Korea's biotech company Deepsonbio is gaining interest for its ultrasound-based brain disorder treatment technology.

The company's recent exploratory clinical trials demonstrated the effect of improving cognitive function for patients with Alzheimer's disease and those with normal pressure hydrocephalus. Deepsonbio plans to enter the market on a full scale.

Based on its multiple-low intensity pilant ultrasound (M-LIPUS) technology, Deepsonbio is projected to revolutionize treatments for brain disorders, such as Alzheimer's disease.

Daily Pharm met with Deepsonbio, a member of the KoreaBIO organization, to listen to the company's potential and vision.

Deepsonbio is led by CEO Lee Dong-hyuk, who is currently a professor at Gachon University of Medicine and Science's Department of Biomedical Engineering. The company's key technology is its proprietary M-LIPUS.

Unlike existing high-intensity focused ultrasound (HIFU) or transcranial magnetic stimulation (TMS), M-LIPUS uses safe, low-intensity ultrasound to non-invasively clear waste from the brain.

Notably, the technology utilizes multiple ultra-sound generating devices, stimulating brain areas with ultrasound energy and promoting the cerebrospinal fluid (CSF) flow, ultimately increasing clearance of amyloid-β (Aβ), known as the pathogenesis of Alzheimer's disease.

Deepsonbio CEO Lee said, "Disorders like Alzheimer's disease are caused by the accumulation of waste in the brain due to decreased CSF flow," and added, "M-LIPUS has been demonstrated to promote the elimination of Aβ and tau proteins, which are key waste in the brain. Clinical results showed that M-LIPUS improved cognitive function and neural functions."

The company's recently finalized exploratory clinical results demonstrated Deepsonbio's technological advancement. It was found that within a month of ultrasound treatments, patients' cognitive function significantly improved.

Furthermore, clinical evaluation showed a clear improvement in cognitive function with the trail making test (TMT) performance time, which is used to evaluate cognitive function in patients with Parkinson's disease, reduced by up to half.

Additionally, biological indicators observed positive changes, including activated glucose metabolism in the brain and a significant reduction in beta-amyloid levels.

When asked, "Are there any barriers to entering the brain disease treatment market using ultrasound technology?" CEO Lee emphasized that a shift in perspective led to the company's unique technology.

Lee said, "Previous research focused more on opening the blood-brain barrier (BBB) rather than improving CSF fluidity. The ultrasound used in those studies was also less effective in humans, so no cases showed the same efficacy as Deepsonbio's low-intensity ultrasound."

Global market entry and strategy to achieve 'KRW 100 Billion' mark

Deepsonbio is targeting the global Alzheimer's treatment market. The global Alzheimer's treatment market is valued at approximately KRW 20 trillion as of 2023, showing rapid annual growth of over 20%.

Deepsonbio aims to complete confirmatory clinical trials by the end of this year and secure additional medical device indications both domestically and internationally by early next year, thereby officially entering the global market. The company's strategy, led by CEO Lee, a regulatory expert, is expected to facilitate rapid market penetration.

Considering that current Alzheimer's new drugs focus on early treatment to slow cognitive decline rather than fundamentally improving symptoms, there is an expectation that Deepsonbio's role could expand significantly.

The company is actively pursuing domestic and international patent applications to enter the global market, including the United States. The company plans to secure a unique global medical device market position.

Specifically, assuming a 6.4% market share of the domestic dementia population after receiving approval this year, Deepsonbio aims for approximately KRW 80 billion in revenue by 2028.

CEO Lee stated, "Deepsonbio's device is not large, so there's no need to secure a separate space, which we predict will allow us to expand our influence in the non-reimbursable market rapidly." He added, "Our goal is to quickly generate revenue through the commercialization of our ultrasound technology."

Expected to expand indications beyond Alzheimer's disease to normal pressure hydrocephalus

Another area where Deepsonbio anticipates treating with its ultrasound technology is normal pressure hydrocephalus (NPH).

The company has demonstrated that even with ultrasound treatment alone, patients with NPH significantly improved walking ability within a week, especially when existing treatments are limited. These results are evaluated to suggest the possibility of future indication expansion.

Lee described Deepsonbio's technology as 'the technology of happiness.' In a reality where brain diseases like dementia and hydrocephalus severely impair the quality of life for entire families, he believes it is an innovative and valuable technology that can restore happiness to both patients and their families.

Finally, Lee presented a vision to expand indications beyond the Alzheimer's disease treatment market to various brain disease treatment areas and to establish strong competitiveness in the global medical device market.

Lee remarked, "Deepsonbio's technology can be a game-changer in the Alzheimer's disease treatment market," and added, "We will overcome the limitations of existing treatments, and our medical device will provide real and sustainable happiness to patients and their families."