Stedical Scientific Announcing the First Patients Enrolling into its PermeaDerm® Clinical Trials in the US and China
Leading medical technology company delivers updates on multi-center clinical trials in the United States and China
The 54th American Burn Association annual meeting was held in Las Vegas, from April 5 – 8, 2022. As one of the most important academic events in the international burn community, experts worldwide had passionate discussions and debates on the latest research results and cutting-edge burn treatment strategies available today. Stedical briefly announced its Burn Clinical Trial enrolment at the ABA Townhall meeting.
In the United States
The US Multi-center Burn Clinical Study by Stedical Scientific, completed its first enrollment in early March and continues to enroll patients actively in multiple sites around the United States. Interim study results should be released later this year in the US. Stedical Scientific believes that PermeaDerm will deliver superior results with efficacy and speed of treatment for patients with partial thickness burns providing burn surgeons with a viable alternative to current biosynthetic wound coverings.
In China
At the same time, Stedical Scientific launched a multi-center clinical trial to evaluate the safety and efficacy of PermeaDerm® in China. The first patient with deep second-degree burns was enrolled, treated, and healed with a single application in only nine days. Currently, in other clinical treatments, the healing time of deep second-degree burns usually ranges from three to seven weeks. In China, over 25 million people suffer from burns and scalds of varying degrees each year; accordingly, wound repair is the focus of clinical practice. This multi-center clinical study initiated by Stedical Scientific will recruit 184 subjects in 4 authoritative clinical centers.
The principal investigator of this study, Dr. Xia Zhaofan, Academician of China Engineering Academy, Director of Burn Surgery, Changhai Hospital/Naval Medical University, said that the biosynthetic skin substitute PermeaDerm® fills the gap in this field of treatment. In addition, the following medical leaders and their respective teams also participated in the study:
Dr. Guozhong Lv, Director of the Burn Trauma Treatment Center of the Affiliated Hospital of Jiangnan University and the President of the Chinese Burn Association
Dr. Yan Liu, the Director of the Burn Plastic Surgery Department of Ruijin Hospital, affiliated with Shanghai Jiaotong University School of Medicine, and the Vice President of the Chinese Burn Association
Dr. Weiguo Xie, Director of the Burn Department of Tongren Hospital, affiliated with Wuhan University and past Vice President of the Chinese Burn Association
Honoring the Innovators
On the evening of April 5th, Stedical held a special event, honoring the "Father of ECMO," Dr. Robert Bartlett and Dr. Aubrey Woodroof (Chief Scientific Officer of Stedical)the inventor of PermeaDerm®and the pioneer of biosynthetic tissue-engineered skin technology. Dr. Bartlett shared details of the many years of his friendship with Dr. Woodroof and a touching story about the evolution of the industry including the development of the ECMO technology. Dr. Bartlett was the newly appointed director of the University of California Irvine Burn Center, where, he invented the ECMO technology. At that time, Dr. Woodroof, who received his doctoral degree from UCLA, , in biochemistry was developing valve technologies at Edwards Lifesciences. Dr. Woodroof was inspired by ECMO as a new technology, which enhanced cell oxygenation saving many lives, and invented the world's first biosynthetic technology-based on simulating human skin. Dr. Woodroof has had a lifelong commitment to inventing skin substitute like technologies with PermeaDerm® being the newest and most advanced to date.
From the Chairman
Ms. Lin Sun, Chairman of Stedical Scientific, expressed what an honour it is to seek better treatment solutions for patients worldwide through innovative research and development. She also shared that the importance of a global business perspective is even more critical based on the current international environment. In clos cooperation with well-known experts at home and abroad, Stedical is actively promoting the development of global businesses and is accelerating expansion in China, the United States, the Middle East, Southeast Asia, Africa, Latin America and other regions.
Stedical Scientific has been deeply involved in tissue engineering technology since its inception. Its world-class leading R&D team continues to develop proprietary innovative technology platform. It is committed to providing higher-quality and more effective innovative medical care solutions for patients and medical staff worldwide.
PermeaDerm® has been cleared by the FDA and can be used for a variety of acute wounds such as partial thickness burns, chronic wounds like diabetic foot ulcers, venous ulcers and post-Moh’s surgery just to name a few. Since the official launch of the product in the United States in 2020, thousands of patients have been successfully treated in burn centers in the United States with PermeaDerm.
About Stedical Scientific
Stedical Scientific is a medical technology company with leading tissue-engineering innovation technology platform and top global wound management solution providers. The company is committed to bringing disruptive innovation into healthcare, accelerating the international clinical application of innovative medical technologies, and enabling more patients to receive cost-effective treatment.