Brian Marckx, CFA
SNWV Hits Another Milestone – CPT III Codes Released
SANUWAVE (SNWV) continues to make progress with commercialization of its flagship device for the treatment of diabetic foot ulcers (DFU). Just last week the company announced that they had made the third and final module filing to the FDA for dermaPACE in DFU. Also announced was additional positive data from their Phase III IDE study that was used to support the regulatory filing.
This morning SANUWAVE followed up with more encouraging news, announcing that the American Medical Association released two CPT III codes (0299T and 0300T) for Extracorporeal Shock Wave treatment (ESWT), the mechanism used by dermaPACE for the treatment of diabetic foot ulcers. CPT III codes are a temporary code used for new technologies – decision to grant a CPT III code lies with the American Medical Association’s (AMA) CPT Editorial Panel – which bases its decision on a review of clinical data, peer-reviewed literature and interest in the technology from physicians. CPT III codes allow for data collection in order to see how widespread use of the technology is (i.e. – are physicians interested in using it?).
Noteworthy is that the AMA released these CPT III codes relatively early in the FDA review process – and well ahead of when dermaPACE would likely receive FDA clearance. While maybe a little too early to read much into this, anecdotally we think the move indicates that there may be real interest in ESWT therapy from the healthcare community.
Assuming eventual FDA approval and launch (which we model in the Q2 – Q3 2012 timeframe), dermaPACE will be the only ESWT device utilizing these CPT III codes. The next step will be to get a CPT I code with a relative value (specifying reimbursement amount) assigned – the assignment of which will be determined by data related to physician interest, collected from use of the CPT III code. We expect the eventual assignment of a CPT I code to be a major inflection point for SANUWAVE and result in a steeping rate of unit placements and utilization.
We picked up coverage of SANUWAVE in May 2011. See below for free access to our 27 page report on the company which provides additional detail about reimbursement for dermaPACE.
For a free copy of the full research report, please email scr@zacks.com with SNWV as the subject.
Follow Zacks Small Cap Research on Twitter at Twitter.com/ZacksSmallCap
SANUWAVE HEALTH (SNWV): Free Stock Analysis Report
Zacks Investment Research
