Industrial Technology Research Institute Validates …

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CALGARY, AB / ACCESSWIRE / June 10, 2015 / Avagenesis Corp. (Avagenesis or the Company) (TSX VENTURE: VVA), is pleased to announce the completion of a third party performance validation study of its automated bioprocessing and stem cell isolation system (Avagenesis System). The results confirm that the Avagenesis System significantly outperforms competing systems in all metrics: high stem cell recovery, excellent reproducibility and rapid processing time. The study was conducted by a team of leading stem cell experts at the Industrial Technology Research Institute (ITRI), the national research organization of Taiwan and a world leader in research, technology and high tech product development.

In the study conducted by ITRI (ITRI Study), the Avagenesis System was evaluated and validated using seven fresh human lipoaspirate samples. Viable nucleated cell recovery and stem cell recovery performances were measured using an ADAM-MC Automated Cell Counter (NanoEnTek Inc.) and colony forming assays and then compared to a study entitled Adipose Stromal Vascular Fraction Isolation: a Head-to-Head Comparison of Four Commercial Cell Separation Systems by Aronowitz JA, Ellenhorn JD, December 2013, Plastic Reconstructive Surgery. 2013;132:932e939e (Aronowitz Study). The Aronowitz Study reviewed the following systems: Celution 800/CRS System (Cytori Therapeutics Inc., USA NASDAQ:CYTX), Multi Station (PNC International, South Korea), Cha-Station (CHA Biotech Inc., South Korea KOSDAQ: 085660.KQ), and Lipokit with MaxStem (Medi-Khan International Inc., South Korea).

Cell recovery yields are key performance metrics representing the ability of a system to extract cells from adipose tissue without damaging the cells. The ITRI Study found that the Avagenesis System yielded a mean of 801,000 167,000 viable nucleated cells (8.01 1.67 x 105) from each gram of human lipoaspirate tissue (mean SD, n=7, median: 786,000 viable nucleated cells/g (7.86 x 105)), with a range of 570,000 1,060,000 viable nucleated cells/g (5.70 x 105 1.06 x 106), representing 2X, 7.5X, and over 20X more viable nucleated cells recovered than the comparable numbers reported for Celution, Multi Station, and Lipokit respectively, in the Aronowitz Study. The viability of cells recovered by the Avagenesis System is 84.8% 3.8% (mean SD, n=7), similar to Celutions 84.7% viability reported in a study entitled The Celution System: Automated Processing of Adipose-Derived Regenerative Cells in a Functionally Closed System (Fraser et al., Adv Wound Care (New Rochelle) 2014 Jan;3(1):38-45)(Fraser Study).

The ITRI Study also found that 7.2% 2.4% of the viable nucleated cells in the output of the Avagenesis System are mesenchymal stem cells (MSCs) as characterized by colony-forming unit-fibroblasts (CFU-F), compared to the reported 0.6% 1.7% achieved by Celution (Aronowitz and Fraser Study), 0.35% achieved by Multi Station and 0.20% achieved by Lipokit. Because of the significantly higher viable cell recovery and stem cell colony counts, the Avagenesis System extracted approximately 14X, 76X, and 640X more mesenchymal stem cells than Celution, Multi Station, and Lipokit did, respectively, from each gram of human lipoaspirate processed. Specifically, the Avagenesis System extracted on average 57,700 MSCs/g of human lipoaspirate processed, whereas Celution, Multi Station, and Lipokit only extracted approximately 1920 3950 MSCs/g (Aronowitz and Fraser Study), 750 MSCs/g and 90 MSCs/g, respectively. A 50 ml sample of lipoaspirate generated on average 2,600,000 MSCs (2.6 x 106) using the Avagenesis System. To obtain the same number of MSCs, approximately 0.7 1.5 liters, 3.8 liters and 32 liters of human lipoaspirate would be needed using Celution, Multi Station, and Lipokit, respectively. Volumes of this size are not attainable clinically due to the limited processing capacities of the systems in the Aronowitz Study and the inherent limitations of liposuction once patient-specific considerations and overall safety are taken into account.

Three Avagenesis Systems were also tested side-by-side by ITRI using four fresh human donor lipoaspirate samples to evaluate machine-to-machine variability, a critical metric bearing on performance reproducibility. The resulting measure of machine-to-machine variability was 2.4%, suggesting that the systems can perform stem cell extraction with exceptional consistency and reproducibility.

The mean processing time in the Aronowitz Study ranged from 88 to 115 minutes. The Avagenesis System had a mean processing time of 65 minutes making it the fastest automated adipose processing system ever developed and manufactured for autologous point of care applications.

With the Avagenesis System, there is now an instrument available to all researchers and clinics that is proven to consistently provide premium stem cells of the highest quality. This cost effective breakthrough in standardization and reproducibility provides the highest quantity and quality of stem cells recovered at the point of care, accelerating the revolution in stem cell research, autologous stem cell therapies and cosmetic surgery, said Dr. Richard Cook, Chief Medical Officer of Avagenesis.

About the Industrial Technology Research Institute

Founded in 1973, Industrial Technology Research Institute is a Taiwan non-profit R&D organization engaging in applied technology research and technical services, aiming to innovate a better future for society. Since its inception, ITRI has incubated more than 260 startups and spinoffs, including well-known global semiconductor leaders such as Taiwan Semiconductor Mfg. Co. Ltd. or TMSC (TWSE: 2330; NYSE: TSM) and United Microelectronics Corp. or UMC (TWSE: 2303; NYSE: UMC). ITRI is one of only seven entities recognized globally as a United States FDA Premarket Notification 510(k)s Third Party Review Accredited Persons under FDA Modernization Act 1997.

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