EMVision Medical Devices Limited (ASX:EMV) today announced that the prototype of its 2nd Generation ultra-light weight helmet scanner, designed for use in road and air ambulances,is ready for bench testing. EMVision’s 2nd gen device is intended to address a huge unmet clinical need in first responder brain imaging.

The Gen 2 headset weighs under 10kgs and will be transported to the point-of-care via a backpack. Its 3D antenna array is designed to cover the entire brain coverage in a single scan.

This advanced prototype is a precursor to the ‘proof of concept’ system, suitable for pre-hospital deployment, which is on track to be assembled in the first half of calendar year 2024, in line with the company’s development timetable.

24_10_2023_Announcement_EMV.pdf

EMV released their latest imaging and clinical trial results to the market on 22nd August 2023.

Trial Result Highlights are below:

• Completion of initial imaging case studies using an advanced AI-powered probabilistic imaging technique being developed by the Company.

• Confirmation of 100% scan success rate through Stage 1 of EMVision’s clinical trial for production of processable signals with mean time for completion of full workflow and brain scan of 9.2 minutes.

• Device met safety objectives of Stage 1, with no patient adverse events nor any adverse device effects occurring.

• Latest imaging case studies will be presented at Stroke Society of Australasia (SSA) conference alongside an abstract on Stage 1 clinical trial insights in press at the International Journal of Stroke.

Particularly encouraged by the statement made by the Principal investigator at Liverpool Hospital Dr Dennis Cortado. He commented “This is an exciting development in stroke and neurological care. We have found the EMVision scanner to be a very user-friendly portable imaging modality. The EMVision scanner has the potential for wide application in both the prehospital and acute hospital settings.”

EMV-Latest-Imaging-and-Clinical-Trial-Insights-22-08-23.PDF

EMVISION has today announced that their clinical trial enrolment is progressing well and the Australian Stroke Alliance (ASA) project enrolment milestone has been achieved.

Highlights:

• All three clinical trial sites now enrolling, with Princess Alexandra Hospital, Brisbane now live.

• Enrolment milestone reached under Project Agreement with the Australian Stroke Alliance (ASA) to trigger a further $600,000 non-dilutive milestone payment.

• Maintaining excellent enrolment rates, exemplifying the non-invasive and user-friendly nature of the EMVision brain scanner, alongside the dedication of our clinical research collaborators.

• A successful outcome from the pre-validation and validation trial phases will demonstrate that EMVision’s portable brain scanner can provide crucial insights that enable clinicians to make critical decisions earlier in stroke care, when time matters, at the point-of-care. In addition, it intends to generate the prerequisite data for major market regulatory submissions, including FDA. 

27_07_23_Announcement_EMV.pdf

EMVision Medical Devices Limited (ASX:EMV) has advised that Stage 2 enrolment has started at their second clinical trial site, The Royal Melbourne Hospital.

The Royal Melbourne Hospital is a comprehensive stroke care centre with a world renowned tertiary academic unit that provides leading care for patients across Victoria.

In addition, enrolment at their first clinical site Liverpool Hospital, has exceeded initial recruitment rate expectations. The third site, Princess Alexandra Hospital in Brisbane, is anticipated to go live in the coming weeks. Stage 2 will enrol up to 150 acute stroke and stroke mimic patients presenting to the Emergency Departments of the three hospital sites. EMVision states that it is encouraged by the early progress with enrolment and grateful for the excellent support and commitment of its clinical collaborators.

Pleased to know that Stage 2 recruitment in Liverpool Hospital was "oversubscribed" and that recruitment is being achieved according to previously stated timelines.

EMVision Medical Devices Limited (ASX:EMV) today advised that it has received a cash progress payment of $1,750,000 under its Modern Manufacturing Initiative (MMI) grant award.

