Business Strategy

Our principal business objective is to discover, develop and commercialize novel therapeutic products for disease indications that represent significant areas of clinical need and where we believe there is a substantial commercial opportunity. The key elements of our strategy are outlined below:

Our business strategy is to:

  • Advance our lead programs through Clinical Development to registration and commercialization;
    • Efficiently conduct clinical development to establish clinical proof-of-concept, evidence of safety and therapeutic benefit;
    • Deepen our understanding of therapeutic mechanisms of action evidence of biological activity;
    • Continue to refine and improve our manufacturing and related processes and technology;
  • Enter into arrangements with business partners to accelerate development and create value;
  • Efficiently explore new high potential therapeutic applications, leveraging third-party research collaborations and our results from related areas; and
  • Continue to expand our intellectual property portfolio.

Email BD@athersys.com or click below to learn more.

Neurology

One focus of our regenerative medicine program is MultiStem administration for the treatment of neurological injury as a result of acute or chronic conditions. Neurological injury and disease represent an area of significant unmet medical need, a major burden on the healthcare system, and also represents a huge commercial opportunity.

Many neurological conditions require extensive long-term rehabilitative therapy and require extended hospitalization and/or institutional care, creating an enormous quality of life and cost burden. Stroke is a leading cause of death and significant long-term disability globally, representing an area where the clinical need is particularly significant. We have published research with independent collaborating investigators that demonstrates that MultiStem administration conveys biological benefits in preclinical models of both ischemic and hemorrhagic strokes, as well as other models of neurological damage and injury, including TBI, neonatal hypoxic ischemia (a cause of neurological damage in infants), and spinal cord injury. We also conducted preclinical work in other neurological areas and have been awarded grants in support of this work, including the potential of MultiStem cells to address chronic conditions such as multiple sclerosis (MS) or Parkinson’s disease. Our research has shown that MultiStem cells convey benefits through distinct mechanisms, including reducing inflammatory damage, protecting at risk tissue at the site of injury, and through direct neurotrophic effects that stimulate the recovery of damaged neurons. As a result, we believe that MultiStem therapy may have relevance to many forms of neurological injury and disease.

Our initial clinical focus in the neurological area involves evaluating MultiStem administration to treat ischemic stroke, which is now in Phase 3 of clinical development. Please visit our stroke page or neurological page to learn more.

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Cardiovascular

The United States and many other countries face a daunting challenge in the years ahead – how to deal with the consequences of a rapidly expanding population of older individuals that will require an increasing amount of healthcare intervention and resources. As we age, we become more susceptible to a variety of aging related diseases and conditions, including heart disease, stroke, vascular disease and a range of other conditions. Data from the National Center for Health Statistics shows that individuals over the age of 65 spend up to ten times as much on healthcare annually when compared to young healthy individuals – and much of this is a direct consequence of aging related diseases and conditions. Increasing rates of obesity, a significant risk factor for cardiovascular disease, stroke, diabetes and cancer, is another significant influence.

Innovative technologies like MultiStem cell therapy could enable more effective treatment of damage from cardiovascular disease, by helping to repair damage following a heart attack, and treatment of vascular disease, congestive heart failure or other conditions. Our first clinical study in the cardiovascular area involved administration to patients that had suffered an acute myocardial infarction.

To learn more, visit our cardiovascular page.

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Inflammatory & Immune

Inflammatory and immune diseases occur in many different forms and range in severity from inconvenient and irritating to debilitating and life threatening. Common conditions involving immune system dysfunction include diabetes, allergies, rheumatoid arthritis (RA), immune deficiency disorders, inflammatory bowel disease (e.g., IBD, Crohn’s, ulcerative colitis), lupus, graft-versus-host disease (GvHD), dermatological conditions (e.g., psoriasis, eczema), pelvic inflammatory disease, pulmonary conditions, scleroderma, transplant rejection, vasculitis and a range of others. According to the National Institutes of Health, there are more than 80 different recognized types of autoimmune disease. Collectively, these conditions affect many millions of individuals in the United States and the rest of the world and represent a substantial healthcare and socioeconomic burden.

Inflammatory and immune conditions are caused by an acute or chronic imbalance in the immune system. In these conditions, cells of the immune system begin to attack certain tissues or organs in the body, resulting in tissue damage and loss of function. While currently available immunomodulatory drugs have proven to be effective for many patients, they have failed to adequately address the needs of many other patients that suffer from inflammatory and immune disorders.

To learn more, visit our inflammatory & Immune page.

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Animal Health

Within our animal health program we have developed our proprietary equine, canine and feline allogeneic cell therapies based on the Multipotent Adult Progenitor Cell (MAPC) technology. The entirety of the manufacturing process is contained within a closed hollow fiber bioreactor system (quantum). Due to the high proliferation capacity of MAPCs, approximately a million-fold more MAPC cells can be generated as compared to MSCs. With the current manufacturing platform, a projected 3 million doses can be created from a single bone marrow aspirate, making this a hugely scalable product for commercialization. Our animal health platform currently includes reCAin® (canine), rEQover® (equine), and reFErse (feline.)

For more information, click the ‘Start the Conversation’ button below.

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Ultracold Storage Capabilities

Cell and gene therapy is an expanding market with global sales expected to grow significantly over the next 5 years. These therapies require ultracold storage units which are often operationally challenging for typical hospitals. As therapies move from earlier stage trials to late stage and commercial, there will be a need to increase storage capacity while improving ease of access for hospital staff. To meet this need, we have developed SIFU® (Secure Integrated Freezer Unit), a unique patent pending system designed for the hospital setting which requires no liquid nitrogen and meets the unmet needs of this growing market.

Typical ultracold cell therapy products are handled in blood banks or cell therapy labs, rather than hospital pharmacies, and require trained staff capable of thawing and processing these therapies. Further, these therapies require large, specialized storage, sourcing and management of liquid nitrogen, and product temperature monitoring services. Most current cell therapy labs operate on constrained hours, limiting the availability of the therapy to patients in need.

There is no current commercially viable solution for these challenges available in the market. SIFU aims to automate and simplify this process in one electrical device with an easy-to-use interface.

Learn more by contacting us below.

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