Stedical Scientific Makes a Splash at the 2022 American Burn Association Annual Meeting, Showcasing PermeaDerm® Clinical Progress in the U.S. and China with First Deep Partial-Thickness Burn Case Successfully Treated

The 54th Annual Meeting of the American Burn Association (ABA) was successfully held in Las Vegas, USA, from April 5 to 8 local time. As one of the most important academic events in the international wound care community, experts in the field of burn care from around the world engaged in vigorous academic discussions on this platform, focusing on the latest research findings and cutting-edge wound treatment strategies. During the conference, the Chinese company CytoCare reported on the progress of clinical trials currently being conducted in both China and the United States.

Saide Dikang’s U.S. acute, multicenter clinical study completed enrollment of the first patient in early March. The trial is planned to be conducted at eight of the top ten burn centers in the United States, with a total of 68 subjects to be enrolled. Professor David Greenhalgh, the Principal Investigator (PI) for the U.S. clinical trial and current President of the International Society for Burn Injuries, introduced PermeaDerm to the attendees.^®Post-U.S. Listing Multicenter Clinical Protocol and Progress

Figure: PermeaDerm^®U.S. Principal Clinical Investigator – Professor David Greenhalgh Announces PermeaDerm^®China-US Clinical Research

During the same period, Saidikang Medical Technology Co., Ltd. launched in China the “Evaluation of PermeaDerm^®“Multicenter Clinical Trial on the Safety and Efficacy of Artificial Dermis.” The first enrolled patient with deep partial-thickness (deep second-degree) burns achieved complete clinical healing after just nine days of treatment with a single application of the product. In contrast, conventional clinical therapies typically require three to seven weeks for healing of deep partial-thickness burns. As a country with a high incidence of burn injuries, China sees approximately 26 million cases of varying severity each year, making wound repair and skin regeneration a persistent focus in clinical practice. Sidericon Medical Technology Co., Ltd. has initiated this multicenter clinical study, which will enroll a total of 184 subjects across four authoritative clinical centers. Professor Xia Zhaofan, an academician of the Chinese Academy of Engineering and Director of the Department of Burn Surgery at Changhai Hospital affiliated with Naval Medical University, who serves as the principal investigator of this study, stated that the bioengineered tissue-engineered skin product, PermeaDerm^®This study fills a gap in this therapeutic area. Furthermore, the research was jointly conducted by Professor Lü Guozhong’s team (Director of the Burn and Trauma Diagnosis and Treatment Center at the Affiliated Hospital of Jiangnan University and Chairman of the Burn Surgery Branch of the Chinese Medical Association), Professor Liu Yan’s team (Director of the Burn and Plastic Surgery Department at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Vice Chairman of the Burn Surgery Branch of the Chinese Medical Association), and Professor Xie Weiguo’s team (Director of the Burn Department at Tongren Hospital affiliated with Wuhan University and former Vice Chairman of the Burn Surgery Branch of the Chinese Medical Association).

Figure: Changhai Hospital Holds a Meeting on PermeaDerm^®China Multi-Center Clinical Trial Initiation Meeting

Fourth from the right: Academician Xia Zhaofan, Principal Investigator of the clinical trial and Director of the Department of Burns at Changhai Hospital; fourth from the left: Ms. Sun Lin, Founder of Cyteir Therapeutics

Professor David Herndon, a master expert in the international field of burn care, Member of the U.S. National Academy of Medicine, and former President of the American Burn Association/International Society for Burn Injuries, delivered a video address at the clinical launch event in China. He congratulated Academician Xia and her wound repair team at Changhai Hospital, stating that they are embarking on a remarkable journey with one of the best products ever available for the treatment of burns and other wounds. This product is a skin substitute called “PermeaDerm.”^®”, capable of treating nearly all types of wounds following debridement. This product serves as a substitute for lost skin functions, remaining in place on the wound until the underlying skin tissue has healed, or, in the treatment of third-degree burns, until autologous skin grafting is performed.

PermeaDerm^®Currently approved by the U.S. FDA, it is indicated for the repair and treatment of difficult-to-heal wounds, including various acute wounds such as burns, scalds, trauma, and combat-related injuries, as well as plastic surgery wounds; and chronic wounds such as diabetic foot ulcers (highly prevalent in the elderly), pressure ulcers, lower extremity venous ulcers, and cancerous wounds. Since its official market launch in the United States in 2020, it has successfully treated thousands of patients across major medical centers in the U.S., with a zero incidence rate of adverse events.

