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About Vorpal Technologies

Vorpal is a full-service virtual subsidiary, enabling international MedTech innovators to enter Japan on their own terms with transparency, confidence and optionality. Vorpal delivers expert solutions in opportunity assessment, clinical development, regulatory affairs, reimbursement, quality and safety management, supply chain and commercialization.

Name

Vorpal Technologies K.K.

Head Office

3-3-16 Nihonbashi Hongokucho, Chuo-ku, Tokyo , Japan

Establishment

April, 2013

Paid-In Capital

JPY 100,000,000

Business

Regulatory and Reimbursement Strategy
PMDA Negotiations
Clinical Trial Management
PMDA Submissions
Product Assessment
Market Forecasting
Health Economics and Market Access
Reimbursement Submissions
Designated Marketing Authorization Holder (D-MAH) services
Import and Sales of Medical Devices, In-Vitro Diagnostics (IVD)
Distributor Selection and Management
Post Marketing Surveillance (PMS) studies
KOL Relationship Management
Subsidiary Establishment and Business Advisory

Our Values

Collaboration

Creativity

We maintain internal and external relationships built on common goals, mutual respect, open communication, trust and teamwork

We approach problems with a positive attitude, acting on needs and opportunities to deliver inspired solutions

Commitment

We are self-starters who mobilize our knowledge, expertise, diligence, and networks to ensure successful execution

Our Team

Samuel Pollard

Representative Director, General Manager

Samuel has over a decade of experience and expertise in biomedical research and the regulatory/clinical space with an extensive background in developing and implementing path-to-market strategies, regulatory submissions, and clinical programs for a wide array of therapeutic technologies in the US, EU, and Japan. As General Manager of Vorpal Technologies, Samuel is passionate about helping companies navigate the complexities of the Japanese regulatory, clinical, reimbursement, and commercialization landscape.

Previously Samuel served as Director of Regulatory Affairs at MCRA, where he focused on the development of regulatory submissions, design and implementation of clinical trials, and assessment of pre-clinical and clinical data in a wide array of therapeutic areas including orthopedics, cardiovascular, and wound care.

Since joining MCRA in 2013, Samuel has developed and reviewed hundreds of regulatory submissions for medical devices including 510(k)s, PMAs, De Novos, and IDEs. In addition, he has developed and reviewed submissions for CDER and CBER products, as well as combination products including IND and pre-IND submissions. He also has many years of international regulatory experience, authoring and reviewing numerous CERs and Technical Files, and assisting with PMDA submissions. Prior to joining MCRA, Samuel worked as a research associate in tissue engineering at the Medical University of South Carolina in Charleston, SC and Clemson University, conducting research in bioprinting and stem cell technology. Samuel received his Bachelor of Science in Bioengineering at Clemson University. Samuel is RAC-certified and is an active member of the Regulatory Affairs Professional Society.

Shinichi Tsugawa

Vice President
Regulatory & Clinical Affairs

Shinichi Tsugawa has over 20 years of experience in the regulatory, reimbursement, clinical, and quality sector. As Director of the Regulatory and Clinical Affairs team at Vorpal, Shinichi oversees the development and implementation of regulatory, reimbursement, and clinical strategies to navigate the PMDA and MHLW processes and Japanese market entry. Shinichi leverages his broad experience to work closely with others on the Vorpal team to develop and execute creative strategies to bring medical products to the Japanese market. His thorough understanding of the PMDA process allows him to ensure the Vorpal team anticipates potential PMDA questions and hurdles and meets these challenges with pragmatic solutions.

Shinichi has over 20 years of experience in domestic and overseas Regulatory Affairs and Quality Assurance in various medical device companies. Prior to joining Vorpal, he managed the Regulatory Affairs and Quality Assurance Department at a global medical device company’s Japanese subsidiary for nearly a decade. He led the establishment of a new functional classification in the national health insurance system for a variety of products with a focus in the Urology field. Shinichi has led a multitude of projects spanning a wide array of therapeutic and product areas including vascular & interventional access, surgical, anesthesia, respiratory, urology inc. interventional urology, hemodialysis, and blood donation set.

