As a reminder, in May 2015 Noridian Healthcare, the west coast Medicare contractor, said to no longer bill skin procedures under CPT Code 0182T ( High dose rate electronic brachytherapy, per fraction ). While there have been some updates to CMS coding which took effect Jan 1, 2016, it unfortunately seems to have done little to clear up the reimbursement picture.
Meanwhile, while ICAD did place one Xoft system in Q4 for non-melanoma skin cancer, the Therapy segment remains hampered by the ambiguity surrounding reimbursement for this indication. These, along with the overall move towards leveraging growth of 3D imaging space should bode well for sustained strength in Detection revenue growth for many years. iReveal just launched in July and will provide another impetus for 2016 and beyond.
#ICAD 2016 SOFTWARE#
launch.Īnd Detection has other tailwinds – including PowerLook upgrades (15% unit placement growth in 2015) and ICAD’s breast density software (113 licenses in 2015, up from 40 in 2014) which continue to perform well. While we don’t expect much in the way of contribution until late 2016, GE’s current installed base of ~600 units already represents an enormous opportunity for ICAD and one which we think makes its initial significant showing on the revenue line in 2017 – perhaps slightly earlier, depending on timing of the U.S. We continue to think tomo holds inflection-point and significant long-term growth opportunity. market, incorporating initial contribution happening in early 2017. We continue to take a more conservative timeline for the U.S. While that didn’t happen, assuming final analysis is also positive, management believes the final module will be submitted this month and U.S.
As of the Q3 earnings call management was hoping to have the PMA final module filed with FDA in January. Per management, “preliminary results are encouraging”. reader study has completed and is now awaiting final analysis.
CE Mark is expected to come this month as well. ICAD continues to guide for the European launch to happen this quarter – specifically a kick-off is at the European Congress of Radiology this week. Timeline for the European tomo launch appears to be tracking management’s most recent expectations. This is subject to change, however as ICAD noted that they remain in “strategic” discussions with Invivo which includes a potential sale of the MRI business. We have moved our forecasted Detection numbers down slightly as it looks as if MRI-Invivo was contributing somewhat more than we had estimated. However, we do not view the contraction (8% yoy, 17% sequential) in Q4 as particularly reflective of the fundamentals of this segment, which remains poised to enter what we believe will be a cycle of long-term growth on the heels of the launch of the initial tomosynthesis product. This shaved about $800k from the top-line compared to Q3 – or ~$200k more than the $600k haircut that we were ballparking.
#ICAD 2016 LICENSE#
This relates to the roll-off of the MRI distribution license with Invivo - and while management had guided on the Q3 call that MRI sales were likely to slip in Q4, we had underestimated the impact. Therapy revenue came in right on our estimate and continues to struggle as a result of lack of clarity over non-melanoma skin cancer reimbursement.ĭetection revenue fell on a yoy basis for the first time since Q1 2014. Results were mostly inline with our estimates with EPS coming in dead-on but a slight miss on the top-line related to the Detection segment. ICAD ( ICAD) announced financial results for the fourth quarter ending December 31. 1H 2016 May Be Soft, Look for Pick Up in 2H on Tomo Contribution
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