Clinical Need. 3) At time of reconstruction there may be complications because the dura has adhered to the scalp

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1 DuraShield

2 DuraShield Contoured Silicone sheet that is implanted after decompressive craniectomy, to prevent epidural adhesions and improve cranial reconstruction

3 Clinical Need 1) Traumatic brain injury results in brain swelling and intracranial pressure rising. A large stroke can also cause brain swelling. 2) Decompressive Craniectomy is performed to allow room for the brain to swell out and back in 3) At time of reconstruction there may be complications because the dura has adhered to the scalp

4 Clinical Aims 1. Minimise surgery time during cranial reconstruction surgery 2. Reduce blood loss from cranial reconstruction procedure 3. Reduction in post operative complications and infections that may occur from dural cuts/tears

5 Application DuraShield is preformed with a cranial curvature. Surgeon cuts to fit defect size Decompression performed leaving the brain to swell out and back in DuraShield is implanted before skin closure

6 DuraShield Large Complete coverage in hemi craniectomies Sterile Sterile easy to handle packaging Contoured Contoured to avoid folds and kinks Drainage holes Fluid collections relieved via subgaleal drain

7 Decompression

8 Reconstruction

9 Smart Helmet Clinical Need No patient specific brain protection. Helmets uncomfortable and patients are non compliant. Our Solution Using 3D printing, we are developing lower-profile, more aesthetically pleasing protective devices Patient-specific Solutions From craniectomy right through to cranioplasty The Future Microelectronics and sensing capabilities to enhance healthcare delivery. Integration with our nextgeneration DuraShield product

10 Smart Helmet

11 DuraShield IP DuraShield US Patent Granted European Patent Granted Australian Patent Granted DuraShield Aust & European CranioShield US Smart Helmet PCT Provisional Patent Smart Cranioplasty PCT Provisional Patent

12 Product Development Clinical First-in-human pilot study of v1 product currently underway in Melbourne expanding recruitment with new sites Regulatory (US) US FDA 510(k) approvals est. mid US consultants PAREXEL. Reimbursement (US) Planning underway Future Improvements Multiple sizes, optimization of curvature for hemi/bifrontal, refinement of holes

13 DuraShield Rx Next-Generation Implant Adhesion prevention + diagnostics/therapeutics Transformative Potential Continuous monitoring and therapy delivery for acute/subacute care and rehabilitation Strong Partnership Collaboration with Australian Commonwealth Scientific and Industrial Research Organisation (CSIRO) Forward-looking Integration of technology with permanent implants

14 DuraShieldRx

15 V1 Product Key Design Goals Long-term implantation, from decompression to cranioplasty (up to 2 years) Continuous monitoring of EEG, temperature, pressure Automated seizure detection, remote alerts Paired with smart, patient-matched, 3D-printed helmet for brain protection Secure, encrypted wireless communication between implant and external/remote systems DuraShield Rx

16 Timeline Project Commencement November st Proof-of-Concept Prototype End 2018 Full Prototype (incl. Helmet) End 2020 Preclinical Testing Estimated end 2021 First-in-Human Study DuraShield Rx

17 Smart Implants Build on device capabilities: Neuromodulation Chemical sensing Drug delivery Advances in basic neuroscience Chronic monitoring will allow new research into brain repair/degeneration during recovery from trauma, stroke Investigation in other clinical settings Technology will support future brainmachine interface concepts DuraShield Rx

18 Smart Implants Neuro Oncology Postoperative monitoring of treatment efficacy & tumour growth Improve management of oedema & hydrocephalus Explore the utility of neurostimulation Monitoring of chemotherapeutic drug levels in CSF, or looking for other biomarkers of drug levels in blood & tissue Monitoring 2-Hydroxyglutarate levels Seizure monitoring Drug delivery via small pump and reservoirs Improving ultrasonic access for postop imaging using novel cranial implant materials and designs Tumour Treatment Fields (TTF) delivered using implanted devices.

19 Smart Implants CardioThoracic PeriCardial sensor sheet ECG Oxygenation Pressure/Temp Contractility Sternal power source Wearable battery WiFi 4G Therapeutic Stimulation Cardioversion Defibrillation Drug delivery

20 Contact: Paul D Urso paul@anatomics.com