Cytori Therapeutics Inc (NASDAQ:CYTX) Gets EC Orphan Drug Status for Cell Therapy Formulations

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Cytori Therapeutics Inc (NASDAQ:CYTX) shares received a strong boost to $3.38 after the European Commission granted orphan drug status to the company’s Cytori Cell Therapy® formulations.

Cytori Therapeutics Inc (NASDAQ:CYTX) is a biotechnology company involved in the development of treatments and devices for a range of disorders using cells as a key part of the therapy. Its primary products comprise a broad range of Cytori Cell Therapy® formulations for patients with scleroderma hand dysfunction, orthopedic disorders, cardiovascular disease, urinary incontinence and thermal burns combined with radiation injury.

On May 10, the orphan drug designation was granted for formulations used for the treatment of hand dysfunction and Raynaud’s Phenomenon in patients with scleroderma. This will give Cytori Therapeutics Inc (NASDAQ:CYTX) the ability to pursue multiple therapeutic formulations for systemic scleroderma that are not restricted to the processing of the adipose-derived cellular therapeutics at the bedside with the Celution® System or other current technology. It also allows adipose-derived cellular therapeutics that are cryopreserved for later administration and provides a pathway for Cytori to expedite conditional market approval in the European Union.

Marc Hedrick, President and CEO of Cytori Therapeutics Inc (NASDAQ:CYTX), acknowledged that this designation can help the company expand their strategic regulatory position and commercial options in Europe.  “We intend to rely on this orphan designation, as well as long term safety and efficacy data from the SCLERADEC-I trial to seek conditional market authorization from the European Medicines Agency (EMA) on an accelerated timeline,” he noted.

Cytori Therapeutics Inc (NASDAQ:CYTX) shares had been trading inside a 52-week range of $0.13 to $0.75, with the recent announcement bringing share prices 1,150% higher. In after-hours trading, shares dipped 93.19% to $3.14, bringing the market cap to approximately $670 million.

Apart from its Cytori Cell Therapy® formulations, the company is also focused on developing ECCO-50 to cure knee osteoarthritis, ECCI-50 to cure urinary incontinence, and DCCT-10 to cure cutaneous thermal injury.

 

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