Roliner

“The Human body changes shape, but prosthetic sockets don’t.”

Our bodies are approximately 1.5 cm shorter in the evening, compared to morning. Our feet and hands are larger in the evening. Most of us don’t notice these changes because we wear flexible clothes.

However, if you lose a leg, you must wear a prosthetic limb attached to your body with a rigid U-shaped structure called a socket. Sockets are made of rigid plastics to carry the bodyweight and hand-made to ensure the best custom fit by following the leg’s contour. However, 75% of amputees are unhappy because the stump changes shape on an hourly basis while their custom-made rigid sockets don’t. This leads to constant skin rubbing causing painful bleeding wounds and ulcers. Replacing sockets up to 4 times annually for the rest of amputees’ lives is currently the best solution costing $7.1billion of public money in the UK, EU and US each year (Excluding the cost of wound care: $2.1 billion in the UK alone (UK Government APPG; 2019).

According to WHO, the global amputee population is 35-40 million. Prosthetic limb fitting is the biggest barrier for amputees to maintain their daily activities. Amputees live dependent on fitting clinics, and therefore, within the first year of amputation, 1 in 6 amputees lose their jobs. 44.3% of working-age amputees are economically inactive, costing $4.89 billion in productivity loss (PapworthTrust, 2016). This issue is even more critical in low-income countries. Public limb fitting clinics can only provide prostheses with basic functionalities for a limited number of people annually (World Health Organization, 2017). When the resources are limited, utilisation of those prescribed systems is even more critical. The entire prosthesis cannot be used if a socket does not fit. Roliner’s AI mimicking the clinical practice and providing an able-bodied-like walking experience will reduce productivity loss and hospital dependency and potentially save $2.3 billion in socket adjustments and $2.4 billion in socket wounds in the US and UK alone.

Due to reduced quality of life and activity, amputees rapidly lose muscles. The probability of an amputee walking with a prosthetic leg more than 500 metres a day is 74% at age 35, while only 34% at age 60, becoming almost wheelchair-bound (Source: Geertzen, Jan et.al; 2005-Claimed-walking-distance-of-lower-limb amputees. Disability-and-rehabilitation). With a first-of-its-kind seamless AI-adaptation, Roliner could increase walking performance, providing an able-body-like walking experience. Reducing socket-induced wounds reduces the risk of infection, and increases mobility, which reduces muscle loss.

Roliner is an innovative prosthetic technology that is developed to fill a long-awaited technology gap in prosthetics, by turning existing prosthetics into state-of-the-art adaptive prosthetics. By utilizing AI (Machine Learning), Roliner is expected to increase amputee employment, mobility, and healthy ageing, while reducing the dependency of amputees on healthcare systems, providing a seamless walking experience, and eliminating painful fitting complications. Once commercialised in the near future, Roliner will be a long-awaited game-changer in the field of prosthetics.

Roliner consists of a soft sleeve worn between the residual leg and socket, a control box, and a smartphone app. The Control Box houses the electronics and manages the air supply to the sleeve, while the app captures users' preferences. It is designed to be controlled with the keypad on the Control Box without needing the Roliner app. However, the app is needed for full functionality.

Roliner understands the hourly and daily changes in the stump and adapts to them in real time. Its Machine Learning reads the data from sensors between the residual leg and socket and learns amputees' comfort preferences to continuously and seamlessly adjust the fitting by inflating or deflating microchannels in the sleeve. It mimics current clinical practices of socket adjustments, learning from amputees' user trends (step count, walking gait, stump volume, temperature, forces) and amputees' comfort preferences (tightness, cushioning) via the Roliner app. This predictive adaptation provides a seamless walking experience and eliminates painful fitting complications before they appear.

Roliner’s innovation is expected to extend the usability of sockets by two times, resulting in significant cost reductions and increased mobility for amputees. Overall, Roliner aims to reduce the dependency of amputees on healthcare systems, thereby utilizing tax-payers' funds more efficiently.

Our goal is to empower amputees, who are unsatisfied not because of the limb loss, but because of the limb fitting.

"Imagine you have a blister on your foot, and you cannot stand up and dance with your partner at your own birthday party. This frustration is my life." – M.A, a lower limb amputee.

“I was devastated that I couldn’t walk across the stage on my graduation and had to roll my wheelchair. Of course, my fitting had to fail me on an important day.” – A.D, a lower limb amputee.

