Our Company’s investments in the bio-tech and medical devices fields, mainly in the image guided treatment business, clinical trials, gene therapy, genomics and drug delivery fields, initiated via the following companies:
InSightec Ltd.
InSightec Ltd. (in which our Company holds approximately 52%), is a market-oriented, technology based company, committed to improve efficacy and quality of healthcare delivery. Its objectives are to become the market leader in Image Guided High Intensity Focused Ultrasound (FUS), achieving a significant improvement in the quality and efficacy of the treatment while demonstrating cost effectiveness. Among InSightec’s shareholders are also GE Equity Capital, a subsidiary of General Electric Company (NYSE: GE) and MediTech Advisors LP.
InSightec is the developer of ExAblate® 2000™, a product that integrates Magnetic Resonance Imaging (MRI) with focused ultrasound energy, as a new treatment modality that can replace invasive procedures reduce the risk of morbidity and potential complications, as well as the direct and indirect costs associated with conventional surgery and provide therapeutic alternatives to millions of patients with serious diseases around the globe.
ExAblate was approved by the U.S. Food and Drug Administration (FDA) in October 2004 to treat symptomatic uterine fibroids and to date over 2,500 women have been treated worldwide for symptomatic uterine fibroids.
InSightec and its clinical partners are performing clinical studies using the ExAblate 2000 for the treatment of breast cancer, breast fibroadenoma (benign tumor), brain tumors through an open flap in the skull and several other indications. First results are very encouraging. InSightec has over 48 sites globally. InSightec is also in advanced stages of development of a second FUS system that is able to focus the ultrasound through the intact skull, opening new possibilities in the non-invasive treatment of the brain.
InSightec assesses the concept of using ultrasound energy, in a controlled manner, to direct drugs. The assessment is focused on the technical and physiological feasibility of the use of FUS in this role.
For additional information please see InSightec’s web site: http://www.inSightec.com/
Gamida Cell Ltd.
Gamida Cell Ltd. (in which our Company indirectly holds 27.4%) is a developer of a pipeline of cell therapeutics to fill the unmet clinical need for products with an ample supply of stem cells, to effectively treat debilitating and often fatal illnesses such as cancer, cardiovascular disease and neurological disorders.
One of Gamida Cell’s great challenges in developing therapeutics based on stem cells is to provide a large enough number of cells for delivery of a therapeutic dose. Gamida Cell has developed several proprietary, small molecule technologies, which expand stem cells in culture with limited differentiation, thereby creating therapeutic doses of effective stem/progenitor cells. Gamida Cell is the only company to demonstrate, in the laboratory and the clinic, significant expansion of stem cells in culture. Gamida Cell’s technologies are simple, reversible, do not involve genetic interference, and are easily scalable. Additionally, Gamida Cell is cost effective and efficient for commercial production. Gamida Cell’s technologies and products are protected by more than 20 worldwide patents and numerous patent applications.
Gamida Cell’s flagship product StemEx®, being developed by the Gamida Cell (a Teva Joint Venture) is poised to answer a dire unmet clinical need in the field of bone marrow transplantation, and has blockbuster potential in supplying alternative cell grafts to patients without a matched, related bone marrow donor. StemEx® is composed of ex-vivo expanded cord blood stem cells, which are transplanted in combination with non-expanded cells from the same cord blood unit. Enrollment will begin soon for the registration, pivotal, global clinical study of StemEx® for the treatment of hematological malignancies, such as leukemia and lymphoma. This study, called ExCell, received a Special Protocol Assessment in October 2006 from the FDA. The same agency granted StemEx® orphan drug designation in March 2005.
In addition to the development of StemEx®, Gamida Cell is developing other products for hematopoeitic cell transplantation. In 2007, Gamida Cell started a clinical trial to transplant patients with storage diseases. In tissue regeneration the Company plans to initiated, a Phase I/II clinical study of CardioCure™ for cardiac regeneration in patients post MI. Finally, Gamida Cell is continuing its ongoing pre-clinical development of products, based on Gamida Cell’s proprietary expansion technologies, for conditions such as peripheral vascular disease, neurological disorders and diabetes.
For additional information please see Gamida Cell’s web site: http://www.gamida-cell.com