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MediStem, Inc. (Formerly known as Medistem Laboratories, Inc.) Licensee RenovoCyte LLC Receives FDA INAD for Universal Donor Endometrial Regenerative Cells (ERC)


7/1/2011 7:08:53 AM

SAN DIEGO, CA--(Marketwire - June 30, 2011) - Medistem Inc. (PINKSHEETS: MEDS) announced today that licensee and collaborator RenovoCyte LLC was granted INAD numbers for the use of Endometrial Regenerative Cells (ERC) in the equine, canine, feline, and lagomorph species, pursuant to the Federal Food, Drug, and Cosmetic Act [section 512(j)] and 21 CFR part 511. This approval is the first step towards commercialization of the ERC in the veterinary market. Medistem's licensing deal involves royalty revenue and access to data generated from RenovoCyte using the Endometrial Regenerative Cells.

"The biggest issue in development of a stem cell therapeutic product is figuring out what diseases your stem cells work the best in. The conventional business model does not allow widespread testing of stem cells in many conditions due to cost. While we are focusing on critical limb ischemia and heart failure based on current data, there are many other diseases that our stem cells could be useful for that we would never know about. We are very fortunate that RenovoCyte has created this novel business model which is a 'win-win' for everyone," said Dr. Vladimir Bogin, Chairman and President of Medistem.

RenovoCyte has developed a repertoire of universal donor cells and rationale for efficacy in a variety of inflammatory, autoimmune, and degenerative conditions. The INAD numbers issued are 012-009 (canine), 012-010 (equine), 012-011 (feline), and 012-049 (lagomorph).

"Medistem's ERC are universal donor, produce higher growth factors as compared to other adult stem cell sources, can generate liver, heart, bone, muscle, blood vessel, brain and pancreatic cells, and are economical to produce," said Dr. Shelly Zacharias, Director of Veterinary Operations of RenovoCyte. "We are excited to be using these cells as a natural treatment for the new field of Regenerative Veterinary Medicine."

The ERC was discovered in 2007 by Medistem scientists, click here for peer reviewed publication (http://www.translational-medicine.com/content/pdf/1479-5876-5-57.pdf), which won the Publication of the Year award from BioMed Central, publisher of over 200 journals. Recently, Medistem reported in the peer reviewed literature that administration of ERC into a heart failure patient resulted in remission, click here for peer reviewed publication (http://www.intarchmed.com/content/pdf/1755-7682-3-5.pdf).

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. 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. ERC can be purchased for scientific use through Medistem's collaborator, General Biotechnology http://www.gnrlbiotech.com/?page=catalog_endometrial_regenerative_cells.

About RenovoCyte, LLC

RenovoCyte (www.renovocyte.com) is a cellular medicine company originating from a combination of laboratory and clinical excellence. RenovoCyte's parent company, General BioTechnology, LLC (www.gnrlbiotech.com), is an internationally respected cell processing, cryopreservation and storage facility established in Indianapolis in 1997. In 2010, GBT joined forces with medical doctors, oral surgeons and veterinarians to launch RenovoCyte with the goal of responsibly and aggressively developing treatments using cell therapy for human beings, companion animals and horses for a wide range of diseases and injuries.

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.


Medistem Contact:
Vladimir Bogin, MD
Chairman of the Board
Medistem Inc.
9255 Towne Centre Drive, Suite 450
San Diego, CA 92122
858 349 3617
Vladimir.bogin@medisteminc.com
www.medisteminc.com

RenovoCyte Contact:
Shelly Zacharias, DVM
Director of Veterinary Operations
RenovoCyte LLC
1102 Indiana Avenue
Indianapolis, IN 46202
317-917-3450
shelly@renovocyte.com
www.renovocyte.com

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