Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - GyroGlove (Development and Commercialisation of an Intelligent Wearable Platforms to Stabilise Hand Tremors in Parkinson’s Disease and Essential Tremor)

Teaser

GyroGear is developing the GyroGlove, an intelligent wearable platform that stabilises hand tremors. Up to 70% of individuals with PD experience tremors (1967, Hoehn). Hand functionality is critical to daily activities of living and quality of life. Hand tremors can thus be...

Summary

GyroGear is developing the GyroGlove, an intelligent wearable platform that stabilises hand tremors. Up to 70% of individuals with PD experience tremors (1967, Hoehn). Hand functionality is critical to daily activities of living and quality of life. Hand tremors can thus be severely debilitating and detrimental. Furthermore, the stigma and fatigue from tremors further reduce quality of life. Current pharmaceutical options can have a limited life span, considerable side effects and require higher doses with disease progression. Using compact, wearable mechanical gyroscopes (\'GyroGlove\'), the device’s mechanical gyroscope instantly, and proportionally counteracts any unwanted movement (tremors) whilst permitting deliberate movement. GyroGear listed 5 specific objectives for this SME Phase 2 project:
- Finalise engineering design specification
- Build functional and pre-production prototypes
- Transfer to manufacture
- Conduct clinical trials and gain regulatory approval
- Develop supply chain agreements and commercial contracts ready for full commercialization
- Prepare for multiple-market entry in early 2021

Work performed

Product development:
- Since September 2018, GyroGear was able to tackle many crucial engineering challenges which led to where we are today.
- The team was able to significantly reduce the package size of both the gyroscope module and the power pack. This made the product much easier and more comfortable to use, which was validated through multiple tests with tremor sufferers.
- Due to the high spinning speed of the gyroscope, necessary to provide enough force to stabilise hand tremors, the GyroGlove creates noise and vibration when in use. To address this, GyroGear balances its gyroscopes using innovative customised balanced machine. The resulting device is a satellite grade gyroscope (G0.4) which is 37 times more balanced than the highest industry balance grade from ISO1940-1.
- Through multiple usability studies, the GyroGlove attachment system evolved from a separate power pack onto the arm and a gyroscope on the back of the hand to a fully-integrated unit onto a single gauntlet. The device is now easy to attach and wear for day-to-day activities.
- In parallel of various prototyping activities, GyroGear also looked for long-term manufacturing partners to help with the commercialisation of the final device. A clear supply chain has been established and initial contracts are already in place for the suppliers of all critical modules. Plan B options have also been contacted and are ready to start work in case of any unforeseen delay or complication with the selected suppliers.
- GyroGear has also started to think about its artificial Intelligence (AI) capabilities. Initial requirements specifications have been drafted related to all data coming in and out of the device and a patent is currently being drafted to englobe this work. This will be submitted by the end of September 2019.
- To meet specific warranty requirements, the engineering team has created multiple accelerated life test rigs to test the GyroGlove in different conditions. So far, the gyroscope module part of the device is able to meet a 3-year lifetime but additional tests are currently underway to validate this life target with a range of different tremors and use cases.

Finance and legal:
- GyroGear currently holds two patent applications and at point of writing, is filing two additional patents. We seek to file 2-3 additional patents by the end of 2019, developed entirely in house, with sole ownership by GyroGear. We do not license any intellectual property. Our attorneys confirm that GyroGear has freedom to operate, including further development of the GyroGlove as an intervention for PD.
- In parallel of this SME phase 2 Horizon 2020 grant GyroGear has continuously been looking for additional funding sources. Other grant applications have been submitted to Innovate UK and various charities. Among many others, GyroGear applied to a TTP Applied Tech Project grant via the Michael J. Fox Foundation which is the largest Parkinson’s Disease charity worldwide. MJFF’s support of this clinical study would be in no small part vital to de-risking and supporting said fundraise, given the importance of high quality clinical data to the commercial viability of the GyroGlove.
- GyroGear is also preparing for another investment raise in the next few months. GyroGear is currently seeking to raise $3-5M via private equity sources. Investment partners have already been identified in Europe, USA and Singapore. Due diligence processes have already started since August 2019.

Human Ressources:
- In order to complete all deliverables and milestones of this SME Phase 2 H2020 grant, GyroGear grew its R&D team from 5 to 8 people in the last year. GyroGear also hired a biomedical engineering post doc to lead all clinical trial management activities.

Quality and regulatory:
- To kick-off this H2020 grant, GyroGear first carried out a detailed design review of the device and created quality documentation (P-diagram and FMEA). Once done, GyroGear implemented its own Qual

Final results

GyroGear has demonstrated efficacy in small user studies (N=5-40) in the home environment (TRL7)with successful usage cases even with severe bilateral hand tremors. The performance was assessed by improvements in participant completion of specific activities of daily living. Results from these proof-of-concept studies have shown significant improvements in activity completion, such as a 40% average improvement of completion in an eating task (in a 5 participant study), and a 30% average improvement in a drinking task (in a 30 participant study). Patient feedback on the device has also been significantly positive in these trials, for example, in a 25 participant trial, 72% and 64% of participants reported a significant improvement in their tremor severity (at least 1 point on the 5 point TETRAS tremor rating scale) for drinking and eating tasks respectively.

With our first pre-submission meeting with the FDA (June 2019), the FDA communicated its impression that they believe the glove to be efficacious and low-risk, with a requirement of 3 months of user data. Further conversations with payers including United Health, Humana, the Centers for Medicare and Medicaid Services, too communicated their enthusiasm for the GyroGlove, its early efficacy and the lack of alternatives in the market. They support the integrated and step-wise approach that GyroGear is taking to bringing this product to market.

Website & more info

More info: http://www.gyrogear.co.