Kumamoto City Hospital Begins 'Postoperative Helmet Therapy' for Conditions Like Craniosynostosis

Japan Medical Company (Chuo-ku, Tokyo, Representative Director and CEO: Hideaki Ono, hereafter 'the Company') announces that 'postoperative helmet therapy' following suturectomy for pathological cranial deformities such as craniosynostosis has begun at Kumamoto City Hospital (hereafter 'Kumamoto City Hospital').

Through this initiative, the hospital is now equipped to provide minimally invasive treatment that manages the cranial shape matching the infant's growth (shape guidance) while paying attention to postoperative head protection.

**│Background and Summary: Importance of a Treatment System Ranging from Differential Diagnosis of Pathological Deformities to Postoperative Management**
Infant cranial shape deformities are categorized into positional cranial deformities, primarily caused by sleeping habits, and pathological cranial deformities requiring surgical treatment (such as craniosynostosis). The treatment policy is decided after comprehensively judging the infant's age, developmental stage, and symptom severity, based on physical examinations and necessary imaging tests to differentiate the cause. Especially when pathological deformity is suspected, it is crucial to connect to appropriate medical pathways based on expert evaluation.

In recent years, while helmet therapy has become widely known, medical institutions have varied systems and evaluation methods, leaving parents often confused about where to consult or what treatment to choose. Specialized institutions partnered with our company, such as university hospitals and children's hospitals, often receive patients seeking second opinions after treatment elsewhere. Given this situation, there is a demand for a comprehensive medical system encompassing proper cranial checkups including differential diagnosis, necessary surgical treatment, and postoperative management.

With the commencement of postoperative helmet therapy at Kumamoto City Hospital, a regional core medical institution is now equipped to offer options that manage cranial morphology according to growth (shape guidance) while ensuring head protection after surgical treatment for pathological cranial deformities. Based on the physician's treatment policy, our company will support smooth postoperative management in coordination with the medical institution.

**│Key Points of Care for Pathological Cranial Deformities: Differentiation, Surgical Treatment, Postoperative Management**
1. Proper Cranial Checkup (Evaluation including Differentiation)
In addition to doctor's examinations, evaluations including differentiation between positional and pathological cranial deformities are conducted based on necessary tests. Early referral for expert evaluation allows for appropriate treatment selection.

2. Surgical Treatment (Treatment Plan Tailored to the Case)
For pathological cranial deformities, surgical treatment may be selected based on a tailored plan. The policy is determined individually, and continuous follow-up, including postoperative management, is crucial. Furthermore, at a young age, a treatment plan combining endoscopic suturectomy and our company's cranial correction helmet may be considered, premised on step-by-step management of the postoperative cranial shape. By utilizing our helmet post-surgery to guide shape according to growth, the cranial formation process can be assisted, making minimally invasive endoscopic surgery a viable option for certain cases. Indications and methods are individually determined by doctors, but it is positioned as a treatment option that integrates surgery and postoperative management.

3. Postoperative Management (Balancing Head Protection and Shape Guidance)
Postoperative helmet therapy is operated to assist in cranial shape management tailored to growth while protecting the surgical wound. Continuous follow-up throughout the treatment period is required, including regular examinations and adjustments matching the infant's condition.

**│Features of Our Custom-Made Helmets: Tailored Design and Operational Support**
1. Design Tailored to Individual Conditions (Utilizing 3D Measurement, etc.)
Cranial shapes are captured via 3D scanning, allowing for a custom design tailored to each infant's condition. It is operated under the doctor's treatment policy to enable design and adjustments that account for the postoperative state.

2. Design Premised on Wearing
Anticipating use during the treatment period, the design considers lightweight and breathable properties (as specified in product specifications).

3. Support Throughout the Treatment Period