CaTe Inc. Completes First Patient In for Clinical Trial of Cardiac Disease Management Program Medical Device

CaTe Inc. (Headquarters: Bunkyo-ku, Tokyo; Representative Director: Kazuhiro Terashima; hereinafter "CaTe") announces that the First Patient In (FPI) has been completed in the domestic clinical verification trial to evaluate the efficacy and safety of the cardiac disease management program "CRS-1" (hereinafter "the Product"), which is under development.

CaTe aims to obtain regulatory approval for the program medical device (SaMD) that supports home-based exercise therapy and other interventions for cardiovascular disease. Through this clinical trial, CaTe will verify the efficacy and safety of the Product and advance efforts toward regulatory approval and the start of sales.

Background and Significance of this Trial

Cardiovascular disease is the second leading cause of death in Japan and the leading cause of death worldwide. In addition, it is known that among patients with heart failure, the one-year rehospitalization rate after discharge is approximately one in three, and the mortality rate is approximately one in seven, indicating a very high rate of severe outcomes. Cardiac rehabilitation is an effective means to reduce rehospitalization and mortality in patients with cardiovascular disease, but participation in outpatient cardiac rehabilitation in Japan has been reported to be only about 7%. As a result, many patients experience repeated rehospitalizations, contributing to increased healthcare costs.

To address these challenges, CaTe is conducting R&D aimed at early social implementation of a cardiac disease management program medical device that supports home-based exercise therapy and other interventions. The Product seeks to create an environment that provides continuous cardiac rehabilitation even for patients who have difficulty attending outpatient cardiac rehabilitation, aiming to increase rehabilitation participation rates, reduce rehospitalization and mortality rates, correct regional disparities, and reduce medical cost burdens.

Overview of the Trial

In this trial, patients in the late recovery phase who are eligible for cardiovascular disease rehabilitation will be assigned to an intervention group receiving comprehensive home-based cardiac rehabilitation using the cardiac disease management program medical device, and to a control group receiving standard outpatient cardiac rehabilitation as standard treatment.

For details of the clinical trial of this Product, please see the following.

Clinical Research Information System (jRCT) Number: jRCT2042260056

URL: https://jrct.mhlw.go.jp/latest-detail/jRCT2042260056

Company Profile

Company Name: CaTe Inc.

Representative Director: Kazuhiro Terashima

Locations: [Tokyo Headquarters] Skyvision Building 5F, 5-25-13 Hongo, Bunkyo-ku, Tokyo 113-0033

[ Nagoya Headquarters ] STATION Ai, 1-2-32 Tsurumai, Showa-ku, Nagoya 466-0064, Aichi

Founded: March 18, 2020

Licenses: Second-class medical device manufacturing and marketing business (13B2X10514)

URL: https://cate.co.jp/