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SAN DIEGO, CA--(Marketwire - Jan 30, 2012) - Medistem Inc. (PINKSHEETS: MEDS) together with its Russian Licensee, ERCell LLC, announced successful dosing of 3 heart failure patients in the Non-Revascularizable IschEmic Cardiomyopathy treated with Retrograde COronary Sinus Venous DElivery of Cell TheRapy (RECOVER-ERC) trial. The announcement was made at the Cardiovascular Stem Cell Research Symposium http://celltherapy.crf.org/.

The trial is aimed at assessing safety and efficacy of the company's Endometrial Regenerative Cell (ERC) stem cell product in 60 heart failure patients who have no available treatment options. The "Universal Donor" adult stem cells will be administered using a novel catheter-based retrograde administration methodology that directly implants cells in a simple, 30 minute, procedure. A recent publication describing 2-year follow-up of angina patients administered bone marrow cells treated with the "retrograde procedure" authored by Dr. Amit Patel of the University of Utah, the International Principle Investigator of the trial, may be obtained at http://www.translational-medicine.com/content/pdf/1479-5876-9-183.pdf.

"We are honored to have had the opportunity to present at the prestigious Cardiovascular Stem Cell Research Symposium, alongside companies such as Athersys, Aastrom, Pluristem, Cardio3, Cytori, and Mesoblast," stated Thomas Ichim, CEO of Medistem. "The RECOVER-ERC trial is the first trial combining a novel stem cell, with a novel administration procedure. Today cardiac administration of stem cells is relatively invasive and can only be performed at specialized institutions, we feel the retrograde procedure will circumvent this hurdle."

Medistem's ERC stem cell product is different from other adult stem cells in that it is derived from the endometrium (lining of the uterus). The endometrium grows every month before menstruation, in anticipation of implantation. The growth of the endometrium is associated with a very high degree of new blood vessel production, a process called angiogenesis. Conditions such as heart failure, and peripheral artery disease occur because of reduced circulation to the heart or legs. Medistem believes that by implanting ERC, the body will generate new blood vessels that will increase circulation. Proof of concept animal studies supporting the use of these cells in critical limb ischemia http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf, and cardiac damage http://onlinelibrary.wiley.com/doi/10.1634/stemcells.2007-0826/pdf have been published in the peer reviewed literature.

Medistem recently obtained FDA clearance to begin Phase I trials in the US for treatment of critical limb ischemia, an advanced form of peripheral artery disease, which causes approximately 150-200,000 amputations per year in the USA. The trial will be conducted by Dr. Michael Murphy at Indiana University.

"Heart failure is one of the major scourges on the Russian population. We are extremely pleased that that the pioneering work Medistem has been performing in the USA, is now being conducted in Russia through Medistem's licensee ERCell LLC," said Dr. Olga Bockeria, Professor of Cardiology at the Bakulev Center for Cardiovascular Surgery, the site conducting the trial.

Tereza Ustimova, CEO of ERCell LLC, who has signed an exclusive license/technology transfer agreement for use of Medistem's ERC product in Russia, stated, "It has been a pleasure to work with the teams of Dr. Leo Bockeria, Principle Investigator and Dr. Amit Patel the International Principle Investigator begin the first clinical trial of a 'Universal Donor' stem cell in Russian history."

"It is critical to emphasize that the stem cells used here are from healthy adult volunteers that have been screening according to strict criteria and do not involve embryonic or fetal tissue," said Sergey Volzhenkin, Board Member of ERCell. "Given that under current manufacturing processes one donor generates 20,000 patient doses, we believe that we are not only developing a stem cell therapy, but an actual drug that can be manufactured inexpensively, distributed extensively, and administered at the patient's bedside without need for complicated procedures."

Although this is the first formal clinical trial assessment of the ERC stem cell in cardiac conditions, Medistem and international collaborators published a peer reviewed paper in 2010 describing the first use of ERC in a heart failure patient. The manuscript is freely available at the following link: http://www.intarchmed.com/content/pdf/1755-7682-3-5.pdf.

"I am pleased with the smooth technology transfer process and agility that ERCell exhibited in working with Bakulev on making our clinical trial a reality," stated Vladimir Zaharchook, Vice Chairman and Vice President of Medistem.

