Kang Sung-ji "Permission is not the end but the beginning... We will continue to innovate"

"We will create a 'digital pharmaceutical company' that views digital through the lens of a pharmaceutical company. Our goal is to achieve healthcare capable of 'ultra-short-term prediction' through continuous innovation."

Kang Sung-ji, CEO of Welt [Photo by Welt]

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On the 19th, Welt's insomnia treatment digital therapeutic device (DTx), 'PillowRx (Welt-I),' successfully received approval from the Ministry of Food and Drug Safety. During a meeting with Asia Economy on the same day, Kang Seong-ji, CEO of Welt, stated, "Approval is not the end but the beginning," expressing his determination to "steadily proceed with the upcoming processes."

CEO Kang first encountered DTx while working in the health development group at Samsung Electronics. Later, through Samsung Electronics' in-house venture program 'C-Lab,' Kang spun off and recalled that the 2017 FDA approval of the drug addiction treatment DTx 'reSET' was a startling shock. He said, "Although I had been paying attention because it was a solution precisely targeting patients, I never thought it would receive FDA approval." He added, "The market began to take shape in earnest, and with the Ministry of Food and Drug Safety and other government bodies starting to establish systems, I began developing DTx with high expectations."

CEO Kang explained, "DTx is completely different from the existing digital healthcare approaches," and emphasized, "We want to position ourselves as a 'digital pharmaceutical company.'" Unlike other digital healthcare sectors, which are built around hospitals or governments and have unclear targets, DTx is designed entirely around the patient, offering a different experience. He said, "Pharmaceutical companies focus on finding those who truly need the product and receiving fair value even if they sell less," and stressed, "We need an attempt to view digital not as digital health but through the pharmaceutical company's approach."

The reason Welt developed a smart belt before fully embarking on DTx development is the same. CEO Kang said, "Although the general public may perceive it simply as a device measuring waist circumference or steps, it actually has various applications." He explained, "The belt can monitor bathroom visit cycles to help manage irritable bowel syndrome (IBS), and it was designed anticipating its potential use in detecting symptoms of diseases like Parkinson's and sarcopenia, which manifest through gait."

Welt's Insomnia Treatment DTx 'PillowRx (Welt-I)'
[Photo by Welt]

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Regarding future challenges, he cited 'evolution.' CEO Kang said, "This market values who evolves faster than when they started," adding, "While we have focused on creating the environment and foundation for this, now we will embark on full-scale evolution." To this end, Welt has concentrated on establishing a development environment within the company. Kang explained, "For innovation, servers, data analysis, quality control, and adverse event reporting must be conducted swiftly," and added, "We believe that all foundations related to planning and development must be established internally, and we have devoted efforts accordingly."

As part of this innovation, PillowRx introduced remote clinical trials during the approval clinical process. CEO Kang emphasized, "Remote clinical trials enable the establishment of an environment for continuous clinical trials," and said, "Data is collected in real-time, and a single clinical center can conduct trials on patients from various regions." He further noted, "This system can serve as a quality control system not only during the approval clinical stage but also after commercialization," and pointed out its potential as a system for bridging clinical trials or securing real-world data (RWD) when expanding overseas.

CEO Kang and Welt's innovation ultimately aims for 'ultra-short-term prediction.' Kang stated, "If continuous updates like this are made, it will be possible to predict emergencies occurring 20 to 30 minutes or 2 to 3 hours later for patients," adding, "If we can foresee and take action in advance, we can prevent the worsening of patients' symptoms."

At the 'Good Brain 2022 International Conference' hosted by Asia Economy at the Westin Chosun Hotel in Jung-gu, Seoul, last September, panelists including Kang Sung-ji, CEO of Welt (second from left), are engaged in discussion. Photo by Kim Hyun-min kimhyun81@

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However, despite the emergence of the 'second DTx,' the success of domestic commercialization remains uncertain. This is because a prerequisite for success?the National Health Insurance reimbursement plan?has not yet been established. CEO Kang expressed hope that the 'Innovation Account,' recently mentioned by President Yoon Seok-yeol, will be the optimal solution. The Innovation Account is a system that provides separate compensation from health insurance during the evidence generation period for safe innovative medical technologies.

CEO Kang explained the advantages, saying, "Using the Innovation Account allows government investment aligned with product performance and market demand," and "If rewards for evolution are not provided, there is a high risk of companies that do not evolve appearing." He also pointed out that the bankruptcy filing of Pear Therapeutics, once considered an industry leader with three FDA-approved DTx products, was largely due to the lack of continuous updates. Therefore, he argued that the government must establish systems that guarantee innovation for the sustainable development of the industry.

Regarding future plans, he mentioned exploring overseas expansion and that development of additional pipelines is already underway. Welt has set up a U.S. branch in Boston and recruited Director Kim Ju-young, formerly of Pear Therapeutics, as the head of the U.S. branch. CEO Kang said, "Our goal is to generate real-world evidence (RWE) comparable to clinical trials based on the networks established locally," and expressed his ambition, "While continuing such validation, we plan to revisit the processes conducted in Korea and conduct research tailored to the local environment." Additionally, while advancing the sophistication of PillowRx, he announced that the next pipeline has already begun confirmatory clinical trials for an eating disorder DTx.

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