Approval Allows for Initiation of Pilot Studies in Horses, Cats, Dogs and Rabbits
SAN DIEGO, CA--(Marketwire - Jun 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 (https://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 (https://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 https://www.translational-medicine.com/content/pdf/1479-5876-6-45.pdf. ERC can be purchased for scientific use through Medistem's collaborator, General Biotechnology https://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.
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