I would say that even with $1.6m in the bank they would need a...

I would say that even with $1.6m in the bank they would need a capital raise at some point, or issue of shares to Parvulus.

I am not sure about AHZs product comparison- need to do more research. I believe AHZs is used for purposes other than the heart??


I did find on the Parvulus Suisse website that the FDA has granted the Intra-annular Annoluplasty Ring "ORPHAN" status:

http://www.parvulus-suisse.com/index.php/products/intra-annular-ring/intra-annular-ring-product-information

"Parvulus Suisse SA has received a Humanitarian Use Device Designation (HUD) from the Office of Orphan Drug Products Development of the Food and Drugs Administration (FDA) for its Intra-annular Annuloplsaty Ring for the surgical treatment of atrioventricular valve regurgitation in the pediatric population.

The Intra-annular Ring received a CE Mark in December 2011 and is now available for use in over 200 countries worldwide."

Also there's a bunch of FAQs on the website with some very interesting info regarding worldwide use, and ongoing trials required for certain countries:

http://www.parvulus-suisse.com/index.php/products/intra-annular-ring/faq

Some important ones:

"Q. : What clinical data do you have ? Is it published ?

A. : At the end of 2011, here have been 16 peer reviewed articles and abstracts published on the Ring. Parvulus also has data in a number of internal clinical databases totalling over 500 patients with the longest follow-up out to 5 years. These data all support the Intra-annular Ring in being safe and effective. Copies of publications can be received by writing to: [email protected]


Q. : Do you plan more clinical trials ?

A. : We are currently initiating a clinical study in 3 centres in the US in children with single right ventricle anomalies (including hypoplastic left heart syndrome). We also operate an Electronic Patient Registry to facilitate data collection and storage. Parvulus is always potentially interested in initiating other clinical studies with the Intra-annular Ring


Q. : Can the Ring be used in countries where it is not yet approved for sale?

A. : Yes, the Ring can be utilised by cardiac surgeons in such countries under a compassionate use exemption. A number of such implantations have taken place in seriously ill children in a number of countries such as the US and Mexico, for example. Please contact: [email protected] for more information on how we might assist you with compassionate use of the Ring."