Avita Medical wins FDA PMA for Recell severe burn treatment device

Avita Medical (ASX:AVH) said today that it won FDA premarket approval for its Recell autologous cell harvesting device, now cleared for use in treating severe thermal burns in patients 18 and older, and that it plans to launch the device in the fourth quarter. The Recell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and cosmetic procedures, the Valencia, Calif.-based company said. “Patients are at the center of everything we do at Avita Medical, and we are pleased to be able to provide an innovative solution for the treatment of severe burn injuries. Today’s approval of the Recell system marks an important milestone for us and provides a new way to treat burns for the thousands of patients with significant unmet medical needs. We are grateful to those patients who participated in clinical trials of the Recell system and to the clinical trial investigator teams whose dedication and scientific rigor made this approval possible. We also greatly appreciate our collaboration with [Biomedical Advanced Research and Development Authority] and the support that they have provided to us throughout the development of the Recell System,” CEO Dr. Michael Perry said in a press release. Approval of the system came based off the results of two randomized, controlled clinical trials comparing treatment with the Recell system against standard of care. Results from ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regenerative Medicine Regulatory/Compliance avitamedical Source Type: news

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Condition:   Burns Interventions:   Other: Early Mobilization;   Other: Late Mobilization Sponsor:   Sunnybrook Health Sciences Centre Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Study met both co-primary endpoints with high statistical significance, demonstrating autograft sparing and durable wound closure at three months with StrataGraft Company plans to submit Biologics License Application to the U.S. Food and Drug Administra... Regenerative Medicine Mallinckrodt, StrataGraft, regenerative tissue, burn wounds
Source: HSMN NewsFeed - Category: Pharmaceuticals Source Type: news
Since the 1980s, deep and extensive skin wounds and burns are treated with autologous Split-Thickness Skin Grafts, or Cultured Epidermal Autografts (CEAs) when donor sites are limited. However, the clinical use of CEAs often remains unsatisfactory due to poor engraftment rates, altered wound healing and reduced skin functionality.In the past few decades, Mesenchymal Stromal Cells (MSCs) have raised much attention due to their anti-inflammatory, pro-trophic and pro-remodeling capacities. More specifically, gingival MSCs have been shown to possess enhanced wound healing properties compared to other tissue sources.
Source: Journal of Investigative Dermatology - Category: Dermatology Authors: Tags: Original Article Source Type: research
The objective of this study was to evaluate efficacy, safety, and duration of postoperative analgesia with liposomal bupivacaine for donor site pain in burn patients. This was an observational, case–control study including adult patients with
Source: Burns - Category: Dermatology Source Type: research
ConclusionsStrataGraft tissue treatment of DPT thermal burns reduced the need for autograft, resulted in wound closure and treatment-site cosmesis comparable to that of autograft, and was well tolerated.
Source: Burns - Category: Dermatology Source Type: research
Publication date: Available online 20 July 2019Source: BurnsAuthor(s): Sarvnaz Sepehripour, Elizabeth Chipp
Source: Burns - Category: Dermatology Source Type: research
There have been significant advances in the care of burns over the past decade. As a result of the improved survival of burn patients, attention has shifted to the optimized management of their wounds. Traditionally, autografts have been described as the g...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Burns, Electricity, Explosions, Fire, Scalds Source Type: news
There have been significant advances in the care of burns over the past decade. As a result of the improved survival of burn patients, attention has shifted to the optimized management of their wounds. Traditionally, autografts have been described as the gold standard treatment in cases of deep second- and third-degree burn wounds; however, they are limited especially in large surface area burns. As such, advancements have been made in the development of biologic dressings, which attempt to mimic the function of the lost epidermis and/or dermis. The ideal biologic dressing is nontoxic, lacks antigenicity, is immunologicall...
Source: Annals of Plastic Surgery - Category: Cosmetic Surgery Tags: Burn Surgery and Research Source Type: research
Publication date: Available online 6 June 2019Source: BurnsAuthor(s): Clifford C. Sheckter, Jeremy Goverman
Source: Burns - Category: Dermatology Source Type: research
Publication date: Available online 5 June 2019Source: BurnsAuthor(s): Michel H.E. Hermans
Source: Burns - Category: Dermatology Source Type: research
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