Isoform socket

Globally, a leg is amputated every 30s and there are 50M amputees worldwide. Unfortunately, these amputees experience poor socket fit, a misfit between their residual leg and prosthetic socket causing chaffing. Thus, 16% of amputees abandon their prostheses and are unable to walk. Without their prosthesis, amputees are confined to a wheelchair, limiting the tasks of daily living they can perform independently and their ability to get sufficient exercise to stay healthy.Prosthesis abandonment costs prosthetists, leading to millions of dollars in lost revenue opportunity in the United States. 

The gold standard for dealing with poor socket fit is sock ply management. Amputees will layer prosthetic socks beneath their socket several times a day to accommodate for their changing leg size. Unfortunately, this is difficult to learn and, if performed poorly, leads to pressure sores. Thus, prosthetists spend countless hours on sock ply education, hours for which they are not reimbursed. If sock ply management does not sufficiently solve the problem, amputees will visit their prosthetist to modify the socket, which is time consuming and only provides a temporary solution, and prosthetists are not reimbursed for those visits.

Globally, there are 50MM amputees and 2MM reside in the United States. Of the 185 000 amputations performed annually in the United States, 86% are lower limb. Our total addressable market is the $13B global prosthetics and orthotics market. Our serviceable addressable market are below-knee amputees in the US, a $1.8B valuation of lifelong customers, which is expected to increase. Diabetes, which is the leading cause of amputation, is experiencing 51% growth (2021-2045). Based on amputees’ eligibility for their first prosthesis and the frequency with which they get a new one, our serviceable obtainable market is $909M annually.

Vessl’s isoform socket is the only socket that automatically adjusts as amputees’ legs change size. Adjustable sockets on the market rely on constant manual operation, making them inaccessible to amputees with poor dexterity or sensation loss. Isoform’s automatic adjustments are more comfortable, more accessible, and reduce pressure extremes that often lead to wound development. Isoform’s patent pending technology redistributes pressure around the leg as it changes volume to maintain a snug fit. With Isoform, amputees avoid pressures extremes, so they can walk around all day comfortably while prosthetists retain their patients.

Our patent pending technology relies on an outer socket shell and moveable panels attached to a mechanical disc, enabling the panels to automatically contract the inner volume of the isoform socket. The level of tension of the panels on the leg is set by the prosthetist during the custom fitting process. The mechanical disc aims to maintain the set level of tension on the leg, without relying on flimsy sensors, heavy batteries, nor expensive motors. Automatic adjustments are the key feature that make our device accessible to those with poor dexterity and sensation loss because they don’t need to consciously initiate socket adjustments.

Demo video: https://docsend.com/view/q92g7...

Our target end users are below knee amputees experiencing limb volume change, which are typically folks with diabetes in the aging population. Thus, our target customers are the prosthetists supporting these amputees, especially prosthetists with 5-15 years of experience who have seen the problem often and are motivated to incorporate new innovations into their practice.

Current limitations for prosthetic solutions lead to 16% of amputees abandoning their prosthesis altogether. Without their prosthesis, amputees are confined to a wheelchair, limiting the tasks of daily living they can perform independently and their ability to get sufficient exercise to stay healthy. With isoform, amputees can move comfortably, thereby improving their health and allowing them to remain independent longer. Also, isoform maintains a perfect fit on the leg to avoid pressure extremes on the residual limb that often lead to wound development, a key to maintaining long-term health. Long-term health is also great for workplaces, allowing employees to focus on their job without unnecessary interruptions or complications. Isoform empowers amputees to focus on their work without actively managing their limb volume changes, giving them peace of mind and allowing them to be more engaged with their community, encouraging high performance and career advancement.

Amputees in rural and lower income countries struggle to access prosthetic solutions at all. Isoform's automatic adjustments mean that folks in rural areas do not need to travel regularly for follow up visits and can continue to use their prosthesis, reducing the abandonment rate and increasing community engagement. Amputees in lower income countries can afford this passive system that does not rely on motors nor batteries to work, thereby increasing the socket's durability and increasing the number of folks who can access it as a solution.

