FDA Approval for Autoinjector
The Medical House PLC ("TMH" or the "Group"), (AIM:MLH) the drug delivery specialist, is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Group's Compact AutoSafety Injector (CASI).This clearance permits the placing of this device in the US market for assisting the self-administered subcutaneous injection of fixed doses of FDA approved drug products which are presented in standard 1ml long pre-filled syringes with staked needles.
The CASI is a version of TMH's ASI disposable autoinjector which is being developed for the global pharmaceutical company which extended its Agreement with TMH in November 2007, a deal which included an immediate payment of £2m.
Ian Townsend, Chairman, The Medical House PLC, said:
"This a key milestone achievement for TMH as it is our first ASI device to receive FDA pre-market notification which allows us to market the CASI in the US. It is also a vital approval for the project involving our global pharmaceutical partner and its commercial strategy. We are all delighted with this news and we look forward to reporting more progress for our Drug Delivery Division in due course".
Publish Date: Tuesday, March 11, 2008