SMARTBrain Retractor

SMART Technology Need

In order to decrease complications and morbidity rates associated with neurosurgery, hospitals and physicians are looking to the widespread adoption of intraoperative neurophysiological monitoring (IONM) systems. IONMs employ various electrophysiologic modalities such as electroencephalography (EEG), electromyography (EMG), and evoked potentials, to monitor the functional integrity of certain neural structures during surgery. In essence, IONMs provide the neurosurgeon vital realtime data of the patient’s condition and specifically the status of the tissue in the operating site in order to provide health status and early complication warnings.

The use of these systems has led to significant reductions in surgical morbidity over the last few decades.  Although most often used during surgery of the head, neck, and spinal cord, IONM systems are also used in orthopedic, cardiac, urologic, otolaryngology, and other surgeries, as well as during neuro-interventional radiology imaging.  The greatest use is believed to be during spinal cord surgery, where the reduction in morbidity has also been the greatest. The cost of these systems can range from $30,000–$50,000 or more depending upon the specific configuration.

SBR Market

Neuro-Kinesis’ SmartBrain RetractorTM (SBR) integrated biosensor array is able to provide a neurosurgeon this important telemetry for use in neurocranial surgeries at a fraction of the cost.

It is estimated that more than 179,000 craniotomies are performed in the United States annually with that number growing at a rate of 3.1 percent a year. Traditional brain retractors are used in just more than 85 percent of those surgeries. These surgeries employing brain retractors will be predominantly for malignant and benign brain tumors and for cerebral aneurysms and intracranial hemorrhage.

The top four indications for using brain retractors were identified as:

  • Malignant brain tumors
  • Benign neoplasms of the brain
  • Cerebral aneurysms, nonruptured
  • Bleeding into the cranium

Although global monitoring of the brain during neurosurgery is now widely accepted, the variety of different brain retractors available all have in common a lack of feedback on the local physiological status of the brain tissue being retracted. As the published incidence of retractor related morbidity in these surgeries is 5 percent to 10 percent, a need is perceived for better monitoring of the physiological status of the brain tissue being retracted. The SBR can provide real-time monitoring that allows it to alert the surgeon to potential impending damage to the retracted brain tissue. The potential market for the device can be conservatively estimated to baseline at $40.3 million in 2020 with maximum potential revenues of $70.8 million.

In a study conducted for the company by Frost & Sullivan in 2010 surgical rates for these four indicators were extrapolated to determine the potential market share growth of the SBR from 2015 to 2020. As diagnoses of malignant brain tumors were forecast to decrease at a rate of 2.3 percent per year, while benign brain neoplasms, nonruptured cerebral aneurysms, and bleeding into the cranium were forecast to grow at rates of 4.2 percent, 6.3 percent, and 7.9 percent per year, respectively, the following chart shows the number of operable cases where the SBR would be needed and could have a significant impact on the outcome.

Surgical Category% of cases requiring surgery2015
total cases / operable cases
2016
total cases / operable cases
2017
total cases / operable cases
2018
total cases / operable cases
2019
total cases / operable cases
2020
total cases / operable cases
Malignant Brain Tumors95%52,127 / 49,52151,104 / 48,54950,082 / 47,57849,059 / 46,60648,036 / 45,63447,013 / 44,663
Benign Neoplasm of Brain75%73,637 / 55,22876,337 / 57,25379,037 / 59,27781,736 / 61,30284,436 / 63,32787,135 / 65,352
Cerebral Aneurysm50%57,566 / 28,78360,787 / 30,39364,007 / 32,00467,228 / 33,61470,449 / 35,22473,669 / 36,835
Bleeding Into Cranium100%23,968 / 23,96825,631 / 25,63127,293 / 27,29328,956 / 28,95630,618 / 30,61832,281 / 32,281
TOTAL207,299 / 157,500213,859 / 161,826220,419 / 166,152226,979 / 170,478233,539 / 174,804240,099 / 179,130

Based on these projections, SBR projected revenues were calculated using the following assumptions.

  • Market penetration estimates were based on the sampled neurosurgeon interviews conducted for the study.
  • The maximum potential use of the SBR in craniotomies was estimated to be 70.8 percent of all craniotomies (85.5 percent of craniotomies involved the use of a brain retractor multiplied by 82.8 percent potential use reported by the neurosurgeons interviewed).
  • Licensing revenue from the sensor sleeves was estimated at $500 per sensor sleeve, based on capturing 50% of an estimated $1,000 value increment for the monitor manufacturer.
 201520162017201820192020
Number of Craniotomies157,500161,826166,152170,478174,804179,130
Market Penetration15%23%30%36%41%45%
Sensor Arrays Sold23,62537,22049,84661,37271,67080,608
Sensor Array Revenues$11,812,514$18,609,999$24,922,796$30,686,015$35,834,769$40,304,169
NOTE: This model is based on the best estimates available at this time.

 

key statistics

  • The need for realtime telemetry for both patient and site tissue health is of increasing demand.
  • This need has led to the widespread adoption of Intraoperative Neurophysiological Monitoring (IONM) systems.
  • These systems currently cost a facility between $30,000 to $50,000 depending upon configuration.
  • The SBR can provide all the needed realtime data for neurocranial operations at a fraction of the cost.
  • With more than 179,000 craniotomies performed in the US with an anticipated increase of 3% /year, the market for SBR technology is tremendous.
  • Based on a study performed by Frost & Sullivan, market revenue for the SBR technology is conservatively calculated to be the baseline at $40.3 million in 2020 with maximum potential revenue of $70.8 million.