Nuroflux

Acute ischaemic stroke, resulting from sudden blockage by a clot in a blood vessel in the brain, is a critical illness with high risks of death and disability. Globally, this type of stroke affects over 10 million new individuals every year, and there are over 93 million survivors with varying levels of disability.

If available, CT or MRI brain scanning, the current gold-standard methods to diagnose stroke, are undertaken early after the onset of symptoms to determine a patient’s eligibility for therapy. In low resource environments, healthcare staff may rely solely on symptomatic presentations prior to administration of therapy. However, patients do not always respond to treatment and are at high-risk of deterioration from complications (i.e. haemorrhage, swelling, or recurrent stroke; exacerbated by lack of objective imaging or monitoring) where standard care relies upon repeat scans where available, and subjective nursing observations. 

There is currently no medical device available to provide objective, continuous monitoring of both brain activity and blood flow, which are key indicators of stroke occurrence, patient deterioration, as well as treatment decision-making and outcome. 

Nuroflux have developed a safe, low-cost, comfortable, non-invasive, wearable device that utilises a multi-modal system (combining ECG and EEG inputs) to provide simultaneous and continuous monitoring of blood flow and electrical activity in the brain. This provides an opportunity for routine monitoring of patients with acute ischaemic stroke in low resource environments; to confirm locality and severity of stroke events, allow for rapid detection and intervention, as well as facilitate follow-on treatment of complications; to ultimately improve patient outcomes. 

A prototype device was implemented in a validation study (manuscript under review) to assess the feasibility of nuroflux’s proprietary method and measure – Electrical Brain Perfusion Index (EBPi) – to monitor changes in brain blood flow in 20 healthy volunteers who completed standard tasks: breath holding, hyperventilation, verbal fluency cognitive task, and aerobic exercise. EBPi was compared to transcranial Doppler ultrasound measures of cerebral blood flow (the current gold standard) captured pre- and post-task, and post-recovery. EBPi showed similar changes and significant positive correlation with transcranial Doppler ultrasound (r=0.27, p<0.01), providing proof-of-concept and validity of the method to continuously monitor cerebral blood flow as well as capture previously reported changes in EEG. 

In a second validation study, EBPi is being retrospectively implemented using clinical ECG/EEG data in ~20 subjects from Westmead Hospital to determine the degree of correlation between EBPi and cerebral blood flow during seizures. Increases in brain blood flow are expected to be highest at scalp electrodes adjacent to seizure location. This highlights the versatility of our device's application to a range of disease indications and the provision of multiple value propositions.

A clinical safety study in a cohort of stroke patients (18 in total) has recently been completed, demonstrating safety of the device and integration into clinical workflows with minimal disruption.

We envisage that EBPi data will be displayed in real-time for healthcare staff to observe, and to inform their decision-making. Alert algorithms will sound upon detection of favorable or unfavorable measures of brain activity and blood flow (i.e. sudden restriction in latter may indicate recurrent stroke). 

It is anticipated, in low resource settings where brain scanning technologies are not available, that the nuroflux device can provide the first objective clinical measurement to inform stroke patient management. Coupled with the fact that the standard of care treatment, tPA, is relatively inexpensive ($AU55.61 per patient), our innovation represents a real opportunity to revolutionise stroke patient management and outcomes in low- to middle-income nations.

The following stakeholder groups stand to benefit from deployment of our medical device solution:

1) Stroke patients and their families. In addition to the global metrics supplied above, in 2020, Australia alone witnessed 27,500 individuals suffer a stroke, making the collective total of 450,000 survivors living in the community. Approximately 30% of stroke events occur in individuals of working age. In addition to the patient detriment, per annum, stroke is estimated to cost $6.2 billion in direct financial costs and a further $26.0 billion in wellbeing loss and early mortality (Deloitte, 2020a).

Real-time detection of deterioration will allow: 1) faster intervention, 2) reduced brain damage and need for intensive rehabilitation, and 3) reduced number of CT scans and radiation exposure if available; to improve patient quality of life. Susceptible patients being monitored continuously will provide peace of mind, knowing that treatment outcomes and/or further deterioration will be rapidly and accurately detected.

2) Stroke clinicians and nurses. Specialists in neurology are responsible for the treatment and management of patients.

Access to objective and actionable clinical data will improve treatment management, and reduce the need for subjective observations. The burden of performing subjective clinical neurological assessments on patients (especially during the night) to determine patient progression will be significantly reduced.

3) Hospitals. Responsible for providing the resources and environment to treat severe ailments (including stroke). Our device will translate into better quality service and improved patient outcomes. This, and improved clinical staff efficiency, resulting in rapid intervention in deterioration events, will result in shorter hospital stay times and higher patient throughput.

4) Paramedics and general practice healthcare professionals. Typically the first-line response in the community, and often triage patients to hospital if required (e.g. in the event of a suspected stroke).

Our device will aid stroke diagnosis and triage of patients to most appropriate hospital, or allow for treatment on-site in the absence of resources. Provision of objective clinical information in an otherwise blind situation will assist decision-making dramatically.

5) Governments. Provide funding and overarching governance to the public health care system. Any cost-effective mechanisms with which to improve patient outcomes and reduce financial burden will be viewed favorably.

The nuroflux team is comprised of Sam van Bohemen (Chief Executive Officer and primary technology inventor) and Dr. David Cardoso (Chief Business Officer), highly motivated and commercially minded individuals committed to the device’s clinical implementation. 

They are supported by strategic advisor David Lester who has decades of experience across regulatory (US FDA) and pharmaceutical (Pfizer) functions, as well as being a prolific co-founder of successful medical device start-ups.

