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Serica Technologies Receives ISO Certification, Meets International Standards for Medical Device Manufacturing
Date:11/19/2008

MEDFORD, Mass., Nov. 19 /PRNewswire/ -- Serica Technologies, Inc., a growth-stage medical device company developing silk-based biomaterial platforms for tissue regeneration, today announced that it has received ISO 13485:2003 certification, meeting stringent international quality standards required for medical device manufacturers. ISO certification is the standard recognized and accepted by most regulatory bodies worldwide as proof of an effective quality system. The company's lead product, the SeriACL(TM), is currently in clinical development as a biocompatible and biodegradable ligament graft, for repair of the anterior cruciate ligament (ACL).

"Receiving ISO certification is a significant milestone for our company, and demonstrates our firm commitment to quality systems in the manufacture of our products," said Gregory H. Altman, Ph.D., President and CEO, Serica Technologies. "With this certification, Serica has taken another important step forward in establishing our company as the leader in silk-based biomaterial platforms for tissue repair."

This international standard specifies requirements for a quality management system wherein a company must demonstrate its ability to provide medical devices and related services that consistently meet both customer and regulatory requirements. "Certification is mandatory for regulatory approval of medical devices in many countries, and an important step towards our goal to commercialization in Europe," said Constance Garrison, Vice President, Regulatory Affairs and Quality Assurance, Serica Technologies.

Serica Secures $6 Million in New Financing

The company also announced today that it has closed on $6 million of additional funding, supported by existing investors, Morningside Technology Ventures, Prism VentureWorks and Ivy Capital Partners. The company has now raised a total of $23.5 million since its inception in 1998.

"With the confidence demonstrated by our investors, particularly in this challenging economic environment, this additional funding provides Serica with a very strong financial position to execute on our commercialization plan for the SeriACL in Europe, and to continue our clinical program to gain approval in the U.S. market," said Altman.

Serica is also moving forward with expanding its clinical, engineering and scientific teams, as part of the company's strategic growth plan. "We have added significant depth in both R&D and quality affairs, and have expanded our staff in other key areas, in our planned approach to prepare for commercialization," Altman added. "We now have 35 employees, including an exceptional team of research, regulatory, manufacturing and business professionals, with additional hiring planned in 2009."

About Serica's Biomaterials

The body's structural tissue can be destroyed, removed or weakened due to trauma, disease or aging. Serica is developing natural, silk biomaterials designed to act as "scaffolds" to provide support and relief to damaged tissues, in order to promote restored function. The company's ligament grafts for ACL repair, surgical meshes and gels, are comprised of the fiber protein of the B. mori silkworm, which has centuries of human use. In pre-clinical studies, Serica's silk-based products are shown to be bioresorbed at slower rates than other common structural proteins, such as collagen, to enable optimal healing. Its products require no re-hydration or advance preparation for surgical implantation.

Serica is developing products for a wide variety of applications where current materials fail to meet the needs of clinicians and patients, including connective tissue repair of the knee, shoulder, abdomen, breast, neck and face.

About Serica Technologies Inc.

Serica Technologies, Inc., formerly Tissue Regeneration, Inc., is a growth-stage medical device company pioneering silk-based biomaterial platforms for tissue regeneration. Incorporated in 1998, Serica's proprietary products currently in preclinical and clinical development are being studied in the areas of orthopaedic and sports medicine, aesthetic and reconstructive plastic surgery and other structural tissue repair needs, and drug delivery applications. Serica's team of engineers and scientists are located in a state-of-the-art 26,000-square-foot office, R&D and manufacturing facility in Medford, MA. For more information about Serica Technologies, please visit www.sericainc.com.

About Morningside Technology Ventures

Morningside is a diversified investment group founded in 1986 by the Chan family which is the controlling shareholder of the Hang Lung Group in Hong Kong. Morningside is engaged in both private equity and venture capital investments in North America, Europe and across Asia Pacific. In recent years, leveraging on its experience investing in biotechnology companies in North America, Morningside has become the leading investor in the life science sector in China. For more information, visit www.morningside.com.

About Prism VentureWorks

Founded in 1996, Prism VentureWorks (Westwood, MA, Santa Monica, CA) is a venture capital firm built by experienced entrepreneurs in technology and life sciences. With approximately $1.25 billion in capital under management across five funds, Prism's primary goal is to deliver superior value to its investors. Its partners have served as the founders, CEOs and senior executives of numerous venture-backed companies. By leveraging its network of seasoned entrepreneurs, skilled executives and long-time industry contacts, Prism identifies and works closely with companies with the potential to be market leaders. For more information, visit www.prismventure.com

About Ivy Capital Partners

Ivy Capital Partners, LLC is a specialized private equity investment firm dedicated to investing in promising companies operating in the musculoskeletal sector of the healthcare industry. Ivy Capital Partners invests in early to mid stage healthcare companies with seasoned entrepreneurial management teams, proprietary products, innovative technologies or compelling service opportunities that have the potential for significant investment return. Within the musculoskeletal sector, the company's portfolio includes investments ranging from sports medicine, joint implants, rehabilitation products and services, trauma, spine and life sciences. For more information, please visit www.ivycapitalpartners.com.


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