Market overview
IRRAS´ clinical focus areas are neurosurgical treatments requiring drainage of excess cerebrospinal fluid, CSF (brain and spinal fluid), and monitoring and regulation of intracranial pressure. The treatments are often associated with traumatic brain injuries (severe blows or impacts to the head or body) and intracranial bleedings such as hemorrhagic stroke (bleeding in the brain) and chronic subdural hematoma (blood accumulation on the surface of the brain).
High need to advance the standard of neurocritical care
There is a great need to establish a new standard of care for patients suffering from traumatic brain injury and intracranial bleeding. These patients are critically ill, often with life-threatening conditions. Yet, they are generally treated with primitive technologies that are plagued by complications. When the brain is disturbed by traumatic brain injury and intracranial bleeding, its ability to autoregulate is often impacted and the ICP can increase to unsafe levels. When this happens, it is of vital importance to drain excess fluid to reduce the swelling of the brain and stabilize the patient.
Primitive drainage systems
Drainage systems, such as external ventricular drains (EVD), are used to manage a patient’s intracranial pressure. By draining excess fluid, an EVD plays a critical role in the recovery of these patients. However, EVDs are generally unsophisticated systems that rely solely on gravity and, as a result, they have been plagued by complications that are well documented in scientific publications, including catheter blockage, infections, excess drainage, and secondary bleeding, any or all of which can result in a negative impact on patient outcomes. It is also known that use of an EVD can lead to incomplete drainage and prolonged treatment times.
Neuromonitoring with limitations
After a traumatic brain injury, brain hemorrhage or other events requiring neuro intensive care, it is important to determine the severity of the patient’s condition and to use diagnostic tools to measure when the patient’s intracranial pressure rises to excessive levels. Placing an ICP monitor in the brain itself can help detect excessive swelling of the brain. Conventional methods of measuring a patient’s intracranial pressure have been accomplished by measuring the pressure through the water column confirmed by a ventricular drainage catheter or a specific ICP probe using fiber optics or strain gauges. Each method has its limitations. A major limitation is the lack of regular calibration which causes the sensor to report inaccurate pressure values over time. The cumulative pressure difference can have negative implications for the patient’s treatment and prognosis.
Advancing the standard of care
IRRAS’ proprietary IRRAflow and Hummingbird product families address the complications associated with EVD and ICP monitoring. The IRRAflow technology provides a controlled fluid exchange system that allows the neurosurgeon to actively manage intracranial pressure and cerebrospinal fluid drainage. Through a process known as active fluid exchange, IRRAflow uses automated irrigation to ensure continuous drainage, reduce the incidence of catheter blockage and associated infection, and dilute toxic blood by-products, making them easier to remove. IRRAflow is the only system that integrates needed fluid drainage, targeted fluid irrigation, and measurement of intracranial pressure in one product. This combination makes it possible to transform the treatment of these critically ill patients from a passive reactive approach to a proactive therapeutic approach. From its commercial launch to date, IRRAflow has been used in over 700 patient treatments in the US and Europe with no reported cases of catheter blockages when IRRAflow’s irrigation has been actively employed, as reported in up to 47%1 of cases where traditional drainage is used.
Large addressable market
Each year, in the US and EU alone, approximately 5.4 million people are affected by traumatic brain injury. , Of those patients, approximately 235,000 people require invasive monitoring of their intracranial pressure where the Hummingbird ICP system can be used. Accordingly, the market value of the Hummingbird line in these regions is estimated at approximately USD 600 million per year. In addition, around 600,000 people in the US and Europe suffer from hemorrhagic stroke and chronic subdural hematoma annually, and approximately 345,000 of these people are treated surgically. In these situations, once the bleeding is under control, the excess blood and the pressure that it creates must be urgently removed to stabilize the patient’s condition. These patients, requiring treatment following intracranial bleeding, represent an addressable market size in Europe and the US combined for the IRRAflow products of approximately USD 1.8 billion, according to IRRAS´estimate based upon current average selling prices. An expansion into targeted intracranial drug delivery in the future would add approximately USD 4.6 billion.
Variety of reimbursement payment models
Medical devices used by healthcare providers are usually financed by insurance companies or public payment systems. In the US and many European markets, the use of products such as IRRAflow and Hummingbird is reimbursed through an established DRG (Diagnosis Related Group) system, a classification of hospital compensation for a procedure. Payment is based on the resources used, length of hospital stay, and the medical device costs. Depending on the treatment, an average DRG payment in Germany, the largest EU market, can reach up to EUR 36,700. Approximately EUR 3,000 of this payment can be earmarked for IRRAflow’s disposable, single-use items. The hospital is usually responsible for the investment of small pieces of capital equipment. In the US, hospitals are paid directly by patients and various public and private third-party payers, including federal Medicare, state-run Medicaid and private health insurance. The average DRG payment can range from USD 35,000 to USD 65,000, depending on the complexity of the procedure.
1. Fargen KM, Hoh BL, Neal D, O’Connor T, Rivera-Zengotita M, Murad GJ. The burden and risk factors of ventriculostomy occlusion in a high-volume cerebrovascular practice: results of an ongoing prospective database. Journal of Neurosurgery. 2015:1-8.
2. Centers for Disease Control and Prevention (2019). Surveillance Report of Traumatic Brain Injury-related Emergency Department Visits, Hospitalizations, and Deaths—United States, 2014. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services
3. Center-TBI EU Traumatic Brain Injury Fact Sheet and Policy Brief.
4. Market Study Report, Global Intracranial Pressure (ICP) Monitoring Devices Market Growth, 2019–2024.
5. Market data from L3 consulting and internal analysis. Combination of incidence rates combined with market specific DRG reimbursement data.
6. The company’s estimate is based on the approximate number of surgically operated cases of hemorrhagic stroke and cases of chronic subdural hematoma in the EU and USA multiplied by the average sales price of the disposable components (IRRAflow tube set and catheter) of the IRRAflow system.
7. Grandview Research Report.
Regulations and requirements
Before any medical device can be commercially marketed, it must demonstrate compliance with the regulatory requirements set by local and global regulatory authorities. Approval in Europe is based on the EU’s common directives and regulations governing medical devices. Products that prove they meet these regulatory requirements are considered CE marked, which allows the product to be sold in any EU country. The United States Food and Drug Administration, FDA, provides the corresponding approval for sales and marketing in the US. IRRAflow received its CE Mark certification in December 2019, which is valid until April 2024. Both IRRAflow and Hummingbird have been approved for use in FDA-regulated markets, including the United States. Many countries in Asia, Latin America, the Middle East, Australia, Canada and Africa are not subject to the CE Mark or FDA approval process. Instead, they generally have direct registration processes based on the documentation required in Europe or the US. Since 2021, IRRAS’ quality management system is certified under the Medical Device Single Audit Program (MDSAP). MDSAP is a rigorous audit process established to enable medical device manufacturers to undergo a single regulatory audit covering the requirements of participating regulatory jurisdictions in Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW) and the United States (FDA). By successfully completing the MDSAP audit, IRRAS has demonstrated that it meets stringent requirements related to the design, development, manufacturing and sale of its products. During 2022, IRRAS received its initial regulatory clearance for IRRAflow in Australia.