• Business Overview

    BioControl Medical develops advanced active implantable medical devices for the treatment of autonomic disorders, conditions whereby the autonomic nervous system ceases to function properly, resulting in a disruption to the control of involuntary body processes. The devices enable controlled electrical stimulation of various nerves to achieve therapeutic results.

    BioControl Medical has developed the CardioFit® System, intended to effectively treat heart failure via vagus nerve stimulation. It has received the CE mark (2008) and is being studied under Investigational Device Exemption in the U.S.

    The same neurostimulation platform is used by Cerebral R.X. to treat drug refractory epilepsy.

  • Manufacturing and Quality Assurance

    We have in house engineering capabilities. Manufacturing is done partly in-house and partly with subcontractors, with final testing done in house. The manufacturing operations are in compliance with the FDA's Quality System Regulations (QSR), which incorporate the agency's Good Manufacturing Practices regulations, and is ISO 13485 certified.Our products are certified with CE Mark.

    Our stimulators are similar externally to other active implantable devices. They include an electronic circuit board and battery, both which are hermetically sealed in a titanium case.

    Stimulator firmware is developed in-house. An external physician programmer, used to non-invasively communicate with the implantable device, is based on an off-the-shelf tablet PC, with proprietary software developed in-house.

  • Collaborations and OEM

    BioControl is looking for collaborations with companies that are interested in using the CardioFit neurostimulation platform for other indications.