won innovation awards in the Health & Wellness and Virtual & Augmented Reality categories at the 'CES 2022' and showcased its technology again at CES 2023.

 

AttnKare uses virtual reality (VR) games for diagnosis. Patients perform VR missions while their hand and body movements, as well as game performance, are recorded. The collected data is analyzed using artificial intelligence (AI) to provide diagnoses and personalized treatments based on international ADHD standards.

 

Tai-Myoung Chung, CEO of Hippo T&C, emphasized, "We analyze 18 aspects such as focus and social skills while playing VR games and prescribe therapeutic games certified by the FDA." He added, "The diagnostic and therapeutic games are designed and developed with various target audiences in mind."

 

Digital therapeutics are also being actively used abroad. The world's first digital therapeutic, 'reSET' by Pear Therapeutics, was developed for treating substance use disorders and received FDA approval for patient treatment in 2017. It consists of an app with cognitive-behavioral therapy features, including chat and games.

 

However, there are concerns that some companies are marketing simple software as digital therapeutics without proven clinical efficacy. Digital therapeutics are intended to prevent, manage, or treat conditions, but there are cases where software disguised as simple games is being presented as digital therapeutics.

 

Professor Han Deok-hyun of the Department of Psychiatry at Chung-Ang University Hospital stated, "Developers must demonstrate clinical improvement and clarify the mechanisms behind digital therapeutics. This is even more stringent for digital solutions." He added, "From the design phase, digital therapeutics should involve physicians and pharmacists in developing the clinical mechanisms. Often, even if the products are released, they remain unused in hospitals," pointing out the need for specific disease mechanisms from the design phase.

 

source : 오늘경제(https://www.startuptoday.co.kr)

original press | http://www.startuptoday.co.kr/news/articleView.html?idxno=120123