Our mission is to design, develop and commercialize medical products that enable the collection, processing and cryopreservation of stem cells and other cellular tissues used in the practice of regenerative medicine. Regenerative medicine is an emerging field that, among other things, aims to repair or restore lost or damaged tissue and cell function using cell-based therapies. Our current products automate the volume reduction and cryopreservation process of adult stem cell concentrates from cord blood and bone marrow for use in laboratory and point of care settings. Our growth strategy is to expand our offerings in regenerative medicine and partner with other pioneers in the stem cell arena to accelerate our worldwide penetration in this potentially explosive market. The Company was founded in 1986 and is located in Rancho Cordova, California.
Our business model is based on the sale of medical devices and the recurring revenues generated from the companion single-use, sterile disposable products. Our products are currently sold in 34 countries throughout the world. Our end user customers include private and public cord blood banks, surgeons, hospitals and research institutions. Our worldwide commercialization strategy is based primarily on the utilization of distributors, with some direct selling in the U.S.
Based upon early clinical results there is accumulating evidence that many of the stem cell therapy trials currently underway by other companies and research institutions may result in approved therapies in disease states and tissue regeneration procedures affecting significant patient populations, leading to a revolution in therapeutics involving stem cells. Although understanding the full potential of cell therapies and their ultimate impact on the practice of medicine remains a longer term prospect, we believe there are significant commercial opportunities in the market today for technologies supporting stem cell research and cell-based treatments.
We provide the tools necessary for the collection, separation, expansion, storage and delivery of stem cells from adult tissue sources including cord blood, bone marrow, (later) adipose and placenta. These tools are being used by health care providers in both the laboratory and point of care setting. Our competitive advantage is achieved through applying our advanced engineering capabilities to develop a complete “tool box” for the healthcare providers advancing regenerative medicine. Our solutions enable our customers to automate their processes, comply with quality regulations and achieve high stem cell yields. We believe our products significantly enhance the safety and viability of stem cell and regenerative medical products and will ultimately expand the use and success of those products in clinical treatment through their ease of use and high cell recovery rates.
During the past year, the regenerative medicine market has experienced significant changes from a macroeconomic, political, and commercialization perspective. Overall worldwide economic conditions have significantly worsened since the summer of 2008. The fiscal crisis reduced the availability of funds for the purchase of capital equipment and forced healthcare entities to reduce their research, capital and operating budgets accordingly. These cutbacks impacted our ability during the year to sell our larger capital equipment devices at the levels experienced in preceding years.
From a political standpoint, the election of President Obama resulted in increased awareness of regenerative medicine, primarily with embryonic stem cells. On March 9, 2009, President Obama signed the stem cell executive order lifting the ban on federal funding for promising embryonic stem cell research. In January 2009, the U.S. Food and Drug Administration (FDA) granted clearance for Geron to commence safety trials for its human embryonic stem cell-based therapy. Their Phase I multi-center trial was established to show the safety of its product for patients with “complete” subacute spinal cord injury. We believe the change of policy in Washington D.C., and the latest clearance from the FDA, will lead to an overall increased public awareness of adult stem cells and the potential of embryonic stem cells.
In addition to increasing research activities, the regenerative medicine market has witnessed the establishment of various commercial partnerships. For example, in 2008, Cytori Therapeutics and GE Healthcare (GEHC) announced a partnership to commercialize Cytori’s Celution System in Europe.
The regenerative medicine market is comprised of companies that either harvest, process, purify, cryopreserve, store or administer stem cells. Key success factors include, among other things: Stem cell recovery rates, Efficiency of cell processing, Cost of care, Product quality and efficacy, Purity, viability and potency of stem cells
Cells are processed in both the laboratory setting as well as in the operating room, or point of care setting. Point of care applications involve the processing of patient cells in conjunction with a surgical procedure in an operating room or in an outpatient clinical setting. The laboratory market requirements include, but are not limited to, Good Manufacturing Practices (GMP) processing, objective quality assurance and the ability to process multiple samples at one time. Requirements for the point of care include sterile field packaging, portability, minimal processing steps and speed of processing. These market requirements must be considered and translated into product features and benefits for successful market adoption.
The availability of stem cells at the point of care enables physicians to apply cells across an array of applications in an already-crowded operating room setting. Physicians may also choose to study patient outcomes to understand the benefit of stem cells under their own independently-sponsored and regulated studies. Such research efforts are growing and already represent studies in diverse areas such as wound healing, radiation injury, breast reconstruction and augmentation, cardiovascular applications, peripheral vascular disease and liver disease among many others.
We expect the breadth of these applications will grow significantly as physicians continue to adopt cell-based regenerative medicine into their treatment strategies based on the availability of safe, clinical grade cells at the point of care.