We have started selling the "Autologel System,"
a wound treatment system for refractory wounds.
January 14, 2025
ROHTO Pharmaceutical Co., Ltd. (Headquarters: Osaka City, Osaka Prefecture; President: Masafumi Sugimoto) will begin sales of the "Autologel System," a platelet-rich plasma gel preparation kit for treating intractable wounds, on January 14, 2025 (Tuesday). This medical device received manufacturing and sales approval in 2022 and became covered by health insurance on October 1, 2024. We aim to contribute to patients suffering from intractable wounds, their families, and those who support healthcare.
The "Autologel System" is a medical device intended for use or intended effect of "promoting wound healing using autologous platelet-rich plasma gel for wounds that do not respond to existing treatments." Blood is collected from the patient, platelet-rich plasma (PRP) is separated, gelled with medication (PRP gel), and applied to the patient's injured area to promote wound healing.
Masafumi Sugimoto, the president, said, "At our company, we aim to deliver 'health' through our products and services and realize a sustainable well-being society. In particular, we recognize that 'being able to walk' is an important action for continuing to live a healthy and vibrant life, in terms of its social significance of extending healthy life expectancy. Diabetic skin ulcers, an example of a difficult-to-heal wound, tend to occur on the feet, and in some cases, healing is difficult with conventional treatment. If skin ulcers or gangrene progress in diabetic patients, and infection spreads to the affected area or blood flow problems do not improve, amputation may be necessary *1. For wounds like these that do not respond to existing treatments, we offer 'Autologel' as a medical device. We have been developing a medical device that can treat a wide range of intractable wounds, such as diabetic ulcers and pressure ulcers, so that the system can provide a new treatment method. Furthermore, this medical device is effective when used according to the correct procedure, and we will also focus on providing information to medical professionals who are providing treatment in the medical field. Now that we are launching the product, we feel the great responsibility and will strive to make it a source of hope for treatment for patients, their families, and those who support medical care on the front lines."
We believe that this medical device will be effective for intractable wounds that do not respond to existing treatments, and will contribute to enabling patients to actively participate in society again. Regarding distribution and sales operations, we have entrusted this to four pharmaceutical wholesale companies (Mediceo Co., Ltd., Evals Co., Ltd., Atol Co., Ltd., and Toshichi Co., Ltd.), which are consolidated subsidiaries of Medipal Holdings Co., Ltd. (Head office: Chuo-ku, Tokyo, President: Shuichi Watanabe), as well as Yon-yaku Co., Ltd. (Head office: Matsuyama City, Ehime Prefecture, President: Makoto Kagayama) and Nakazawa Ujiie Pharmaceutical Co., Ltd. (Head office: Nankoku City, Kochi Prefecture / Ayauta-gun, Kagawa Prefecture, President: Koji Nakazawa), and we will work together to deliver the product to as many patients as possible.
Rohto Pharmaceutical will continue to offer the "Autologel System" as a treatment option for patients suffering from intractable wounds, and will focus on providing information for correct treatment. Through the treatment of intractable wounds, we will strive to contribute to a well-being society.
*1: Japanese Dermatological Association Guidelines
attached file
The process leading up to the start of sales
What is the Autologel System?
This medical device is a kit that promotes wound healing by applying a gel made from platelet-rich plasma separated from the patient's own blood, which has been gelled with medication, to the patient's injured area.
Overview of insurance coverage
| Sales name |
Autologel System |
| common name |
Platelet-Rich Plasma Gel Preparation Kit |
| Medical Device Approval Number |
30400BZX00273000 |
| Classification etc. |
Specially controlled medical devices (Class III), biological products |
| Main purpose of use |
Promoting wound healing using autologous platelet-rich plasma gel for wounds that do not respond to existing treatments. |
| Insurance application date |
October 1, 2024 |
| Related technology fees |
J003-4 Platelet-rich plasma treatment 4,190 points (with changes to facility standards, etc.) |
*2: Centrifuge: <Medical device for combined use> Product name: Centrifuge ATGC-01 Notification number: 07B2X00007000026, Counterweight: <Optional accessory sold separately> Product name: Counterweight for ATGC-01
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" is a registered trademark of ROHTO Pharmaceutical Co., Ltd.