Designation provides priority regulatory review of the Manus NeuroMotor Pen™ designed to aid the diagnoses of Parkinson’s Disease
Manus Neurodynamica Limited (“Manus”), which develops and markets products and technologies for neuromotor assessment, announces that it has been granted Breakthrough Designation by the U.S. Food and Drug Administration (“FDA”) for its Neuro-Motor PenTM (“NMP”) device.
Breakthrough Designation has been granted for the proposed indication of using the NeuroMotor PenTM to support health care providers (HCPs) in differentiating between Parkinsonian and non-Parkinsonian tremors in adult patients who are suspected to have Parkinson’s Disease (PD) but have not been diagnosed by other means.
The FDA Breakthrough Device programme is intended to accelerate regulatory approval and help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or debilitating diseases and conditions. This Breakthrough Designation represents a major step towards the technology’s approval in the US market.
Differentiating between a Parkinsonian tremor and other tremor disorders is challenging.1 Early and correct differential diagnosis is crucial to quickly provide access to best medical treatments and other forms of support. In a community-based study of the accuracy of PD diagnosis, essential tremor (ET), the most common movement disorder, accounted for 48% of the misdiagnoses.2
The widespread lack of tremor measurement equipment in the clinic with the ability to detect very subtle tremors is a significant part of the cause for not being able to differentiate between PD and ET.3 4 5 6
The NeuroMotor Pen™ is a unique scalable digital solution for the differential diagnosis of ET and PD that combines sensor technologies, built into a digital pen, with software and an analytical engine with Decision Support System. The interface enables users to record movements non-invasively and analyse parameters of minute limb and hand motion, quantifying fine motor skill. These quantified parameters are used as ‘digital biomarkers’ to provide objective information about movement abnormalities, enabling the accurate differentiation between ET, PD and other tremor disorders.
Once registered in the US, the NeuroMotor Pen™ will be the only device for PD with clinical claims for differential diagnostic decision making. The Company will now agree a study protocol with the FDA in anticipation of a successful US-based clinical trial demonstrating a similarly high specificity and sensitivity in differential diagnostic decision making, as was achieved in European trials.
The prevalence of PD and ET are at least 1.7 and 7 million respectively in the US, and the current annual cost of treatment for PD in the United States is currently estimated at $14.4 billion.7 As the population ages and life expectancy increases, the number of individuals in the US with PD is projected to double in the coming generation, representing a very substantial existing and growing market for Manus’ NMP technology.8 9 10
Dr Rutger Zietsma, CEO of Manus, commented: “I am delighted that we have been granted Break-through Designation for the NeuroMotor Pen™ to aid in the differential diagnosis of complex forms of Parkinson’s Disease, which is a large and growing cause of long-term illness and disability in the US and the rest of the world.
“Obtaining Breakthrough Designation represents an important milestone in our path to providing a more effective diagnosis for this irreversibly debilitating disease to improve the lives of this under-served patient population. We look forward to building on this achievement by utilising the Break-through Devices Programme to facilitate our pursuit of U.S. regulatory clearance for differential di-agnosis of Parkinson’s in close collaboration with the FDA.”
Neurologist and Movement Disorders specialist, PD Dr med Angela Deutschländer, MD (Fellowship, Mayo Clinic, FL) said: “Objectively measuring and interpreting signs, including very subtle ones, with the NeuroMotor Pen™ device has the potential to significantly improve the understanding of the underlying disease of a patient. This can potentially be achieved already during a first clinical appointment. As the correct diagnosis can be established faster and more efficiently, best medical care can be provided faster. Best medical care can further be monitored with the NeuroMotor Pen™ with high accuracy, and thus it can be adapted fast and efficiently. An early and correct diagnosis is crucial to give individuals with PD and other tremor disorders access to the best treatments and other forms of support available and to maintain their health and well-being. It is furthermore of uttermost importance for identifying patients for clinical trials aimed at finding a disease-modifying agent.”
