ISSN0535-1405

公益財団法人

日本国際医学協会誌
I NTERNATI ONAL MED I CAL NEW S
International Medical Society of Japan
Since 1925

第 63 回 国際治療談話会総会

医療系ベンチャー〜How to start up№ 521
2024.January

International Medical News

Page 2The 63nd International Congress on Therapy

Medical Ventures 〜How to start up
O p e n i n g r e m a r k s: T a r o

K o n d o ,M D (M a n a g i n g d i r e c t o r , I M S J)

Congratulatory remarks: K i c h i r o M a t s u m o t o , M D (President, Japan Medical Association)

Discourse Chair：Kenichi Ishibashi, MD, PhD (Chairman, Board of Directors, IMSJ)
Discourse: Current trends in technology transfer and academic entrepreneurship in Germany
Axel KARPENSTEIN (Director, German Academic Exchange Service (DAAD) – Tokyo Office)Medical Ventures 〜How to start up
Medical Lectures Chair：Koichi Ito, MD, PhD (Managing director, IMSJ)
T a r o K o n d o , M D (Managing director, IMSJ)

Lecture I: Challenges and future outlook of a healthtech startup
Seigo Hara M.D(CEO, MICIN, Inc.)

Lecture II: Digital Therapeutics: Shaping the Future of Medicine
Kohta Satake, MD, MPH, MBA.
(President/CEO, CureApp, Inc. & Representative Director, Department of Respiratory Medicine,Japanese Red Cross Medical Center)

Lecture Ⅲ: Leading Edge of Cybernics Medical Health Care Innovation
Yoshiyuki Sankai, Ph.D.
(Professor/ Executive Research Director/ Director,
Institute of Systems and Information Engineering/ Center for Cybernics Research/ R&D Center for
Frontiers of MIRAI in Policy and Technology, University of Tsukuba.
President and CEO, CYBERDYNE Inc.
Program Director, SIP Program, Cabinet Office, Japan.)
Closing remarks:

Kenichi Ishibashi, MD, PhD (Chairman, Board of Directors, IMSJ)No. 521
INTERNATIONAL MEDICAL NEWSInternational Medical Society of Japan
Since 1925
January 31, 2024
Published by International Medical Society of Japan,
Chairman, Board of Directors: Kenichi Ishibashi, MD, PhD
Editors:

K. Ito, MD, PhD, T. Kondo, MD,

K. Ichihashi, MD, PhD, T. Murakami, PhD, R.Nagai, MD, PhD,
T. Sumiyama, MD, PhD, I. Taniguchi, MD, PhD, and T. Yamazaki, MD, PhD
1-11-9-3F Kamiuma, Setagaya-ku, Tokyo154-0011, Japan.
TEL03(5486)0601

FAX03(5486)0599

E-mail: imsj@imsj.or.jp https://www.imsj.or.jp/

Opening Remarks
Taro Kondo, MD
Managing director, IMSJCongratulatory message
Kichiro Matsumoto, MD
President,
Japan Medical Association
On behalf of the Japan Medical Association, I would like to extend my heartfelt congratulations
on the occasion of the 63rd International Congress on Therapy.
With a deep commitment to advancing global healthcare, the Japan Medical Association
endeavors to make international contributions to the field of medicine through enhanced
collaborations with the World Medical Association (WMA), the Confederation of Medical
Associations in Asia and Oceania (CMAAO), other national medical associations, relevant
government ministries and agencies, and international organizations.
Following the earthquake in Turkey and Syria in February this year, the Japan Medical
Association initiated a support fund for the Association of Medical Doctors of Asia (AMDA) tosupport their emergency relief efforts in the affected areas, which amounted to 5 million yen(including 3‒million‒yen contribution to the Turkish Medical Association). Our local medical
associations and members across Japan also donated over 156 million yen, which was sent tothe Turkish Medical Association in May.
In addition, to aid Ukraine, which is grappling with a military invasion by Russia, the Japan
Medical Association donated 213 million yen to the WMA in March. This fund was sourced fromthe contributions of our local medical associations, members, and the general public.
During the WMA Nairobi Council meeting held in April, emergency resolutions were adopted,
including the WMA Council Resolution for an Immediate and Effective Ceasefire in Sudan and
the Protection of Health Care, the WMA Council Resolution on Anti‒LGBTQ Legislation in Uganda,
and the WMA Council Resolution on Proposed Legislation in UK on the Treatment of Migrants
Disregarding the Injunction Interim Measures Rule 39 of ECHR. Furthermore, the WMA Kigali
General Assembly, held in October, adopted some urgent matters, including the WMA Resolution
Condemning the Violence against Physicians in Nepal.
The CMAAO Dhaka General Assembly held in September adopted the “CMAAO Declaration of
Dhaka: Pandemic preparedness is built upon a robust primary health care system.”Now, the theme for this year’s International Congress on Therapy is “Medical Ventures: How
to start up.” In alignment with the Startup Development Five‒year Plan announced by the
Kishida administration in November last year, the government is currently focusing its efforts on
supporting startup initiatives. As medical DX continues to advance, the number of ventures islikely to increase not only in the field of IT but also in the medical domain, including drug
discovery. A comprehensive promotion of such endeavors will hopefully lead to delivery of safe,
secure, and high‒quality healthcare services.
Lastly, I would like to express my best wishes for the success of this congress, the continued
growth of the International Medical Society of Japan, and the wellbeing and professional
accomplishments of all attendees. Thank you.