This frustration has become a part of millions of amputees around the world. Losing a leg is devastating enough for them, but remaining in pain for the rest of their lives and knowing that there is no comforting solution is even worse. This is not because of amputation, this is simply because of prosthetic fitting. Poor-fitting leads to painful sores chaining amputees to the wheelchairs for weeks. While waiting for a new fitting, they become hopeful that this time it will be better. Weeks later, the same wounds occur, and that unpleasant wheelchair is taken out of storage once again. Besides sitting in a wheelchair, amputees cannot resume their daily lives, such as going to work, exercising, or socialising, when feeling in constant pain. Amputees live dependent on fitting clinics, and therefore, within the first year of amputation, 1 in 6 amputees lose their jobs. 44.3% of working-age amputees are economically inactive in the UK alone.

Roliner is developed with amputees, for amputees. It mimics the current clinical practice of socket adjustments, without visiting hospitals. Roliner learns from the amputee’s user trends (step count, walking gait, stump volume, temperature, forces) and amputees’ comfort preferences (tightness, cushioning) to continuously adapt when the stump changes shape and size over time. Combined with microfluidics, Roliner's machine-learnt adaptation provides an able-body-like seamless walking experience and eliminate painful fitting complications, before they appear.

It aims to reduce the dependency on healthcare services and enable amputees to control their own prosthetic fitting while promoting active living. It will reduce the painful ulcers (user), the endless hours spent at clinics for fitting adjustments (user), the cost of staff time (buyer), the cost of transporting amputees to the clinics (buyer), the cost of wound care (buyer), and the productivity loss due to the time spent at clinics (user & society).

As a registered volunteer for Action for Kids, Plan International, and Limbless Association charities, I have a deep understanding of the needs of the communities we aim to empower. Additionally, I have a sponsor daughter in Niger, which gives me a personal connection to the community we ultimately aim to help through our solution.

As the Team Lead, I bring my experience in public engagement events with amputees, where I and the team explained the science behind the technologies that can help them. This experience has given me valuable insights into the challenges faced by individuals with disabilities and the importance of providing effective solutions that meet their needs.

To ensure that Roliner is meaningful and relevant to the end users, we are engaging them in the design and implementation process. We are working closely with local partners and community organizations to gain a deeper understanding of the challenges and opportunities that exist within the communities. We have held focus group discussions and interviews with community members, local leaders, and other stakeholders to understand their needs, expectations, and aspirations. This engagement process has allowed us to tailor our solution to the unique needs of each community we collaborated.

Our team includes individuals from diverse backgrounds and experiences, including those with disabilities, to ensure that our solution is inclusive and multi-angled. We have also established partnerships with organizations and individuals within the communities to ensure that their input, ideas, and agendas are integrated into the design and implementation of our solution.

We understand that designing and delivering a solution that meets the needs of the target population requires ongoing engagement and collaboration with the communities. As such, we are committed to continuous feedback and evaluation to ensure that our solution remains relevant and effective. We conducted a pre-clinical study to gather feedback from the communities and stakeholders we are working with and have incorporated this feedback into the development and implementation of our solution.

As a team, we are uniquely positioned to design and deliver a solution that meets the user's needs. Our personal experiences, community engagement, and commitment to inclusivity and collaboration ensure that our solution is meaningful, relevant, and effective in improving the lives of those we aim to empower.

So far, we have engaged with 120 stakeholders (clinicians and amputees) and designed a pre-clinical study (n=7). A larger clinical investigation (n=14) is in the process of ethics and medical device approval and is due to start in August 2023. By the end of this year, we aim to be FDA-listed and UKCA-approved. In the first year, we aim to reach 50 users. This conservative approach is to diligently assess and validate the design, usability and novel manufacturing methods we have invented.

If our application is successful, Solve will be a prestigious recognition from across the ocean, which will be strategically aligned with our commerical strategy.

We aim to register Roliner with the FDA by the end of 2023. So far, 60% of the messages we received from amputees are from the US market. Indeed, we have ongoing conversations with two prosthetic limb clinics (San Fransisco and New York City). However, our understanding of the US market (and also the US market's understanding of us, as a UK start-up) is limited. This programme will help us to expand our connections and build strategic partnerships in the US.

The uniqueness of the Innovation: There are hundreds of research analysing the pressure applied by the residual leg onto the internal wall of the socket. Analysing the constantly changing pressure to design a non-changing system does not work. Our innovation, however, instead of focusing on the surface pressure, focuses on the trapped air pressure between the leg and socket (within Roliner's microfluidic channels). We proved that the air pressure and leg’s volume have a simpler and directly proportional relationship: If the leg expands, and therefore squeezes the air channels, the air pressure increases. The counteraction to reduce the pressure is to deflate the tubes. In contrast, if the leg shrinks, there will be more room for air, and the pressure drops. The counteraction is to inflate the tubes and reach the desired pressure level that the amputee feels comfortable.

