Emunamedica is a leading diagnostics company that has developed a patented and clinically-tested system designed to assess whether a chronic wound, such as a diabetic foot ulcer will heal given the current course of therapy. Currently there are NO accurate quantitative diagnostics available to clinicians to help them assess whether a chronic wound will heal. This leads to patients staying on the wrong therapy for far too long, wasting valuable tissue healing time and hundreds of millions of healthcare dollars for payers.

Chronic wounds affect over 6 million people in the United States alone and cost health insurers, including Medicare nearly $10 billion annually. This figure is growing at 8% per year with about 1 in every 6 diabetics getting at least one chronic wound in their lifetime.

There are over 20 different types of wound therapies to choose from, with efficacy rates well below 50%, which leaves clinicians with lots of choices but no real guidance as to WHEN to switch therapies.  These therapies can cost between $10 per application for simple dressings to $40,000 for a full course of hyperbaric oxygen therapy. The more expensive therapies, which amount to about a $3 billion spend per year, can last between 12 weeks for applications of dermal grafts to 16 weeks for negative pressure wound therapy. Utilizing our system we believe we can get the patients off the wrong therapy sooner and onto the right therapy faster, improving healing rates for patients, putting quantitative data in the hands of clinicians and savings healthcare payers hundreds of millions of dollars per year.

In our recent clinical study (Wound Repair Regen. 2012 Nov-Dec;20(6):911-7.) we found that our system had a sensitivity of 90% and a specificity of 86% (p-value < 0.002) for predicting whether a wound would heal after just 4 weekly readings. Discontinuing ineffective treatments after 4 weekscould have potentially saved over $12,600 per patient, based on the treatment regimen of patients in this study. This compares favorably to the current practice of utilizing wound size as a healing metric, which has been found to have 58% accuracy in the same 4-week period.

We received our US Category III CPT reimbursement code (0286T) and have started discussions with payers, which have been encouraging. We have produced systems for our clinical study and are currently preparing commercially-designed models for FDA 510(k) clearance and CE Mark. Each system includes hardware, which is about the size of a desktop printer, software and system-specific disposables to prevent re-use.

Wound care patients either visit wound care clinics, podiatrists or are housed at an assisted living facility where they receive their wound care. We estimate that there are over 35 million patient visitsper year across these 27,000 treatment facilities, offering a large and growing opportunity to improve patient wound care while maximizing value for Emunamedica shareholders.