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Biotechnology News Magazine

MCRA Acquires Vorpal Technologies K.K.

Vorpal is the preeminent MedTech consulting firm for Japan and leader in new regulatory approvals, strengthening MCRA's position as the leading global MedTech consulting firm

MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating U.S. and International Regulatory Affairs, Clinical Trial Operations, Reimbursement and Market Access, Healthcare Compliance, Cybersecurity, and Quality Assurance support, is pleased to announce its recent acquisition of Vorpal Technologies K.K.

This acquisition is an important milestone in MCRA’s globalization as it allows MCRA to provide an expanded service offering to its clients, leveraging the extensive experience and track-record of the highest caliber MedTech consulting firm in Japan. Concurrent with the acquisition, MCRA has announced Samuel Pollard as the General Manager (GM) of Vorpal.

Founded in 2013 and headquartered in Tokyo, Vorpal is a full-service virtual subsidiary, enabling international MedTech innovators to enter the Japanese market by providing expert guidance and solutions in opportunity assessment, clinical operations, regulatory affairs, reimbursement, quality and safety management, supply chain and commercialization. Over its 9-year history, Vorpal has established itself as the leader in Japan for new category MedTech approvals.

With a total of 49 approvals, Vorpal is the market leader in Japan for Class III and Class IV approvals. Recently, Vorpal secured three approvals in a single week to close out a successful 2021, where Vorpal secured seven Class III and Class IV shonin approvals – more than any other consulting firm this year.

In addition, Vorpal has secured four new category premium reimbursement listings with an additional four ongoing reimbursement programs, constituting over 5% of new category MedTech reimbursement programs in Japan. Vorpal’s expertise has resulted in the majority of its US-based clients achieving a successful exit through IPO or M&A.

Vorpal also provides Designated Marketing Authorization Holder (D-MAH) services to its clients, which enables foreign manufacturers to comply with legal requirements to market products in Japan while minimizing the initial investment and maintaining control over all strategic options. Key therapeutic areas of expertise include Orthopedics, Cardiology, Imaging, General and Plastic Surgery, Neurology, Urology, ENT, Oncology, Ophthalmology, Dermatology, and Psychiatry.

The Vorpal staff consists of bilingual, highly skilled and experienced regulatory, clinical, logistics, quality and reimbursement experts, ensuring clients receive the highest quality strategic advice. MCRA is committed to maintaining the exceptional Vorpal team and continuing to recruit a team of like-minded MedTech experts.

Robert Claar, Co-founder of Vorpal said “Our vision in founding Vorpal was to provide a full-service team of experienced professionals to help medical technology companies through the Japanese clinical, regulatory, and commercialization processes. We are delighted to join the MCRA team to expand our reach and impact in providing patients in Japan and abroad with innovative and proven therapies. Becoming part of MCRA enables Vorpal’s team to expand our capabilities and meet our clients’ needs as the premier portal into Japan for worldwide MedTech innovations.”

MCRA’s acquisition of Vorpal is an important step in its international growth strategy, focused on providing best-in-class strategic and operational services tailored to meet the needs of clients around the globe. MCRA is committed to maintaining and recruiting the highest level of talent to serve its clients in the most successful manner.

This expansion allows MCRA to offer clients a more accessible approach to navigating the Japanese regulatory and clinical processes as part of the client’s overall global commercialization plan.  The Japanese market is the second-largest single country MedTech market, but has historically been an isolated market with high barrier to entry. Although Japan has been an insulated market, the pace and dynamics of innovation are evolving beyond geographic borders with the global market now connected more than ever before. The expansion into Japan allows MCRA clients to leverage the reach of our global team to achieve their global commercialization goals.

MCRA’s President, David Lown, said “We are very excited to welcome the Vorpal team to the MCRA family and are enthusiastic to leverage their expertise and experience, which will strengthen MCRA as industry leaders in the world of medical technology and commercialization throughout the US, Europe, and Japanese markets. Expanding MCRA’s history of pioneering the integrated medical technology service industry into new geographical regions has been a primary focus of MCRA’s growth strategy, as it allows us to better serve our clients. The Vorpal team brings a breadth of knowledge and experience across the Japanese MedTech industry, which will enable the global MCRA team to provide greater support to our clients that share interest in expanding their presence in other markets, including Japan. We are excited to continue the great work that Vorpal has started under Samuel’s leadership. In his over eight years at MCRA, Samuel has demonstrated himself to be a leader on the regulatory and clinical team and has been an integral part in growing MCRA’s service offerings into cardiovascular, wound care, and pharmaceuticals across hundreds of regulatory submissions. Samuel brings to this role deep regulatory knowledge paired with strong relationships across MCRA’s team, and we believe that Samuel’s expertise and passion will allow for a seamless integration of the Vorpal and MCRA teams.”

Samuel Pollard, Vorpal’s newly appointed GM, added “This collaboration between MCRA and Vorpal will provide clients a truly global partner in implementing international regulatory, clinical, and commercialization initiatives. I am excited to bring these teams together under a singular mission of providing the highest quality advice and service to our clients.”

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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