Prof Richard Walker, Northumbria NHS Foundation Trust, Professor of Ageing at Newcastle University, commented: “There is great potential for this device in helping us to assess movement and tremor in older people who may have Parkinson’s or other conditions. It can help with making a diagnosis and also with assessing response to treatment.”
ENQUIRIES
| Manus Neurodynamica Ltd Dr Rutger Zietsma, Chief Executive Officer | +44 131 563 5465 r.c.zietsma@manusneuro.com |
| Walbrook PR (PR advisors to Manus) Lianne Applegarth / Phil Marriage | +44 20 7933 8780 +44 7584 391 303 / +44 78 67 984 0 82 manusneuro@walbrookpr.com |
Notes to Editors
About Manus Neurodynamica – www.manusneuro.com
Dr Rutger Zietsma founded Manus in August 2008. The Company’s main activity is designing, patenting and marketing innovative technologies used in medical devices and personal care products which have the capability to improve people’s health and wellbeing. The Company implements quality procedures to medical standards.
The principal product is a sensor pen designed for use in the diagnosis and monitoring of neuromotor impairments. As a first indication, the pen has been configured for use in Parkinson’s disease and uses limb and hand motion to diagnose patients quickly and non-invasively. It has applications across not just diagnosis but also screening, monitoring, rehabilitation and drug development for a number of different movement disorders.
About NeuroMotor Pen™
NeuroMotor Pen™ ( is a unique, patented and CE-marked system that combines sensor technologies built into a digital pen with software and an analytical engine with Decision Support System. The interface enables users to record non invasively and analyse parameters of minute limb and hand motion. This enables quantification of fine motor skill. These parameters are used as ‘digital biomarkers’ to provide objective information about movement abnormalities. NMP can be used to support diagnosis and monitoring of Parkinson’s Disease and other neuromotor impairments.
It has the potential to be a quick, inexpensive, non-invasive, and objective aid to diagnosis that can provide a low-cost alternative to brain scans.
1 Dr N Aly, The differential diagnosis between various causes of tremor may prove clinically challenging. Parkinson’s disease tremor: differential diagnosis and management, GM, 47 (4), April, 2017
2 J. Meara, B. K. Bhowmick, and P. Hobson, Accuracy of diagnosis in patients with presumed Parkinsons disease, Age Ageing, vol. 28, no.2, pp. 99-102, 1999
3 Dr N Aly, The differential diagnosis between various causes of tremor may prove clinically challenging. Parkinson’s disease tremor: differential diagnosis and management, GM, 47 (4), April, 2017
4 J. Meara, B. K. Bhowmick, and P. Hobson, Accuracy of diagnosis in patients with presumed Parkinson’s disease, Age Ageing, vol. 28, no.2, pp. 99-102, 1999
5 Kraus P.H., Lemke M.R., Reichmann H., Kinetic tremor in Parkinson’s Disease – an underrated symptom, J.Neural Transm, 2006.
6 Mary Ann Thenganatt1 and Elan D Louis, Distinguishing essential tremor from Parkinson’s disease: bedside tests and laboratory evaluations, Expert Rev Neurother. 2012 Jun; 12(6): 687–696. doi: 10.1586/ern.12.49
7 Parkinson’s Disease Information Page https://www.ninds.nih.gov/Disorders/All-Disorders/Parkinsons-disease-Information-Pages
8 12 Wanneveich M, Moisan F, Jacqmin-Gadda H, Elbaz A, Joly P. Projections of prevalence, lifetime risk and life expectancy of Parkin-son disease (2010–2030) in France. Mov Disord 2018; published online Aug 25. DOI:10.1002/mds.27447.
9 Dorsey ER, Constantinescu R, Thompson JP, et al. Projected number of people with Parkinson disease in the most populous nations, 2005 through 2030.
10 Neurology 2007; 68: 384–86. 14 Rossi A, Berger K, Chen H, Leslie D, Mailman RB, Huang X. Projection of the prevalence of Parkinson’s disease in the coming decades: revisited. Mov Disord 2018; 33: 156–59.