Can DTx Save Time and Costs and Advance to Precision and Predictive Medicine?

With the approval of the first and second domestic digital therapeutics (DTx) devices this year, interest is growing in the impact DTx will have on medical advancement. Although it has been nine months since the first approval, the first domestic prescription has yet to be made. However, there is hope that once DTx is actually introduced, it will reduce the time and cost burdens patients have had to bear while advancing toward predictive and precision medicine that enhances treatment effectiveness.

Germany Enables 'Free and Rapid Treatment' Through Reimbursed DTx

Christian Philipp Angern, CEO of Sympatinet, emphasized the greatest advantage of DTx as "being able to receive treatment quickly and free of charge through reimbursement" at the 'Innovative Digital & Electronic Therapeutics in Future Medicine (DTx)' symposium held on the 3rd at Samsung Medical Center in Gangnam-gu, Seoul, hosted by Samsung Medical Center's Smart Healthcare Research Institute and Digital Therapeutics Research Center. He stated, "Even before COVID-19, there was tremendous demand for psychiatric treatment in Germany, and patients had to wait 4 to 6 months to receive care," adding, "Still, about 100 million people with mental illnesses in Europe remain untreated," highlighting the necessity of DTx. He also pointed out the vicious cycle in which many patients' symptoms worsen under these circumstances. Angern said, "If someone has social phobia, they isolate themselves to avoid symptoms like tachycardia and tremors, preventing them from going to work," adding, "This can create a 'malignant anxiety cycle' that triggers more symptoms, so it must be broken."

Christian Philipp Angern, CEO of German Sympatient, is giving a lecture at the symposium on "Innovative Digital and Electronic Therapies in Future Medicine," hosted by Samsung Medical Center Smart Healthcare Research Institute and Digital Therapeutics Research Center, held on the 3rd at Samsung Medical Center in Gangnam-gu, Seoul.
[Photo by Lee Chunhee]

Sympatinet's anxiety and depression DTx, 'Invirto,' was developed to break this vicious cycle through 'exposure therapy.' Users download an application (app) on their smartphones and use a smartphone VR device to simulate situations patients tend to avoid, such as supermarkets, elevators, and subways. While conducting this therapy in the real world would require significant resources and long waiting times, Invirto allows patients to do all this at home. Angern explained, "By doing this, they realize that their fears are about trivial things like urinating or passing gas," adding, "These are ordinary events for most people but unbearable for them, and through simulation, they learn they can endure these situations."

Invirto has shown significant improvement in anxiety scales and has succeeded in permanent reimbursement registration through Germany's DTx promotion program, the Digital Health Application Program (DiGA). Angern said, "Through years of clinical research, we have seen that Invirto can be as effective as classical treatments," and added, "Ultimately, we are thinking a lot about enabling patients to receive complete treatment at home."

DiGA operates an innovative reimbursement support system that allows DTx prescriptions at the manufacturer's proposed price for one year after approval. If the real-world data (RWD) collected during this period is favorable, permanent reimbursement registration is possible. However, if the RWD is poor, the product can be immediately withdrawn. Angern emphasized the high patient satisfaction, stating, "We have treated over 5,000 patients, and 9 out of 10 were satisfied with the treatment," adding, "Despite the VR components, 98% rated the DTx as easy to use."

Real-Time Data Collection Impossible in Analog... Could This Be the Start of 'Predictive Medicine'?

Although the first and second domestic DTx devices have been approved this year, there are still no commercially available DTx products in Korea. Domestic DTx companies preparing for development and commercialization emphasize 'precise predictive medicine' as an advantage of DTx. They aim to utilize DTx's ability to collect real-time data, which was difficult to obtain through traditional analog methods, to predict patient conditions and enable tailored interventions accordingly.

Jin Sang-man, professor of endocrinology and metabolism at Samsung Medical Center, who is developing an automated insulin therapy DTx based on continuous glucose monitoring (CGM), said, "A new diabetes medical service market is opening through CGM," but added, "This requires the premise that CGM data can be automatically analyzed and interpreted according to the individual's medical condition." Since it is difficult for the general public to know how to respond to blood glucose patterns such as rapid spikes, professional advice should be provided accordingly.

