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Wave Therapeutics

Solving a $30B problem by preventing bedsores

USA, Illinois
Market: Medicine
Stage of the project: Prototype or product is ready

Date of last change: 26.11.2024
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Idea

Wave Therapeutics has developed an affordable and effective soft robotics platform to prevent bedsores, save lives, and reduce a significant cost and care burden for families and facilities.

Current Status

2024 - Second US patent issued
2024 - First European patent issued
2024 - Selected for the TechCrunch Disrupt Startup Battlefield 200
2024 - Selected for Global Entrepreneurship Program in the UK
2024 - Presented data at the Wound Healing Society annual meeting
2023 - Selected for the AARP Age Tech Collaborative
2023 – Completed mHub Medical Device Accelerator
2022 – Completed Techstars Future of Longevity Accelerator
2022 - First US patent issued
2021 - Signed CRADA agreement with Veterans Health Administration

Market

Pressure injury is the only facility acquired condition that is increasing year over year, despite government mandates to get the problem under control. Staffing shortages and the lack of affordable devices have been identified as reasons for the increase, and the problem is going to get worse as our population ages, unless something changes. Wave Therapeutics is that change.

Our first customers will be long term care facilities, followed by hospitals. We've engineered our products to be built affordably, and developed a subscription model to quickly get cushions under the patients who need them, without a large capital outlay.

Our TAM for long term care and hospitals in the US, Canada and Europe is over $40B, and that doesn't account for the many other medical or consumer uses. Our SOM is conservatively estimated at $125M within 5 years.

Problem or Opportunity

Long term care facilities have a huge problem with pressure injuries (bedsore). Every year 20% of their patients are considered high risk for development of a pressure injury. Facilities currently use a manual turning schedule to reduce risks. This requires staff to physically lift and reposition each at risk patient every 2 hours around the clock. Despite these efforts, every year 5% of their patients develop a wound. The government has declared that these injuries are caused by patient neglect, and facilities must pay all costs for treatment and this amounts to millions of dollars each year.

Solution (product or service)

Our technology combines two clinically proven therapies, alternating pressure and sequential compression, in a unique way that is designed to eliminate pressure hot spots and improve blood flow to bring fresh, oxygenated blood to at risk tissues. We pair our cushions with a powerful analytics platform that allows remote patient monitoring by staff or family members to ensure compliance with prescribed care. Our technology can be used in a variety of products including wheelchair cushions, mattress toppers, surgical beds, and a variety of consumer comfort products.

Competitors

It's important to know that in the US insurance does not pay for devices for bedsore prevention. This results in the best selling products being ineffective and more focused on comfort and patients needing to develop a life-threatening wound before insurance will cover the product.

The best selling wheelchair cushion in the market is made by Roho. Their cushions are static air pillows and users still need to manually reposition every two hours. These cushions sell for about $450 and they are the best selling due to the lack of affordable alternatives. However, long term care facilities do not buy them because they still require manual repositioning of patients.

The best selling alternating pressure cushion is made by Aquila. Their cushions cost nearly $5,000. Few people can afford to buy these outright, and insurance will only consider this cushion if a patient has an open pressure sore. Facilities do not use these cushions due to high costs.

The cushioning market is filled with other static pads filled with foam, gel, or air. The purpose of these cushions is comfort and distribution of pressure points, but none of these will prevent a pressure injury.

Advantages or differentiators

Our unique approach is that we've engineered our cushions to be both effective and affordable. We're going to market for $900, and we've also developed a unique subscription model service that will allow nursing staff to get our cushions to their patients without waiting for the facility to approve a major capital expenditure. We'll save facilities millions of dollars on treatment costs, while helping relieve staffing shortages, and we’ll make money on volume sales.

We also provide remote patient monitoring to quickly alert caregivers to situations that need personal attention, and to document compliance with care. This documentation is valuable to facilities because pressure injury is the second leading reason for medical malpractice lawsuits. Facilities lose 87% of those lawsuits and pay, on average, $250K per injury.

Our second generation cushions will use a full sensor array to detect minute changes in skin temperature and moisture. These are the earliest signs of skin damage. Eventually we'll use AI enabled predictive analytics to automatically determine if a patient needs their cushion to cycle differently or offload pressure for longer in a particular area.

To protect our IP we've filed multiple patents in the US, Canada, The UK and The European Union. We've also hired engineers to tell us how they would reverse engineer to get around our patents, and then we've filed additional claims to better protect against this. We've been granted our first US patent, and in September 2024 received word that our second US patent will be granted and our first European patent will be granted.

