SAN DIEGO--(BUSINESS WIRE)--Veriskin, Inc., a start-up medical device company, has invented and is developing novel technology for skin cancer diagnostics and screening. Veriskin has received FDA Breakthrough Device Designation for its TruScore device in July, 2020. Development of this innovative technology is being supported by grant funding from the National Cancer Institute and seed-round capital from private investors. Veriskin has completed two IRB-approved clinical studies. The Company is initiating a third clinical study, preparatory to designing the clinical trial needed to obtain FDA approval to market its device.
Skin cancer is the most common form of cancer in the United States, accounting for just under half of all cancer diagnoses. The American Cancer Society predicts that 106,110 new melanoma cases will be diagnosed and 7,180 people are expected to die of malignant melanoma in 2021. It is estimated that approximately 5.4 million basal and squamous cell carcinomas are diagnosed each year, affecting 3.3 million people and leading to more than 15,000 lives lost. Skin cancers are very difficult for non-specialists, such as primary care practitioners, to differentiate from non-malignant skin abnormalities. Uncertainty in initial diagnosis can lead to 1) failure to detect cancer at an early, more treatable stage, 2) hundreds of malpractice claims due to missed cancers, and 3) many unnecessary referrals to specialists and unwarranted biopsies. Fortunately, the majority of skin cancer cases can be cured when detected early. "Development of an accurate diagnostic device for use by frontline practitioners provides a significant opportunity for saving lives and reducing healthcare costs," said Veriskin CEO, Mirianas Chachisvilis, PhD.
Veriskin's TruScore is a proprietary, non-invasive, low-cost, hand-held device that aids non-expert users to rapidly and objectively determine whether a suspicious skin lesion is cancerous. It works on both pigmented and non-pigmented skin lesions and produces a quantitative score. Use of the device can potentially reduce the number of missed cancers and unnecessary biopsies. Veriskin's patented technology is based on a novel, orthogonal approach: active perturbative hemodynamic measurements combined with a proprietary machine-learning algorithm. The device detects both structural and functional vascular abnormalities associated with pathological angiogenesis (a well-established, early hallmark of cancer). The resultant diagnostic information content is significantly higher than provided by competing imaging-based technologies. IRB-approved clinical studies performed in multiple dermatology clinics in California and Arizona have demonstrated sensitivity of greater than 99% and specificity of 94% in a set of 125 biopsy-verified lesions. "Veriskin anticipates that TruScore will help primary care practitioners and dermatologists to detect potentially dangerous skin cancers earlier and with higher accuracy," said the CEO.
Veriskin's development of its innovative technology has been supported by multiple grants from the National Cancer Institute (totaling $3.9 million with opportunities for additional funding). Recently, Veriskin raised over $1M in a seed-round co-led by Pasadena Angels and Ariel Savannah Angel Partners, with participation from Frontier Angels and TiE SoCal Angels. "We are delighted to be able to support Veriskin in the commercialization of its innovative technology," said Kevin Herzberg, Vice Chairman of Pasadena Angels.
About Veriskin, Inc.:
Veriskin is a start-up medical device company developing new tools for primary care practitioners and dermatologists to facilitate evaluation of suspect skin lesions for cancer. Veriskin's mission is to improve patient outcomes and to reduce healthcare costs by improving diagnostic accuracy. From Veriskin’s headquarters in San Diego, California, Chief Executive Officer, Mirianas Chachisvilis, PhD, leads a world-class team of scientists, engineers, physicians, regulatory and commercialization experts located throughout the United States, United Kingdom and Germany. TruScore is a non-invasive, hand-held device that uses patented technology and artificial intelligence to detect skin cancer within minutes. The TruScore device is investigational and is not currently available for sale. To learn more, visit www.veriskin.com.
Research reported in this press release was supported by National Cancer Institute of the National Institutes of Health (NIH) under award numbers: R44CA203038 and R44CA250768. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.