Revivicor Inc. is a regenerative medicine company focused on applying leading-edge animal biotechnology platforms to provide a superior quality, high-volume, human-compatible, alternative tissue source for treatment of human degenerative disease. The Virginia-based company was formed in 2003 as a spin-out from the UK company PPL Therapeutics, which produced the first cloned animal: Dolly the Sheep. Revivicor has subsequently built on this technology, cloning the first genetically-engineered (GE) pigs, and now produces pig islets, organs, and medical devices aimed at human clinical applications.
Revivicor’s product development pipeline addresses focus areas of large unmet clinical need and thus large commercial markets. For diabetes, there are currently 3 million patients in the U.S. with Type1 diabetes, on insulin, who could be transplanted now, if not for the dire shortage of donor tissue. At $20,000 net sales per transplant, this is a projected $60 billion market. Recently published results demonstrated that pancreatic islet cells from Revivicor pigs, when transplanted into diabetic monkeys, cured diabetes for over 1 year with complete normalization of blood glucose levels (van der Windt et al., 2009). The pigs used in these studies were engineered such that a human gene (“CD46”) was added, and a key pig gene (alpha-Gal) was deleted, as a means to overcome transplant rejection issues. It is anticipated that insulin-producing islet cells from Revivicor’s cloned pigs could be in human clinical trials within 3 years time.
Beyond diabetes, Revivicor is applying its livestock genetic engineering platform to produce GE pig organs: kidney and heart for long term use; and livers suitable for short term bridging in humans. Approximately 10% of patients die awaiting a human transplant due to lack of donor organs available. The economic impact of end-stage organ failure is $50 billion, and for diabetes $95-100 billion in the US annually. Pig organs will meet this need.
Further down the pipeline, the company is also engaged in developing GE pigs capable of producing fully human antibodies for use as vaccines against infectious agents (ie. anthrax, MRSA, H1N1, HIV); this is an ongoing pre-clinical program which has been funded through the Department of Defense with a market potential capable of surpassing all other products combined.
Revivicor has also formed partnerships with the medical device industry for orthopedic and skin-derived products derived from its GalSafe™ pigs. Near-term licensing and milestone revenues from these partnerships will help fund the longer-term cell and organ-based commercial platforms. These non-viable tissue products will follow a more rapid medical device FDA regulatory path and could be on the market within 2 years. First products are medical device scaffolds for hernia repair and breast reconstruction and tendons for ACL repair. Cardiovascular devices (heart valves and blood vessels for cardiac bypass) are also in the pipeline.
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