Thought I'd look a little more deeply at the "competitive landscape for burn care" product list outlined in this article.
I’ve relisted the products below with comments.
If you read the full copy of the article reproduced above, you’ll find that the author is particularly keen on the relatively new StrataGraft product, to which he thinks doctors might switch their allegiance from Novosorb.
Not a doctor myself, but, based on my basic research, I don’t think that’s likely.
Novosorb BTM – fully synthetic biodegradable polyurethane dermal matrix. As well as having US 510(k) clearance, Novosorb BTM is currently in a pivotal clinical trial designed for FDA (PMA) approval in severe burns. Novosorb BTM is also approved in Europe and Australia for use in all full dermal loss procedures: full thickness burns, trauma, reconstructive / wide excision surgery, revision of scar, venous leg ulcers, diabetic foot ulcers, pressure injuries and any loss of dermis needing repair.
Cytal Wound Matrix - Derived from pig urinary bladder. EU CE Mark approval excludes full thickness burns. Now owned by Integra.
Matristem Micromatrix – Particulate of pig urinary bladder. Short persistence in wound. EU CE Mark approval excludes full thickness burns. Now owned by Integra.
Aroa Myriad Matrix – Derived from sheep forestomach. EU CE Mark approval only for dermal soft tissue reconstruction of complex wounds, tissue resections and injuries from trauma.
Avita Recell – Skin cell product for epidermal regeneration. Uses patients' own cells, taken from a skin sample, which are processed with animal-derived enzyme. Has CE Mark and TGA approval but approved indication details are not provided.
From the product labelling:
RECELL is not intended to be used alone (i.e., without meshed autograft) for treatment of acute full-thickness burn wounds or full-thickness skin defects after traumatic avulsion (e.g., degloving) or surgical excision (e.g., necrotizing soft tissue infection) or resection (e.g., skin cancer).
The safety and effectiveness of RECELL used alone (i.e., without meshed autograft) have not been established for treatment of partial-thickness burn wounds:
o On the hands and articulating joints
o >320 cm2
o In patients with wounds totaling >20% Total Body Surface Area (TBSA)
The safety and effectiveness of RECELL plus autografting have not been established for treatment of full-thickness burn wounds:
o On the hands and articulating joints
o In patients younger than 28 days of age (neonates)
Hyalomatrix – Derived from hyaluronic acid (HA), the main component of synovial fluid. The HA used is created through recombinant DNA technology. The genetic code for HA is programmed into a bacterial cell, and the bacteria then produce HA. CE-marked as a dermal substitute for the immediate coverage, prior to grafting, of deep wound burns. It is also indicated for the treatment of partial- to full-thickness post-traumatic, post-surgical or deep-chronic wounds, such as vascular ulcers or diabetic foot ulcers.
Integra BMWD - Derived from cow tendon collagen and shark cartilage.
Primatrix - Derived from foetal bovine dermis. Currently under global recall. Integra owned.
Kerecis Marigen - Derived from fish skin (Icelandic cod).
EZ Derm – Derived from pig dermis. Has been available since 1980s.
Suprathel - Synthetic epidermal skin substitute, owned by PolyNovo's German distributor partner, Polymedics.
Biobrane – Combo of nylon mesh, silicone and pig skin collagen. Suitable for superficial and partial thickness wounds only. Invented in 1970s.
Oasis Burn Matrix - Derived from 2 layers of pig small intestinal submucosa. Not suitable for full thickness burns.
Stratagraft - allogeneic cultured keratinocytes and dermal fibroblasts in murine (mouse) collagen. FDA approval for adults with deep, partial thickness burns. Only suitable for thermal burns containing intact dermal elements.
Shelf life of 12 months when stored between -70°C and -90°C. Shelf life of 12 months for Stratagraft Hold Solution when stored at 2° to 8°C.
In operating theatre, requires two operators for preparation. Preparation includes a minimum 45 mins heating of holding solution in a heating cabinet, between 15 mins and 4 hrs soaking of construct sheet in warmed holding solution and then meshing in a meshing machine.
Comes in one size, ~ 100cm². Cost ~US$4000. (BTM equivalent size approx. cost of US$850).
Contraindicated for patients with known allergies to murine collagen or products containing ingredients of bovine or porcine origin or those with glycerin sensitivity.
Contains cells from human donors and may transmit infectious diseases or infectious agents, e.g., viruses, bacteria, or other pathogens, including the agent that causes transmissible Creutzfeldt-Jakob disease (CJD) or variant CJD.
Epicel - cultured epidermal autografts composed of the patient’s own keratinocytes grown ex vivo in the presence of murine (mouse) fibroblasts.
PNV Price at posting:
$1.48 Sentiment: Buy Disclosure: Held
(20min delay)