Cytori Therapeutics Inc., a company that engages in the development, manufacture, and sale of medical products and devices to enable the practice of regenerative medicine, has announced that its Celution® One System, the next generation device of the Company’s Celution® platform, has been granted European CE Mark approval. Celution® One has been designed specifically for the hospital as a platform device with potential life-critical applications across numerous specialties. The Celution® platform is a GMP-compliant technology that extracts and concentrates the patient’s very own stem and progenitor cells from adipose, or fat, at the point-of-care.
The Celution® One System is intended for hospital-based usage with key improvements, which include: greater cell yield, increased efficiencies and versatility of potential treatments, and increased range of processing volumes and faster processing times. Also, it has new features for an improved ease-of-use.
“Approval of Celution® One in Europe is an important achievement that lays the foundation for further growth in the European hospital market,” said Christopher J. Calhoun, Chief Executive Officer of Cytori. “In addition to offering the device to hospitals in Europe, we are using the Celution® One in our pivotal heart attack trial, ADVANCE, with the goal of seeking expanded market access through broader indications-for-use and subsequent reimbursement applications.”
Cytori Therapeutics, Inc. engages in the development, manufacture, and sale of medical products and devices to enable the practice of regenerative medicine. Regenerative medicines focus upon repairing or restoring lost or damaged tissue and cell function. Its main products include the Celution family of products, which processes patients’ adipose-derived stem and regenerative cells (ADRCs) at the point of care. The Celution family of products are made up of a central device, a related single-use consumable used for each patient procedure, proprietary enzyme reagents, and related instrumentation. Its core product, the Celution System, offers physicians with clinical grade stem and regenerative cells for use in the cosmetic and reconstructive surgery market.
For more information on the company, visit their website at www.cytoritx.com
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