Sydney’s background as a biomedical engineer (MEng), Oleksiy’s skills as a clinical anatomist (PhD), and their extensive entrepreneurial training set Vessl up for success. They have extensive prototyping, research and end-user design experience from building research projects from the ground up. The Medical Innovation Fellowship trained them in medical device development and entrepreneurship. Vessl’s luminary advisors bring unique insights and experiences that are invaluable to the team. Ben Banaszak is a practicing prosthetist in New York with a background in biomaterials engineering, while Trey Bowles is a successful serial entrepreneur and Jim Price’s new products have generated nearly $1B in sales. Other key advisors who are close to our target communities are Josh, whose PhD is in prosthetics and who owns two prosthetics consulting and research-based companies, and Geoff, a double leg amputee whose worked for many prosthetic companies as a socket tester and in sales. Vessl is also supported by several incubators: Techstars Physical Health Fort Worth, Brampton Venture Zone, Velocity, Western Accelerator, BioNext, and Accelerator Centre.

We have a working prototype that we are mechanically testing for strngeth and durability before it is worn by amputees. We have conducted problem validation with customers (prosthetists, 160) and users (amputees, 75), which proved that limb volume change is a critical problem that current solutions do not adequately address. We conduct regular surveys and voice of customer engagements to answer critical market and design validation questions. We are working with amputees and prosthetists from 5 healthcare centres at the American Veterans Health Administration on product validation. There are two parts to our engagement: 4 one-hour video calls where prosthetists and amputees can provide feedback on our design and recommendations for the future, and an in-person demonstration of our prototype after changes are made based on the added insights they provide. We will use this feedback to inform our design and strengthen our data supporting the need for our solution. We were also accepted into Mitacs’ E-Accelerate program to work with Western University on product validation and testing. Lastly, we were accepted into the Hamilton Ecosystem to Accelerate and Leverage Trials of Health Innovation (HEALTHI) program. We are working with St. Joseph’s Healthcare Hamilton to create a clinical case study roadmap to guide research and validation of our socket. Throughout all of these opportunities, we are actively involving the customer and end user in the design process. As an engineer taught about the critical nature of end-user design, it is something we are actively focused on.

We applied to Solve to expand our network globally and attract research partners. Our next major milestones include clinical research and U.S. product launch. For clinical research, we have identified several potential partners and spoke to several prosthetists about what tests they want to see so that the outcomes collected are relevant to their decision making process. For product launch, we are building relationships with 23 clinics servicing 7500 below knee amputees. We will register with the FDA (medical device class 1) in Q3 to prepare for launch in Q4. The funds will be critical in securing manufacturing contracts in advantageous geographical locations (centered around the southern states, eastern states, and California where reimbursement rates and rates of amputation are highest). Therefore, Solve's network across the world would be critical in connecting us with high impact partners. We want to help folks displaced by the civil unrest un Ukraine, Israel, and other countries, which Solve can help with. We also want to work with respected researchers in the United States to conduct research to support our claims.

Our device is automatically adjusting; it overcomes the barriers many amputees face to using currently available adjustable sockets, especially the aging population. Therefore, it is easier to use than the status quo. It is also more comfortable because it automatically adjusts to minute changes in limb volume. It will not disrupt prosthetists' workflow, which is a current barrier to prosthetists choosing to adopt the existing products. Our device also allows for an increased degree of adjustability to accommodate a wider range of limb volume changes through precise microadjustments, again making it more accessible to a wider range of end users.

For leg amputees who struggle with poor socket fit due to residual limb volume changes, Vessl’s Isoform socket automatically adjusts to changes in leg size to maintain a comfortable fit, encouraging amputees to wear their prosthesis and engage in activities of daily living. Continued prosthesis use also allows prosthetists to continue to fabricate sockets over the amputee’s lifetime, instead of making one prosthesis that is quickly abandoned. For prosthetists who spend countless hours on non-billable socket adjustments, Vessl’s Isoform socket eliminates the need for socket adjustments, thereby allowing prosthetists to focus their time on billable tasks.

