Minor bump in the road to 510k submission
RUA have released a precautionary announcement noting a minor delay to the 510k submission for its large bore vascular graft. This was almost certainly due to the handling of the batch of un-implanted grafts, and we share RUA’s frustration with the resulting delay. Since we had not yet updated our valuation for a June 2021 510k submission, our fair value remains unchanged.RUA announced a delay to their 510k medical device submission to the FDA for their large bore vascular graft. Surprisingly, a chemical analysis detected cellulose in an early batch of un-implanted grafts. The delay is very much a precautionary move as RUA’s Elast-Eon-coated medical devices are completely artificial – cellulose (an inert, natural, plant-derived material) is NOT used in their manufacture, and none has been detected in the three components (yarn, Elast-Eon and plastic packaging). The grafts must have been accidentally contaminated prior to leach testing.
Our valuation remains at £115.4m or 520p per share. We had been expecting to alter our valuation after the 510k submission and continue to await this announcement to amend it.
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