Congratulatory Telegram
Hideto Takahashi MD
President, Japan Dentist Association
Please accept our sincere congratulations on the success of the 63nd International Congresson Therapy.
We truly wish further development of your Society and the health of your members.

Nobuo Yamamoto MD
President, Japan Pharmaceutical Association

I'm delighted that the 63nd International Congress on Therapy is held in such a grand scale.
Through events and lectures such as these, your association contributes to both the
improvement of health care in Japan and the development of international medical exchange as
well. I truly respect everything you do.
I hope your association will continue to prosper and grow.

Introductory Message from the Chair
Kenichi Ishibashi, MD, PhD
Chairman, Board of Directors, IMSJ

Discourse
Current trends in technology transfer
and academic entrepreneurship in Germany

Axel KARPENSTEIN
Director
German Academic Exchange Service (DAAD) – Tokyo Office

Lecture Ⅰ
Challenges and future outlook of a healthtech startup
Seigo Hara M.D
CEOMICIN, Inc.

The regulations on telemedicine were lifted in Japan in 2015, and the rules wereclarified in the 2018 revision of reimbursement for medical services, and theinstitutional environment began to move forward. However, restrictions on eligiblediseases, low profitability, and strict implementation requirements have kept
telemedicine from becoming widespread.
However, the situation changed drastically with the spread of the COVID‒19
epidemic, and telemedicine received dramatic attention due to the temporary
relaxation of restrictions on eligible diseases.
While patients were reluctant to visit hospitals due to the risk of infection during
travel and in the hospital, telemedicine services were increasingly needed by both
medical institutions and patients to continue treatment, reduce the burden of
hospital visits, and prevent secondary infections.
In fact, the number of medical institutions that have adopted our telemedicine
service “curon”, which we have been providing since 2016, now exceeds 6,000, andthe number of consultations is now more than 10 times higher than before COVID‒
19.
With the revision of the medical service fee in April 2022, the reimbursement iscloser to that of face‒to‒face consultations, and telemedicine can now be used formore diseases.
Digital therapeutics（DTx） has recently been reimbursed by insurance both inJapan and overseas, and evidence of its effectiveness has begun to be obtained inclinical trials, making it a viable treatment option.
We are also developing its Digital Therapeutics business, with products that support
not only disease management but also prevention, diagnosis, treatment, andintervention through software interventions based on medical evidence, including
the launch of the “MedBridge” treatment assistance application, the “BSA‒01”
biometric sound measurement application, a biometric information sharing
application that has received regulatory approval, and the development of a
cognitive behavioral therapy application.
While institutional arrangements, technological and environmental improvements,
and issues of acceptance by both healthcare providers and patients are required forthe widespread use of DTx, with the progress of utilization and the accumulation ofevidence, the value of DTx and the resolution of the process will increase, and it will
be optimized as a product, leading to the creation of products that truly contributeto medical outcomes.

