AVAILABLE PRODUCTS
EViTARTM I Cell & Drug Delivery Device
A major goal of advanced cell and drug delivery systems is to deliver therapeutic stem cells directly to target tissue. Clinical benefits of site-specific delivery systems can include increased safety, increased efficacy, reduced toxicity, more reliable therapeutic drug levels, and decreased and simplified dosing requirements. NexGen’s acute cell and drug delivery catheter, EViTARTM I is a proprietary medical device for cell therapy of the central nervous system in patients with tumors, neurodegenerative diseases, and stroke. EViTARTM I is indicated for the injection of material into, or the removal of material from, the brain during intracranial procedures. EViTARTM I is designed for low volume, high concentration delivery of therapeutic stem cells and drugs directly to target tissues in the brain and spinal cord, which can significantly reduce side-effects associated with systemic delivery. The design of EViTARTM I overcomes major limitations of current marketed products, including inaccurate dosing due to reflux of injected material along catheter shaft and tissue damage from repeated catheter insertions, high pressure injections and/or trapped air bubbles. The Company expects to commercialize the EViTARTM infusion catheters in conjunction with FDA approval of drugs or stem cells for direct intracranial delivery.
EViTARTM II Cell & Drug Delivery Device
EViTARTM II is indicated for the injection of material into, or the removal of material from, the brain during intracranial procedures. EViTARTM II is designed for low volume, high concentration delivery of therapeutic agents directly to target tissues in the brain and spinal cord, which can significantly reduce side-effects associated with systemic delivery. The design of EViTARTM II also overcomes major limitations of current marketed products, including inaccurate dosing due to reflux of injected material along catheter shaft and tissue damage from repeated catheter insertions, high pressure injections and/or trapped air bubbles.
PRODUCTS UNDER DEVELOPMENT
EViTARTM NTr
[Under Development – Not Available for Use in the US]
NexGen is developing the EViTARTM neurotrauma device for monitoring and treating patients with traumatic head injury. Unlike currently marketed products, the NTr provides multiple treatment and monitoring functions in a single catheter-based device, including drug delivery, cerebrospinal fluid drainage, intracranial pH, pressure and metabolic monitoring, and high resolution tissue perfusion imaging. The traumatic brain injury market comprises over 1.5 M patients with annual costs estimated at over $4B in the U.S. alone. The market for catheter based interventions to address traumatic brain injury is currently estimated at $70M, but this is likely to rapidly expand as medical procedures are optimized to monitor and treat neurotrauma. The Company believes that the NTr will quickly gain market acceptance by simplifying treatment of traumatic brain injury and eliminating the need for implanting multiple intracranial devices.
CSF FLOWMETER
[Under Development – Not Available for Use in the US]
NexGen is developing an implantable medical device that will improve the standard of care for managing hydrocephalus patients by enabling routine and reliable readouts of cerebrospinal pressure and flow remotely. In addition to providing an early indication of CSF shunt failure, the new device will be designed to automatically store pressure and flow information along with a time stamp, so that the history of these parameters will become available to the physician telemetrically or at regular post-operative clinical visits.
EViTARTM III Implantable Drug & Cell Delivery Device
[Under Development – Not Available for Use in the US]
NexGen’s chronic drug and cell delivery catheter, EViTARTM III, is a proprietary implantable medical device for drug and cell therapy of the central nervous system in patients with tumors, neurodegenerative diseases, and stroke. EViTARTM III is designed for low volume, high concentration implantable delivery of therapeutic agents directly to target tissues in the brain and spinal cord, which can significantly reduce side-effects associated with systemic delivery.
EViTARTM MulticoilMR
[Under Development – Not Available for Use in the US]
The Company is developing a magnetic resonance (MR) microcoil-based physiologic imaging and spectroscopy technology, EViTARTM MulticoilMR, which will be integrated with the EViTARTM neurocatheters. The EViTARTM MulticoilMR will expand the utility of the EViTARTM delivery system in the neurosurgery market by offering physicians the option of utilizing drug and cell delivery catheters under direct MR guidance.
CHANNEL CATHETER
[Under Development – Not Available for Use in the US]
NexGen’s proprietary Channel Catheter device is designed to deliver drugs to any solid organ in the body using ‘channels’ in the tissue that are created using small diameter stylets, which are withdrawn prior to infusion of the drug. Since infusion through the channels produces a larger distribution of the infusate compared to standard catheters, the need for multiple infusion sites is eliminated. NexGen believes that the Channel Catheter will improve and simplify the treatment of body, head and neck tumors in patients undergoing direct tissue delivery of chemotherapeutic agents.
CYTOMETER
[Under Development – Not Available for Use in the US]
NexGen is also developing a catheter-based device to facilitate delivery of stem cell-based therapies by counting individual labeled cells that move through the delivery catheter. The CYTOMETER comprises an EViTARTM type of catheter modified to incorporate a system of optical fibers for real-time cytometry of cells exiting the port of the catheter. As the cell slurry is pumped through the catheter, autofluorescence of the cells is monitored by the observer fibers on the opposite sides of the port holes, and the signal strength is used to estimate the number of viable cells. The CYTOMETER device thus enables the clinician to monitor the specific number of cells delivered into target tissues and to confirm that they are viable during the delivery process. The device also improves control over the cell delivery process by permitting adjustment of the flow rate from a pump in response to real-time cell counts. The CYTOMETER technology is being developed in collaboration with Oak Ridge National Labs, the University of Virginia, and Virginia Commonwealth University.