Figure: Academician David Herndon Delivers Remarks at the China Clinical Launch Meeting

On the evening of April 5, Caidi Kang held a grand symposium themed “ECMO (Artificial Lung) and Burn Care Technologies.” Many authoritative experts in the field of burn care attended, including Professor Robert Bartlett, known as the “Father of ECMO,” and Dr. Aubrey Woodroof, pioneer of biosynthetic tissue-engineered skin technology and Chief Scientific Officer of Caidi Kang/PermerDerm.^®honors were bestowed upon the inventor. During the event, Professor Bartlett shared touching stories about his long-standing friendship with Dr. Woodroof and how technological innovation has driven industry progress. At that time, as the newly appointed Director of the Burn Center at the University of California, Irvine, Professor Bartlett invented ECMO technology. Meanwhile, Dr. Woodroof, a biochemist developing valve technologies in Edward and a graduate of the University of California, Los Angeles, was inspired by ECMO technology to enable effective oxygenation of skin cells. He invented the world’s first therapeutic technology simulating and replacing human skin based on biosynthetic techniques and dedicated his life to this field.Also attending the exchange were many distinguished experts in the field of burn care, including Professor Lee Cancio, Director of the U.S. Army Burn Center; Professor Robert Christy, an expert in combat trauma and burn injury research at the U.S. Army Institute of Surgical Research; Professor William Hickerson, President of the American Burn Association; Professor David Herndon, Member of the National Academy of Medicine and former President of both the American Burn Association and the International Society for Burn Injuries; Professor David Greenhalgh, former President of the American Burn Association and current President of the International Society for Burn Injuries; Professor Tina Palmieri, Director of Burn Surgery at Shriners Hospitals for Children – Sacramento and former President of the American Burn Association; Dr. Linwood Haith, former President of the American Burn Association; and Professor Paul Glat, Director of Plastic Surgery and the Burn Unit at St. Christopher’s Hospital. Each of them shared their valuable insights in the field of burn care.

The photo shows Dr. Aubrey Woodroof, Chief Scientific Officer of Saidikang, and Professor Robert Bartlett, the father of ECMO, delivering inspiring speeches.

Pictured: Mr. Leo Spiegel, Co-founder of Sidecon, Delivering Opening Remarks

Academician Herndon shared with the audience his fond memories of several trips to China with Dr. Woodroof in the early 1980s, which marked the beginning of a nearly half-century-long friendship with Chinese experts, and he fully acknowledged Dr. Woodroof’s significant contributions to the field of biosynthetic tissue engineering technology. Professor William Hickerson, President of the American Burn Association, commented on “PermeaDerm”^®The patented technology provides a disruptive and innovative treatment solution for skin replacement in burn patients, further meeting therapeutic needs and improving patients' quality of life. In addition to its clinical performance in the field of second-degree burns, PermeaDerm^®"Clinical applications in the field of third-degree burns are also highly promising, significantly alleviating patient suffering. The adoption of this technology undoubtedly represents a new milestone in burn treatment."

The image shows Professor David Herndon, a member of the U.S. National Academy of Medicine, delivering a speech.

Figure: Group photo of the team from Shriners Hospitals, the largest pediatric burn center in the United States and the U.S. clinical lead institution

Second from left: Professor David Greenghalgh, Principal Investigator of U.S. Clinical Studies, Director of Shriners Burns Hospital, President of the International Society for Burn Injuries, and Former President of the American Burn Association

Left 3: Dr. Aubrey Woodroof – Chief Scientific Officer of Cidicon, Inventor

Second from right: David N. Herndon, MD, Former Director of Shriners Hospitals for Children – Galveston, and Former President of the American Burn Association and the International Society for Burn Injuries

Far right: Professor Tina Palmieri, Director of Burn Surgery at Shriners Hospitals for Children—Sacramento, California, and former President of the American Burn Association

Since its founding, CytoDex has been deeply engaged in the fields of tissue engineering and regenerative medicine. Its industry-leading R&D team continuously develops globally patented innovative technology platforms, committed to providing higher-quality and more effective innovative medical solutions for patients and healthcare professionals worldwide.

Ms. Sun Lin, Chairwoman of Saide Dikang Medical Technology, stated, “We are honored to seek better treatment solutions for patients worldwide through innovative research and development. We hope that a small group of patients in China will be the first to benefit from this clinical study, and we look forward to extending these benefits to more families soon, thereby contributing to the Healthy China 2030 initiative and helping to build a healthy medical ecosystem.” Given the current international landscape and environment, the importance of a global commercial layout has become even more prominent. With the global market for tissue engineering and regenerative medicine valued at hundreds of billions of dollars, Saide Dikang is actively promoting the integrated development of its global operations through close collaboration with renowned experts both domestically and internationally. The company is accelerating its expansion in China, the United States, the Middle East, Southeast Asia, Africa, and Latin America.

Cydicon Medical Technology is a China-based, globally oriented medical technology enterprise. It boasts a world-leading innovative technology platform in tissue engineering and regenerative medicine, with R&D centers and production bases established in both China and the United States. In 2021, it ranked first among the global Top 10 providers of wound management solutions. The company is committed to introducing disruptive innovations into the healthcare sector, accelerating the global clinical application of innovative medical technologies, and enabling more patients to receive cost-effective treatments.