Business Strategy
Medgenics intends to complete development of the Biopump Platform Technology core elements and associated key devices and concurrently enter into multiple licensing agreements using the same core Biopump Platform Technology for different applications. Proof of basic safety and efficacy in patients (phase I/II) will be developed for specific proteins and clinical indications, and then out-licensing agreements will be negotiated with appropriate strategic partners.

In addition to developing new protein applications of the Biopump, Medgenics is planning practical scale-up and commercial implementation including automated Biopump processing technology. This would utilize single-use sealed cassettes in the context of regional or local Biopump processing centers capable of producing and storing Biopumps for hundreds or even thousands of patients per year, in a cost-effective manner. The Company intends to work with third-party engineering firms to design and develop a closed chamber system where each Biopump resides in its own sealed chamber.

Regulatory Strategy
Medgenics' overall regulatory strategy is aligned with its business strategy of partnering with pharmaceutical, biotech, or medical companies to advance clinical development, request regulatory approvals, and eventually commercialize approved products. To that end, the Company's strategy is to perform laboratory and animal feasibility studies and early clinical feasibility (phase I/II clinical trials) to demonstrate the potential of the Biopump application. Generally, a strategic partner is sought after sufficient Phase I/II data have been gathered to show proof of concept; however, as with hemophilia, feasibility or partnering agreements may be reached at an earlier stage, even before start of preclinical development. For most applications after the completion of phase I/II clinical trials, clinical development will continue through the product approval stage with a partner or collaborator who provides funding for the development.

Intellectual Property
Medgenics' goal is to obtain, maintain and enforce patent and trademark protection for our products, processes, methods and other proprietary technologies of the Biopump Platform Technology, and preserve Company trade secrets both in the United States and in other countries. Policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible for our Biopump Platform Technology through a combination of contractual arrangements, trade secrets, patents and trademarks, both in the U.S. and elsewhere in the world.