Industrial Technology Research Institute Validates Avagenesis Bioprocessing and Stem Cell Isolation System

Calgary, Alberta (FSCwire) - Avagenesis Corp. (“Avagenesis” or the “Company”) (TSXV: 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;132:932e–939e (“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 Celution’s 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.

ITRI continues to seek strategic collaborative partners from around the world. Key partners include Corning Glass, Underwriters Laboratories, and Applied Materials of the United States; Asahi Kasei, Nidec, and AIST of Japan; Evonik, Heraeus, and Fraunhofer of Germany; TNO of the Netherlands; VTT of Finland; Ericsson of Sweden; and the National Research Council of Canada.

With international partners and overseas offices in Silicon Valley, Tokyo, Berlin, Moscow, and Eindhoven, ITRI is able to remain globally competitive and connected. Its efforts in technological innovation have been recognized by prestigious honors such as the Wall Street Journal's Technology Innovation Awards and R&D 100 Awards.  Visit (www.itri.org.tw) for additional information.

About the Avagenesis System

The Avagenesis System allows physicians and researchers input up to 60 ml of human adipose tissue and automatically isolate a consistent, high quality, potent unit of rich regenerative cells and mesenchymal stem cells. The entire process is  standardized and automated in a closed system.

The easy-to-use proprietary patented and patent-pending technology is designed for point of care applications where safe, reproducible, quality controlled cellular fractions with regenerative properties are desired.   The resulting high quantity of isolated recovered cells are of pristine quality, high purity and superior concentration, isolated within 65 minutes of adipose tissue harvesting.  The Avagenesis System is only 22kg and compact enough to fit on counters.  

The Avagenesis System is easy to use with minimal training, provides a cost effective premium alternative to manual processes and other competing systems, and is currently available to select researchers and clinics globally.

About Avagenesis Corp.

Avagenesis is a biotechnology company engaged in the commercialization of medical technologies for use in the practice of cosmetic surgery and regenerative medical aesthetics. Avagenesis’ development activities are focused on the complex task of efficiently isolating high quality, viable and potent adipose-derived adult stem cells and regenerative cells using patent-pending and patented bioprocessing and cell isolation technology.  For licensing and strategic reasons, all patent registrations, FDA registrations and other regulatory certificates are arranged through an exclusive licensing agreement with a related and affiliated company.

Neither the Exchange nor its regulation services provider (as that term is defined in the policies of the Exchange) accepts responsibility for the adequacy or accuracy of this press release.

Cautionary Statements

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Avagenesis' current belief or assumptions as to the outcome and timing of such future events. Actual future results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that Avagenesis may not successfully transition to a clinical stage company and the risk that Avagenesis may not successfully execute its development and commercialization activities. Various assumptions or factors are typically applied in drawing conclusions or making the forecasts or projections set out in forward-looking information. Those assumptions and factors are based on information currently available to Avagenesis.  Avagenesis cautions the reader that the above list of risk factors is not exhaustive. The forward-looking information contained in this press release is made as of the date hereof and Avagenesis is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein.

Further Information

For further information, please contact:

Avagenesis Corp.

Alan Tam, CPA, CA

Chief Financial Officer

Telephone: (604) 377-7575

Email: atam@avagenesis.com

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