Stedical Scientific unveils stunning results from PermeaDerm® clinical trials at the 2022 Annual Meeting of the American Burn Society

Leading medical technology company delivers updates on multi-center clinical trials in the United States and China, revealing transformative burn treatment insights

CARLSBAD, Calif., April 25, 2022 (GLOBE NEWSWIRE) — 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 management field, experts worldwide had passionate discussions and debates on the latest research results and cutting-edge burn treatment strategies available today. Stedical Scientific reported clinical research progress in the United States and China at the meeting.

In the United States
The US Multi-center Burn Clinical Study by Stedical Scientific, completed its first enrollment in early March. Dr David Greenhalgh, the principal clinical investigator of the US burn study and the President of the International Society of Burn Injuries, introduced the progress of the multi-center clinical study of PermeaDerm^® in the United States to the meeting attendees. The plan is to conduct the study at eight of the top ten burn centers in the United States, with sixty-eight subjects.

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, the theme of which was “ECMO and Burn Technology”. Several renowned experts in the field of burns presented and honored the “Father of ECMO,” Dr. Robert Bartlett and Dr. Aubrey Woodroof (Chief Scientific Officer of Stedical and the inventor of PermeaDerm^®), the pioneer of biosynthetic tissue-engineered skin technology. Dr. Bartlett also shared details of the many years of friendship with Dr. Woodroof and a touching story about the evolution of the industry including the development of this technology. Dr. Bartlett was the newly appointed director of the University of California Irvine Burn Center, during which time, he invented the ECMO technology. At that time, Dr. Woodroof, who graduated from the University of California, Los Angeles, as a biochemist was developing valve technology at Edwards Lifesciences. Dr. Woodroof was inspired by the ECMO technology, which enhanced oxygenation to cells, and invented the world’s first biosynthetic technology-based skin substitute simulating human skin. Dr. Woodroof has had a lifelong commitment to inventing these skin substitutes with PermeaDerm^® being the most advanced of his products.

Participants included but not limited to:

• Dr. Lee Cancio, Director of the US Army Burn Center
• Dr. Robert Christy, an expert in combat trauma and burn injury research at the US Army Surgical Center
• Dr. Booker King, director of NC Jaycee Burn Center, former Director of US Army Burn Center
• Dr. William Hickerson, immediate past President of the American Burn Association
• Dr. David Herndon, Academician of the National Academy of Medicine, past President of American Burn Association, and International Society of Burn Injuries
• Dr. David Greenhalgh, past President of the American Burn Society and President of the International Society of Burn Injuries
• Dr. Tina Palmieri, Director of Burn Surgery, Shriner’s Children’s Burn Hospital Sacramento Center, California, past President of the American Burn Association
• Dr. Linwood Haith, past President of the American Burn Association

Dr. Herndon shared his memories of visiting China with Dr. Woodroof several times in the early 1980s and establishing friendships with Chinese experts which have lasted for nearly half a century. He also fully affirmed Dr. Woodroof’s expertise and great contributions in the field of biosynthetic burn technology. Dr. William Hickerson, immediate past President of the American Burn Association, commented that “PermeaDerm^® technology provides a subversive and innovative treatment solution for burn patients, further meeting the clinical needs and improving the quality of life of patients.”

From the Chairman
Ms. Lin Sun, Chairman of Stedical Scientific, expressed what an honor 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 close 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 burns, chronic wounds, bedsores, venous lower extremity ulcers, post-Moh’s surgery and many more. 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 zero adverse effects.

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.

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/de371a37-475f-4d3c-9300-b77b3828d49f

https://www.globenewswire.com/NewsRoom/AttachmentNg/e37b3828-60c4-40db-a110-e0feaa841a71

CONTACT: CONTACT:
Leo Spiegel, Executive Chairman
Stedical Scientific, Inc.
lspiegel@stedical.com