SynPhNe – A wearable device for enhancing brain and muscle function in humans.

Principal Investigator: Dr Heng Kok Hui, John Gerard

Email:

mkhheng@ntu.edu.sg

Office:

N3.2-01-24

Tel:

(65) 6790 5900

Last Update: Mar 2016

PROJECT DESCRIPTION:

SynPhNe (Synergistic Physio-Neuro Rehabilitation device) is a wearable, non-invasive technology which highlights a person’s unconscious responses which may be hampering performance. It uses a person’s brain and muscle signals to assess, train and enhance functional capabilities. The person becomes aware of maladaptive, habitual brain-muscle responses in real- time while performing various tasks. These responses are then “self-corrected” using the SynPhNe protocol. SynPhNe is a home-use solution that can be administered by a non-medical person.

At the outset, SynPhNe Pte. Ltd. Singapore is targeting the multi-billion dollar stroke and cerebral palsy disability market which has a worldwide manpower and technology shortage. Every year, 5 million people are left disabled and incidence levels are growing. Average annual spend per patient ranges from $100,000 to $12,000 in developed and developing countries respectively. Our initial target self-pay markets, Singapore and India, account for an existing population of over 7 million existing patients and 1.5 million new patients each year.

Architecture

Fig 1 shows the wearable arm gear and head gear. It acquires, amplifies and transmits 8 channels of brain and 8 channels of muscle data simultaneously for real-time feedforward and feedback. The snap-on arm gear and head gear can be worn and taken off quickly with two fingers. Reports using our novel metrics can be sent to the therapist for follow-up using an inbuilt GSM capability. SynPhNe puts effective stroke therapy “in a box” for use at home, thus solving a massive global health need. In 2013, WHO reported the total disability population to be 1billion.

SynPhNe was awarded the prestigious SMART Innovation Grant, 2012 by The Singapore-MIT Alliance to help in commercialization efforts. It also received the SPRING TECS grant award, Singapore. It found mention in the top 6 of projects from SE Asia shortlisted by World Health Organization and in the EU April 2013 newsletter on ASEAN innovation. In 2016, it received its first firm LOI for a case cotrolled pilot study at Harvard Medical School, Boston, USA.

Results of Clinical Studies with Stroke Patients

Clinical studies with stroke patients whose improvement had plateaued 12-44 months post stroke showed visible and significant improvements in a 4 week, 12 session intervention. Our patented low intensity therapy routine demanding fewer exercise repetitions per session resulted in functional gains of upto 70% as compared to starting baseline. Incremental changes in performance that could not be captured by typical clinical scales were successfully captured by our brain-muscle sensors. Usability scores captured with rating scales administered to patients averaged 4.3 on a scale of 5. Fatigue measured by rating scales averaged less than 1 out of 4. No adverse events were reported after 500+ hours of patient testing.

A case study for cerebral palsy (CP) in a 6 year old boy was successfully completed and the results will be presented at World Congress of Neurorehabilitation, USA in May 2016. CP trials have been initiated at Apollo Hospitals, India. For more information and scientific publications on the SynPhNe system, please visit www.synphne.org

Go-to-Market Roadmap

Market Segments: 1. Stroke patients: Sell device through franchise therapy centres
2. Cerebral Palsy: Sell device through franchise therapy centres
Initial Target Markets: Year 1, 2 – India, Singapore
Year 3 – USA
Year 5 - Europe, China.
Key milestones, June 2016 Start of Phase II adoption trials at Singapore, India
Beta commercial prototype manufacture, franchise centres
Formalization of executive team- Singapore, India
Completion of ISO 13485 compliance, CE Mark filing ready
Readiness for clinical trial at Harvard Medical School, USA
Market Launch: Aug 2016