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WaferGen Biosystems, ImmuneRegen BioSciences and University of Texas Southwestern Medical Center to Collaborate on Novel Wound Healing Research

Studies at UT Southwestern to Leverage WaferGen's SmartChip Platform to Evaluate Efficacy of ImmuneRegen's Drug

FREMONT, Calif. and SCOTTSDALE, Ariz., March 24 /PRNewswire-FirstCall/ -- WaferGen Biosystems, Inc. (OTC Bulletin Board: WGBS), a leading developer of state-of-the-art genetic analysis systems, and IR BioSciences Holdings, Inc. (OTC Bulletin Board: IRBS), a development-stage biotechnology company focused on the research, development and licensing of ImmuneRegen's wound healing drug candidate, Homspera(R), today announced the establishment of a novel wound healing research collaboration with the University of Texas Southwestern Medical Center. Under terms of the collaboration, UT Southwestern researchers will conduct preclinical and clinical studies to evaluate the efficacy of Homspera. As part of these studies, WaferGen's SmartChip(TM) Real-Time PCR System will be used to understand the mechanism of action of Homspera.

The collaborators believe that these studies may demonstrate the key role that the innovative capabilities of the SmartChip system can play in the field of drug development, particularly in validating relevant gene expression biomarkers and assessing their impact on patient response to treatment. Additionally, the studies are expected to provide ImmuneRegen with important data to support potential applications for Homspera in a range of therapeutic applications.

These studies, which provide the first opportunity for the SmartChip platform to assist in the drug development process, are expected to demonstrate the following key SmartChip system capabilities:

  • Support of both preclinical and clinical studies
  • Validating potential biomarkers in many samples with rapid turnaround time, allowing for expedited drug development decisions
  • High sensitivity and accuracy with limited amount of sample from needle biopsy

"The opportunity to involve our SmartChip Real-Time PCR System in the development of a promising therapeutic agent such as Homspera is a significant achievement for WaferGen and one that we believe will provide immensely valuable validation for the SmartChip platform," stated Alnoor Shivji, WaferGen's chairman and chief executive officer. "We expect this collaboration to provide a clear demonstration of the value that the SmartChip system can offer in the area of drug discovery and development, particularly as it pertains to harnessing the potential of biomarkers."

"We are very excited to be able to incorporate the WaferGen SmartChip technology into our studies at UT Southwestern," said Hal Siegel, Ph.D., ImmuneRegen Chief Scientific Officer. "The reality is that many physiological processes consist of a dynamic interplay among many biochemical factors. Unfortunately, many analytical tools provide a static snapshot and can thus be misleading. The ability to rapidly analyze hundreds of samples taken over the course of the healing response promises to provide us with unique insights into the healing process and the role our developmental candidate plays in enhancing the rate at which wounds heal."

"This collaboration places UT Southwestern in the enviable position of evaluating the potential of two cutting-edge scientific assets in a single study," stated Spencer Brown, Ph.D., Director of Research, Nancy Lee and Perry Bass Advanced Wound Healing Laboratory in the Department of Plastic Surgery at UT Southwestern. "We are excited to work with Homspera and the SmartChip system, as we believe both possess the potential to play a key role in the development of innovative therapeutics in the area of wound healing."

In January 2009, WaferGen and UT Southwestern established a separate collaboration under which UT Southwestern is conducting novel research projects using the SmartChip Real-Time PCR System in order to identify and validate gene expression biomarkers related to wound healing.

About the SmartChip Real-Time PCR System

The SmartChip Real-Time PCR System is designed as the first whole genome, high-throughput gene expression real-time PCR platform. This innovative system, combined with next-generation chemistry and optimized assays being developed by WaferGen, promises to deliver significant speed and cost advantages to researchers in the gene expression and genotyping markets. Based on collaborations established with leading research institutions, WaferGen believes that the SmartChip Real-Time PCR System is positioned as the platform of choice for biomarker discovery and validation. It is estimated that the genetic analysis market alone (comprised of gene expression and genotyping analysis) had approximately $2.4 billion in worldwide revenues in 2006 ($1.74 billion for gene expression and $650 million for genotyping).

