Cytori is a leader in the cell therapy industry, set apart by our unique cell source, the extensive research and development and our razor-razorblade commercial model.

We have invested more than $200 million in research, product development and clinical trials. This experience gives us a significant first-mover advantage, a head start in filing for patents, and amass a body of proprietary knowledge that strengthens barriers-to-entry against potential competition.

Adipose tissue is one of the richest cell sources. As a result, we can make a patient’s own cells available to them in real-time at the point of care using our patented and proprietary Celution® system.

With over 4,000 patients treated around the world, including our three completed clinical trials, we have established ourselves as a leader in this innovative field.

Cytori has completed enrollment in and reported long term data from two clinical trials:

• The PRECISE trial: 27 patient, randomized, double-blind, placebo-controlled multi-center trial for chronic myocardial ischemia.
• 18 month data demonstrated a statistically significant improvement in cardiac functional capacity (MAX VO2) and a lower cardiac mortality in cell treated patients.
• The APOLLO trial: 14 patient, randomized, double-blind, placebo-controlled multi-center trial for acute myocardial infarction.
• 18 month data showed a consistent, substantial reduction in the size of injury to the heart and improvement in the amount of blood the heart can pump.

Currently, we are enrolling patients in our first US clinical trial for chronic myocardial ischemia (ATHENA) and a European approval trial for acute myocardial infarction (ADVANCE).

Based on the strong results from the PRECISE trial, we have applied to our EU notified body to expand our regulatory approvals to include no-option chronic myocardial ischemia patients. If we are successful, we will have the first cell therapy approved for cardiovascular disease anywhere in the world.

Learn more about our clinical trials platform.

Cytori pioneered the therapeutic use of a mixed (heterogeneous) population of uncultured (i.e. fresh) cell types found in adipose tissue, known as ADRCs. The Celution® System family of products for automating the extraction of ADRCs embodies our pioneering approach to cell therapy.

Our global patent portfolio is built around the Celution® system and on the paradigm-shifting idea of using a heterogeneous population of fresh or un-manipulated adipose derived stem and regenerative cells for therapeutic effect. This global patent estate includes 46 issued patents and over 75 patent applications relating to devices, methods, uses and cellular populations.

Our strategy for protecting our competitive position goes beyond our patent estate and includes knowledge, brand and economics-based barriers-to-entry. All of the barriers to entry that we are establishing collectively help maintain our leadership position in the field of regenerative medicine.

Knowledge-based barriers

• Technological leadership and global portfolio of issued and pending patents related to ADRCs
• Proprietary know-how for tissue processing and delivery of adipose-derived stem and regenerative cells
• Significant first mover advantage allowing for development of next generation products to improve therapeutic benefit, reduce processing times, reduce footprint, reduce cost, etc.

Brand-based barriers

• First mover advantage in establishing brand loyalty
• Partnerships with leading healthcare brands and partners
• Scientific reputation amongst prospective hospitals and customers.

Economics-based barriers

• Substantial capital investment ($200MM+) in development and manufacturing of technology
• Exclusive supply for certain critical components
• Clinical development, regulatory approval and reimbursement advantages

Cytori believes that a comprehensive strategy to protect our products and approach to cell therapy from competitive forces is in place.

Learn More: Intellectual Property Fact Sheet