FDA Clears First-of-Its-Kind Medical Device for Second-Degree Burn Care

The US Food and Drug Administration (FDA) has cleared an innovative placental extracellular matrix medical device to manage second-degree burns—the first of its kind¹.

The device, called InnovaBurn, is the newest in a series of InnovaMatrix products by global medical device and technologies company, Convatec. The company specializes in ostomy, wound, continence, and infusion care.

InnovaBurn is a xenograft and is the only placental-derived device cleared, suited, and commercially available, to treat complex wounds such as burns, incisions, lacerations, surgical incisions (including Mohs), and ulcers (diabetic, pressure, and venous).

Raw placental tissues are sourced, processed, decellularized, disinfected, preserved, processed, and sterilized to enter their final form. InnovaBurn adheres directly to the wound and does not require special storage.

In a press release, Convatec credited its unique source material to help manufacture some of the largest Extracellular Matrix (ECM) sizes in the industry to provide a more affordable, accessible option to patients. The company said it has received feedback from physicians showing appreciation for the special sizing and InnovaBurn's ease of use to manage larger wounds, including burns.

According to both the press release and the American Burn Association, more than 486,000 Americans receive medical treatment for burns annually. Of this number, 40,000 patients are admitted to hospitals, while 30,000 are admitted to burn centers.

Historically, placental tissue has been used in several skin and dermatological spaces, including skin transplant procedures and Mohs micrographic surgery procedures².

References

1. Convatec. FDA clears first placental extracellular matrix medical device for management of second-degree burns. PR Newswire: press release distribution, targeting, monitoring and marketing. March 2, 2023. Accessed March 2, 2023. https://www.prnewswire.com/news-releases/fda-clears-first-placental-extracellular-matrix-medical-device-for-management-of-second-degree-burns-301760248.html
2. Doubleup. Applications of placental tissue in dermatology: Mohs micrographic surgery. StimLabs. October 3, 2022. Accessed March 2, 2023. https://stimlabs.com/applications-of-placental-tissue-in-dermatology-mohs-micrographic-surgery/