Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today that it has entered into an agreement with Idis Managed Access, part of the Clinigen Group plc, to establish a Managed Access Program (MAP) in select countries across Europe, the Middle East, and Africa for patients with impaired hand function due to scleroderma. A MAP will allow Cytori, upon completion of the statutory legal and regulatory requirements, to offer patients and their healthcare providers access to Cytori Cell TherapyTM, known as ECCS-50, in advance of the product’s full marketing authorization in their respective countries.

Dr. Marc H. Hedrick, Cytori President and CEO said, “European regulations allow patients access to innovative therapies under development in certain situations, and given the safety profile and promising data thus far for ECCS-50, we think granting limited access is clearly in the best interest of patients with scleroderma of the hand.”

ECCS-50 is an autologous, adipose-derived cell therapy produced at the patient’s bedside and administered via a series of hand injections, in a single same-day procedure. ECCS-50 is an investigational product currently in Phase III clinical trials in the U.S. and France.

“Patients with this rare and debilitating condition have limited treatment options as there are currently no approved products available for impaired hand function due to scleroderma. By partnering with the global leader in the design and implementation of Managed Access Programs, we believe we can offer a new choice of treatment for these patients,” said Russ Havranek, Director of Marketing at Cytori Therapeutics. “We also plan to collect real-world data to better understand how ECCS-50 is best used in clinical practice.”

Managed Access Programs provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available. The source of medicine funding varies and may include the hospital’s budget or country’s sickness fund or social security system.

“Idis has significant experience and expertise in the rare and orphan disease space, having managed early access to over 70 investigational rare disease drugs, across 130 countries, worldwide. Further, our involvement with the EURORDIS Round Table of Companies, CheckOrphan, and the Global Genes Project ensures Idis MA is well known to key stakeholders and provides a strong platform to provide appropriate access to this important product,” said Simon Estcourt, Managing Director at Idis Managed Access.

About Cytori

Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information visit www.cytori.com.

About IDIS Managed Access (part of the Clinigen Group)

Idis has 30 years of experience of partnering with pharmaceutical and biotechnology companies to create regulatory-compliant, ethical access to medicines for healthcare professionals and their patients with unmet medical needs. Since 1987, Idis has developed and managed access to thousands of medicines from every therapeutic category, impacting the lives of hundreds of thousands of patients in countries around the world.

Idis leverages decades of experience, regulatory insight, and a thorough understanding of local and global requirements to create access to medicines at every stage of a product’s lifecycle from pre-approval to market exit, and in times of unexpected production shortages.

The company’s European headquarters are located in Weybridge, United Kingdom, and North American headquarters are located in Princeton, NJ. For more information about Idis please visit www.idispharma.com.

About Clinigen Group

Clinigen Group is a global pharmaceutical and services company with a unique combination of businesses dedicated to delivering the right drug to the right patient at the right time.

The Group consists of four synergistic businesses that provide medicines to patients with unmet medical need; through Clinigen Clinical Trial Services we manage the supply of commercial medicines for clinical trials, through Idis Managed Access we run early access programs for our own and other companies’ portfolios, our Idis Global Access team works directly with healthcare providers to enable ethical compliant access to unlicensed medicines, and through Clinigen Specialty Pharmaceuticals, we market our own portfolio of niche commercial products.

Clinigen is the global leader in ethically sourcing and supplying unlicensed medicines to hospital pharmacists and physicians for patients with a high unmet need. In October 2015, Clinigen acquired Link Healthcare, further strengthening our international distribution network in the AAA region – Asia, Africa and Australasia.

For more information, please visit www.clinigengroup.com

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements that involve known and unknown risks and uncertainties. All statements, other than historical facts are forward looking statements. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks include Cytori’s ability, through its partnership with Idis, to establish and successfully conduct a Managed Access Program in one or more countries, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings, included in our annual and quarterly reports.

There may be events in the future that we are unable to predict, or over which we have no control, and our business, financial condition, results of operations and prospects may change in the future. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless we have an obligation under U.S. Federal securities laws to do so.

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