There are two reasons our business is hard to duplicate. For one, we protected our intellectual property early on by patenting our designs with broad claims. This will deter competitors from creating copies of our isoform socket design. The other reason is perspective; our co-founders are not prosthetists so while we are designing a solution for prosthetists, our creativity is not hindered by a narrow way of thinking from decades of experience in the field. Rather, we bring expert insights from engineering and clinical anatomy with a passion for designing for our customer and end user, ultimately creating an easy to use and clinically relevant solution.

This product has the opportunity to disrupt the prosthetic industry and become the new gold standard socket prescribed to every lower limb amputee.

We have conducted problem validation with customers (prosthetists, 160) and users (amputees, 75), which proved that limb volume change is a critical problem that current solutions do not adequately address. We conduct regular surveys and voice of customer engagements to answer critical market and design validation questions. We are working with amputees and prosthetists from 5 healthcare centres at the American Veterans Health Administration on product validation. There are two parts to our engagement: 4 one-hour video calls where prosthetists and amputees can provide feedback on our design and recommendations for the future, and an in-person demonstration of our prototype after changes are made based on the added insights they provide. We will use this feedback to inform our design and strengthen our data supporting the need for our solution. We were also accepted into Mitacs’ E-Accelerate program to work with Western University on product validation and testing. Lastly, we were accepted into the Hamilton Ecosystem to Accelerate and Leverage Trials of Health Innovation (HEALTHI) program. We are working with St. Joseph’s Healthcare Hamilton to create a clinical case study roadmap to guide research and validation of our socket. Throughout all of these opportunities, we are actively involving the customer and end user in the design process. As an engineer taught about the critical nature of end-user design, it is something we are actively focused on.

To date, we have 6 signed letters of intent from prosthetists and 3 signed letters of support from other key stakeholders. We have also begun engaging with 5 Veterans Affairs healthcare centers on product validation, filed two patents, conducted pressure-sensor testing with a custom-made demo limb, have a dozen amputees on our waitlist, and have raised over $1M CAD in dilutive and non-dilutive funding combined.In one year, we aim to sell 62 isoform sockets and in 5 years, this grows to 38K isoform sockets sold, positively impacting thousands of amputees’ lives, and thousands more prosthetists, caregivers and community members. Current sockets are abandoned by 16% of users due to frustration and pain. Without their prosthesis, amputees are confined to a wheelchair, limiting the tasks of daily living they can perform independently and their ability to get sufficient exercise to stay healthy. With isoform, amputees can move comfortably, thereby improving their health and allowing them to remain independent longer. Long-term health is also great for workplaces, allowing employees to focus on their job without unnecessary interruptions or complications. Isoform empowers amputees to focus on their work without actively managing their limb volume changes, giving them peace of mind and allowing them to be more engaged with their work community, encouraging high performance and career advancement.

In one year, we aim to sell 62 isoform sockets and in 5 years, this grows to 38K isoform sockets sold, positively impacting thousands of amputees’ lives, and thousands more prosthetists, caregivers and community members. Current sockets are abandoned by 16% of users due to frustration and pain. Without their prosthesis, amputees are confined to a wheelchair, limiting the tasks of daily living they can perform independently and their ability to get sufficient exercise to stay healthy. With isoform, amputees can move comfortably, thereby improving their health and allowing them to remain independent longer. Long-term health is also great for workplaces, allowing employees to focus on their job without unnecessary interruptions or complications. Isoform empowers amputees to focus on their work without actively managing their limb volume changes, giving them peace of mind and allowing them to be more engaged with their work community, encouraging high performance and career advancement. We will measure these goals through our sales as well as the size of our community (folks on our newsletter, folks following us on social media, number of visits to our booths at conferences and trade shows, etc.), and patient reported feedback on the impact of our device (post-sale and as part of planned research studies).

Our patent pending technology relies on an outer socket shell and moveable panels attached to a mechanical disc, enabling the panels to automatically contract the inner volume of the isoform socket. The level of tension of the panels on the leg is set by the prosthetist during the custom fitting process. The mechanical disc aims to maintain the set level of tension on the leg, without relying on flimsy sensors, heavy batteries, nor expensive motors. Automatic adjustments are the key feature that make our device accessible to those with poor dexterity and sensation loss because they don’t need to consciously initiate socket adjustments.

