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3 Geron Street POB 2713
Yehud, 56100 Israel
phone:+972-3-632-2126
fax:+972-3-632-2125
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| Symbol |
Private |
| Founded |
1999 |
| Employees |
24 |
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| www.biocontrol-medical.com
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| Research Sector |
Medical Devices & Tech |
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| Summary Description |
| Selective Neurostimulation of the Vagus Nerve to Treat Cardiovascular Conditions |
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| Management |
| Ehud Cohen, Ph.D., CEO |
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| Keywords |
| Vagus Nerve Stimulation, Electrical Stimulation, Heart Failure, Interstitial Cystitis, Urinary Incontinence |
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| Description |
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BioControl Medical is an Israeli company developing implantable devices incorporating electrical stimulation technology for the treatment of autonomic nervous system dysfunctions. |
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| Products / Services |
BioControl's flagship product, the miniaturo, treats various forms of urinary incontinence. The miniaturo has received CE Mark approval for the treatment of interstitial cystitis and overactive bladder syndrome. The company has also developed the CardioFit system, which addresses heart conditions via vagus nerve stimulation. BioControl's therapy augments the effect of beta-blockers: it reduces activity in the sympathetic nervous system (responsible for the "fight or flight" response) by impacting the heart upon demand via selective parasympathetic neurostimulation. Preclinical studies in animals have demonstrated CardioFit's role in enhancing nitric oxide production (which, in turn, dilates the blood vessels for improved blood flow) and regulates gene and protein expression of nitric oxide synthase enzymes.
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| Technology / Differentiation |
| The company's proprietary technology directs selective and unidirectional stimulation to target organs and nerves in a manner that emulates natural physiological activity (while minimizing non-related side effects). The CardioFit system consists of an electro-stimulator device with a nerve cuff electrode and an intra-cardiac electrogram (EGM) sensor. Continuously monitoring the EGM signal ensures that stimulation is adjusted to the patient's optimal heart rate. The vagus nerve is then stimulated through the proprietary tri-polar cuff electrode that provides accurate control over specific nerve fibers, thus avoiding cross activation of undesired fibers. In a short procedure, the electrode is positioned in the neck, around the vagus nerve, while the device is placed in a subcutaneous pocket inside the chest. |
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| Market / Customers |
According to the HFSA, nearly five million Americans of all ages are affected by heart failure and more than 400,000 new cases of heart failure are diagnosed yearly. The Study Group on Heart Failure Awareness and Perception in Europe reports that approximately 14 million Europeans currently suffer from heart failure; this number is forecasted to increase by one million annually.
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| Strategy |
In April 2006, American Medical Systems exclusively licensed BioControl's technology for its miniaturo(tm) system, to develop it as a treatment device for urge incontinence and interstitial cystitis. Funds secured from that transaction are being used to support the development of the CardioFit system for the treatment of Congestive Heart Failure.
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| Status |
| BioControl's technology has received ten U.S. patents to date, with an additional twenty patents pending. In April 2006, BioControl Medical sold its urology line of products to American Medical Systems. American Medical Systems also acquired an exclusive license for use of BioControl's electrical stimulation technology in the treatment of pelvic floor conditions, along with other urological and gynecological indications. As of October 2007, BioControl Medical has distributed the CardioFit system to seven clinical trial sites in Europe. Along with facilities in Israel and Australia, these sites are involved in an open-label study of patients with advanced congestive heart failure. |
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Healthcare Services
Medical Devices & Tech
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