I'm posting this in the hope that I can elicit the opinions of others, and specifically that of hottod, who although not a frequent poster on the CZD board, does maintain a keen interest. Hottod, are you around?
I note that in the US Regulatory Udate BTM is described as "BTM Wound Dressing," not as a tissue scaffold. The text of the announcement elaborates on this as follows:
"PolyNovo has filed a 510(k) submission to the US FDA for clearance to market its NovoSorb Biodegradable Temporising Matrix ("BTM") as a surgical wound dressing. A successful submission will allow the BTM to be marketed in the US.
"The BTM Wound Dressing is indicated for the management of wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second degree burns, and skin tears) and draining wounds. The device is intended for one-time use."
I am not certain whether this represents a strategic or a tactical change of emphasis, but I note that within this description is included the same indications as for the NPT dressing, except that this dressing is "intended for one time use". That sounds like a tissue scaffold. But perhaps this is a distinction without a difference.
I never really understood the need for changing the NovoPore dressing, except that traditionally, dressings get changed.
Obviously being able to simply leave a dressing in place in a sterile chronic ulcer means the healing can take place without repeated reopening of the wound. That makes a lot of sense to me, and seems more of a game changer than simply using a NovoPore dressing as little more than an improved Granufoam.
Does anyone else see this as a possibility or an explanation for the change of emphasis?
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