Font Size
Product Search
Product Category
Product Information
(Impact: High / Likelihood: High / Potential Timing of Occurrence: At any time)
If claims arise with respect to products manufactured and sold by the Group due to issues attributable to sales, manufacturing, or services, the Group may incur losses not only from repair costs and compensation for damages, but also from the loss of customers and harm to patients.
To address these risks, we have taken the following measures: ensuring compliance with standard procedures, implementing corrective actions to prevent recurrence, providing training and education, coordinating between manufacturing and quality control, and maintaining liability and product liability insurance.
Nonetheless, even with these measures, sudden and unforeseen changes in laws and regulations in different countries may reduce their effectiveness, potentially leading to serious violations or damage to our reputation, which could affect the Group’s financial condition and business performance.
(Impact: High / Likelihood: Medium / Potential Timing of Occurrence: At any time)The ratio of the Group’s net sales accounted for by our top three major customers is as shown in the table below. The Group maintains very good relationships with these customers, and transactions have been stable and ongoing. We believe that these good relationships will continue; however, if for any reason the relationship with these customers changes, or if transactions through distributors are suspended due to factors such as acquisition of distributors by competitors, the Group’s financial position and operating results may be affected.
To address these risks, the Group works to create added value for our products, maintain relationships with existing distributors, and strengthen sales capabilities by developing new distribution channels and new distributors.
(Impact: Medium / Likelihood: Medium / Potential Timing of Occurrence: At any time)The products manufactured and sold by the Group belong to relatively niche markets. In addition, there are high barriers to obtaining regulatory approvals and establishing distribution channels, which allows us to maintain relatively high profit margins. However, if new entrants adopt low-price strategies or competitors pursue high-volume, low-margin strategies, we may be forced to reduce the selling prices of our products.
As countermeasures, we work to minimize the risks arising from such events by promoting collaboration and relationship-building with customers and preparing alternative products for expanded sales. Nonetheless, even with these measures, if we are forced to reduce the selling prices of our products, the financial condition and business performance of the Group may be affected.
(Impact: Medium / Likelihood: Medium / Potential Timing of Occurrence: At any time)The Group is working to expand its overseas operations. Political instability in foreign markets, trade sanctions including additional tariffs imposed in retaliation, differences in culture and legal systems, and unique labor relations may hinder smooth business operations and could affect the financial condition and business performance of the Group.
As countermeasures, the Group conducts legal reviews for each product or service and investigates geopolitical risks, including trade sanctions, at the start of service. In addition, the Group works with local partners who are well-versed in regional conditions to minimize country risks.
(Impact: Medium / Likelihood: Medium / Potential Timing of Occurrence: At any time)The Group conducts business not only in Japan but also in overseas markets. Economic slowdowns and changes in economic conditions abroad may alter competitive environments and affect profitability. The Group strives to expand product deployment across diverse regions to mitigate the impact of economic trends; however, if demand from customers does not grow as expected or if the Group’s customer base is weakened due to competitors, the financial condition and business performance of the Group may be affected.
As countermeasures, the Group strives to promptly capture information regarding overseas competitors and market trends, and maintains a system to formulate timely responses.
(Impact: Medium / Likelihood: Low / Potential Timing of Occurrence: At any time)Technological innovation is advancing rapidly due to significant developments in science and technology, and new services are constantly being introduced. The Group closely monitors industry trends and intends to respond promptly and appropriately to such changes. If the Group’s response to these changes is delayed for any reason, services may become obsolete and competitiveness may decline. Even when a response is possible, additional costs may arise from improving existing systems or developing new ones, which could affect the financial condition and business performance of the Group.
(Impact: Medium / Likelihood: Low / Potential Timing of Occurrence: At any time)The Group procures materials both domestically and internationally. Factors such as increases in resource prices, labor costs, and yen depreciation may lead to higher costs for purchasing products from suppliers. If these increased costs cannot be passed on to customers, profitability may decline.
As countermeasures, the Group seeks to reduce costs by increasing order volumes, proposing regular purchases to suppliers, and reviewing procurement channels. If raw material prices rise and profits are compressed despite these measures, the financial condition and business performance of the Group may be affected.
(Impact: Medium / Likelihood: Low / Potential Timing of Occurrence: At any time)Delays or disruptions in the supply of materials may occur due to factors such as deterioration in the financial condition of suppliers, changes in their business plans, or natural disasters.