EMVision was awarded $5 million under the Federal Government’s MMI Medical Products Translation stream to establish commercial production of EMVision’s world first portable brain scanner 1st Gen product. EMV states that pleasing progress has been made against project milestones under the program, including design verification, progression of systems testing and certification, and preparation of technical documentation for release of the product in its multi-site clinical trials. In addition, activities to set up production layout and processes, alongside work and test instructions have progressed well. These are prerequisites for product verification and validation activities that form part of regulatory submissions and for the establishment of commercial manufacturing capabilities. The final project milestones ‘manufacturing capability established’ and ‘first production run’ are anticipated to be achieved before May 2024 under the program, which is when the final grant payment of $1,250,000 is due.

Happy to continue holding EMV as they remain on track to reach their target of commercial viability in FY2025.

EMVision Medical Devices Limited (ASX:EMV) has provided a clinical trial and product development update.

Highlights:

•Device improvements introduced for Stage 2 of the multi-site clinical trial, ensuring the Gen 1 portable brain scanner is easy to operate and deploy.

•$600,000 non-dilutive grant payment received following pivotal milestone for Gen 2 device in partnership with the Australian Stroke Alliance (ASA).

•Collaboration with Titan Neurosciences Research Australia (‘Titan’), the Australian Stroke Alliance's national digital telehealth partner, for core imaging lab services and preparation for telehealth integration.

EMVision CEO, Dr Ron Weinberger commented: “We are making strong progress and it’s great to see the learnings from the Gen1 device being incorporated, while more importantly we have another attractive consumable revenue stream in the integrated disposable cap and fiducial marker.

Bringing Titan on board will enable state of the art imaging expertise and analysis of the CT and MRI datasets from our trial and we look forward to integrating with Titan’s national telehealth platform.

In the background we have also made substantial progress with the design and development of Gen 2 and are excited to display and test the proof of concept device within the next two quarters.”

17_04_23_Announcement_EMV.pdf

EMVision Medical Devices Limited (ASX:EMV) has today provided an update on its clinical trial and the achievement of an important technical development milestone.

The pre-validation phase of the clinical trial is on schedule, with approximately half of the 30 participants for Stage 1 successfully enrolled. All 30 participants should be enrolled in the coming weeks and then Stage 2 of the trial will be activated.

The Company has also successfully achieved an important technical development milestone for its portable imaging devices under the Commonwealth of Australia Medical Research Future Fund (MRFF) program in partnership with the Australian Stroke Alliance (ASA), “Technical Validation of Algorithms commenced and in progress”. This has triggered a $600,000 milestone payment from the ASA.

It is quite early days of course, but management continue to meet their own expectations and that of shareholders. The non-dilutive funding that has been obtained through milestone payments is one of the most attractive features of this stock. I'm content to continue holding this company in both my SM and RL portfolios based on my evaluation of the risk/reward.

Here is the full announcement is here

EMV Update on Clinical Trial & Technical Development Milestone.pdf

EMV APPENDIX 4C – 30 SEPTEMBER 2022 QUARTERLY ACTIVITIES & CASHFLOW REPORT

Particularly pleasing to note how the companying has executed on their Non-Dilutive funding strategy up to now. EMV_Appendix_4C_Sept_2022 quarterly.pdf

Highlights:

• Ethics approval received for upcoming multi-centre clinical trial; 1st Gen portable brain scanner devices scheduled for delivery to first site in November 2022 to commence clinical trial upon governance “green light”.

• During device commissioning for the trial, valuable intellectual property relating to factory and in-situ calibration techniques has been generated, alongside internal hardware verification confirming the 1st Gen hardware performance is significantly improved upon our original clinical prototype.

• $5m Modern Manufacturing Initiative (MMI) non-dilutive grant Funding Agreement signed, unlocking $2m upfront payment. The Medical Products Manufacturing Translation Stream award will support establishment of commercial production of EMVision’s 1st Gen portable brain scanner product.

• IDR Medical conducted valuable US market assessment providing insights on current stroke patient workflows, evaluation of the EMVision value proposition, alongside testing willingness to pay, pricing models, likely use profile and scan volumes. These insights have reaffirmed the strength of our product value proposition, the multitude of unmet clinical need opportunities available to us and confidence in our go-to-market strategy.