Professor Jin said, "Currently, 41 abnormal blood glucose signs can be automatically detected," and explained, "We are collaborating with a smart insulin pen (SIP) company to receive blood glucose information and integrate software, planning a business model that charges based on the number of app program interface (API) uses." His plan is to develop a '5-step SIP' that automatically analyzes the user's blood glucose levels and injects only the necessary amount of insulin in real time in the short term, and in the long term, to develop personalized dietary guidance for diabetic patients through meal analysis algorithms.

Professor An Gang-mo of the Department of Pediatrics and Adolescents at Samsung Medical Center is giving a lecture at the "Innovative Digital and Electronic Therapies in Future Medicine" symposium held on the 3rd at Samsung Medical Center in Gangnam-gu, Seoul, hosted by the Samsung Medical Center Smart Healthcare Research Institute and Digital Therapeutics Research Center.
[Photo by Lee Chun-hee]

Professor Ahn Kang-mo of the Department of Pediatrics and Adolescents at Samsung Medical Center, who is developing DTx for pediatric allergic diseases, also mentioned that DTx can identify various factors related to atopic dermatitis and enable tailored treatment. He explained, "Atopic dermatitis is heavily influenced by environmental factors such as temperature, humidity, dust, ozone, and air pollution," adding, "Because the causes of atopic dermatitis are complex, treatment is not easy."

However, by utilizing DTx, it is possible to analyze which factors are central to a particular patient among various causes, allowing for more appropriate treatment and even warnings when symptoms may worsen, according to Professor Ahn. He said, "We continuously monitor indoor and outdoor environments through Internet of Things (IoT) sensors and public air quality sensors," adding, "If fine dust levels and symptom scores move together, it indicates the patient is sensitive to fine dust exposure, enabling prediction and notification of how the patient will be affected based on fine dust levels."

Kang Sung-ji: "We Must Create Products No One Can Follow"... Dreaming of 'Future Medicine' Through Connected Evolution

Kang Sung-ji, CEO of Welt, which developed the insomnia DTx 'WELT-I' and received approval as the second DTx from the Ministry of Food and Drug Safety, pointed out that the competitiveness of DTx lies in 'evolution,' and through this, it must advance toward precision and predictive medicine. He said, "In addition to currently used smartphones, we are conducting wearable-linked clinical trials for WELT-I 'version 2.0,' which utilizes various wearable devices such as smartwatches and smart rings as measurement devices to collect helpful data," adding, "Minimizing disconnection of treatment outside the hospital 24 hours a day is the solution to creating 'future medicine.'"

Kang Sung-ji, CEO of Welt, is giving a lecture at the symposium on "Innovative Digital and Electronic Therapies in Future Medicine," hosted by Samsung Medical Center Smart Healthcare Research Institute and Digital Therapeutics Research Center, held on the 3rd at Samsung Medical Center in Gangnam-gu, Seoul.
[Photo by Lee Chun-hee]

He also envisioned evolution using artificial intelligence (AI) methods such as the emerging large language models (LLM). Moving beyond the simple chatbot-level AI embedded in existing DTx, he dreams of the next stage of use, such as informing patients whether they will sleep well that night. Kang expects that if LLMs advance to the level of conversing like a real doctor, they will have a significant effect on medication adherence, which is the biggest concern in all treatments.

Regarding potential issues arising from AI malfunctions, he believes they can be controlled and verified by other AI systems. He said, "I don't think AI should be controlled like humans," adding, "Whenever implementing new innovations, we try to control and verify them with AI."

Kang, who proposed a 'digital similer' strategy in Europe similar to biosimilars (biopharmaceutical generics) and a 'DD (drug + DTx) combo' strategy combining drugs and DTx as overseas expansion strategies in the U.S., also emphasized that the ultimate strength lies in competitiveness. He said, "The best market access strategy is a product no one can follow," adding, "I believe the best strategy is to create and maintain superiority through technology at the points patients need."

This content was produced with the assistance of AI translation services.