I’m ambitious. I’d like to see both Options 2 and 3 adopted!...

I’m ambitious. I’d like to see both Options 2 and 3 adopted!

Rather than viewing Option 3 (use of Real World Evidence) as unlikely, I’m really keen on the possibility of PolyNovo using this option.

The following is from an FDA document which sets out 90 examples of RWE being successfully used in regulatory submissions for medical devices. Of the various types of RWE that can be used, one is medical records

Utilizing medical records as a primary source of clinical evidence is common in submissions seeking an indication expansion. Other submissions illustrate use of RWE to support modifications to the indications for use statements for legally marketed devices. In most cases these modifications include use to treat a new disease or use in a new patient population or anatomic location. These submissions often incorporate systematic reviews or meta-analyses of existing literature to develop comparators or provide context for the real-world performance of the subject device.

As well as indication expansion, RWE can be used to support labelling to specifically include paediatric populations

This section examines the benefits of the use of RWE for pediatric patients, a population that has historically been difficult to study in traditional clinical trials. From the sections organized by data source above, examples have been selected in which RWE from pediatric patients was used to support modifying device labeling to explicitly include use in pediatric populations.

Both the current pivotal burns trial and the previous feasibility study have restricted patients to adults aged between 18 and 75 years of age. Unfortunately, it is possible that any approval based on these trials alone would restrict the approved indication to treatment of severe burns in adults. But we know from the use of BTM in severe burns in the real world over the past 5+ years that many children have been successfully treated and with great results. Why not use medical records as evidence to support approval of BTM in severe burns, even in paediatric populations? And possibly also in the population aged 75+?

Or what about labelling that doesn’t exclude use of BTM when infection is present? The PMA that was granted to Integra’s dermal regeneration template for use in full-thickness and deep partial-thickness thermal injuries contraindicates its use in clinically diagnosed infected wounds. What if RWE could be used to argue that this contraindication is not required for BTM?

By the way, Integra was granted PMA approval in full thickness burns almost 30 years ago (March 1996). To my knowledge, Integra remains the only FDA PMA approved dermal template for full thickness burns. Integra has built and maintained its market leadership in burns in the United States on this basis. As Swami Raote has said, the granting of a PMA in the treatment of full thickness burns will “dramatically move the adoption curve” for BTM in the United States.