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cytori therapeutics inc (CYTX) Snapshot

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02/21/14 - $3.47
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11/12/14 - $0.36
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cytori therapeutics inc (CYTX) Details

Cytori Therapeutics, Inc., a cell therapy company, develops cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and other medical conditions. It primarily provides the Celution System, a tissue processing system that automates the process of digesting fat tissue, releasing the ADRCs. The company also offers the StemSource Cell Bank, a suite of products to allow hospitals or tissue banks to cryopreserve adipose-derived stem and regenerative cells; and StemSource 900/MB, a research laboratory equipment. Its products also include Celution 800 System that has CE Mark approval for certain soft tissue procedures, such as breast reconstruction, tissue ischemia, deficiency or injury of skin, fat, and muscle and fascia, as well as soft tissue wounds or fistulae associated with trauma, diabetes, ischemia, and radiation injury. In addition, Cytori Therapeutics, Inc. develops products in therapeutic areas, such as the treatment of thermal burns, and orthopedics and sports medicine indications, as well as specifically heart failure due to ischemic heart disease. The company markets its systems, instrumentations, and consumables directly, as well as through a network of distributors to hospitals, clinics, tissue banks, stem cell banking companies, and researchers performing investigator-initiated and funded studies worldwide. Cytori Therapeutics, Inc. was founded in 1996 and is headquartered in San Diego, California.

115 Employees
Last Reported Date: 03/14/14
Founded in 1996

cytori therapeutics inc (CYTX) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $406.6K
Chief Medical Officer and Executive Vice Pres...
Total Annual Compensation: $333.3K
Compensation as of Fiscal Year 2013.

cytori therapeutics inc (CYTX) Key Developments

Cytori Therapeutics, Inc. Approves Amendment to Amended and Restated Certificate of Incorporation

Cytori Therapeutics, Inc. approved an amendment to the company's Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 145,000,000 shares to 290,000,000 at the Special Meeting of Stockholders held on January 6, 2015.

Cytori Therapeutics, Inc. Presents at 7th annual Biotech Showcase Conference 2015, Jan-12-2015 03:30 PM

Cytori Therapeutics, Inc. Presents at 7th annual Biotech Showcase Conference 2015, Jan-12-2015 03:30 PM. Venue: Parc 55 Wyndham San, Francisco - Union Square, San Francisco, CA 94102, United States. Speakers: Marc H. Hedrick, Chief Executive Officer, President and Director.

FDA Grants Cytori Conditional Approval for a U.S. Pivotal Clinical Trial in Scleroderma

Cytori Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted conditional approval for an Investigational Device Exemption (IDE) for a pivotal clinical trial, named the STAR trial, to evaluate Cytori Cell Therapy as a potential treatment for impaired hand function in scleroderma, a rare autoimmune disease affecting approximately 50,000 patients in the United States. The STAR trial is conditionally approved to be a randomized, double blind, placebo-controlled pivotal clinical trial of 80 patients in up to 12 U.S. sites. The trial evaluates the safety and efficacy of a single administration of Cytori Cell Therapy in scleroderma patients affecting the hands and fingers. More than 90% of scleroderma patients have hand involvement that is typically progressive and can result in chronic pain, blood flow changes and severe dysfunction. The limited available treatments for scleroderma may provide some benefit but do little to modify disease progression or substantially improve symptoms. Cytori's cell therapy processing technology, known as the Celution System, is regulated as a Class III medical device by the U.S. FDA and requires a successful pivotal trial and premarket authorization (PMA) before it can be marketed in the United States. The Celution System produces an autologous cell product from adipose tissue known as adipose-derived regenerative cells. The STAR trial is predicated on a completed pilot trial, SCLERADEC-I. In data presented earlier this year, patients in SCLERADEC-I showed, on average, 50% improvement at six months across four important and validated endpoints used to assess the clinical status in patients with systemic scleroderma with impaired hand function. This data was published in the Annals of the Rheumatic Diseases in May 2014. The STAR trial plans to use the Cochin hand score, a validated measure of hand function, as the primary endpoint measured at 6 months after a single administration of Cytori Cell Therapy or placebo. Patients in the placebo group will be eligible for crossover to the active arm of the trial after all patients have completed 12 months of follow up. Additional details about the trial will be disclosed once finalized and agreement is reached with the FDA. The trial is anticipated to begin enrollment in 2015.


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