Periodic Reporting for period 1 - Microbot Medical (SCS – a self-cleaning shunt for the continuous prevention of shunt blockage in hydrocephalus and NPH patients)
Reporting period: 2018-06-01 to 2018-11-30
"Hydrocephalus, also known as ""water in the brain"" is a medical condition in which there is abnormal accumulation of cerebrospinal fluid in the ventricles of the brain. An estimated 750,000 people are living with it in the US alone, with similar numbers in Europe. It causes increased intracranial pressure inside the skull and progressive enlargement of the head, convulsion, tunnel vision, and mental disability, as well as death. In elderly people, it is the only common form of dementia that is reversible. Treatment is done by implanting shunts, used to drain excess fluids from patients’ brain, but are needed to be replaced regularly in a brain surgery.
Blockage, or occlusion, is by far the most frequent event that results in shunt failure. Microbot Medical's Microbot Medical’s innovative Self Cleaning Shunt (SCS) is based on micro-robotic cleaning mechanism assimilated in a shunt, powered and controlled by external magnetic unit. It has vibration movement throughout the tip of the shunt, for cleaning and preventing occlusions, without interfering with the cerebrospinal fluid drainage. The SCS will help lower the number of surgeries done annually around the world, estimated at over 40,000 in the US with similar number in the EU, with a total cost of over $2B.
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Blockage, or occlusion, is by far the most frequent event that results in shunt failure. Microbot Medical's Microbot Medical’s innovative Self Cleaning Shunt (SCS) is based on micro-robotic cleaning mechanism assimilated in a shunt, powered and controlled by external magnetic unit. It has vibration movement throughout the tip of the shunt, for cleaning and preventing occlusions, without interfering with the cerebrospinal fluid drainage. The SCS will help lower the number of surgeries done annually around the world, estimated at over 40,000 in the US with similar number in the EU, with a total cost of over $2B.
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Due to the level of technical and clinical novelty of the SCS, device improvement and pre-clinical studies were required in order to ensure success from technical, commercial and financial perspectives prior to the launch of the Phase II project, which was the ultimate objective of the feasibility study, with the following results:
- The SCS prototype development included improvement of system design, its manufacturability, functionality and the preparation of the phase I pre clinical studies
- Phase I animal study was performed in Washington University in St. Louis, MO. Initial observations suggest that the cellular response to the Microbot SCS™ is no different than the response to standard shunts.
- Phase I in vitro study was performed in Wayne State University in Detroit, MI. Initial results from the small-scale study, showed that the device can potentially remove early spreading of cells across the shunt holes a first step towards occlusion prevention.
- In order to further study the European market, we worked with a business coacher funded by the H2020 program on finding KOLs in the neurosurgery area, reviewing different marketing approaches, pricing and reimbursement strategies in Europe in general and in Germany in particular.
- The SCS prototype development included improvement of system design, its manufacturability, functionality and the preparation of the phase I pre clinical studies
- Phase I animal study was performed in Washington University in St. Louis, MO. Initial observations suggest that the cellular response to the Microbot SCS™ is no different than the response to standard shunts.
- Phase I in vitro study was performed in Wayne State University in Detroit, MI. Initial results from the small-scale study, showed that the device can potentially remove early spreading of cells across the shunt holes a first step towards occlusion prevention.
- In order to further study the European market, we worked with a business coacher funded by the H2020 program on finding KOLs in the neurosurgery area, reviewing different marketing approaches, pricing and reimbursement strategies in Europe in general and in Germany in particular.
The results will definitely help us to develop a European business plan after completion of phase 2, that is going to define the capabilities of our SCS device and the exact point on the spectrum between a regular commercial shunt (that is averagely occluded every 2 years) and a highly innovative device that prevents the occlusion.