Lecture Ⅱ
Digital Therapeutics: Shaping the Future of Medicine
Kohta Satake, MD, MPH, MBA.
President/CEO, CureApp, Inc.
Representative Director,
Department of Respiratory Medicine, Japanese Red Cross Medical Center"Digital Therapeutics (DTx)" refer to applications used on general devices such as
smartphones for therapeutic purposes, whose efficacy has been proven throughclinical trials and have been approved by regulatory authorities as medical devices.
These apps are gaining attention as a new modality of treatment options that target
patients' behaviors and cognition. As of October 2023, in Japan, DTx for nicotine
dependence and hypertension have been launched and are covered by insurance.
"CureApp SC Nicotine Dependence Treatment App and CO Checker" is a DTx productfor nicotine dependence, which demonstrated significant improvements incontinuous smoking cessation rates in a randomized Phase III trial and wasapproved in 2020. Additionally, "CureApp HT Hypertension Treatment Support App(CureApp HT)" is a DTx product for essential hypertension that aims to improve
lifestyle habits. It demonstrated significant improvements in 24‒hour average bloodpressure in a randomized Phase III trial and was approved in 2022.
With the advent of Therapeutic Apps, DTx as a new treatment option has emerged,
combining Therapeutic Apps with medical consultation. DTx primarily targets
behavioral changes in patients. When people change their behavior, they go throughfive

stages:pre‒contemplation,

contemplation,

preparation,action,andmaintenance. To advance the stage of behavioral change, it is necessary tounderstand which stage the patient is currently situated and to intervene accordingly.

Key points include providing optimized interventions based on patient characteristics,
making small steps instead of achieving significant changes at once, and providing
positive feedback for desired behaviors. However, traditional outpatient lifestyle
guidance was provided by healthcare professionals only during the patient's visit to
the medical institution, making it challenging to provide detailed guidance due totime and location constraints. In DTx, combining physician guidance at medical
institutions with Therapeutic Apps allows for overcoming these constraints andreaching out to patients. Furthermore, based on inputs from patients and connected
devices, tailor‒made guidance optimized for the patient at that time can be provided.
In Japan, as an example of DTx, we introduce DTx for hypertension using a
Therapeutic Apps for hypertension. Hypertension is an established risk factor forstroke and cardiovascular events, and providing effective treatment is a significant
societal challenge. Hypertension treatment guidelines strongly recommend "lifestylemodifications" for those with non‒normal blood pressure, but it is challenging toprovide adequate guidance within limited consultation time. To address this, theCureApp HT was developed to intervene in daily lifestyle habits and provide effective
education within limited consultation time. This product consists of two apps: onefor patients and one for doctors. Patients carry out the content delivered to the app
daily and record daily measurements such as blood pressure taken at home. The
information provided includes the purpose of treatment, knowledge about thedisease, and suggestions for behavioral changes in daily life. Necessary actions arenotified based on the patient's basic data and input, and are individually optimized
for each patient. Patients are encouraged to record not only blood pressure but also
weight, sleep duration, stress level, daily physical condition, behaviors, and diaries
in the app daily. Physicians can check this information in the doctor's app before andduring the consultation, allowing them to guide patients based on the transition ofhome blood pressure, learning content about hypertension, and changes in lifestyle
habits at home. As a result, patients can understand how their actions affect theirblood pressure, enhance their sense of self‒efficacy, and function as positive
feedback.
With the spread of DTx, it is anticipated that the patient's treatment experience will
fundamentally change. As of October 2023, Therapeutic Apps in the fields ofhypertension and smoking cessation have been launched, and preparations areunderway for insurance application after regulatory approval for a therapeutic app
for insomnia. Development is also underway in various disease areas such as
diabetes, mental disorders, and cancer. DTx products represent a new treatment
method that merges medicine and technology, promoting behavioral changes andoffering new approaches to diseases that were previously difficult to treat. By
actively managing health in daily life, there is a shift from physician‒centered topatient‒centered healthcare. Moreover, by grasping the patient's condition andtreatment progress at home in real‒time, it becomes possible to address issues earlyand propose preventive measures. Such technological advancements and theirapplications are likely to shape the new direction of 21st‒century healthcare.

