FDA approval of RapidAI’s software can potentially accelerate growth of ischemic stroke market

GlobalData Healthcare 28 August 2020 (Last Updated August 28th, 2020 15:20)

On August 13, 2020, RapidAI received FDA clearance for its large vessel occlusion (LVO) detection software, which is claimed to identify suspected LVOs in as few as three minutes. GlobalData expects that this software has the potential to rapidly increase the patient pool of LVO patients, in turn increasing market opportunity for manufacturers in this space.

FDA approval of RapidAI’s software can potentially accelerate growth of ischemic stroke market

On August 13, 2020, RapidAI received FDA clearance for its large vessel occlusion (LVO) detection software, which is claimed to identify suspected LVOs in as few as three minutes. GlobalData expects that this software has the potential to rapidly increase the patient pool of LVO patients, in turn increasing market opportunity for manufacturers in this space.

LVOs are the most disabling ischemic strokes for which thrombectomy procedures have been shown to produce effective outcomes. However, treatment is time-sensitive and only select patients are eligible for treatment. GlobalData estimates that there are over 300,000 LVO cases per year in the US but only around 10–15% of all LVOs undergo thrombectomy procedures.

Rapid LVO will allow physicians to screen patients at a much faster rate, potentially identifying and triaging eligible patients who were previously missed, or were identified as being eligible, but had passed the allotted time window for receiving a thrombectomy procedure due to slower decision-making. RapidAI is currently the only clinically validated platform and is considered the gold standard for advanced cerebrovascular imaging.

GlobalData estimates that while the number of thrombectomy procedures is currently growing at a compound annual growth rate (CAGR) of 10–15% each year due to better availability of resources and awareness of better patient outcomes from this procedure, RapidAI’s software could potentially accelerate this into a high double-digit growth, as more patients are treated.

The fast growth of thrombectomy procedures will open up many opportunities in thrombectomy devices, particularly in aspiration catheters. Aspiration catheters are continuously improving, allowing for faster removal of the clot compared to stent retrievers, and usage is also growing among new physicians and facilities as the first line of treatment given their ease of use. This creates a huge opportunity for existing manufacturers dominating this space, such as MicroVention and Penumbra, to continue gaining a larger share of the ischemic stroke market.