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A simple, repeatable way to completely remove a clot from the brain in one pass

Periodic Reporting for period 1 - Perfuze (A simple, repeatable way to completely remove a clot from the brain in one pass)

Reporting period: 2019-08-01 to 2020-07-31

Perfuze is developing clot removal, medical device technology, the Millipede Clot Ingestion System (CIS) to treat Acute Ischemic Stroke.

Acute Ischemic Stroke (AIS) Stroke is a devastating disease, it is the No. 2 cause of death and the leading cause of adult physical disability. Globally, 17 million people had a stroke in 2019. Of these, 33% died and 33% were permanently disabled. A stroke occurs when an artery in the brain is blocked by a clot, preventing blood flow, restricting oxygen and nutrients and inducing brain damage.

The clinical and economic burden on health providers is enormous. In 2018, in the EU and US, the direct and indirect healthcare cost of stroke was estimated at greater than €100 billion. Between 2012 and 2030, total direct medical stroke-related costs are projected to triple. Among patients discharged from the hospital after stroke, 30% are discharged to long-term nursing facilities.

These mediocre outcomes are no longer acceptable.

The critical metric for assessing a positive clinical outcome post treatment is complete reperfusion i.e. complete extraction of the clot from the brain. Today, complete reperfusion is achieved on the first attempt in approximately 31% patients. To improve clinical outcomes the physician requires tools that enable the entire clot to be removed from the brain in a single pass. Perfuze has designed technology that can increase this number significantly, our testing to date indicates that we achieve this in up to 90% of cases.

The overall objective of the H2020 project is : 1)validate the technology in a First-In-Human clinical study 2) prepare the company for EU commercialisation and scale, and 3) secure US regulatory approval for a large clinical trial.

Our vision is to completely reperfuse (restore blood-flow) the brain in order to dramatically improve outcomes, and reduce healthcare costs.
The project has been very well received by our key stakeholders, primarily physicians and hospital purchasers. The problems Perfuze are attempting to address still remain. Clinical appreciation of the potential advantages of the Perfuze Millipede technology in improving stroke outcomes is increasing, with a number of physicians approaching us to participate in future clinical studies. The publication of our first clinical paper has significantly increased awareness of Perfuze and our technology in the clinical community.

Summary of pertinent points of the project so far:

- We have doubled our headcount from 7 to 14 employees. In relation to gender balance, Perfuze continues to be an equal opportunities employer, we now have a workforce of 8 males and 6 females.

- Device Design and Performance: We have successfully performed three cadaver (human body, donated to science) studies on 7 cadaver specimens with multiple device modifications and iterations. Each cadaver study was a significant input into selecting the final design

- Research and development: Comprehensive tests have been developed for all critical performance characteristics. Competitive head to head testing has been conducted across a range of attributes to verify and establish benchmarks for performance and pass fail criteria in design verification and validation testing.

- Manufacturing Capability: In-house manufacturing capability is in place including a fully controlled cleanroom with ability to manufacture large lots of devices. This capability has been pivotal in our ability to execute on the project throughout the Covid-19 pandemic since we have limited reliance on outsourced manufacturing partners. Approved operating procedures for manufacture of the device are in place. We have a credible cost of manufacturing model with potential reduction options.

- We are on track to submit for both EU and US regulatory approvals

- We have received approval to proceed to treat our first patient
In August 2019, we were granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). The designation recognises the novelty of the Millipede technology and its potential to offer significant advantages over existing alternatives for treatment of acute ischemic stroke. Breakthrough Device Designation from the FDA is granted to certain medical devices that provide for a more effective treatment of life-threatening or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development, assessment, and review. Additionally, we have developed in-house sophisticated test capability to assess the performance of the device in the laboratory. To our knowledge Perfuze is the only company using doated, real human blood clots to develop blood clots for testing. In June 2020, we published our first academic paper in the prestigious Journal of NeuroInterventional Surgery (JNIs) articulating the major outcomes of this test program to date and demonstrating superior performance comparison with currently marketed technologies.

The expected results to the end of the project are as initially intended. Perfuze will complete the following before the
- validate the technology in a First-In-Human clinical study
- prepare the company for EU commercialisation and scale
- secure US regulatory approval for a large clinical trial.

The potential impacts are significant. If the Millipede technology provides evidence in upcoming clinical studies and abaility to improve clinical outcomes (including the socio-economic impact and the wider societal implications of the project so far)