Scottish tech firm Manus Neurodynamica has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) for its NeuroMotor Pen device.

The pen helps health care providers to establish the difference 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.

Manus’ Breakthrough Designation represents a “major step” towards the technology’s approval in the US market, the firm said.

Differentiating between a Parkinsonian tremor and other tremor disorders is challenging. 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.

The widespread lack of tremor measurement equipment in clinics – 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.

Commenting on the news, Dr Rutger Zietsma, CEO of Manus, commented: “I am delighted that we have been granted Breakthrough 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 underserved patient population.

“We look forward to building on this achievement by utilising the Breakthrough Devices Programme to facilitate our pursuit of US regulatory clearance for differential diagnosis of Parkinson’s in close collaboration with the FDA.”

Manus Neurodynamica’s pen combines sensor technologies, built into a digital pen, with software and an analytical engine with Decision Support System.

The interface lets users 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, letting doctors differentiate 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 said it 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.

Recommended

• UK Cyber Strategy calls for more powers to combat cybercrime
• Can businesses juggle outsourced and homegrown digital talent?
• DPL scheme offers 100 fully funded places to learn digital skills

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 there is currently estimated at $14.4 billion.

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.

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.”

Deutschländer added: “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.”

Get the latest news from DIGIT direct to your inbox

Our newsletter covers the latest technology and IT news from Scotland and beyond, as well as in-depth features and exclusive interviews with leading figures and rising stars.

We will keep you up to date on the pivotal issues impacting the sector and let you know about key upcoming events to ensure that you don’t miss out on what’s going on across the Scottish tech community.

Click here to subscribe.