As countermeasures, the Group ensures transactions with multiple suppliers, maintains approximately six months of inventory, collaborates with and provides training to suppliers, and conducts thorough inspections upon receipt of materials. If production is broadly affected despite these measures, it may become difficult to maintain or acquire customers, which could affect the financial condition and business performance of the Group.
(Impact: Low / Likelihood: High / Potential Timing of Occurrence: At any time)The Group strives to maintain strict inventory management. If irregularities are detected at the time of material procurement, or if storage periods or inbound and outbound inventory controls are not appropriately managed, inventory valuation losses may occur and delivery delays may arise due to inventory shortages.
As countermeasures, the Group implements appropriate inventory management, provides IT training, conducts timely reviews of system automation, and promotes thorough workplace organization. If deficiencies in inventory management result in excess inventory or inventory shortages despite these measures, the financial condition and business performance of the Group may be affected.
(Impact: High / Likelihood: Medium / Potential Timing of Occurrence: At any time)The Group is subject, in Japan, to regulations under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the “Pharmaceuticals and Medical Devices Act,” or “PMD Act”) and related laws and regulations. In order to sell medical devices manufactured by the Group, certification for each product must be obtained from a registered certification body authorized by the Minister of Health, Labour and Welfare (third-party certification).
At present, no events have occurred that would result in the revocation of approvals or certifications. If, however, any violations of laws and regulations were to occur in the future due to insufficient specialized knowledge or other factors, the Group may be subject to administrative actions or guidance, including business suspension, under the PMD Act. In addition, such events could result in health damage to users and reputational harm to the Group.
Furthermore, amid rapidly advancing demographic changes such as a declining birthrate and aging population, unforeseen reforms to the medical insurance system or other changes in medical-related government policies could occur. Depending on trends in such administrative measures related to the medical system, the financial condition and business performance of the Group may be affected.
In addition, in overseas markets, the strengthening of medical device regulations in various countries and regions has increased the need to obtain medical device product registrations in accordance with local requirements. To properly register medical devices in each country and region, it is necessary to obtain and respond to medical device regulatory information in real time. Specifically, to export to Europe, it is necessary to comply with the requirements of the Medical Device Regulation (MDR), and to export to the United States, registration with the U.S. Food and Drug Administration (FDA) is required.
As countermeasures, the Group takes steps to obtain timely and comprehensive information on legal regulations and medical policies by participating in relevant domestic and international associations and organizations. The Group also examines the need for additional measures in order to proactively prepare for changes or strengthening of legal regulations. In addition, by undergoing the review processes for medical device regulations in each country and region, such as the MDR and FDA, the Group exports products that comply with local regulatory requirements.
Nevertheless, if related legal regulations are changed or strengthened, additional time may be required to respond, which could affect the continuity of the Group’s business and may also have an impact on the financial condition and business performance of the Group.
(Impact: Medium / Likelihood: Low / Potential Timing of Occurrence: At any time)The Group endeavors to protect its intellectual property rights through measures such as obtaining patents. However, if intellectual property owned by the Group were to be leaked due to inadequate management of data such as drawings, intentional disclosure by employees, or leaks from business partners, it could not only damage the Group’s corporate image and credibility, but also, if the Group unintentionally infringes on a third party’s intellectual property, result in injunctions, claims for damages, or license fee demands.
As countermeasures, the Group: (i) enters into agreements regarding intellectual property with employees and customers, (ii) provides thorough education and awareness programs for employees on intellectual property, and (iii) utilizes experts as appropriate. Nevertheless, even with these measures, if intellectual property is leaked or disputes with third parties arise, and significant lawsuits such as claims for damages or injunctions are brought in the future, the financial condition and business performance of the Group may be affected.
(Impact: Medium / Likelihood: Low / Potential Timing of Occurrence: At any time)The Group takes measures to prevent inappropriate contract execution or contractual violations by having its legal counsel review contract terms in advance whenever there is ambiguity in contract content or legal interpretation with business partners.
Nevertheless, if these measures fail due to sudden changes in laws and regulations or various factors within the Group and among stakeholders, significant violations may occur or the Group’s social credibility may be impaired, which could have an impact on the financial condition and business performance of the Group.
