Overseas Diabetes and Cancer DTx Racing Ahead... Domestic Market Now Ready to Run

[DTx Era⑧] 5 of 23 DTA Listings Are Diabetes DTx

Voluntis' Diabetes 'Insulia' & Cancer 'Olina'
US FDA Approval Granted... Focus on R&D
Active Partnerships with Big Pharma like AZ & BMS

Limited to Information Provision & Data Collection
Treatment Effects Grow Through Disease Prevention & Management

No Official Approval for Chronic Diseases in Korea
Companies Challenge... "Development Will Progress Step by Step"

Voluntis' cancer DTx 'Oleena'

[Asia Economy Reporter Lee Chun-hee] Can digital therapeutics (DTx) be used to treat chronic diseases such as cancer or diabetes?

Andy Molnar, CEO of the Digital Therapeutics Alliance (DTA), confidently answered this question by saying, "It can do everything." He explained that various related DTx products have already been launched and can help enhance the effectiveness of medications. Although called ‘therapeutics,’ DTx also includes the prevention and management of diseases within its scope. The Ministry of Food and Drug Safety’s DTx guidelines also state the purpose of DTx as ‘prevention, management, and treatment of medical disabilities and diseases.’

Overseas, the development and adoption of DTx related to cancer and chronic diseases are already active. Among the 23 DTx products recognized by the DTA as meeting the definition of DTx, diabetes-related products account for the largest share with five. Representative examples include WellDoc’s ‘BlueStar,’ Voluntis’s ‘Insulia,’ Hygeia’s ‘d-Nav,’ Dario Health’s ‘Dario,’ and HelloBetter’s ‘HelloBetter.’ 'The Era of DTx'

Regarding cancer, Kaiku Health’s DTx of the same name, which enables symptom self-reporting by cancer patients and feedback from medical staff, is listed on the DTA’s list. Voluntis, besides Insulia, received FDA approval in 2019 for the cancer treatment symptom self-management app ‘Oleena,’ showing a focus on research and development of cancer and chronic disease DTx. They have also partnered with global big pharma companies such as AstraZeneca (AZ) and Bristol-Myers Squibb (BMS). AZ released ‘eCO’ for ovarian cancer patients for research purposes, and BMS is promoting cancer symptom management DTx using its own platform ‘Theraxium Oncology.’

Helping Treatment through Disease Prevention and Management

Chronic diseases have been a topic addressed since the early days of DTx. BlueStar received FDA approval seven years earlier than reSET, Pear Therapeutics’ drug addiction treatment DTx, which is considered the first DTx and was approved in 2017. However, since cancer and chronic disease DTx have not yet advanced into the treatment field, reSET is still widely regarded as the first DTx. Unlike previous products, reSET was developed as a DTx for addiction treatment. On the other hand, BlueStar is limited to non-treatment purposes such as ‘providing information to help diabetes self-management’ and ‘collecting, storing, and transmitting blood glucose data reliably.’

There is also a counterargument that prevention and management alone can produce significant therapeutic effects. Diabetes DTx have shown many results improving biomarkers. d-Nav recorded lower glycated hemoglobin in 90% of users within three months, and BlueStar also reduced glycated hemoglobin by an average of about 2% during the first 3 to 6 months. Nam Byung-ho, CEO of Herings, said, "Even if DTx does not directly intervene in treatment, if the prognosis improves compared to existing treatments, it can be seen as a complementary therapeutic effect," adding, "There are also visible side effects such as reducing unnecessary emergency room visits."

Still in Korea... "Will Gradually Emerge"

In Korea, no DTx related to cancer or chronic diseases has yet received formal approval or clinical trial plan authorization. An industry insider said, "In fact, the mental illness field already has established treatment algorithms, so it tends to be relatively concentrated," but added, "As experience accumulates in the industry, development will gradually proceed."

Some companies in Korea have also taken on the challenge. Regarding diabetes, Hurei Positive, and for cancer, Herings and LifeSemantics are developing or providing various services. Since 2018, Hurei Positive has been servicing the diabetes self-management app ‘MyHealthNote,’ developed in partnership with Samsung Fire & Marine Insurance. When blood glucose is measured with a Bluetooth-enabled glucose meter, the data is automatically saved in the app, and it also offers coaching for dietary improvement and medical staff consultation responses.

Samsung Fire & Marine Insurance - Hurey Positive's 'My Health Note'

Herings is preparing ‘Healiary,’ an integrated management platform for cancer patients, and ‘Ostomy Care,’ a platform for stoma patient management. Healiary, currently a service that helps manage diets for patients who have undergone gastrectomy due to stomach cancer, plans to expand to other cancer types and evolve into a comprehensive management service including nutrition, exercise, and psychological care. Since it is not a service requiring formal clinical trials, it aims to launch in the market as early as next month.

LifeSemantics is also developing ‘RedPill Care,’ which provides customized treatment plans to help cancer survivors recover and rehabilitate at home. Initially, it will address rehabilitation therapies to prevent lymphedema that may occur after lymph node dissection during surgeries for breast and uterine cancers. It has completed exploratory clinical trials and is preparing for confirmatory clinical trials.

As Korea approaches a super-aged society, the number of patients with chronic diseases, including degenerative brain diseases, is expected to surge, leading to a sharp increase in related social costs. There are calls to use DTx to reduce these costs. Professor Lee Jin-yong of Seoul National University College of Medicine emphasized, "DTx can help manage chronic diseases through lifestyle changes, thereby reducing socioeconomic burdens," and stressed, "National-level preparation is necessary for the introduction and expansion of DTx."

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