During the minimum viable product (MVP) testing project, we iterated the prototype design while testing its strength, durability, and comfort, to prepare for clinical case studies. Our focus was on 3D printing and mechanical testing. We 3D printed socket components, as well as sourcing some components from 3rd party providers. We created our own demonstration limb that can expand and contract as controlled by a computer. The demonstration leg was placed inside the socket with pressure sensors attached to measure how the socket responds to changes in limb size. Preliminary data shows that the socket maintains a consistent level of pressure on the leg as it changes size. We will continue this line of testing in collaboration with researchers at Western University in London ON Canada.

Going forward, we will use an Instron machine to test the strength and durability of our socket through static and cyclic load testing. The ISO 10328 standard outlines the static and cyclic loads that a socket must withstand to be safe for clinical use. Thus, we will test to these standards. This testing will allow us to finalize the materials of our design and ensure it is safe for use. Lastly, we will test the comfort of our device with volunteer amputee participants to try on the device and fill out patient reported outcome surveys in response to their experience with the socket. We are working with a clinical collaborator in Texas on a clinical case study to show qualitative and quantitative improvements in comfort by using our isoform socket (Dr. Graci Finco, faculty at University of North Texas). This feedback will be critical in ensuring our socket is ready for clinical case studies.

3 full time staff, 8 contractors/ advisors

Vessl was incorporated on June 21, 2022; thus, co-founders Sydney and Oleksiy have been working full time since then. Ed, our biomedical engineer, was hired a year later in May 2023 and has been working full time since.

Vessl is co-founded and co-owned by a female youth founder. Sydney Robinson is a young person who identifies as a woman. There are many barriers that women face when starting companies and especially when raising funding. As such, Sydney has ensured that diversity, equity, and inclusion is baked into the company policies. Oleksiy, co-founder, was born and raised in Ukraine and is therefore dedicated to increasing diversity of the Vessl team. Company hiring includes working with an HR consultant to ensure the candidates screened for each position are from diverse backgrounds; a diverse hiring pool increases the changes of a diverse individual being hired for the position. Sydney is also part of The Fourth Effect, a community that connects eligible women and diverse individuals to board positions; Vessl plans to use this platform to build a diverse board of directors to guide the company to success.

Vessl operates in a business-to-business model that will begin by selling in the United States. The United States has a larger market and is more willing to reimburse adjustable sockets than their Canadian counterparts. We plan to expand to Canada and Europe once we have an established presence in the United States. We will sell our socket to prosthetists through our own sales force and then through distributors as we expand. Then, prosthetists are reimbursed through the CMS coding system. We are confident that we will be reimbursed based on existing L-codes and the level of coverage that our competitors have. The socket payment is a one-time fee, but amputees are eligible for a socket replacement every 3 years or by recommendation from their doctor, which supports a recurring revenue model.

We have already started engaging with Veteran’s Affairs (VA) and will use their 2% market share and uniquely strong funding model to enter the industry. We are working with amputees and prosthetists at 6 VA healthcare centres on product validation and will continue to foster those relationships for a seamless transition to commercial sales. Next, we will make a strong push to be adopted into the Hanger distribution network, which represents almost a quarter of all clinics. Hanger has a long-standing relationship with the VA, so as our relationship with the VA strengthens, our integration into Hanger becomes easier. Also, we have been engaging with Hanger prosthetists who can act as advocates and early adopters of the isoform socket. In March 2023, Hanger launched a Venture division, indicating their interest in fostering innovation in the prosthetics industry; we've met with the lead of the venture division and are eager to foster that relationship. Together, these large distribution channels (VA, Hanger) will give us the resources and foundation to target the next 10 biggest clinic organizations outside of Hanger, followed by smaller clinic networks and individual clinics. Along the way, we will generate demand at conferences and tradeshows, with the two biggest ones being American Academy of Orthotics and Prosthetics (AAOP) and American Orthotic and Prosthetic Association (AOPA) every spring and fall respectively.