Shinichi holds a master’s degree at Kumamoto University Graduate School in Applied Science.

Hiroshi Ichinose

Director
Regulatory Affairs

Hiroshi Ichinose has 18 years' experience in R&D at a Japanese pharmaceutical company, including clinical trial design, KOL engagement and development of R&D-related systems. He then joined the founding team of a US medical device company's Japanese subsidiary and created the SOPs for a good clinical practice (GCP) clinical trial in advanced wound care. As part of this work, he led the conduct of a GCP clinical trial in Japan. Following regulatory approval, he designed and ran the post-marketing surveillance (PMS) study, established the safety management system, and became the company's safety manager. Since then, Hiroshi has managed regulatory submissions at foreign-affiliated medical and dental device manufacturers. He has a broad range of experience over his 30-year career and has performed safety manager, quality manager and overall responsible person roles. In his free time, Hiroshi enjoys gardening, scuba diving and other marine sports.

Hideki Watanabe

Director
Operations

With over three decades of SCM experience in a wide variety of industries including healthcare, fine chemical, FMCG, confectionery, and publishing, Hideki has in-depth experiences and successful outcomes in conducting demand/supply planning, procurement, logistics, customer facing, and IT/infrastructure to bring different functionalities into one Supply Chain where synergy throughout the supply chain occurs. Hideki’s recent focus is in the medical device industry, where he has worked for over 16 years, with experience across a variety of product areas, including vascular access, urology, anesthesia, respiratory, orthopedics, cardiology, and contact lenses.

Hideki’s strong expertise across a variety of product types, requirements, and regulations, allows Vorpal to provide SCM model to new and innovative medical devices.

Mari Teshirogi

Director
DMAH QA manager (Hin Seki)

After graduating from university and working across a variety of Japanese companies, Mari Teshirogi started her quality management career in a foreign-affiliated medical device manufacturer where she supported external partnerships with key clients and contributed to oversight quality activities including supplier qualification and audits. Next, she moved to Fresenius Kabi Japan where she gained pharmaceutical and medical device quality management experience, serving as Quality Manager to develop and oversee quality strategy to ensure inspection readiness for assigned projects in collaboration with global team members. Mari joined Vorpal in 2017 and leads the quality team, overseeing foreign manufacturing site registrations (FMR), quality management system (QMS) applications and ongoing quality management for approved products for which Vorpal is designated marketing authorization holder (DMAH). Mari serves as Vorpal's quality manager (i.e., Hin Seki), a role she has served in for over five years.

Hiroshi Torikai

Director
DMAH SA Director (An Seki)

Hiroshi Torikai began his career in medical device sales and business development at two Japanese medical device import distributors and a Japanese medical device dealer, gaining a deep understanding of the medical device distribution network and hospital system in Japan over 25 years.

He then transitioned to regulatory affairs and safety management, first at Medtronic Japan and then at Straumann Japan where he focused on developing regulatory and safety programs for neurosurgical medical devices at Medtronic Japan and for dental implants at Straumann Japan. In total Hiroshi has over 40 years of experience across the medical device industry. As Vorpal's safety manager, Hiroshi oversees the Safety Management department, conducting good vigilance practice (GVP) activities for approved products for which Vorpal is designated marketing authorization holder (DMAH).

Robert E. Claar

Founder, Advisor

Rob Claar co-founded Vorpal Technologies in 2013 to help create solutions for Japan’s device lag and become the premier pathway into Japan for innovative MedTech solutions.

-Vorpal is a full-service virtual subsidiary, enabling overseas medtech innovators to enter Japan on their own terms with transparency, confidence and optionality. Vorpal delivers expert solutions in clinical development, regulatory affairs, reimbursement, quality and safety management, logistics and market development.

-Prior to Vorpal, Rob founded Junicon K.K., a healthcare market research and strategy consulting firm. Junicon now has a global reach with offices in the US and Europe and strong affiliations in all major markets.

-Rob has nearly three decades of experience in healthcare innovation management, opportunity assessment, strategy development and implementation. He is passionate about developing innovative solutions for access to Japan’s healthcare market.

