"Prescription of 'Sumtun' for Pulmonary Disease Patients... Increase in Regular Exercise Rate from 60% to 97%"

[DTx Era③] Interview with Kwon Hee, Director of Life Semantics
Respiratory Rehabilitation DTx 'Redpill Sumtun' Confirmatory Clinical Trial... Targeting Commercialization Next Year

[Asia Economy Reporter Kim Young-won] LifeSemantics is one of the five companies currently conducting confirmatory clinical trials after receiving clinical approval for digital therapeutics (DTx) from the Ministry of Food and Drug Safety. Their pipeline includes the respiratory rehabilitation DTx 'Redpill Sumtun,' which has entered confirmatory clinical trials, and the post-cancer treatment rehabilitation and management DTx 'Redpill Care.'

Redpill Sumtun is a prescription DTx designed to enable patients with respiratory diseases such as lung cancer and chronic obstructive pulmonary disease (COPD) to perform rehabilitation independently at home. COPD is one of the top 10 causes of death worldwide and leads to reduced physical activity due to breathing difficulties. Breaking the vicious cycle of muscle loss and worsening dyspnea is crucial. Respiratory rehabilitation helps alleviate symptoms and shorten hospital stays through exercise and dietary control, aiding patient recovery.

Among respiratory rehabilitation methods, Redpill Sumtun focuses on aerobic exercise. By collecting activity levels and oxygen saturation through personal measuring devices, Sumtun provides a 12-week customized exercise program based on these metrics. Medical professionals can refer to exercise records and other data collected via Sumtun. If biometric data such as oxygen saturation and heart rate can be measured, Sumtun can be used regardless of the device type. Kwon Hee, Director of DH·DTx at LifeSemantics, explained, "When requiring actions for rehabilitation of patients with severe chronic diseases, safety issues cannot be ignored. We use biometric monitoring data as a criterion to judge whether rehabilitation is being conducted at an appropriate state and intensity."

Redpill Sumtun demonstrated effectiveness in an exploratory clinical trial conducted over eight months in 2017 with patients suffering from pulmonary diseases. Among 90 lung cancer patients and 153 COPD patients who used Sumtun, the proportion exercising regularly three or more times per week increased from 60% to 97%. Improvements were also confirmed in walking distance, degree of dyspnea, and quality of life. Currently, a multicenter confirmatory clinical trial is underway with 100 patients.

Increasing the usability of DTx is also a goal of LifeSemantics. Due to the nature of rehabilitation, consistent use is important, and users unfamiliar with digital technology may find it difficult to use DTx. Director Kwon stated, "Some services only need to encourage patients to use them enjoyably, but DTx requires patients to use it even if they dislike it. We continuously research user experience (UX) and user interface (UI) excluding the core system." He added, "As time passes and more generations become familiar with digital technology, usability will naturally improve."

Overseas, COPD-related DTx and digital healthcare products are also being released and developed. Propeller Health in the U.S. offers DTx for managing respiratory diseases such as COPD and asthma by attaching sensors to inhalers to improve medication adherence and enable self-management. It has received medical device approval as DTx from the U.S. Food and Drug Administration (FDA), Canada, and the European Union (EU). The UK's National Health Service (NHS)-approved COPD DTx 'myCOPD' supports self-rehabilitation by providing symptom tracking, inhaler usage guidance, and respiratory rehabilitation videos. Director Kwon emphasized, "What differentiates Sumtun from overseas products is that it has an algorithm with keywords related to aerobic exercise in the respiratory rehabilitation domain."

LifeSemantics is also developing Redpill Care, a DTx that assists cancer patient rehabilitation. Specifically, it focuses on edema management for female cancer patients such as those with breast cancer. Director Kwon explained, "Patients with breast or uterine cancer often undergo lymph node dissection during surgery, which can cause edema in the limbs. If not properly managed, the edema can become hardened. We aim to support rehabilitation therapies to prevent this through digital software." Although it has not yet received clinical approval from the Ministry of Food and Drug Safety, they plan to conduct internal research and challenge clinical approval around next year.

This year, LifeSemantics aims to complete the confirmatory clinical trial of Redpill Sumtun, obtain approval from the Ministry of Food and Drug Safety, and commercialize it next year. Song Seung-jae, CEO of LifeSemantics, stated, "If the Redpill Sumtun clinical trial is successfully completed, we plan to introduce various DTx pipelines based on it. We will share extensive know-how related to DTx development and operation with related companies to build an ecosystem where the entire digital healthcare industry can grow together."