Stedical Scientific Hosts Clinical Trial Investigator Symposium
By Lin Sun and Leo Spiegel, co-founders of Stedical Scientific
In advance of Stedical Scientific’s clinical trials launching in China, for our bio-engineered temporary skin substitute, the company hosted industry luminaries in Shanghai for a Clinical Trial Investigator Symposium on January 12, 2021.
We were delighted to welcome China National Engineering Academician Dr. Zhaofan Xia, Dr. Hongtai Tang and the institute office Director Ms. Li Zhang from Shanghai Changhai Hospital, Dr. Guozhong Lv, Chairman of China Burn Association and from Wuxi Affiliated Hospital of Jiangnan University, Dr. Yan Liu, Vice Chairman of China Burn Association and Dr. Zhiyong Wang, from Shanghai Ruijin Hospital, and Mr. Xiangxian Xu, COO of Stedical Scientific. This illustrious group shared a diverse set of perspectives, brilliantly inspiring us to define a set of clinical trials that are well-designed, well-controlled and effectively monitored. Clinical trials are an integral part of the discovery and development process and we were so very grateful to all participants for their contributions --putting us on the best path to safety and effectiveness of our products.
Academician Dr. Zhaofan Xia from Shanghai Changhai Hospital delivered the opening speech at the seminar
Dr. Zhaofan Xia talked about our focus on skin repair materials and our success in being able to address the required clinical needs. Stedical Scientific’s new bioengineered skin substitute utilizes technology that now fills a long-standing gap in this field. We are on the cusp of clinically validating its effectiveness and how it can be used to the transformational benefit of patients in China and all over the world.
Dr. David Herndon, member of the US National Academy of Medicine, via video
Dr. David Herndon, Editor of Journal of Burn Care and Research, Chairman of Scientific Advisory Committee at Stedical Scientific in both China and the U.S., joined us via video conference. Dr. Herndon recapped the history of working with Dr. Aubrey Woodroof in the 19080s on the introduction of Biobrane, the first biosynthetic skin substitute and a precursor to Stedical’s PermeaDerm offering. He shared how the innovations of PermeaDerm’s advanced technology has surpassed Biobrane on all dimensions including faster healing, less inflammation, and reduced fluid accumulation. Dr. Henrdon commented on PermeaDerm’s remarkable success in the United States and his desire to work with the Chinese clinicians participating in the upcoming clinical trials. We all share his excitement in bringing this monumental advancement in burn and wound care to the world.
Ms. Lin Sun, Chairman of Stedical Scientific concluded the proceedings with a presentation on the global development of bio-engineered temporary skin substitutes over the past 50 years
PermeaDerm, the product for the clinical trials discussed at this event, was developed and cleared by the FDA in 2016. The cleared products include PermeaDerm B for acute wounds, PermeaDerm C for chronic wounds and PermeaDerm G, the glove for treatment of hand burns. In 2018, PermeaDerm was certified with ISO13485, and began to enter clinical practice in the United States. In 2019, PermeaDerm began its access and expansion to the global clinical market. Also, in 2019, the Stedical team initiated the first discussion with China Academician Zhaofan Xia on the clinical development of PermeaDerm technology in China. We look forward to increasing global access to innovative healthcare technologies and matching these innovations to unmet needs globally. This represents the driving spirit of our company’s everyday efforts.
Experts at the symposium spoke enthusiastically about the upcoming trials
Stedical’s headquarters is in Shanghai, with a subsidiary in San Diego, California. The company is committed to bringing disruptive innovation to healthcare and increasing global access to innovative medical technologies. This year, we will launch multi-center clinical studies of PermeaDerm in both China and the United States. The China studies will be led by Academician Zhaofan Xia. We believe that through the rigorous clinical research and practice of all the top clinicians the company's products will contribute to the improvement of the well-being of patients in China and all over the world.