Sistemic Announces Customer Agreement with Cytori Therapeutics

Cytori to Utilize Sistemic’s SistemQC™ to Strengthen Understanding of  Mechanisms & Support Design of Next-Generation Cell Therapies Boston, Mass., USA, June 20, 2012 / B3C newswire / – Sistemic Ltd. (“Sistemic”), a leading provider of microRNA-based problem-solving services and kit-based products, has formed a customer relationship with Cytori Therapeutics (“Cytori”). Cytori will utilize Sistemic’s proprietarySistemQC™  technology platform in its U.S. cardiac cell therapy clinical trial to molecularly characterize adipose-derived stem and regenerative cells (ADRCs). “Research has shown that within adipose tissue, as well as other cell sources like bone marrow, there are multiple distinct cell types that can contribute to efficacy,” commented Sistemic chairman and CEO Jim Reid. “Cytori selecting our SistemQC serves as another validation of our technology, particularly its flexibility to characterize a wide variety of cells for identity and potency, on a molecular level. We could not be more pleased to have reached this agreement with Cytori.” The announcement was made at the 2012 Bio International Convention in Boston, where Mr. Reid is moderating a panel on stem cell therapeutics featuring leaders from the industry, on Wednesday, June 20, at the Boston Convention Center. “SistemQC will be incorporated into our clinical development to understand which cell types within our Celution® System’s autologous heterogeneous population of ADRCs are the greatest contributors to efficacy,” said Douglas Arm, Ph.D., Senior Vice President Operations at Cytori. “With Sistemic’s novel technology, we can strengthen the mechanistic understanding of our cell output and at the same time support the design of next-generation cell therapies.” About Sistemic Ltd Sistemic’s primary business is focused on providing innovative microRNA-based problem-solving services and kit-based products to areas of unmet need within Pharmaceutical, Biotechnology and the Cell Therapy research, development and manufacture markets. MicroRNAs are seen as the master controllers of a cell and as such Sistemic believe that they are providing instructive information on effects on a whole cell or organism rather than an isolated pathway. This system approach means that the data produced is more indicative of the biology and more diagnostic of actual effect. Their extensive suite of tools for the Cell Therapy community includes SistemQC™ which is used to characterise cells including stem cells (Cell Identity, Purity, Potency, and Safety) as well as monitoring the QC of production. In addition, the drug development markets are served through a range of products which include SistemTOX™, SistemKB™ and SistemRNA™. About Cytori Cytori Therapeutics, Inc. is developing cell therapies based on autologous adipose-derived regenerative cells (ADRCs) to treat cardiovascular disease and repair soft tissue defects. Our scientific data suggest ADRCs improve blood flow, moderate the immune response and keep tissue at risk of dying alive. As a result, we believe these cells can be applied across multiple "ischemic" conditions. These therapies are made available to the physician and patient at the point-of-care by Cytori's proprietary technologies and products, including the Celution® system product family. Contact Dr. Verna McErlane Director of Commercial Operations + 44 (0)7855 376 358 verna.mcerlane@sistemic.co.uk

Sistemic highlights the need for better cell characterisation in regenerative medicine

03 October 2011: Sistemic, UK:  Sistemic, the cell characterisation problem-solving service provider that uses miRNA, is a strong advocate for the potential of regenerative medicine. Dr Verna McErlane, Sistemic’s Director of Commercial Operations, recently took part in a round-table discussion with leading stem cell researchers http://www.sistemic.co.uk/publications. The scientific, ethical and moral debate about the use of stem cells continues and will soon be taken up in earnest at the World Stem Cell Summit, taking place from 3-5 October in Pasadena, California, where Dr McErlane is a key participant.

 “The future for regenerative medicine is huge, but there are issues to be faced on this road to success,” said Dr McErlane. “Firstly we need to establish reliable cell standards, and secondly these standards should inform the development of a validated and dependable toolbox for monitoring and characterising stem cells during research and manufacturing. Only through characterisation can this technology enter the mainstream clinical practice and provide the patient benefits we are all hoping for.”

 Sistemic has developed a stem cell focused miRNA-based approach called SistemQC™ which molecularly characterises cells and monitors their quality. Not only does it give a succinct read out on the status of the cells but also provides an insight into the underlying biological effects associated with any change observed. SistemQC™ is being used by the stem cell community to optimise and guide the differentiation process, benchmark differentiated cells and, from a manufacturing perspective, provide identity markers, purity and potency control. Innovative developments such as this, as well as other new tools and a consensus on the standardisation of the process, are that will really drive this industry forward to reach its full potential.

 Dr McErlane went on to say, “Without adequate control, this unique opportunity to positively impact on the treatment of many untreatable conditions will be lost. Standardisation is key and Sistemic are at the forefront of assisting in making Regenerative Medicine a reality for clinical practice.”

 Initiated in 2009, the World Stem Cell Summit (http://www.worldstemcellsummit.com/) has quickly become one of the largest interdisciplinary, networking meetings of stem cell stakeholders, which unites the regenerative medicine industry and biomedical research. For 2011, one of the industry key note addresses, given by Dr Gil Van Bokkelen co-founder and CEO of Athersys and Chairman of the Alliance for Regenerative Medicine, of which Sistemic is a key member , will be; ‘The transformational potential of regenerative medicine, and how it will change healthcare as we know it’.

 Sistemic looks forward to meeting old colleagues, new faces and learning about the most recent developments in the field at the upcoming World Stem Cell Summit. Visitors can meet the team at the Scottish Development International Booth in the exhibit hall. In the meantime, anyone interested in Sistemic and its products should visit: www.sistemic.co.uk

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How to progress safe and effective cell therapies for clinical use!

Sistemic to present miRNA-led cell characterisation at Stem Cell Europe

18^th July 2011: Sistemic, UK:  Sistemic believe cell characterisation is an essential element in progressing safe and effective cell therapies for mainstream clinical use.  They offer unique miRNA analytical services that provide reliable and cost-effective, characterisation and QC tools that are applicable to all cell systems. Toward this end, Dr Vincent O’Brien (Chief Scientific Officer) and Dr Verna McErlane (Director of Commercial Operations, International) will present data supporting the utility of miRNA in the provision of superior cell characterisation and QC methods at the forthcoming Stem Cells Europe conference (20-21 July 2011, Edinburgh). 

Dr. Vincent O’Brien will present a poster entitled; ‘A novel microRNA-based stem cell characterisation and monitoring tool’,and Verna McErlane will join: Marilyn Robertson, SSCN; Aidan Courtney, Roslin Cells; Dr. David Hay, Fibromed; and, Michael Leek, Immunosolv, at the Scottish Stem Cell Network (SSCN) Panel showcase, “Progress to Therapy and Market” on Wednesday 20 July at 5pm.

 Sistemic Ltd are a global company offering unique miRNA-based products and services such as SistemQC^TM, designed for the sophisticated molecular characterisation of cells, which combines robust miRNA profiling, statistical analysis and contextual analysis. Further information on all Sistemic’s proprietary services, including; SistemRNA^TM, SistemQC^TM, SistemTOX^TM and SistemKB^TM, can be found at: www.sistemic.co.uk

Please Contact:

Dr Verna McErlane, Director of Commercial Operations,  +44 7855376358