From Bad to Worse for CRY. Tenaxis Medical receives FDA approval.:
March 4, 2013 - Tenaxis Medical®, Inc. Receives FDA Approval for its ArterX® Surgical Sealant
Tenaxis Medical, Inc., a medical device company focused on the development of functionally designed surgical sealants has received FDA approval to bring its innovative ArterX Surgical Sealant to the market.
My Opinion: I think this is a product that may compete directly with BioGlue. If Tenaxis Medical can develop an effective distributor network, they could put a spear into the heart of CRY's profitability and free cash flow. BioGlue appears to be the only cost center that makes any money. BioGlue appears to have about an 85% gross profit margin and perhaps roughly a 33% net operating income from BioGlue. If Tenaxis Medical's "ArterX" negatively affects BioGlue sales and in addition would negatively affects BioGlue margins, CRY could be headed down a lot.
Also, it appears that CRY has some FDA issues with BioGlue too (see except from FDA wraning letter below):
Complaint 1663 involving a patient death was initiated on 01/31/12 and indicated BioGlue was not very viscous and was running deeper into the lumen. Upon review of DHR for the associated lots, syringes were rejected due to particulates for Lot Numbers 11MJX009 and 11MJX015 during filling of the 10 mL BioGlue syringes. The First Re-inspection for 11MJX015 showed that 61 out of (b)(4) syringes were rejected. The First Re-inspection for 11MJX009 showed that 49 out of (b)(4) syringes were rejected. An investigation was not generated for these two lots, and the re-inspection of the affected BioGlue did not document the reason for the rejected syringes.