• IP Portfolio strengthened, US Patent allowed relating to one of EMVision’s imaging techniques.

• Substantial non-dilutive cash funding of at least $5.7 million expected in the next quarter from grant programs and the Company’s FY22 R&D tax incentive rebate. Cash reserves of $4.9 million as at 30 September 2022.

EMVision Medical Devices Limited (ASX:EMV) , which is focussed on the development and commercialisation of medical imaging technology for stroke , announced today it has received Human Research Ethics Committee (HREC) approval for its clinical study which will take place at Liverpool Hospital, Royal Melbourne and the Princess Alexandra Hospital, Brisbane.

Ethics approval is confirmation that EMVision has completed the necessary safety testing required to commence its multi-centre clinical trial in Australia.

The Pre-validation phase of the study aims to verify hardware and safety and to provide acute stroke/stroke mimic data for AI algorithms. The subsequent validation phase will confirm efficacy.Completion of both stages is expected to generate the prerequisite data for EMVision’s first regulatory approvals.

The study is expected to show that EMVision’s portable brain scanner can provide crucial insights toenable clinicians to make critical decisions earlier, when time matters, at the point-of-care.

A further $1.2 million in non-dilutive milestone payments has been triggered under the Australian Medical Research Future Fund (MRFF) grant program in partnership with the Australian Stroke Alliance.

EMV_Ethics-Approval-Received-For-Multi-Centre-Clinical-Trial.PDF

EMVision Medical Devices Limited (ASX:EMV) , today advised that it has progressed in-principle agreements with the first two clinical sites for its upcoming clinical trials at Royal Melbourne in VIC and Liverpool Hospital in NSW.

Additional trial sites will be announced progressively. In addition, EMVision has appointed Avania Clinical a global leading medical technology Clinical Research Organisation to support EMVision’s upcoming multi-centre study.

The Royal Melbourne Hospital is a comprehensive stroke care centre with a world renowned tertiary academic unit that provides leading care for patients across Victoria. Liverpool Hospital is one of the largest stroke referral centres in NSW, including an active endovascular clot retrieval service. Both sites have a special interest in providing excellence in the diagnosis and management of acute stroke patients. The sites will be activated progressively, commencing with Liverpool Hospital.

Avania is a leading, global full-service contract research organisation focused on the management of clinical studies for medical devices, IVDs, biologics, and device-drug combination products internationally. Avania supports products from the first-in-human phase through the post-market phase.

EMVision is targeting study commencement this quarter, multi-centre ethics has been submitted to the Human Research Ethics Committee and devices are in advance stage of commissioning. The Company will provide further information on the clinical trial plan shortly. Next steps include execution of clinical site contracts, completion of device commissioning, alongside ethics and governance approval to commence patient enrolment.

Happy to hold (both on SM and IRL) based on this progress and look to increase my position if the share price drops in the near future.

EMVision Medical Devices Limited (ASX:EMV) announced on 09/03/2022 that Professors Geoffrey Donnan and Stephan Davis, eminent neurologists and recognized leaders in the field of stroke care, will join the EMVision’s Clinical Advisory Board in an ex-officio capacity as Co-Chairs of the Australian Stroke Alliance. Professors Donnan and Davis will also be joined by stroke neurologist and Mobile Stroke Unit (MSU) expert Dr Angela Dos Santos.

EMVision CEO, Dr Ron Weinberger, commented “Geoff, Steve and Angela are incredibly strong additions to our Clinical Advisors. They bring significant international stroke care experience and connectivity, which is important as we advance our products towards realization and commercialisation. We have developed an excellent working relationship with Geoff, Steve and Angela via the Australian Stroke Alliance, we are privileged to have attracted them to participate in our Clinical Advisory Board and am looking forward to their ongoing guidance as we execute on our product, clinical and commercial strategy”.

