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31/03/15

00:07

Post #: 15008127
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Originally posted by ajbhu ↑

From my understanding, the current situation is based only on the fact that EMA has to deal with a novelty protein.

We have a Medical Device that is VitroGro.

We live in Europe and we have asked to a local health authority what can be our case based on available informations.

The answer is the following:
In general, the common cases that have to been approved by EMA CHMP is a Device only or a Medical ancillary product.
And here come the issue.
We have a fantastic product that has both characteristics in one item. This is a huge innovation to current practice, but in the meantime create the regulatory hassle to approve two items in one item.

Let's explain.

We have a scaffold (gel) that to cure hard to heal wounds has two elements.
One is Vitronectin that bind directly with the tissue and is already in our body and in our case is acting as a Device. (Practically, the gel binding with the existing skin tissue create the optimal sterile environment for skin cell reproduction).
The other element available in VitroGro is the Ancillary Medicine and this is IGF-1, that operate as a medicine and provide the tissue replication for closing the Hard to Heal Wounds.

Therefore, being a Medical Device with two properties in one (quite unique scenario as EMA has never had such a case) is in need to further get some documentation (to be made in laboratory) to properly regulate the Medical Device with both properties.

This is the reason of the additional questions.

Nobody has ever challenged the curative properties of the Medical Devices, that based on the successful clinical trials with Prof. Hardings have demonstrated to be unique in results and substantially improving patient health.

But still the product need to have proper labelling, and is fully understandable, as in the end in the Hospitals, Pharmacies and Health Providers will be essential to know specifically the storage duration of the product (in the label).

The May SWAP meeting will be oriented to build a platform of questions and answers that will satisfy the regulators to approve in the current year the product with a Scientific Opinion that cover the full spectrum, including the ancillary medicine IGF-1 that is in VitroGro.

In conclusion, this is now purely a mutual step that is needed to get final approval.

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