How to Revolutionize Treatment for Ischemic Stroke?
Next-gen Medtech Startup Perfuze Leads the Way
By John Yianni, Partner at Earlybird Health
Every year, seventeen million people globally suffer a stroke.¹ Stroke is the second most common cause of death worldwide¹, often leaving victims debilitated and their families physically and emotionally vulnerable. There has to be a solution.
So what is ischemic stroke? It occurs when a blood clot travels through the arteries to the brain, restricting blood flow, and leading to warning signs and symptoms we might be familiar with: numbness limited to one side of the body, garbled speech, vision changes, confusion, and loss of balance. Brain tissues require constant oxygen and nutrients, without a blood supply the brain cells will not survive and will die in minutes. As a result, an ischemic stroke is considered to be a medical emergency and the prompt removal of the blood clot is crucial to reduce its potentially devastating consequences.
If we first consider how ischemic stroke has been historically treated, the original intervention consisted of a class of medication that dissolved the blockage. These drugs, called tissue plasminogen activators (tPAs), are associated with a limited clinical benefit (11–13% improvement) to ischemic stroke patients, primarily due to their therapeutic lag time.² Subsequently the first thrombectomy (or clot extraction) device emerged as a potentially time-saving alternative. Aptly named Stentrievers, they are catheter-based metallic cages that snare blood clots and resolve blockage to the arteries mechanically, offering a more targeted and rapid alternative to the drug-based intervention.
However, there is a caveat: due to design limitations, they either do not fully retrieve blood clots or they break the clots up into fragments that can potentially go further into the brain and induce another stroke in the smaller downstream vessels. Therefore, these technologies, while an improvement over the use of tPA drugs, are still not the optimal solution. At present, we see new generations of aspiration devices being launched that are designed to retrieve the majority of the clot via vacuum. Nonetheless they still possess significant procedural limitations and complications.
As a response to the short comings of existing stroke technology, Perfuze has built a solution that might become the next disruptive innovation in stroke treatment and transform the stroke treatment market. Its large diameter catheter with extraordinary flexibility and navigation capabilities allows Perfuze to go deeper within the brain, closer to the clot and generate greater aspiration power to potentially remove clots more fully and in fewer passes.
As a response to the short comings of existing stroke technology, Perfuze has built a solution that might become the next disruptive innovation in stroke treatment and transform the stroke treatment market.
Enter Perfuze
Incorporated in Ireland, Perfuze is led by cofounders Wayne Allen and Liam Mullins. Both previously founded Embo Medical which developed vascular embolization devices to treat diseased peripheral vessels (a condition affecting blood vessels outside of the heart) and was sold to BARD in 2015.
I knew the team well and had developed a relationship with them prior to their founding Perfuze. When I was first introduced to their technology in 2018, it was immediately clear to me that Perfuze’s innovation would bring to the stroke treatment field, significant improvement over other technologies that were available or are currently in development – whether via clot retrieval or aspiration methods. I previously had experience in the stroke interventional field via Reverse Medical which I co-founded some years earlier and that had since been acquired by Medtronic in 2014.
Perfuze’s proprietary Millipede catheter technology is designed to ingest the complete blood clot in a single attempt. Its flexible catheter construction offers physical and mechanical adaptations to access blood vessels within the deep brain regions and its large diameter increases aspiration power by 50%, which increase the potential for complete clot aspirations. The flexibility and increased aspiration power of their aspiration catheters are the reasons behind the promising outcomes in removing clots and restoring normal blood flow to the brain. See the explainer video below:
The technology has proven excellence through prestigious grants received from Horizon 2020 and the Disruptive Technologies Innovation Fund. Moreover, the Perfuze team demonstrated their experience throughout their preclinical and clinical studies.
Not only did they a) achieve the “FDA breakthrough device” designation approval as the first interventional treatment for stroke, b) receive CE Mark approval at the beginning of this year, but c) since their commencement of first-in-man (a milestone clinical phase) in March, they’ve confirmed eleven successful clinical cases to date – without significant device modifications. Normally, the development of medical devices is a costly and time intensive process from the standpoint of R&D, as major refinements are often necessary after clinician feedback from the first human cases. Perfuze accelerated this process through the building of a strong in-house R&D and catheter manufacturing capability.
The Earlybird Health team is proud to be associated with this tremendously innovative technology which is already demonstrating its life-saving capabilities in early clinical use. Earlybird positions the potential impact on patient outcomes at the forefront of our thinking when we consider investment targets. Perfuze is a perfect example of how our investment criteria can bring value to patients and bring cutting edge new technology to medical market. Furthermore, we believe that the positive, early clinical data and optimistic clinician feedback will position Perfuze very favorably for their upcoming Series A round.
Earlybird positions the potential impact on patient outcomes at the forefront of our thinking when we consider investment targets.
Stay tuned! If you are revolutionizing healthcare and want to reach out to us at Earlybird Health, please visit our contact page.
References
1. Mozzafarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al., on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics — 2016 update: a report from the American Heart Association. Circulation 2016;133(4):e38–360
2. Marler JR, Tilley BC, Lu M, et al. Early stroke treatment associated with better stroke outcome: the NINDS rt-PA stroke study. Neurology 2000;55:1649–1655.
