“AutoloGel System,” a wound treatment system for refractory wounds, now covered by Japan’s National Health Insurance
October 3, 2024
ROHTO Pharmaceutical Co., Ltd. (Headquarters: Osaka City, Osaka Prefecture; President: Masashi Sugimoto) is pleased to announce that the Autologel System, a platelet-rich plasma gel preparation kit, a wound treatment system for difficult-to-heal wounds, will be covered by insurance from October 1, 2024.
Refractory wounds and the development of necessary treatment methods
Intractable wounds are diseases that are difficult to treat due to a lack of healing ability and are characterized by long-term consequences. In Japan, with the aging population and increasing number of diabetes patients, it is expected that the number of patients with chronic wounds, including diabetic ulcers, will increase. In particular, diabetic ulcers, which are common on the feet, can lead to lower limb amputation if they worsen, and it has been reported that the mortality rate within five years of amputation is 70% *.
For these intractable wounds that are difficult to treat and have poor prognoses, there is a need in the medical field to develop innovative treatments that are less invasive, and in recent years, the usefulness of autologous platelet-rich plasma (PRP) therapy for wounds has been reported both domestically and internationally. Our company has been developing PRP therapy as a new medical device and has obtained manufacturing and sales approval.
With this insurance coverage, the Autologel System no longer requires compliance with the Act on the Safety of Regenerative medicine, which was previously required for conventional PRP therapy. This is expected to make PRP therapy more accessible to patients as a treatment option. We will work to quickly establish a sales system so that we can contribute to patients and their families who are suffering from intractable wounds, as well as to all those who support medical care.
*：Singh et al. JAMA 2005; 293 217-228
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 conventional medical 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.) |
What is the Autologel System?
This medical device is a novel treatment system for wounds that are resistant to existing treatments, using autologous platelet-rich plasma (PRP) therapy, which is suitable for various diseases. It is a kit that promotes wound healing by applying platelet-rich plasma separated from the patient's own blood, gelled with a drug, to the wound site.
- Feature 1: Gelling makes it easy to apply to the damaged area
- Feature 2: Efficacy and safety evaluated through clinical trials and approval obtained
- Feature 3: Prepared from autologous blood, which reduces the risk of new infections and rejection reactions
*Autologous platelet-rich plasma (PRP) therapy: By administering autologous platelet-rich plasma (PRP), which is made by separating and concentrating platelets from blood collected from the patient, to damaged tissue, the high concentration of various growth factors contained in the autologous platelet-rich plasma (PRP) promotes tissue regeneration.
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" is a registered trademark of ROHTO Pharmaceutical Co., Ltd.