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Expansion clinical utility - integrate MEG in mTBI clinical pathway

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Expansion clinical utility - integrate MEG in mTBI clinical pathway

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1. Define and implement a forceful development plan to expand utility to mTBI
2. Take into consideration the OPM opportunity to take advantage of the synergies between these two

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Expansion clinical utility -  Autism Partnership with PN (Proteus Neuro Dynamics) machine learning based therapy

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Expansion clinical utility -  Autism Partnership with PN (Proteus Neuro Dynamics) machine learning based therapy

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Expansion of clinical utility - Oncology - Integration of MEG in diagnosis and treatment pathway

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Expansion of clinical utility - Oncology - Integration of MEG in diagnosis and treatment pathway

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Epilepsy market expansion in US, Europe and China - surgery centres

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Epilepsy market expansion in US, Europe and China - surgery centres

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Target expansion 2 sites 2021
5 sites 2022
10 sites 2023
20 Sites 2024
Based on release of MVP new software released by Q1 2022 and
Launch version 2 2022

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Develop OPM and electronic hardware offering

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Develop OPM and electronic hardware offering

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1. Define our OPM strategy (Dec doc)
2. Make a strategic investment, using external funding, to build capability and overcome the competitive threat.
3. Identify and purchase a competitor to mitigate this risk.
4. Link the OPM strategy to clinical expansion strategies.

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Global initiative
Where are the focus markets.
US/Europe/China
What patients advocacy groups do we need to influence.
What is the need for this
OEM partner with big oncology companies, opening up to large volume of customers
See Miikka's report

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Quantification of this opportunity is dependent on market assessment
1/2billion investment going into OPM tech. Significant competitor activity.

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- Product concept not known (addressing by exploration and concept study)
- Partner currently not known/available
- We may need to create our own product rather than leverage someone else's

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In 100,000 population​

138–414 mild traumatic brain injuries per year:​

100–300 diagnosed and treated in hospital​

38–114 not diagnosed or treated in hospital​

50–150 patients with no or inaccurate diagnosis after ED visit​

21–62 patients with persistent postconcussion syndrome

However, mTBI would improve our ability to sell to more customers for mixed use (epilepsy + mTBI diagnostics) but would not multiply our sales alone without other indications.

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USA better understood- 124 level 4 centres in US and only 20 MEG units - what do we believe the realistic potential to be and over what time period?
What is the € value of each expansion?

China - Fiducia report due for completion in September will help Quantify this market

Europe - Quantify European centres from papers presented.
What is the size of the European Market.
Stefan Ramp paper - Europe focussed

100 Centres in India
Need to define return on investment models for each country.

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1 in 60 children diagnosed with Autism worldwide.
1.8M USA - with auditory impairment.
Number of patients that would benefit/we can serve with the technology?

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We need to understand clinical pathways
Determine the solution that supports the required software solution.
Identify KOLs globally as influencers.
Build market awareness.

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Value: Very high
Success: Moderate
Resource: Very high
Timing: 36+ months

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1 prog. coordinator
1 sales/BD
R&D SW team
$250,000 ???
- Centre mapping to prioritise outreach
- Financial modelling cost benefit
- Awareness Training Programmes
- AEF Patient engagement programme
- MEGIN CCT resources expansion, application support, support platforms
- Role out resourcing and tracking

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- Standard meg
No resources dedicated to this
Not known what is required to turn this into a product and s

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Customer adoption as new customer group has no exposure to MEG
Japan - impact in this marketplace.
Collaboration with other market leaders - Phillips and Siemens

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Will technology be adopted for managing TBI? Diagnostic accuracy.

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What are the buying criteria for each market / Business case for L4 centre to purchase MEG
Where does Epilepsy surgery actually occur.
Need for clinical Marketing needs

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Process towards FDA 510(k) clearance and other regulatory approvals unknown
What will the product actually deliver for patients
MEGIN's role and ability to contribute unclear/unknown
MEGIN's ability to leverage unknown/questionable without regulatory approvals

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Value: Moderate
Success: Likely (given focus on regulatory-approved product and adequate resources)
Resource: Moderate
Timing: 24+ months to regulatory approval

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Value/Success/Resource/Timing

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Value: Moderate
Certainty: High
Resources: Moderate (available)
Timing: 12 months

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Value: High
Success: Low–Moderate
Resource: Unknown
Timing: Unclear

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Expansion clinical utility - Radiology Awareness and adoption programme

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Expansion clinical utility - Radiology Awareness and adoption programme

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MEGIN has commenced an outreach program that is geared towards greater integration and adoption of the technology for radiology.  It is expected to generate greater radiology awareness and adoption given the proven benefits associated with MEG’s superior temporal and spatial resolution in evaluating brain function.

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Not on radar of Radiologist right now.
Longterm potential but not short term.
Threat from other technology

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Significant longterm investment with new customer group

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Value/Success/Resouce/Timing

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Megin's future and form of expansion.

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- Apply a rigorous process to understanding this opportunity before making decisions regarding investments

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Fiducia market study currently under way will quantify potential.
Preliminary outlook:
2021 - 2 systems
2022 - 4 systems
2023 - 6 systems
2024 - 8 systems
2025 - 10 systems
After sales to grow with the market

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What is the value /potential? Potential 1-2 systems a year.
I would add this as a strategic objective - Craig
The opportunity in Japan must be objectively assessed before decisions are made regarding expansion and investments

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Market study: 40k € (supported by BF is approved).
Initially handled by John, Juha & Michael (10% FTE each)
Asia business Lead needs assessing.

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What does this look like???
4 people currently
Gabs and Beth refreshing training and webinar plan

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What the management of these businesses create to the impact on the current management structure.
What is the real focus of the China Brain Initiative.
Implications of OPM on the competition.

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Value/Success/Resource/Timing

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Value/Success/Resource/Timing

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India Market Expansion (Blue Star distributor)

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India Market Expansion (Blue Star distributor)

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Distributor signed up.  Initial customer not had positive experience. New Delhi installation positive.

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not understood

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Expansion clinical utility  - Integrating MEG in early diagnostic and treatment pathway for Dementia

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Expansion clinical utility  - Integrating MEG in early diagnostic and treatment pathway for Dementia

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1. Define and implement a forceful development plan to expand utility to dementia diagnostics/prognostics
2. Take into consideration the OPM opportunity to take advantage of the synergies between these two

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Funding available / Research body belief in it./ Proven tech.

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Value/Success/Resource/Timing

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Evaluations of opportunity
Would need 1 person fulltime

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What is the opportunity?

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Value/Success/Resource/Timing

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Complete SWOT analysis to better understand where this opportunity exists.