Our partnership with The George Institute for Global Health, led by Prof. Craig Anderson and A/Prof. Candice Delcourt, demonstrates our commitment and access to underserved communities. This will be leveraged strongly upon clinical validation of our device.

LinkedIn profiles of mentioned individuals and entities:

1) David Almeida Cardoso, PhD | LinkedIn

2) Sam van Bohemen | LinkedIn

3) David Lester | LinkedIn

4) Craig Anderson | LinkedIn

5) Candice Delcourt | LinkedIn

6) The George Institute for Global Health: Overview | LinkedIn

7) Nuroflux | LinkedIn

The co-founding team of nuroflux (Sam van Bohemen, and Dr. David Cardoso), as well as strategic partners (including The George Institute for Global Health) are highly motivated to ensure the deployment of our continuous monitoring solution in low resource environments. We believe this challenge represents a fantastic opportunity with which to align our company with this vision early on.

Nuroflux has one intellectual property position assigned – a method/apparatus for detecting blood flow change in the brain of a subject (WO 2021/077154 A1). Reference: https://patentscope.wipo.int/s...

PCT application has been published and received a clear international preliminary report on patentability with broad claims. The rights have been assigned exclusively to nuroflux, from all the inventors including current nuroflux Chief Executive Officer (Mr. Sam van Bohemen).

National phase filing of IP position has occurred recently, with prosecution ongoing: Australia, United States, European Union, Japan, South Korea, China and India. 

Our technology represents the first tangible opportunity to provide objective monitoring of stroke patients (and other neurological disorders) in low-resources environments, and as such, expect it to heavily influence current clinical workflows in these communities.

The below represent the SDGs for which the nuroflux device and corporate vision are able to influence.

The ensuing year for nuroflux will involve demonstrating strong clinical efficacy data in well-resourced environments (commitment received from The George Institute for Global Health, who is heavily involved in deployment of low-cost healthcare solutions in underserved communities, to fund small-scale pilot).

The next five years will see nuroflux have strong clinical efficacy data, regulatory approval for clinical use of our device, as well as deployment of our device into low resource settings through existing and new partnerships.

1) Clinical efficacy greater than 90% demonstrated in terms of specificity and sensitivity in determining location and severity of stroke events.

2) Regulatory approval of our device achieved through FDA, EMA and TGA.

3) Strategic partnerships formed with healthcare networks and organisations for deployment of nuroflux device into low resource settings.

Please find below an overview of our Theory of Change.

Described in our intellectual property position above, the nuroflux technology repurposes existing technologies for a novel measurement and application. It is able to utilise ECG measurements across the sensors on the scalp, with reference to the chest, to infer blood flow changes. It is also able to incorporate quantitative EEG metrics that have been demonstrated by others to have sensitivity in stroke. 

The nuroflux device data outputs will be able to be collected by clinical healthcare staff in low-resource environments. Metrics will be displayed in real-time, with minimal upskilling in device deployment or data interpretation required. The incentive to use the nuroflux device is clear cut, it will be the first provision of objective and continuous monitoring of brain activity and blood flow in low resource environments, allowing for clinical decision-making to be better informed in stroke patient management (as well as a host of other neurological disorders).

The broader research and development (represented via The George Institute for Global Health), as well as nuroflux management teams represents a unique composition of demographic [gender (40/60% female-to-male) and cultural background (50% foreign-born)] and experiential (professional stage, even split between senior-, mid- and early-career) diversity. This translates into increased creativity and robustness of decision-making processes; to synthesise the best quality solution.

The George Institute for Global Health, a key strategic partner, is an inherently global organisation (sites in Australia, China, India, and United Kingdom), with a motivation for providing health solutions to underserved populations; in clear alignment with the values of nuroflux. 

As employment of additional capabilities occurs within nuroflux, these principles of diversity will be carefully considered and adhered to.

Our business model encompasses four major categories, which will occur in concert to ensure a profitable venture and facilitate maximal positive healthcare impact. These include:

1) Hardware (medical device, as well as consumable accessories such as electrodes and device cleaning solutions),

2) Software (subscription to real-time data display, analytics, and storage platform),

3) Technical support (service maintenance contracts, and training modules for clinical staff to allow for continuing professional development), and

4) Data analytics (de-identified patient data sold to research entities, and to allow for construction of predictive artificial intelligence models).

Given the early-stage nature of nuroflux, only the device hardware can be priced with any reasonable degree of accuracy. The cost of goods currently stands at around $1000, with the vast majority represented in the printed circuit board responsible for processing signals. An in-depth health economics assessment has yet to be performed, which strongly influences the sale price, but this low-cost will improve accessibility of our solution to previously under-served markets (e.g. low- and middle-income nations).

Given the high regulatory burden and long lead times to market, nuroflux will rely primarily on non-dilutive grant opportunities and equity investments in the shorter-term to fund company activities. Following regulatory approvals, device sales (included within the above business model), will allow for recurring and self-sustaining revenues.

Nuroflux are also actively exploring the deployment of our device as a research tool, given the lower barrier to entry, to generate early revenues.

MVP Grant: $50,000 of matched funding for the development of a proprietary printed circuit board for signal processing.

Cerebral Palsy Alliance: $82,500 of equity investment.

Building Better Futures for Health (IDE Group): $25,000 awarded following first place in international pitching competition.

University of New South Wales: $10,000 in SAFE note.

The George Institute for Global Health: $10,000 in SAFE note.

There are several other awards and competitions won, but the above represent the most significant.