WaferGen believes the SmartChip Real-Time PCR System will be the first platform to combine the high-throughput capability and cost efficiencies of existing microarrays, with the sensitivity and accuracy of real-time PCR. Specifically, the SmartChip Real-Time PCR System's high density, rapid cycling configuration is expected to provide industry-leading throughput levels, while offering discovery and validation capabilities in a single step. The result is expected to be the ability to conduct gene expression research at a fraction of the time and cost currently produced by existing instrument systems. For example, the company anticipates that whole genome assay time may be significantly reduced with the SmartChip Real-Time PCR System as compared to several days or months with microarrays or real-time PCR, respectively. This decrease in research time has broad economic implications across the drug development industry, particularly for pharmaceutical companies seeking avenues for reducing time to market for their therapeutics. Further, the company believes such throughput will dramatically impact the cost of such assays.

Beyond the significant time and cost advantages, the simplicity of the SmartChip Real-Time PCR System is unparalleled. The system will provide a number of key ease-of-use features including content-ready chips with gene panels optimized for cancer, toxicology and whole genome. The user-friendly SmartChip Real-Time PCR System will be preloaded with some of the reaction components. At the same time, the system will only require a very small sample size as compared to other technologies and platforms and will offer real-time detection and sophisticated read-out options while assuring detection sensitivity and temperature uniformity across chips.

About WaferGen

WaferGen Biosystems, Inc. is a leader in the development, manufacture and sale of state-of-the-art systems for genetic analysis for the life science and pharmaceutical industries. The company is actively developing its SmartChip(TM) product for the gene expression and genotyping markets. SmartChip is being developed as the first whole genome, high throughput gene expression real-time polymerase chain reaction (PCR) platform. This innovative system, combined with next-generation chemistry and optimized assays being developed by WaferGen, promises to deliver significant speed and cost advantages to researchers in the gene expression and genotyping markets. Based on collaborations established with leading research institutions, WaferGen believes that the SmartChip Real-Time PCR System is positioned as the platform of choice for biomarker discovery and validation. WaferGen currently markets its SmartSlide(TM) family of products to companies and organizations involved in stem cell and cell biology research. SmartSlide represents the first fluidics integrated micro-incubators enabling cell biology and stem cell research.

About ImmuneRegen BioSciences, Inc.

ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc., (OTCBB:IRBS) is a development-stage biotechnology company focused on the research, development and licensing of Homspera(R) and its derivatives. Homspera is an adult stem cell active compound that in study results has been shown to regenerate and strengthen the immune system and enhance wound healing. Viprovex(R), a derivative of Homspera, is being developed for potential use against infectious diseases as a stand-alone or combination therapy and as a vaccine adjuvant. To advance its mission, the Scottsdale, Arizona based company has forged numerous study partnerships with industry and academic leaders, including Celgene Cellular Therapeutics, HemoGenix, Lovelace Respiratory Research Institute and Virion Systems. For more information, please visit

Forward-Looking Statements

This press release contains certain "forward-looking statements". Such statements include statements made by WaferGen and ImmuneRegen BioSciences relating to each company's goals, plans and projections, anticipated results of research, performance, reliability and cost-effectiveness of the company's SmartChip and other systems, and other statements that are not historical facts, including statements which may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words.

Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the control of the company. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risks that: (i) each company may be unsuccessful in achieving the anticipated results of research and/or in commercially developing its products or in achieving market acceptance of new and relatively unproven technologies; (ii) each company will need to raise additional capital to meet its business requirements in the future and the company may not be able to do so on reasonable terms or at all; (iii) each company's proprietary intellectual property rights may not adequately protect its products and technologies; and (iv) each company expects intense competition in its target markets, including from companies that have much greater resources than the company, and there can be no assurance that the company will be able to compete effectively. More detailed information about the company and the risk factors that may affect the realization of forward-looking statements is set forth in each company's filings with the Securities and Exchange Commission, including each company's Annual Report on Form 10-K for the year ended December 31, 2007, and its subsequent Quarterly Reports on Form 10-Q filed with the SEC. Investors and security holders are urged to read this document free of charge on the SEC's web site at Each company does not undertake to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.


    Vida Communication (Media)                The Trout Group (Investors)
    On Behalf of WaferGen                     On Behalf of WaferGen
    Tim Brons                                 Peter Rahmer
    415-675-7400                              646-378-2973              San Francisco, CA

    ImmuneRegen BioSciences
    Dr. Hal Siegel                            Christine Yang
    480-922-3926                              646-378-2929                   New York, NY

SOURCE WaferGen Biosystems, Inc.
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