| Unmet medical needs in Europe |
|  | In Europe, there are more than 30 million sufferers from one of the 4,500 identified rare diseases.
In most cases, the treatment of such patients requires the combination of drugs and medical products. As for orphan drugs, specific needs also exist for « orphan » medical products (devices, annex therapeutic products…)
addmedica 's focuses on the market of medical products for treatment of rare diseases, metabolic disorders and genetic diseases where numerous unmet medical needs exist.
|
|
| | | Unlike the US or Japan (see Orphan medical device), there is currently no specific regulation yet encouraging the development and the use of Orphan Medical Devices in Europe. However, anticipating such regulation, addmedica's mission is to address this medical demand and to provide medical devices to the population suffering from rare diseases in Europe. |
| Examples of targeted products | - Immuno-adsorption columns for immune disorders
- Skin and dermal substitutes
- Electro stimulation for rare diseases
- “Frontier products” between drugs and devices (skin protections against radiation, physiological substitutes…)
|
The WHO has established a list of 4,500 rare diseases throughout the world. There are some 20 million sufferers in the United States, out of a total population of 280 million and similar figures and ratios have been observed in Europe, representing approximately 9% of the total European population, i.e. 30 million sufferers out of 330 million people.
This type of patient needs specific drugs, but also specific medical devices or medical supplies or food diets. Particular regulations have been put in place to speed registration and availability of these kinds of products.
Today, the situation is quite similar for orphan medicinal products in the US, Japan, and recently in Europe with a set of official guidelines to regulate orphan drugs and to accelerate changes in this market segment. On the contrary, however, the situation is very varied for orphan medical devices, despite the pressure from patient associations and medical demands. |
|
Annex therapeutic products
|
| | Many unclassified medical products usually grouped in an « Annex therapeutic products » category are increasingly used in emerging medical and surgical technologies
|
Examples of targeted products
| - Solutions for organ transplantation
- Haematopoietic cytokines included in cell expansion protocols
- Other products or media used ex-vivo
|
|
© ADDMEDICA - adding value for health
Legal Information
|
