FDA grants Breakthrough Device Designation for Podascan™ Chronic Wound Diagnostic
October 28, 2020 (Davie, FL) - Emunamedica LLC, a wound diagnostics company announced today that Podascan™, its chronic wound diagnostic device had received Breakthrough Device Designation from the United States Food & Drug Administration (FDA). The device is a noninvasive diagnostic tool that enables clinicians to better assess whether a chronic wound (such as a diabetic foot ulcer or pressure ulcer) will heal given the selected treatment in use. Today, the current standard of care for assessing whether a chronic wound will heal is the use of wound size measurements, which have significant variability from clinician to clinician, and which in clinical studies have been shown to only offer a 58% positive predictive value as compared to the Podascan™, with 82% positive predictive value, as demonstrated in its published clinical study.
“The evaluation of the healing of chronic wounds and the efficacy of the many available treatment options have always been dependent on changes in the length, width, and depth of the wound. The measurements themselves are inaccurate, because of differences in training and technique of those doing measurements and because of variation in the geometry of wounds themselves” said Michael S. Weingarten, MD, MBA, FACS, FSVS, Professor of Surgery Chief, Vascular Surgery, Drexel University College of Medicine and one of the clinical studies co-authors.
Per Dr. Weingarten “the use of near infra-red technology to quantify wound healing provides an accurate way to assess wound progression over time. This technology allows healthcare providers to monitor specific therapies, discontinue therapies that are not working, and continue therapies that truly promote healing. Thus, ineffective treatments can be eliminated, patient suffering reduced, more limbs salvaged, and money saved”.
Breakthrough Device Designation provides for enhanced FDA interaction and prioritized review of regulatory submissions, and is awarded to devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Chronic wounds affect 1%-2% of the population of developed countries who will have at least one chronic wound in their lifetime. In the United States alone there are over 6.5 million people with at least one chronic wound, the majority of these patients being 65 or older, driving Medicare costs including related hospital stays to over $10 billion per year and leading to 5-year mortality rates similar to common types of cancer.
“Tissue repair and wound healing is common, complex and costly. It takes an enormous toll on our patients, who often endure tremendous suffering with wounds that last for months and even years. Of this suffering and of the tens of billions of dollars that are spent in the USA alone on chronic wounds, so much could be saved if we simply work to measure what we manage. What is so exciting about this current FDA "Breakthrough Designation" is that we now see technologies that might be guiding us toward that goal” said David G. Armstrong, DPM, MD, PhD, Professor of Surgery at Keck School of Medicine of University of Southern California.