Roliner approaches the complex biomechanics problem by offering a practical solution. Since pain and comfort are subjective, quantitative approaches (such as biomechanical analysis) cannot solely give an objective answer. We, therefore, believe in giving control to the users, who can customise the dynamics of the system depending on the physical sensation they feel. These adjustments will then be implemented automatically by Machine Learning to reduce the dependency on adjustment clinics.

When shape-changing prosthetic liners (sleeves) are considered, Roliner will be the first one in the prosthetic market. However, in terms of shape-changing sockets, there are two major start-ups at different stages:

A) One of them is reimbursed by Medicare in the US and has been working with Veteran Affairs,

B) The other one has been partially acquired by Otto Bock, the largest manufacturer.

These companies focus on the hard shell surrounding the leg, socket. They develop shoelace-like structures to manually adjust the shape. We, however, focus on the sleeve that goes between the hard shell and the leg, which is designed to automatically change its volume, and surface geometry and to provide cushioning. Roliner could turn any rigid prosthetic socket into an adaptive system and could work with all existing prosthetic systems without needing to buy an adaptive socket, unlike other suggested adaptive innovations. Additionally, Roliner will modify the socket geometry from the inside and potentially reduce the need for a precise (and hand-made) leg impression (molding), which is challenging and complex.

The reason why Roliner will be the first of its kind is that its essential concept, Soft Robotics, is a recent development that has not been applied to many disciplines in a scalable and feasible way. Our patents solved this scalability barrier for Roliner’s commercialisation.

2024: 50 unit sales (B2C, feedback phase)

We are currently preparing the regulatory paperwork for the FDA listing and UKCA approval as a medical device. We are also in the process of setting up our production facility.

2025: 1000 empowered amputee users and partnership with 10 clinics (B2B, revenue phase)

We have a 3000 p.a. production line plan in place that has been developed by the Manufacturing Technology Centre. We are in ongoing conversations with 3 prosthetic limb centres, and we are preparing a health economic model.

2026: First $150 million savings in healthcare expenditure in the US, UK and EU.

• $2 million Series B investment round to expand distribution and manufacturing.
• 10,000 empowered amputee users in USA, UK and EU and expanding into low-income countries after proving business viability.
• Clinical Trial for the 2nd product: Shoe insoles for the prevention of diabetic foot ulcers.

Diabetic Foot Ulcers (DFUs) are the most common cause of amputations. If they can be prevented, amputations secondary to diabetes could be prevented. Our clinical advisors are experienced vascular surgeons treating DFUs, and our patents cover the development of various devices in which pressure distribution and skin comfort are essential (Exoskeleton interfaced, shoe insoles, and other wearable interfaces). Lastly, our manufacturing method is suitable for developing these devices, and we developed proof-of-concept insoles for testing.

2027-2028:

• 200,000 empowered amputee users, $3 billion in savings of healthcare expenditure.
• Launch of the 2nd product and expansion of the product portfolio into other medical devices (wheelchair seats, patient mattresses, compression therapy sleeves).

We continuously monitor and update our health economics model as we collect more user data during the pre-clinical study phase. We use validated condition-specific, visual analogue scales (VAS) and quality of life (EQ5D-5L) questionnaires to inform the Quality Adjusted Life Year (QUALY) and other model parameters.

We use assessment tools which are well-accepted in clinical research and used to build health economics models. These tools (general and condition-specific validated questionnaires) have been used in clinical trials which commercialised numerous prosthetic limb devices (such as microprocessor knee and ankle). We use these scales during the pre-clinical study, which is designed to assess the gait quality of the users in an advanced motion capture laboratory. These tools will also be used in the clinical investigation that is currently in the ethical approval process.

Our theory is that if we observe improvements in these assessments, then we will make a difference (save money and time) in the clinical domain. We designed a clinical investigation that has 95% statistical power to measure the primary outcome (Ambulation Scale of Prosthetic Evaluation Questionaire). Additionally, we cross-check the improvements in these validated assessments with Participant Reported Outcome Measures (PROMs) (i.e., amputees' own perception of how they feel when they use Roliner). The preliminary results are due to be published this summer.

Roliner's technology combines microfluidics, human factors, design engineering, material science, soft robotics, machine learning and software development.