PROMISING CLINICAL TRIAL DATA DRIVES CONFIDENCE FOR EXPANDED STUDIES

The results of a pilot clinical trial designed to collect data to tune the EMVision algorithms, has been announced by EMV today

• Key findings:

o The EMVision device was able to classify stroke type (haemorrhagic or ischaemic)

with an overall accuracy of 98% in the sample of 50 stroke patients

? Urgent neuroimaging is key to the diagnosis and treatment of acute stroke.

Proven and effective time-critical therapies require differentiation between ischaemic and haemorrhagic stroke.

o It was observed that the EMVision device was able to localise target/s

in the same quadrant as on comparator CT or MRI scans with an overall accuracy of 78%

? Localization provides useful guidance to the area of abnormality.

• The primary end point was met, with data collected throughout the study which has informed the value proposition and guided improvements in headset design, patient positioning and software.

There were no device related adverse events.

This was an observational data acquisition study and not intended to be an interventional study.

Appropriate caution should be used in extrapolating these results to those of the general population at this stage of the development.

EMVision’s CEO, Dr Ron Weinberger, commented “The results indicate that the ability to distinguish stroke types was very high. This is the most critical element as it goes directly to the type of intervention that needs to be made in hospital and importantly whether clot busting drugs could reliably be introduced in the field in the future in road and air ambulance settings. The results in this respect are very encouraging. We are pleased with the progress achieved and the data points towards our ability to achieve positive outcomes in our wider clinical trials planned for next year.”

EMVision Medical Devices Limited (ASX: EMV) lodged an update with its Quarterly Cashflow Report for the period ended 30 September 2021.

In partnership with The University of Queensland (UQ), EMVision is developing and commercialising medical imaging diagnostics for various disease states and medical emergencies.

Key activities undertaken during the quarter are outlined below:

• 1st Gen successfully manufactured,
• enrolment of 20 additional patients in pilot trial completed

During the quarter, EMVision reached an important milestone with the fabrication and assembly of the Company’s 1st Gen portable brain scanner intended for commercialisation.

Testing of the 1st Gen units will include functional, reliability, integration (software and hardware), preliminary safety, performance, compliance and other tests intended to meet international regulatory standards.

Product suitability for manufacturability, assembly, shipment (environmental impact), use, service and repair will also be assessed.

They report that the progress of testing has been pleasing in preparation for the Company’s planned expanded clinical studies.

Subsequent to the end of the quarter, EMV advise it has completed enrolment of the additional 20 patient enrolment (50 in total), of its pilot trial. The final results of the clinical study will undergo a detailed review and are anticipated to be released during November 2021.

After a rigorous peer-review process, EMVision had its patient case study images and an introduction to its novel portable brain scanner technology published in the medical journal Frontiers of Neurology. 

EMVision recently provided an update on its application for Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA). Feedback received is that the preliminary evidence supports the potential of the technology to differentiate and localise haemorrhagic and ischemic stroke, however additional clinical study data is required by the FDA, which EMVision will generate through further clinical development. 

EMV and the ASA (The Australian Stroke Alliance) have signed a project agreement. Under the Project Agreement, EMVision will receive $8 million of non-dilutive cash funding in staged payments over the five-year project, weighted to the earlier years. The funding will support EMVision’s development and clinical validation of its planned first responder model for air and road ambulances (2nd Gen device) commencing with validation of EMVision’s portable brain scanner’s diagnostic capabilities in the hospital environment (1st Gen device). The funding is contingent on the project progressing in a manner that warrants continued funding at each stage and the ongoing achievement of project milestones

EMV have advised their first device intended for commercialisation is on track to be completed next month. It allows for bedside decision support and monitoring of stroke patients. Consumables being developed should contribute to recurring revenue.

EMV Half Yearly Update ending 30.06.2020.  Good progress still being made.

The Company has completed its enrolment in its clinical trial and scanning of stroke patients at the Princess Alexandra Hospital. The patient datasets are now being processed and will undergo clinical review. Results from the study are expected to be released in the 4th quarter of CY2020. It is seeking to commercialise a cost effective, portable, medical device using microwave imaging for diagnosis and monitoring of stroke and other medical applications.