Stroke Intervention Market Gets Even Hotter
The clinical practice guideline for stroke intervention was recently revised to expand the time window for intervention. I’ll start with a quick summary of the significance of clinical practice guidelines, then explore which companies are poised to benefit the most from the expanded guidelines.
Clinical practice guidelines (“CPGs”) are descriptions of the best practices for a given clinical situation, including direction for diagnostic approaches, treatment decisions, and follow-up activities. They represent the consensus opinion of key opinion leaders and specialists in a given medical field and are typically based on significant clinical evidence. In many ways, CPGs can be seen as a how-to guide for medical decision making.
Because of the influence that CPGs have on the way medicine is practiced, the introduction of new or revised guidelines has impact far beyond patient care decisions.
Reimbursement: CPGs are typically a major driver of reimbursement decisions by healthcare payers. A revised CPG which expands the recommended patient age for a certain therapy may result in a healthcare payer deciding to reimburse for that therapy across a larger patient age set.
Regulatory Approval: A major component of regulatory approval is the demonstration of clinical efficacy. Because CPGs often establish the time-to-intervention or appropriate patient population for a therapy, new CPGs often shape the context for regulatory decisions regarding data required to support clinical efficacy.
Commercial opportunities for existing products: as a result of items #1 and #2, companies who provide products or services that are affected by a revised CPG will likely see a direct change in demand, in line with the recommendation of the CPG.
New product development: items #1-3 directly impact the two macro factors that dictate whether a new product will be commercially successful: market value and regulatory environment. If a CPG expands the recommended patient age for a therapy, it could have the double-upside of increasing the value of the addressable market for that therapy as well as making the statistical support for clinical efficacy less burdensome.
The 2018 Guidelines for the Early Management of Patients with Acute Ischemic Stroke established that for patients with large vessel occlusion, mechanical thrombectomy (i.e., physically removing the blood clot) is safe up to 16 hours after the stroke for select patients; the previous guideline recommended intervention only up to 6 hours post-stroke. It also established under certain conditions, specifically when advanced brain imaging is available, that mechanical thrombectomy is safe up to 24 hours after stroke. Finally, the guideline broadened the eligibility for administration of IV alteplase (Genentech’s Activase) to include patients with mild stroke instead of only those with severe stroke.
Taken together, the major points of the revised CPG have increased the attractiveness of the already-hot stroke therapy market. This is because the revisions result in an increase in patients eligible for existing treatments (due to the expanded time horizon and severity criteria) and provide more margin for the analysis of safety and efficacy data for treatments currently being developed.
There are a few established players active in the acute ischemic stroke treatment space, as well as a growing number of companies with therapies currently in development. Refer to Table 1 for a summary of these companies and products.
Table 1: Summary of acute ischemic stroke interventions currently on the market or in development
Among these companies, there are two particularly poised to capitalize on the expanded guidelines
Medtronic ($MDT) is the current leader in devices to treat acute ischemic stroke, with their Solitaire platform and Riptide devices. MDT was a co-sponsor of the DAWN and DEFUSE-3 clinical trials, which concluded in 2018 and provided the evidence that drove the expansion of the clinical practice guidelines. MDT is also a co-sponsor of the SWIFT DIRECT clinical trial (currently enrolling) designed to demonstrate whether mechanical thrombectomy alone is as effective as a combination treatment of mechanical thrombectomy with IV t—PA pharmaceutical intervention. This puts them in the driver’s seat in shaping the next generation of acute stroke intervention.
DiaMedica ($DMAC) showed promising results in an early clinical trial of DM199 (which is a recombinant form of a protease already used in Asia as a treament for acute ischemic stroke) and in December successfully completed an IPO to fund REMEDY, a multi-center, double-blind, randomized, placebo-controlled Phase 2 clinical trial.
In summary, the ongoing unmet need for acute ischemic stroke treatments continues to drive paradigm-shifting research. This research has led to a recent expansion in the clinical practice guidelines for stroke intervention, and there are several companies who stand to benefit including $MDT and $DMAC.
Sources:
2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association, Stroke.
New ischaemic stroke guidelines widen mechanical thrombectomy window to 24 hours in selected patients, Neuro News.
Potential benefits, limitations, and harms of clinical guidelines, BMJ.
Clinicaltrials.gov