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Photobiomodulation as low-cost, rapid, effective & noninvasive new technology for curing the #1 cause of amputation worldwide: diabetic foot.

The solution comes from an academic research with surprising results to solve some of the major challenges of medicine. The technology used in this project received the Summer Institute at MGH - Harvard - MIT People's Choice Award 2015. Today we have an innovative, affordable, effective and fast solution for treating hard-to-heal wounds, specially a condition commonly called Diabetic Foot, which affects more than 100 million people worldwide and is the number one cause of amputations. With the method and equipment developed for this treatment, we were able to completely close and cure hard-to-heal wounds in an average of 15 to 90 days. The same wounds that had been open and exposed for more than 2 years without showing sign of improvement. This solution is more efficient than any other existing method, but it does not need to substitute them. It can be used simultaneously to the existing methods for better efficacy and reduce drastically the costs of treatment. With great popular acceptance, this project overcame its goal in a crowdfunding campaign in Brazil aimed to finance clinical trials, reaching R$80,610 (around 25k US dollars) in 60 days in 2016.

Today there is no effective treatment or procedure offered for patients suffering from this problem. The current treatment in hospitals and clinics is merely palliative and aims to cushion the complications of the patient. Our team have the solution for diabetic foot and hard-to-heal wounds, offering the first technology developed exclusively to treat this burden. 

We developed an equipment hardware with embedded technology employing electromagnetic wavelengths that can give genetic commands to the tissue increasing the speed and capacity of healing and cicatrization by angiogenesis and diminishing the inflammatory process, while another wavelength is employed to eliminate microorganisms that would cause infections, such as multi-drug resistant bacteria.

In the next 3 months we will finish our industrial prototyping , having the final product ready to be registered at FDA and Anvisa (in Brazil). From 6 to 9 months right after that period we'll have the registration process concluded being ready to start our go-to-market. For that we already have partners to outsource the registration process in their industrial plant and manufacturing that product once the registration is completed.

The cost for this product is going to drop significantly making it even more accessible. Other technologies, approaches and treatments using the same core principle of photobiomodulation are being studied by us as this moment, and will be ready to be launched as new equipments in the next few years. Along with that, we are working on an app to be used with the equipment that helps the diabetic patient maintain a healthy diet according to their levels.

We plan to start with a B2B approach selling for clinics and hospitals at first. Next step is offering the solution for home care, physiotherapy, independent healthcare professionals such as home doctors and nurses. When the price for the equipment drops sufficiently we will offer it for the final beneficiaries via selling or rental.

Because it is a medical device and it requires FDA-like registration, the beneficiaries today are the patients that participate the clinical trials we perform. So far 7 patients were treated successfully. All of them had previously suffered an amputation due to a diabetic foot wound, and had a second or third wound open, and had the amputation surgery scheduled. All of them got their wound completely closed and didn't had to amputate their foot.

12 months is the period we'll remais pre-operational due to the registration process. However, in February we'll perform a phase 2B clinical trial with more 30 patients. Once our registration is granted, thousands of people will benefit from our technology every year.

We are a multidisciplinary team with deep experience and skills on R&D, marketing, sales, business development, medical business development, finance, design, engineering, public relations and social impact.

We'll start with a B2B approach selling for clinics and hospitals at first. Next step is offering the solution for home care, physiotherapy, independent healthcare professionals such as home doctors and nurses. When the price for the equipment drops sufficiently we will offer it for the final beneficiaries via selling or rental on a B2C approach.

There are several reasons we are applying to Solve. The reasons that stands out more are: we believe we can create a great network; gain visibility and validation for our business; funding; access international market; being positioned not only as a biotech startup, but as a social impact focused biotech startup.

The key barriers for our solution to succeed are: funding access (in Brazil it is really hard to be a capital intensive startup since investors here doesn't like to invest in risky opportunities); Leverage internationally.

Solve can help us a lot with those two issues.