The RECOVER-ERC TRIAL

The clinical trial will recruit 60 patients with congestive heart failure, which will be randomized into 3 groups of 20 patients each. Group 1 will receive 50 million ERC, Group 2 will receive 100 million and Group 3 will receive 200 million. Cells will be administered via catheter-based retrograde administration into the coronary sinus, a 30 minute procedure developed by Dr. Amit Patel's Team. Each group will comprise of 15 patients receiving cells and 5 patients receiving placebo. Efficacy endpoints include ECHO and MRI analysis, which will be conducted at 6 months after treatment. The trial design is similar to the recent Mesoblast Phase II cardiac study, in order to enable comparison of efficacy.

About Medistem Inc.
Medistem Inc. is a biotechnology company developing technologies related to adult stem cell extraction, manipulation, and use for treating inflammatory and degenerative diseases. The company's lead product, the endometrial regenerative cell (ERC), is a "universal donor" stem cell being developed for critical limb ischemia and heart failure. A publication describing the support for use of ERC for this condition may be found at http://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf.

Cautionary Statement
This press release does not constitute an offer to sell or a solicitation of an offer to buy any of our securities. This press release may contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking information. Factors which may cause actual results to differ from our forward-looking statements are discussed in our Form 10-K for the year ended December 31, 2007 as filed with the Securities and Exchange Commission.

SAN DIEGO, CA--(Marketwire - Jan 30, 2012) - Cytori Therapeutics (NASDAQ: CYTX) has received an Investigational Device Exemption (IDE) approval from the U.S. FDA to begin the ATHENA trial. ATHENA will investigate the use of the Celution® System, an innovative medical device to prepare adipose-derived stem and regenerative cells (ADRCs) to treat a form of coronary heart disease, chronic myocardial ischemia (CMI). The IDE application was originally submitted to the FDA in December 2011.

ATHENA is a multi-center, randomized, double blind, placebo controlled, pilot trial to investigate the use of autologous, clinical-grade ADRCs, processed at the point-of-care with Cytori's proprietary Celution® System. The trial will enroll up to 45 patients with no-option CMI who have limited therapeutic options. It will evaluate a variety of clinical and functional outcomes, including safety, peak oxygen consumption (mVO₂), and clinical outcomes at 12-months.

"Following our pre-IDE meeting with the FDA, we received constructive guidance and implemented the Agency's recommendations, ultimately resulting in rapid approval to initiate the ATHENA trial," said Christopher J. Calhoun, chief executive officer for Cytori. "We look forward to working with the FDA on further defining our clinical strategy in the U.S."

Previously, Cytori reported six and 18-month trial data from PRECISE, a European clinical trial for this same indication showing improvement in mVO₂. In Europe, Cytori has applied to expand its Celution® System CE Mark to include no-option CMI claims based on data from the PRECISE trial. Cytori is also enrolling ADVANCE, a European pivotal trial investigating the Celution® System for acute myocardial infarction (heart attacks).

In the U.S., it is estimated that 120,000 to 250,000 patients are diagnosed each year with chronic myocardial ischemia, a subset of the approximate 5.8 million patients who currently have some form of heart failure. CMI patients typically have undergone multiple revascularization procedures that have not improved their condition and are at a stage where they have few therapeutic options remaining.

About Cytori
Cytori is a leader in providing patients and physicians around the world with medical technologies that harness the potential of adult regenerative cells from adipose tissue. The Celution® System family of medical devices and instruments is being sold into the European and Asian cosmetic and reconstructive surgery markets and available in the United States only for use as an investigational device under Cytori's FDA approved IDE. Our StemSource® product line is sold globally for cell banking and research applications. Our PureGraft® products are available in North America and Europe for fat grafting procedures. www.cytori.com

Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position, such as the successful initiation of a clinical trial of the Company's Celution® System for chronic myocardial ischemia, our efforts to expand our CE Mark. 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 clinical and regulatory uncertainties, such as those associated with the ATHENA clinical trial, including risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, and other risks and uncertainties described under the "Risk Factors" in Cytori's Securities and Exchange Commission Filings. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.