(Impact: High / Likelihood: High / Potential Timing of Occurrence: At any time)Futoshi Inoue, President and CEO, is the founder of the Company and a major shareholder. Since the founding of the Company, he has served as the Chief Executive Officer and plays an extremely important role in determining and executing the Group’s management policies and business strategies. Therefore, if Mr. Inoue were unable to continue his duties for any reason, there could be delays in management decisions and business execution, which may affect the Group’s business development, financial condition, and business performance.
As countermeasures, the Group is strengthening its ongoing management system, developing executive personnel, and promoting the sharing of Mr. Inoue’s extensive experience and knowledge, thereby building a management system that does not rely excessively on Mr. Inoue.
(Impact: High / Likelihood: Medium / Potential Timing of Occurrence: At any time)The Group is exposed to the risk of information leakage, falsification, loss, or other information security incidents due to external cyberattacks on the Group’s IT systems and file servers, virus infections through received emails, intentional disclosure by employees, or leaks from business partners. As countermeasures, the Group implements the following measures: (i) strengthening IT security by updating security software to the latest version and replacing outdated systems, (ii) ensuring thorough awareness and training of employees on cyberattack risks and response measures, (iii) properly operating internal regulations, (iv) managing access control and logs for file servers, (v) executing agreements with employees regarding the handling of personal information, and (vi) entering into confidentiality agreements with business partners and other third parties.
Nevertheless, if information leakage occurs due to unforeseen factors, or if a third party bound by confidentiality agreements with the Group improperly uses information without the Group’s knowledge, the Group’s corporate image could be impaired, potentially affecting business operations, financial condition, and business performance.
(Impact: High / Likelihood: Low / Potential Timing of Occurrence: At any time)The possibility of disasters occurring at the Group’s production and office locations is as indicated in disaster prevention information published by the respective municipalities.
[Shizuoka Headquarters Factory: Completed in August 2020] Fuji City Disaster Prevention Map estimates seismic shaking at a lower 6 on the Japanese seismic intensity scale in the event of a Nankai Torafu earthquake, with no areas designated as tsunami inundation zones or landslide hazard zones, and internal water (flood) hazard maps indicate flooding of less than 0.5 meters.
[Tokyo Office: Completed in December 1991] Minato-ku Seismic Susceptibility Map estimates a seismic intensity of 6.4–6.5 for a hypothetical M7.3 earthquake directly beneath the southern part of central Tokyo. According to the Minato-ku Tsunami Hazard Map, flooding could range from 0.8 to 1.5 meters depending on the condition of coastal protection facilities. The Minato-ku Landslide Hazard Map indicates no landslide hazard zones at the office location, and the Minato-ku Flood Hazard Map estimates internal flooding of 0.5 to 1.0 meters.
Although these buildings were constructed in compliance with the updated seismic standards under the Building Standards Act and large-scale disasters are not expected to cause significant damage, the Group concentrates most of its manufacturing functions at the Shizuoka Headquarters Factory. Therefore, in the event of an earthquake, typhoon, or other natural disaster, accident, or fire that exceeds these assumptions, resulting in the suspension of manufacturing and sales operations or damage to buildings and equipment, the continuity of the Group’s business operations could be adversely affected.
As countermeasures, the Group has implemented (i) internal seismic reinforcement measures, (ii) the establishment of cooperative arrangements with external partners for emergencies, and (iii) the stockpiling of certain products and raw materials to prepare for potential temporary supply disruptions caused by unforeseen natural disasters. Nonetheless, if a disaster impacts production activities on a wide scale, it could become difficult to maintain or acquire customers, and significant costs may be incurred to restore facilities. As a result, the Group’s business operations, financial condition, and business performance could be adversely affected.
(Impact: Medium / Likelihood: High / Potential Timing of Occurrence: At any time)The Group recognizes that securing talented personnel is a key issue for sustainable growth in the future. However, if recruitment becomes difficult due to changes in employment conditions, or if unexpected employee turnover occurs, it could lead to reduced production capacity, product shortages, delayed deliveries resulting in lost sales opportunities, and a decline in competitiveness due to the inability to transfer technical skills.
As countermeasures, the Group conducts regular interviews, improves employee compensation and working conditions, operates a performance evaluation system, increases production at external partners, and implements department and job rotations for manufacturing staff. These measures aim not only to prevent employee turnover but also to actively attract new talent through initiatives such as graduate recruitment and sending direct messages to job seekers via the web. Despite these measures, if changes in employment conditions occur or if the Group is unable to recruit the necessary personnel as planned, the Group’s financial condition and business performance could be adversely affected.