Our team strive to create an environment where everyone's voices are heard and respected. We are proud of the safe and inclusive environment we have built. We are also proud to be a culturally and ethnically diverse team, and also aware of the importance of neurodiversity and have team members who identify as neurodiverse. We recognize the unique perspectives and talents that diverse individuals bring to the table and believe that this diversity drives our innovation and success. By embracing diversity and promoting equity and inclusion, we believe we can create a better world for everyone, and our novel prosthetic technology is just one example of how we are putting these values into practice. This inclusive practice has been recently recognised. Our team leader, Ugur, received the President’s Excellence Award for Societal Engagement by Prof Alice Gast, the President of Imperial College London. He has been featured in the sixth chapter of "Engineers Making a Difference" book by Dr Shini Somara, a book emphasising the importance of equality, diversity and inclusion in engineering. As a token of his contribution to London's diverse community, Ugur was also selected as Mayor's Entrepreneur of the Year in 2020 by the Mayor of London, Sadik Khan.

As we develop prosthetic technology, our team's commitment to equity and inclusion is central to our work. We understand that individuals with limb differences face unique challenges, and we strive to create solutions that address these challenges and promote accessibility for all. We aim to increase equity and inclusion by providing access to cost-efficient, high-quality prosthetics that are tailored to individual needs and preferences. In addition, we work closely with organizations and communities to understand their specific needs and challenges, and we collaborate with them to develop solutions that are tailored to their unique circumstances. We believe that this approach is essential to creating products and services that are truly inclusive and equitable.

We will follow a two-phase business plan. In phase one, we will operate B2C and directly sell to 50 amputees (early adopters), who have been already signed up on our website and waiting for the commercialization. These amputees are in the UK and the US. We have established a partnership with a UK charity for outreach. During this B2C phase, we will collect feedback from the early adopters' cohort. When the design and user expectations are ensured and ready for larger production, we will move on to the second phase: B2B. In this phase, we will be selling Roliner to healthcare providers, both public and private insurance, and also private clinics. We are already in touch with two private clinics and waiting for the FDA listing to advance our partnership.

Our B2B buyers will need Roliner because Roliner will extend the utilisation of prosthetic limbs for which they pay.  Roliner will be a more cost-efficient solution than the currently available solutions. At present, silicone liners are replaced twice a year due to wearing out and they cost between $500-1000. However, when the volume change occurs, the silicone liners cannot adapt and the socket is replaced. Each socket replacement costs ~$3500-7000 and can occur up to 4 times in a year. Roliner could reduce socket replacements by more than 50%, saving money and time as well as preventing costly wound complications. These savings will be even more critical in low-income regions where the healthcare budget is limited.

So far, project Roliner has received $2.1 million funding via research grants. These UK government and European Union grants help us to:

• create industrial research know-how,
• establish a manufacturing plan,
• prepare the regulatory approval paperwork
• bring the project to the market readiness level from the ideation level.

By the end of this year, we aim to have our first investment round to fund the shortfall during the early adoption (B2C) activities, which will bring us to the revenue-generating B2B phase in 2025. In this phase, we will be hybrid-funded by sales and investments. Once we reach the breakeven point in the 3rd year, we will organically grow our sales. When we become financially sustainable via growing sales, we aim to donate Roliners in low-income regions as part of our social responsibility.

2018

• Best Student Talk, BioMedEng 18 International Conference
• The first patent was filed
• Won an $85,000 research grant from MedTech SuperConnector

2019

• Won the $670,000 Innovation Award of the European Union (EIT Health). Unhindr was selected as one of the most innovative 15 start-ups in the European Union.
• The second patent was filed.
• Won Business Innovation Award for London Region by South East Healthcare Technology Alliances (SEHTA)
• Commercial interest received by prosthetic manufacturers
• Featured as a case study for Connecting Capability Fund of UKRI
• Featured by the Royal Society of Medicine for Roliner's potential impact.

2020

• Mayor's Entrepreneur of the Year in Health Category ($25,000)
• PhD Showcase Award 2nd Place (Imperial College London)
• The patents entered national phases.

2021

• Won a $625,000 grant funding by Innovate UK for Industrial Research
• Won President's Excellence Award in Societal Engagement (Imperial College London)
• Mafucturability and scalability proven

2022

• Won a $630,000 grant funding from Innovate UK for further Industrial Research
• Won a $35,000 regulatory affairs grant (Centre Process Innovation - CPI)
• The Project Lead, Ugur, won the Medical Innovation Award of Turkey from Ten Outstanding Young Persons of the World Programme (Junior Chamber International - JCI)

2023

• The pre-clinical study showed a statistically significant result.
• A national clinical trial is being prepared by Imperial College London.
• FDA and UKCA approvals as a Class I medical device are being prepared. (Target December 2023).