Lecture Ⅲ
Leading Edge of Cybernics Medical Health Care Innovation
Yoshiyuki Sankai, Ph.D.
Professor/ Executive Research Director/ Director,
Institute of Systems and Information Engineering/ Center for Cybernics Research/
R&D Center for Frontiers of MIRAI in Policy and Technology, University of Tsukuba.
President and CEO, CYBERDYNE Inc.
Program Director, SIP Program, Cabinet Office, Japan.
The number of patients and persons requiring care is increasing with the super‒aging of society.
Hospitals, facilities, and homes need to provide daily treatment, functional improvement, healthmanagement, and nursing care support for patients and persons requiring care. In addition,
there is a need for innovative technologies that can handle progress observation, continuous
treatment, health management, early detection, prevention, improvement and maintenance ofphysical function and physiological state, and measures against lifestyle‒related diseases in an
integrated manner. Against this background, we have been challenging to pioneer the future
through researching, developing, and utilizing "Cybernics" (a fusion of Humans, AI Robots, andInformation Systems) that integrates "Human" and "CyberPhysical space" in an integrated
manner. Our pioneering areas include various robotics technologies from the cell culture level,
cyborg technology, AI, IoH/IoT, human big data, cloud computing, supercomputer data analysis
and AI processing, international standardization, social implementation, treatment, diagnosis,
and prevention technologies, and health maintenance and promotion connecting medical andnon‒medical fields. In order to develop "Cybernics Medical and Health Innovation" while solving
various difficult problems from basic research to social implementation, commercialization, andinternational deployment, it is necessary to take on intense challenges with passion over a long
period of time.
CYBERDYNE, a university‒launched startup, initially started with five people (University ofTsukuba professors and Ph.D. students) and was listed on the Tokyo Stock Exchange Mothers
in 2014. It is an R&D‒oriented future pioneering company (capital 42.6 billion yen (including
capital reserve)) that engages in research, development, manufacturing, sales, and services ofcybernics‒based medical devices, and is also a designated research institute designated by theInternational Medical Device Quality Management System (ISO13485), the Ministry of Educationand Science and the Minister of Education, Culture, Sports, Science and Technology. In 2014, it
was named IPO of the Year in 2014 and Innovative Equity of the Year in 2015, the company
focuses on startups, IPOs, international expansion, funds, and the Cybernics industry, with afocus on R&D that integrates basic and practical aspects, social implementation, and humanresource development to promote innovation. Cyberdyne is a leading Cybernics company inJapan.
One of the representative achievements of Cybernics is the wearable cyborg HAL. The wearable
cyborg HAL connects humans to HAL using bio‒potential signals derived from the cranial nervous
system, and functionally integrates humans with AI technology, robots, and information systems.
The HAL enables functional regeneration therapy in which synaptic connections between nerves
and nerves, and between nerves and muscles, are strengthened and adjusted. Cybernics
therapy with the medical HAL approved as a new medical device has been approved as a medical
device throughout Europe and is covered by public workers' compensation insurance for spinal
cord injuries in Germany.
In Japan, medical insurance has been applied through clinical trials for progressive
neuromuscular intractable diseases (8 diseases) such as SMA, ALS, SMBA, CMT, and muscular
dystrophy, and subsequent use‒results surveys have also shown remarkable therapeutic resultsin long‒term application. Recently, in Japan, two diseases, HAM and hereditary paraplegia, wereshown to be effective through clinical trials, and the coverage was expanded to 10 diseases. As
for medical HAL, Cybernics treatment platform for cranial nervous system diseases, motor
instability, and other diseases is in progress in 20 countries around the world, and remarkabletherapeutic effects have been demonstrated through the 4‒year post‒approval use‒results
survey after the medical insurance coverage. Recently, "combined therapy combining the latest
drugs and medical HAL," such as the latest nucleic acid drug for spinal muscular atrophy (SMA),
is attracting attention as a new treatment method with a high synergistic effect. Furthermore,as the next initiative, various developments of Cybernics technology in the field of regenerative
medicine have also begun. A Cybernics Medical Innovation base for regenerative medicine has
been constructed at the King Sky‒Front facing Haneda Airport and has been in operation sinceJanuary 2023.
The HAL for independence assistance is used at home and in nursing care facilities, mainly for
waist‒type and single‒joint types. The HAL series is IoH/IoT‒enabled and data linkage is possible.
Cyvis, which enables daily monitoring of various phisiological data (e.g., electrocardiogram,
electroencephalogram, body temperature, oxygen saturation and respiratory status (optional)),will also be available as a medical device. With Cybernics, various cybernics technologies, andC‒Cloud that realize the fusion of different fields, the realization of a "health future society" thatencompasses regional and wider areas by connecting "hospitals and homes," "doctors andpatients/users," "people and technology," and "people and people" is also on target.
In this speech, I would like to talk passionately about the "Cybernics Medical Health Innovation"
initiative with the latest information.

Closing Remarks
Kenichi Ishibashi, MD, PhD
Chairman, Board of Directors, IMSJ