Janus Beierholm, MSc, and Otto Ømann | VulCur MedTech
Competition Sponsor: EIT Health
Awardee Year: 2020
Chronic wounds result in an amputation every 30 seconds and is accounting for 2-4% of the total healthcare expenses in the Nordics. These wounds are closely linked to diabetes and therefore hit the American population even harder with 6.5M new cases every year (2% of the total population). The wounds are infected with a group of antibiotic-resistant bacteria producing something called biofilm which acts as a shield between the bacteria and conventional treatments like antibiotics.
Our product FlashHeal is a stand-alone device which uses Subcutaneous Thermal Bacterial Ablation (SuTBA) – a technique that we have developed precisely for killing bacteria in chronic wounds. It works using thermal energy delivered in small energy bubbles in a 3D grid within the wound by a laser device fitted on a six-axis robotic arm. The device operates itself, relying on visual and other sensory inputs for treatment and analysis. By collecting data on wound size, wound depth, bacteria loads, hemoglobin levels, and temperature, we hope to be able to predict the outcome of new wounds using a machine learning algorithm.
We have filed two patents with one being in the PCT phase, and we expect to obtain our 510(k) approval by October 2020. We can then proceed to test the device with our partners at Wound Care Advantage – a chain of 41 wound clinics in California.
Flash-Heal will most likely be reimbursed as a form of skin debridement, ensuring Medicare / Medicaid coverage at 88 to 150 USD per treatment depending on the state. We want to own the device and the data, thus lending the device out for free and get paid per treatment thereafter. We estimate that 18 treatments are needed for each patient on average.
The project is supported by Horizon 2020 and we have secured a seed round of 700,000 USD. Our next step is to file our 510(k) application and carry out our pre-clinical trials on humans which has been approved by the Danish Council of Ethics.
To learn more about this proposal, email email@example.com.