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Other Disclosures4263SUSMED,Inc.Information and Communications, Services and Others

Start of a Confirmatory Trial for the Tinnitus Treatment App “KRP-DT123”

Kyorin Pharmaceutical and SUSMED,Inc. will begin a confirmatory clinical trial of the tinnitus treatment app “KRP-DT123/SMD403.” Following completion of the trial, Kyorin Pharmaceutical plans to file for regulatory approval in Japan.

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Announced details

KRP-DT123/SMD403Tinnitus treatment app
Applicable field (uses covered by this announcement)

Treatment of patients with distressing chronic tinnitus

What the company reported numerically
Quantitative Effects

Evaluate the app’s efficacy and safety when used for 16 weeks

Relationship between the counterparty and the company
SUSMED,Inc.4263
Relationship with the Company

Kyorin Pharmaceutical and SUSMED,Inc. are jointly developing the app. Kyorin Pharmaceutical provides expertise in the disease area, clinical development capabilities and sales capabilities, while SUSMED,Inc. provides a development platform for treatment apps, a clinical trial system and research and development expertise.

CounterpartySUSMED,Inc.

Head office: Chuo-ku, Tokyo; Representative Director and President: Ueno Taro (上野太郎). SUSMED,Inc. is a research and development company advancing digital healthcare. It develops treatment apps for conditions including insomnia and provides clinical development support systems.

In this announcement the company addresses none of Contract Value / Offering price / Impact on Business Performance.

Source (materials cited by the company)

Clinical Practice Guideline for Tinnitus (Japanese Audiological Society, General Incorporated Association)

Web-Based Survey of Tinnitus Care in Japan (Audiology Japan 67:548-557, 2024)

Announced details
ItemDetails
Names of Products / Services CoveredKRP-DT123/SMD403, Tinnitus treatment app
CounterpartySUSMED,Inc.
Counterparty overviewHead office: Chuo-ku, Tokyo; Representative Director and President: Ueno Taro (上野太郎). SUSMED,Inc. is a research and development company advancing digital healthcare. It develops treatment apps for conditions including insomnia and provides clinical development support systems.
Relationship with the CompanyKyorin Pharmaceutical and SUSMED,Inc. are jointly developing the app. Kyorin Pharmaceutical provides expertise in the disease area, clinical development capabilities and sales capabilities, while SUSMED,Inc. provides a development platform for treatment apps, a clinical trial system and research and development expertise.
Applicable areaTreatment of patients with distressing chronic tinnitus
Quantitative EffectsEvaluate the app’s efficacy and safety when used for 16 weeks
SourceClinical Practice Guideline for Tinnitus (Japanese Audiological Society, General Incorporated Association), Web-Based Survey of Tinnitus Care in Japan (Audiology Japan 67:548-557, 2024)
Items this document does not state (11)
Contract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scaleUsage historyImpact on Business Performance

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

The companies aim to evaluate the app’s efficacy and safety in patients with distressing chronic tinnitus and provide a new treatment option for patients suffering from tinnitus.

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Start of a Confirmatory Trial for the Tinnitus Treatment App “KRP-DT123” | SUSMED,Inc. (4263) timely disclosure | Komori