Guidelines on Transparency with Medical Institutions, etc.

July 1, 2022

Vorpal Technologies K.K.

Article 1 (Purpose)

In accordance with Transparency Guidelines with Medical Institutions in the Medical Device Industry established by the Japan Federation of Medical Devices Associations (hereinafter referred to as the "Transparency Guidelines"), Vorpal Technologies K.K. will disclose funding information to medical institutions, etc. in order to ensure that our corporate activities are highly ethical and that our relations with medical institutions, etc. are transparent.

Article 2 (Method of Disclosure)

We will disclose the funding we have made to healthcare providers through our website for the prior year's one-year funding after the close of the year's financial results. The funding provided through us by our clients shall be handled by individual clients in accordance with individual guidelines, etc., and shall not be included in the scope of our disclosure.

Article 3 (Subject to Disclosure)

The object and contents of the information to be disclosed shall be as follows.

1.Research and development expenses, etc.

Include costs of tests, studies, reports, and investigations (clinical studies, clinical trials, post-marketing studies, reports on defective/infected cases, post-marketing investigations, etc.) conducted under various guidelines including public regulations such as ministerial ordinances under the Clinical Research Law and the Pharmaceuticals and Medical Devices Law

・Joint research expenditure: Name of the facility to which the product is provided: ○○ cases, ○○ yen

・Outsourced research expenses: Name of the facility to which the project is to be provided: ○○ cases, ○○ yen

・Clinical trial expenses: Name of the facility to which the product is to be provided: ○○○○ yen

・Post-marketing clinical trial expenses: Name of the facility to which the product is to be provided: ○○ cases, ○○ yen

・Expenses for reporting defects and infectious diseases: Name of facility to which information is provided: ○○ cases, ○○ yen

・Post-marketing surveillance expenses: Name of the facility to which the product is to be provided: ○○ cases, ○○ yen

・Other R&D expenses-Name of facilities to be provided: ○○ cases, ○○ yen

2.Grants-in-Aid for Scientific Research

Includes scholarships, general donations, and donations from academic societies and joint sponsorship of academic societies to support the promotion of medical technology and research subsidies.

・Scholarship donation ••○○ University ○○ Classroom: ○○ case ○○ yen

・General donations: ○○○ University (○○ Foundation): ○○ case ○○ yen

・Donations from academic societies: The ○○ Society (○○ Regional Society, ○○○ Workshop): ○○ case ○○ yen

・Joint sponsorship fee…○○ seminar for the ○○○ Society: ○○ case ○○ yen

3.Materials for writing manuscripts, etc.

Expenses related to the outsourcing of business, such as lectures, draft writing, and consulting, for the provision of information on the proper use of in-house medical devices are included.

・Instructor's fees: ○○○ University (○○ Hospital) ○○○ Department Professor (General Manager): ○○ case ○○ yen

・Writing materials, supervisory fees, Professor ○○○ at ○○ University (○○ Hospital) and Professor ○○○ (Department Manager): ○○ case ○○ yen

・Consulting, etc. Consignment Fee: Professor ○○○ at ○○ University (○○ Hospital) and Professor ○○○ at ○○ Department (General Manager): ○○ case ○○ yen

4.Information-related expenses

Expenses for lectures, simulated practical guidance, briefings, etc. required for the proper use and safe use of the Company's medical devices for medical professionals are included.

・Lecture fee: Annual number and total amount

・Briefing expenses: Number and total amount per year

・Annual total amount of expenses for provision of medical and medical engineering-related literature, etc.

5.Other expenses

Expenses such as hospitality as social courtesy will be included.

・Expenses for hospitality: Annual total

Supplementary Provisions

This provision shall be effective as of July 1, 2022.

Funding to Medical Institutions, etc. from January 1, 2021 to December 31, 2021

R&D expenses, etc. Not applicable.
Grants-in-Aid for Scientific Research Not applicable.
Materials for writing manuscripts, etc. Not applicable.
Information-related expenses Not applicable.
Other (Hospitality expenses, etc.) Not applicable.