Finance

Our first product is our wheelchair seat cushion. We'll offer this to long term care facilities at a subscription cost of $50/month/cushion. Our cushions have an expected lifetime of 2 years and when manufacturing at volume will have a COGS of about $150. We will eventually sell these directly to home health users at a costs of $900.

Our second product is our full mattress topper. We have not developed this product yet, but it is based on the same technology as the seat cushion, with cushions daisy chained together to make a mattress topper. We are still working on pricing for this product. Our COGS is estimated at $1400.

Business model

We are pre-revenue and currently receiving short runs of cushions for testing. We are raising money now to support our product launch. Our first customers will be long term care facilities where we can provide an ROI within months. We have conducted over 500 stakeholder interviews and have identified a subscription model service as the quickest route into facilities. We will use our own sales team, and will eventually work with established distributors and DME retailers to reach a wider market.

Money will be spent on

The first $1M will be spent on our final firmware development, safety testing, FDA registration (as class 1 exempt), pilot studies (we have several facilities that are ready to run paid pilots), and team expansion.

The next $1.5M will be spent on factory automation and high volume tools to lower our COGS, sales and marketing for our full commercial launch, and hiring of sales and marketing personnel.

The final $500K of this raise will be spent on the development of our full mattress topper, additional tooling needed for this product, and additional automation to lower COGS further.

Offer for investor

We're currently raising on a SAFE and are open to negotiating terms with the proper lead investor. We have broken our raise into the 3 tranches listed above. The first $1M is being raised via SAFE with a $12M post money valuation cap. We expect that after completing our pilot studies we will be able to connect with a lead investor in this space and negotiate terms.

We project that the company will be profitable after this $3M raise, but we may choose to raise another round to accelerate our growth.

Risks

One of our biggest risks right now is funding. We have accomplished amazing things with a very limited amount of money, but we cannot complete our safety testing until we raise money, and we must complete that testing before long term care will buy our products. So, running out of money before we reach market is a very real risk.

Another risk is that long term care doesn't currently use cushions in their facilities. Using our cushions will create a need for staff workflow to change. We've attempted to mitigate this risk by conducting over 500 stakeholder interviews. What we've learned is that facility administrators are reluctant to buy our cushions outright due to the large capital expenditure, but they are willing to use them as a subscription service. Among staff, 100% of the nurses we spoke to saw the value in our product and said they would use it for their patients if the facility would allow them to.

Our team has a lack of experience in selling into long term care and hospitals. This is another risk. We will mitigate this risk by hiring a COO and a sales person who have experience in medical devices and long term care. We can't make these key hires until we have raised additional capital.

Incubation/Acceleration programs accomplishment

2023 - mHub MedTech accelerator (based in Chicago)
2022 - Techstars Future of Longevity accelerator
2020 - gBeta accelerator (Gener8tor free program)

Won the competition and other awards

2024 - Winner of Aging 2.0 Nashville pitch competition (national)
2024 - Winner of a grant from NBA Foundation in the All Star Pitch competition (regional)
2023 - Winner of a grant from The Disability Opportunity Fund Pitch Competition (national)
2023 - Finalist for Entrepreneur of the Year at the Techpoint Mira Awards (regional)
2022 – Winner of CTA Startup competition for free exhibit booth at CES (international)
2022 – Winner of Crossroads Seed Pitch Competition (regional)
2022 - Winner of National Women’s Fast Pitch Competition (national)
2022 – Winner of Midwest region Women’s Fast Pitch Competition (regional)
2022 – Finalist in Calgary Inventures “Game Changing Health” category (international)
2022 – Judges and audience choice winner at Boston Revolutionize Aging 2.0 conference. (national)
2021 - Winner Techrise pitch competition
2021 - Winner Women in Bio pitch competition

Invention/Patent

Our first US patent was granted in 2022. This patent is on the collection and aggregation of data from medical cushioning products. We were recently notified that our second US patent has been approved. This patent covers our unique air venting system to help keep skin cooler and dryer, and the use of gussets in our air bladders.

We have numerous patents pending in the US, Europe, The UK and Canada. These patents cover multiple facets of our technology including use of air, gel or fluid to change pressure, design of our bladders, use of vacuum technology, filling bladders with foam and other technology. We are happy to provide a complete list of pending patents on request.

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