Market research has suggested that neuromodulation devices make up the fastest-growing segment of the medical device sector, forecasting some $7 billion in sales within five years. Although medical device giants Medtronic, St. Jude Medical and Boston Scientific dominate the market, there are a number of young companies working on nerve stimulation devices to treat pain and bladder control issues, and other nerve-related disorders.
One of those companies, Case Western Reserve University spinoff ConservoCare LLC, recently reached an important milestone by securing licensing options from the university to develop a nerve stimulation device that restores bladder function in patients with urinary retention or incontinence.
ConservoCare says patients with spinal cord injuries will likely be the first to benefit from its device, which comprises implantable nerve cuff electrodes, a stimulator and a wireless control unit that directs the activation of the device.
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Some patients with spinal cord injury and infection experience nerve damage that affects their urethral sphincter, a group of muscles in the pelvis that control the flow of urine from the bladder. When those muscles don’t work properly, the bladder may not be able to empty properly, putting the patient at risk for urinary tract infections or kidney problems.
ConservoCare’s device uses high-frequency electrical nerve stimulation to eliminate spasms of the urethral sphincter and allow the bladder to function. Medtronic’s InterStim device works in a similar way, using electrical pulses to modulate the sacral nerves that control the bladder.
“The ConservoCare implant will provide doctors a safe, reversible alternative to destructive and ineffective treatments,” said company President Adam Boger in a statement.
As a former research assistant at Case’s Neural Engineering Center, Boger was part of the research team that developed the technology. The startup company has since been doing preclinical feasibility work on the device with Kenneth Gustafson, an associate professor and research scientist whose own lab at the Louis Stokes Cleveland VA Medical Center has been developing prostheses to restore bladder function.
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In order to proceed with feasibility testing in humans, ConservoCare needs an OK from the FDA. That’s part of the startup’s plans for 2013, along with validating a screening protocol.
So far, the company has been financed by a $125K Phase I Small Business Technology Transfer grant from the National Institutes of Health, and by Case’s Translational Research Partnership with the Wallace H. Coulter Foundation. It’s based in Atlanta, where Boger is studying intellectual property law at Emory University.
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