Cytori Forgoes Drugs for Devices

Cytori Therapeutics may be on to something. The San Diego firm is using stem and regenerative cell therapies to develop products for treating cardiovascular disease and performing reconstructive surgery. But unlike so many stem cell companies that are looking to commercialize their technologies through drugs, Cytori is taking a quicker and less grueling route, by bringing its treatment to market in the form of a device, reports TheStreet.com.

The device, cleverly named Celution System, automates a process that releases stem and regenerative cells residing within adipose (fat) tissue. The adipose tissue is taken from celution-system.jpgthe patient using a minor liposuction-like procedure, placed into the system and, with the touch of a button, the processing begins. About an hour later, following a tissue wash, cell separation and concentration — also performed by the device — a meaningful dose of stem and regenerative cells may be delivered back to the patient. According to TheStreet.com, at $2,500 to $10,000 per treatment, the procedure “looks downright cheap for stem cell-based therapy.”

Cytori is using this device to target two main areas: reconstructive surgery, the most clinically advanced of the two, and cardiovascular disease. Through a procedure known as cell-enhanced tissue transfer, the Celution System augments soft tissue that is transfered from one part of the body to another, with a patient’s own stem and regenerative cells. The company is seeking indications for breast reconstruction and augmentation, and as a treatment for complications of tumor removal and radiation damage in breast cancer patients.

Eric Daniels, senior director of business development for Cytori, tells TheStreet.com that the company is addressing a real unmet need: “After a complete mastectomy, an implant is a very viable reconstruction option. But with partial breast removal, that isn’t the case. There are zero options for these patients.”

Cytori’s CEO, Christopher Calhoun, tells the online pub, “The breast [application] is a $100 million to $300 million opportunity.”

The company is looking at end of this year for approval of the Celution System for the reconstructive indication. TheStreet.com says sales could reach $85 million by 2010 for this application alone.

In the cardio space, Cytori is hoping to use adipose stem and regenerative cells, processed from the Celution System, to regenerate damaged heart muscle. The company is currently sponsoring a trial for chronic myocardial ischemia, which has been approved to begin enrolling patients. TheStreet.com says European and U.S. approvals for this indication could come in three and four years, respectively.

Cytori streamlined its focus on regenerative cell therapies earlier this month, when it sold its spine and orthopedic implant business to Kensey Nash or $3.2 million.

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