Occupies Peripheral Position in Neurodiagnostics Market
by James Cavuoto, editor
While several companies competing in the neurodiagnostics market
have chosen to concentrate on the central nervous system, manufacturing
devices such as electroencephalography or magentoencephalography
systems, Waltham, MA-based NeuroMetrix
Inc. has set its sights on the peripheral nervous system. The
company, founded in 1996 by Shai N. Gozani as a spin-off from the
Harvard-M.I.T. Division of Health Sciences and Technology, manufactures
a new class of non-invasive products for point-of-care testing of
NeuroMetrix founder Shai Gozani invented most of the core technology
in use at the firm. He holds degrees in computer science, biomedical
engineering, and neurobiology from the University of California,
Berkeley, and a medical degree from Harvard Medical School. He has
been an instructor of both neurophysiology and electrical engineering
at Harvard and nearby Massachusetts Institute of Technology.
The venture capital firm Harris &
Harris Group was the original seed investor in NeuroMetrix in
1996. Other investors included Whitney & Co., BancBoston Ventures,
Delphi Ventures, Commonwealth Capital Ventures, and MIT. The firm
closed a second round of financing of $14 million in 1999 and a
third round of $13 million in 2001.
Among the peripheral nerve disorders that NeuroMetrix is
targeting are repetitive stress injuries, diabetic and toxic neuropathy,
and low-back pain. Perhaps the most common form of repetitive stress
injury is median nerve entrapment (often referred to as Carpal Tunnel
Syndrome). It occurs because of excessive pressure on the median
nerve as it runs through the carpal tunnel. The median nerve may
become pinched or entrapped between the swelling of the flexor tendons
and carpal bones of the wrist.
Ulnar neuropathy can be caused either by entrapment or by systemic
factors. The most common entrapment is called cubital tunnel syndrome,
which occurs at the elbow. Entrapment of the ulnar nerve at the
wrist, known as Guyons canal syndrome, is less commonly seen.
Ulnar neuropathy can also occur as the result of a systemic neuropathy,
such as diabetes or drug toxicity. Systemic neuropathy can result
from diabetes, drug toxicities, and toxic exposures.
The companys current product line includes a nerve-conduction
monitoring system called NC-stat, biosensors used with the median
and ulnar nerves, and a management information system that connects
a clinicians office with a report-generation system engine
located at NeuroMetrix offices. NC-stat includes a battery-operated
monitor, preconfigured disposable biosensors, and a docking station
that receives patient data from the monitor and transmits it to
the companys onCall information management service.
The monitor measures DML and F-wave latency by stimulating the median
or ulnar nerve with short electrical impulses. The system then detects
and processes the bioelectric activity associated with the particular
muscle response. Using a process known as volume conduction, NC-stat
eliminates the need to locate specific recording sites on a muscle.
Clinical trials have demonstrated that NC-stat yields DML and F-wave
latency values virtually identical to those obtained with traditional
electrode positioning. NC-stat received FDA approval for sensory
nerve evaluation in 2001 and for lower extremity nerves in 2002.
The median and ulnar biosensors incorporate electronic circuitry,
stimulating and sensing electrodes, a proprietary electrochemical
gel, and a temperature sensor that automatically adjusts for temperature
variations at the measurement site. Each single-use biosensor is
preprogrammed with a unique serial number to link patients to their
test results. NeuroMetrix maintains that its biosensors eliminate
the most time-consuming and error-prone steps in nerve conduction
studies: placement of electrodes on the patient and connection of
electrodes to the diagnostic instrument.
In the long run, perhaps the most lucrative product in the NeuroMetrix
line is its onCall Information Management System. Neurotech
Reports projects the market for neurodiagnostic reports to grow
from $26 million this year to $110 million in 2005. Physicians access
onCall via the Internet or fax. The onCall website provides physicians
patient specific information that corresponds directly
to the information contained in the onCall report.
Physicians may search the onCall database for recent visits, collect
all nerve conduction study results on a specific patient ID, or
query for the most elevated or abnormal results. The web site also
provides population based information that summarizes
the practices patient population. Reports can be generated
that summarize nerve conduction study results, by organization group,
age, height, and other patient parameters.