10 GHP / Q1 2020 , Feb19124 Best Medical Technology Manufacturer – UK & Healthcare Management Innovators of the Year - UK Manus Neurodynamica’s NeuroMotor Pen™ Manus Neurodynamica Ltd is an innovative medical device company, based in Edinburgh which was founded in 2008 to apply its expertise in neuroscience and sensor technologies to innovation in healthcare. Its first product is the NeuroMotor Pen™ (NMP) in development as a low cost, accurate, non-invasive diagnostic for Parkinson’s Disease (PD) and for clinical outcomes assessment. NMP may help specialists to improve the certainty of differential diagnosis and save time and money, dramatically improving the overall efficiency of the PD pathway in both primary and secondary care. NMP is a unique pen that the patient uses to complete simple, standardised handwriting and drawing tasks on a tablet computer. It has built-in highly accurate sensor technologies, which, combined with its analytical software, process minute limb and hand motion parameters to quantify fine motor skills, and classify these into ‘motion features’. These motion features are clinically validated biomarkers which provide clinicians with objective information about movement abnormalities. Challenges with diagnosing and treating Parkinson’s Disease An early and accurate diagnosis of Parkinson’s is crucial to give patients access to the range of treatments and therapies available; early intervention can improve quality of life. Diagnosing PD is currently a challenge even for the most experienced specialist. Physical Parkinson’s-like symptoms may be a result of a number of underlying causes, not just PD, each requiring a different therapeutic approach. Conclusive diagnosis of PD can require expensive brain-imaging equipment and specialist expertise; waiting lists for specialist assessment are common. Distinguishing between PD and other neuromotor impairments can be difficult, even for specialists, and the gold standard diagnostic for PD is a radio-labelled neuroimaging agent. This is expensive, requires skilled operators and specialised facilities, and can be unpleasant for patients. Reliable comparisons of subjective observations that were made by different physicians or at different points in time can not be made with any degree of accuracy. GPs in most countries will refer patients with suspected Parkinson’s to specialists, although some make the diagnosis themselves. Diagnostic accuracy by GPs of 50% has been reported and 30% of PD patients are only ever seen by a GP. A simple inexpensive test is required to identify referrals to the specialist, while at the same time avoiding over-referrals, and to support patient monitoring for clinical outcomes assessment and treatment optimisation. The NMP Solution The NeuroMotor Pen can increase the certainty of diagnosis by recognising differential diagnostic and disease progression biomarkers of Parkinson’s Disease. The results help physicians to differentiate between Parkinson’s Disease and other neuromotorimpairments, such as essential tremor, or signs of normal ageing which may mimic the symptoms of Parkinson’s Disease. Regular use of the NeuroMotor Pen enables the clinician to monitor disease progression and the patient’s response to medication. This innovative technology can be used by general practitioners as an aid to make a more accurate assessment before referral to neuromotor specialist services, where it can support differential diagnosis and clinical management of Parkinson’s Disease and other neuromotor impairments. The test requires no specialist training and can be completed in less than 20 minutes in the clinic or GP surgery avoiding the need to schedule separate appointment for scans and follow up assessments. This can help to increase the efficiency of specialist services and reduce costs. It is also being used in academic and industrial research to support the development of pharmaceuticals monitoring the effects of drugs on neuromotor function. The system is CE marked as a medical device, which means it can be sold throughout Europe to support the diagnosis of Parkinson’s disease. Immediate cost savings per diagnosis of between £200 (for an obvious case) to up to £2000 (for complex cases involving brain scanning) can be demonstrated. Savings can also be made on clinical outcome assessment of up to £500 (for complex tremor assessments). Clinical studies Clinical validation of NMP was conducted under the supervision of Parkinson’s specialists at the University Medical Centre Groningen (Netherlands), Mater Misericordiae Hospital (Dublin) and the Northumbria Healthcare NHS Foundation Trust, in collaboration with six surrounding NHS Trusts. The latter investigation was a prospective study under the leadership of Professor Richard Walker in undiagnosed patients for whom there was diagnostic uncertainty and DaTSCAN (Ioflupane I123 injection) was required to confirm the diagnosis, i.e. the most difficult to diagnose patients. NMP was found to have a differential diagnostic accuracy of 78% with a sensitivity of 80%, at least as good as DaTSCAN. Moreover, motor skills assessed to quantify patients’ response to medication were objectively quantified with high resolution and higher accuracy than the ‘Unified Parkinson’s disease rating scale’ (UPDRS) part III, the most commonly used scale in the clinical assessment of PD.