The Problem

Problems with the conventional electrode application methods include:

• Trained electro-neurodiagnostic technologists are typically required to place the electrodes, connect the leads and record the EEG. There is a critical shortage of registered technologists, so much so that hospitals now contract with outside firms to administer EEGs on an outsourced basis – which is expensive.  There are only 10-12 schools in the U.S. training technologists.  Each school typically graduates less than 20 persons per year.
• The shortage of registered technologists causes many hospitals to limit or forego the use of EEG.
• Even registered technologists do not always measure the placement of electrodes, resulting in inconsistent electrode locations and EEG results.
• Due to practitioner shortages, EEGs are often performed by untrained or cross-trained personnel and the test results may be are inadequate for diagnostic purposes.
• Typically, setting-up an EEG can take 25 to 45 minutes.
• Even though digital EEG processing equipment is becoming more widespread, signal acquisition with old electrode methods involve significant noise and electrical interference, distorting EEG results.  Existing electrode methods typically use a waxy paste cream to affix the electrodes to the scalp and facilitate conductivity, but the paste is not optimal for reducing impedance and electrical interference.
• Loose, spread out wires result in an antenna effect and can cause electrical artifact and spurious results.
• The more advanced digital EEG monitoring equipment is designed for ease of use by “non-expert” doctors and nurses, but the technological advantages of the new equipment is undermined by the archaic electrode signal acquisition systems that require experienced technologists and hinder signal quality, among many other problems. Thus, hospitals cannot take advantage of the advanced ICU/ER monitoring equipment.
• Patients may be comatose or combative and difficult to control, making conventional electrode placement even more challenging.
• Most electrodes and lead wires are reusable, yet there are no uniform standards for cleaning them, and infection can easily result. Often reusable electrodes soaked in a sink used for washing hands, and a dirty tooth brush is used to clean electrodes. And leadwires are seldom unplugged from the amplifier when cleaned.  The unclean nature of conventional EEG administration may lead to infections that are not only avoidable and unacceptable, but addressing conditions caused by those infections are not longer reimbursable by Medicare.
• Just affixing standard electrodes to the scalp can involve abrasions, as pumice -- an abrasive -- is used in the preparation and a heavy hand can exfoliate the skin and cause bleeding.
• Up to 2 dozen leadwires are used, one for each electrode. Besides increasing the risk of infection, these leadwires can introduce electrical artifact into the EEG, creating inaccurate or misleading results.
• One of the greatest problems facing neuro-critical care today is not having the means to perform emergency EEGs. Current protocols call for EEGs within 30 minutes for the approximately 5 million ER and ICU patients with possible status epilepticus or brain injuries annually. Yet EEG set up time, shortages of qualified staff and the other factors mentioned above artificially restrict the availability of EEGs.

These problems and others are widely regarded as restricting the use of EEGs, even though there is a pronounced and growing need for them to diagnose a widening scope of medical conditions. In effect, the supply of resources has not kept up with the demand.

The Solution

The StatNet headpiece is a disposable soft layered integrated circuit “sandwich” that solves virtually all of the problems of conventional EEG electrode applications. Its revolutionary “peel and stick” EEG headpiece is pre-gelled, embeds silver-etched integrated wiring, and does not require prepping of the skin before application. Its intended use is for ER, ICU, OR or any other situation requiring a fast determination of a patient’s brain activity. Benefits include:

• The headpiece takes an average of 5 minutes to apply.
• Because the electrodes are part of the headpiece, in predetermined locations, consistent electrode placement is virtually assured.
• The integrated nature of the device -- essentially a pliable printed circuit board.
• The headpiece can be set up by doctors, nurses and other practitioners with no EEG training.
• The StatNet uses two simple connectors, eliminating errors and infection-related issued with in leadwire connection.
• Virtually no patient preparation is required; the electrodes are pre-gelled.
• Results can be read by a physician either on-site, or remotely via the Internet.
• Using the StatNet increases the productivity and satisfaction of all users, including registered technologists.
• The headpiece is very comfortable and can be worn for extended periods of time, up to 4 hours. It can be re-gelled for longer use.
• Because it is disposable and does not abrade the skin, the risk of infection is very low.
• There is a single integrated cable, reducing noise and artifact that can otherwise distort test results.

The first application of the technology is for STAT or emergency situations, but future configurations can readily be made to accommodate long-term epilepsy studies, traditional EEG applications, sleep diagnostics and even mobile applications in ambulances, in the battlefield or on football fields.

FDA 510(k) clearance was obtained in January, 2010. EU approval is expected later in 2010.

The StatNet™offers significant clinical and other benefits over conventional electrodes as well as direct direct and indirect cost savings. StatNet™ reduces labor cost, resource tie-ups, set up time, clean up time, the cost of managing a possible infection of the patient, provider or other person, and the possible need to re-do the procedure due to inaccurate first-time results, among other savings. Furthermore, the provider’s liability is reduced because of reduced risk of infection and improved patient prognosis. Studies have shown that a typical healthcare acquired infection (HCAI) can cost $50,000 to $90,000 besides risking the life of the patient.

Some StatNet Benefits/Savings

Labor Savings -- Do not need a trained technologist and even nurses and other practitioners would spend less time administering an EEG.

Resources Savings -- The faster time to administer an EEG frees up hospital resources to perform other revenue generating services.

Accuracy Benefits --  StatNet's more precise nature significantly reduces the probability of having to repeat an EEG because the results were uncertain.

Safety Benefits -- StatNet's single use, safer and more sanitary design can significantly reduce infections to and from patients and practitioners and save substantial sums in treating an unreimbursable hospital-borne infection.

Revenue Benefits -- StatNet makes EEGs more accessible to more conditions, especially in the ER and ICU, and makes brain dysfunction diagnosis more accurate so that the proper treatment can be administered.

Outcome Benefits -- Because EEGs can be given more accurately and more safely to more patients, outcomes are likely to improve.

Staff Morale Benefits -- Because of the issues associated with standard electrodes and EEG interfaces, hospital staff is reluctant to get involved.  StatNet changes the picture.