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Digital medical device targets post-stroke dysarthria patients

Efficacy, safety confirmed through multi-center confirmatory clinical trial

Device links clinical treatment with daily rehab ahead of hospital rollout

Digital healthcare company Hi announced Wednesday that its digital medical device Repeech, designed for post-stroke dysarthria patients, has been designated an innovative medical device under the advanced technology category (Integrated No. 137) by the Ministry of Food and Drug Safety.

Repeech is a standalone software as a medical device, or SaMD, developed to allow patients with post-stroke dysarthria to carry out speech rehabilitation training in their daily lives under the supervision of a speech-language pathologist, following a doctor's prescription. The device is designed so patients can continue repetitive rehabilitation exercises outside medical facilities using their personal smart devices.

Dysarthria is a motor speech disorder caused by damage to the neuromuscular control of the articulatory and phonatory systems, typically resulting from stroke. Continuous rehabilitation training is essential, but the company said some patients struggle to maintain adequate treatment due to the cost of in-person speech therapy and uneven access to specialists across regions.

Hi developed Repeech with a focus on bridging the gap between speech-language pathology treatment at medical institutions and patients' at-home training. Rather than replacing in-person rehabilitation, the device supplements it by helping patients continue repetitive exercises outside clinical settings. The user interface was also designed to be accessible to patients who are not accustomed to digital devices.

The company said Repeech confirmed its efficacy and safety through a multi-center confirmatory clinical trial involving post-stroke dysarthria patients. Building on the designation, Hi plans to establish a digital speech rehabilitation environment linked to medical institutions and push for adoption in clinical settings.

The integrated review for innovative medical devices is a system in which relevant agencies jointly examine whether a device qualifies for the innovative medical device designation, whether it is covered or excluded from health insurance reimbursement, and whether it requires a new health technology assessment. The Ministry of Food and Drug Safety operates the integrated review system to streamline the market entry process for innovative medical technologies.

"Continuous training is critical for dysarthria, but some patients are unable to maintain sufficient rehabilitation due to practical constraints," said Kim Jin-woo, chief executive of Hi. "We will prepare to bring Repeech into clinical settings so it can connect hospital-based treatment with patients' daily lives and improve the continuity of rehabilitation."


hong@heraldcorp.com