A biodynamic hematogel composed of platelet-rich plasma gel prepared from a small sample of a patient’s own platelets and plasma as a catalyst for healing indicated for the treatment of wounds. Marketed in the U.S. under Section 361 for the Platelet Rich Plasma and under 510(k) clearance as of September 2007.
ORGANOGENESIS, INC. & NOVARTIS AG
A bi-layered living skin substitute made from a dermal layer of human cells (fibroblasts) in a bovine type I collagen and an overlying cornified epidermal layer of living human keratinocytes. Apligraf is indicated for the treatment of chronic venous leg ulcers and diabetic foot ulcer. Approved by U.S. FDA in July 1998 and June 2000, respectively.
A cardiovascular scaffold which facilitates endogenous stem cells and other cells to regenerate and repair damaged tissue for the treatment of cardiovascular abnormalities. Marketed in the U.S. under 510(k) clearance as of 2014; marketed in Europe under CE Mark as of 2013; received medical device license in Canada in 2014; approved in Singapore in 2015.
A dermal substitute used to help in the wound closure of diabetic foot ulcers. It is made from human cells (fibroblasts), placed on a dissolvable mesh material. Organogenesis acquired Dermagraft from Shire in 2014. Approved by U.S. FDA in September 2001.
A permanent skin replacement product grown from a patient’s own skin cells. The autologous keratinocytes are co-cultured with irradiated murine cells to form cultured epidermal autografts (CEA). Epicel is indicated for treatment of deep dermal or full thickness burns. Epicel has been used in the U.S. and other countries since 1988; approved in the United States in 2007 as a Humanitarian Use Device (HUD) under a Humanitarian Device Exemption (HDE).
An autologous skeletal myoblast preparation approved in Japan in 2015 for the treatment of patients with serious heart failure.
A cultured epidermal autograft composed by culturing autologous keratinocytes. It is transplanted to the wound and aids in regeneration of the dermis and develops into new skin. Holoderm is indicated for the treatment of skin disorders such as burns, vitiligo, nevi and scars. Approved in S. Korea in 2002.
CHA BIO&DIOSTECH CO LTD
A cell therapy which cultivates autologous skin fibroblasts in 3D scaffolds formed of hyaluronic acid derivatives for the treatment of diabetic foot ulcers. Conditionally approved in S. Korea in July 2007.
A combination product of autologous cultured chondrocytes and collagen gel approved in Japan in 2012 for the alleviation of clinical symptoms of traumatic cartilage defect or osteochondritis dissecans of the knee.
An epidermal cell sheet produced from keratinocytes isolated from a patient’s own skin tissue, approved in Japan in 2007 for use in patients with deep dermal and full-thickness burns covering 30% or more of the total body surface area; approved in Japan in 2016 to treat patients following the excision of giant congenital melanocytic nevi to facilitate the closure of the wound.
AUTOLOGOUS CULTURED CHONDROCYTES ON A PORCINE COLLAGEN MEMBRANE / VERICEL
An autologous cellularized scaffold product, indicated for the repair of single or multiple symptomatic, full-thickness cartilage defects of the knee with or without bone involvement in adults. Approved by the U.S. FDA in December 2016.
The product consists of three-dimensional collagen-chondroitin sulphate scaffolds with embedded autologous chondrocytes in a cell suspension. Marketed in the EU for for articular cartilage repair since 2003.
An advanced bilayer dermal regeneration matrix for the treatment of diabetic foot ulcers. Approved by the FDA in 2016.
Ortho-ACI is an autologous chondroctye-based cellularized scaffold to treat symptomatic defects of the articulating cartilage of the joints, predominately the knee and ankle. Approved in Australia 2017.
An autologous bone cell implantation for the treatment of bone defects in patients caused by degeneration, drugs, intense physical stress, diet, genetics, obesity, smoking, alcohol or disease. Approved in S. Korea in 2009, approved in India in 2017.
An autologous cell harvesting device that enables a to create a regenerative epithelial suspension using the sample of the patient’s skin for the treatment of ulcers. Marketed in Europe as of 2015.
An autologous cell harvesting device that enables a to create a regenerative epithelial suspension using the sample of the patient’s skin for the treatment of skin discoloration. Marketed in Europe as of 2016.
Rethymic is a one-time tissue therapy to treat immune reconstitution in pediatric patients with congenital athymia. It was approved by the US FDA in October 2021.
Startagraft (Allogeneic cultured keratinocytes and dermal fibroblast in murine collgen-dsat) is a allogeneic cellularized scaffold product. It was approved by the FDA in June 2021 to treat deep partial-thickness burns.
A tissue-engineered skin substitute made from a nylon mesh and a silastic semi permissible and biocompatible layer for the treatment of Epidermolysis Bullosa. Approved by the FDA in 1998, acquired by Organogenesis from Shire in 2014.
A device composed of homogenous human recombinant type I collage for use in wound treatment. Marketed in Europe as of 2016.
A matrix made of collagen type I for use in the treatment of connective tissue disorders. Marketed in Europe as of 2016.