(Impact: Medium / Likelihood: Low / Potential Timing of Occurrence: At any time)As the Group’s business expands, the number of officers and employees increases each year, which may give rise to fraudulent activities such as embezzlement or insider trading by internal personnel.
As countermeasures, the Group provides necessary education to employees, encourages information sharing with the Risk Management and Compliance Committee, establishes external whistleblowing hotline, monitors operations through internal audits, implements approval workflows, and conducts regular monitoring of emails and system logs. Despite these measures, if the internal management system cannot keep pace with the expansion of business to detect fraudulent activities in a timely manner, significant violations or damage to social trust may occur, which could adversely affect the Group’s financial condition and business performance.
(Impact: Medium / Likelihood: Low / Potential Timing of Occurrence: At any time)The Group handles a large volume of personal and other customer-related information, and therefore considers it essential to maintain a robust information security framework.
Regarding the handling of personal information, operations are conducted in accordance with the Personal Information Handling Policy. For example, when obtaining personal information, the Group establishes a privacy policy based on this regulation and publishes it on the Company’s website. Furthermore, as part of safety management measures under the same policy, physical copies of personal information are stored in locked cabinets, while digital data is managed in accordance with the Information Security Management Rules, including the setting of access permissions and monitoring of file server logs. The Group also publishes its information security policy on the Company’s website to reinforce these measures.
In the fiscal year ended March 2025, the Company experienced an incident in which funds were misappropriated overseas following an email instructing a transfer that impersonated an overseas supplier (loss amount: JPY 25 million). In response, the Company revised its operational procedures under the Quality Management System (QMS)* to strengthen information security. Measures include verifying account changes by telephone in addition to email, implementing two-step authentication for overseas transfers, and establishing interdepartmental checks using a dedicated format.
*QMS refers to one of the ISO management system standards, “Quality Management System.”
Despite these measures, if the Group is subjected to an unexpected cyberattack or other information security incident, there is a possibility that the Group’s business performance and financial condition could be adversely affected.
(Impact: Medium / Likelihood: Medium / Potential Timing of Occurrence: At any time)The Company’s shareholders consist of Futoshi Inoue, the President and CEO of the Company, and his asset management company, Kitazato & Co., Ltd. among others.
Going forward, the Company intends to further improve the liquidity of its shares through measures such as requesting existing shareholders to sell a portion of their holdings and raising growth capital in line with the Company’s business plan through public offerings. Nevertheless, if for any reason the liquidity of the shares falls below the level at the time of listing, trading of the Company’s shares in the market could stagnate, which may affect the supply-demand balance of the shares.
(Impact: Medium / Likelihood: Low / Potential Timing of Occurrence: At any time)Mr. Ignacio Bermejo, an outside director of the Company, serves as the Managing Director of Biomedical Supply, S.L. and as the Chief Executive Officer of Biomedical Supply US, Inc. The Company has sales transactions of its products with these companies, which are considered related party transactions.
Related party transactions carry the risk that unnecessary transactions could be imposed or transaction terms could be distorted, potentially resulting in the unfair loss of benefits that should accrue to the Company’s shareholders.
Mr. Bermejo’s appointment as an outside director originated when he was in charge of the procurement division of the IVI Group, Spain’s largest fertility treatment facility, and the Group considered procuring medical devices from the Company. Subsequently, due to local regulations, it was determined that supplying the IVI Group directly with the Company’s products was difficult, and no transactions were initiated at that time. Later, Biomedical Supply, S.L. was established, and upon Mr. Bermejo’s appointment as Managing Director, business transactions between the Company and Biomedical Supply, S.L. commenced. Given his extensive managerial experience and deep industry insight, Mr. Bermejo was recognized as an essential person for the Company’s overseas strategy and was invited to serve as an outside director.
Biomedical Supply, S.L. and Biomedical Supply US, Inc. are group companies of IVIRMA Global, a worldwide network of fertility clinics.
Being ISO certified company,we ensure high-quality product and also be environmentally-friendly.
Manufacture of physical instruments
※Administrative department in the manufacturing of infertility treatment devices.
