Dive Brief:

• Hologic has received a CE mark for its LOCalizer wireless radio frequency identification breast lesion localization system, clearing it to sell the device in the European Union.

• LOCalizer is a tag that is implanted up to 30 days before breast-conserving surgery to enable the marking and targeting of lesions.

• Hologic acquired the device in its $85 million takeover of Faxitron Bioptics and has since picked up regulatory clearances on both sides of the Atlantic to expand its use.

Dive Insight:

Hologic doubled down on its established breast health unit in the wake of the underperformance of its big bet on medical aesthetics company Cynosure. The pivot back toward breast health has paid off so far, enabling Hologic to beat expectations and raise its outlook last quarter.

Faxitron contributed to breast health sales growing 12.7% in that quarter and has since set the stage for further growth by receiving regulatory green lights for LOCalizer. In January, FDA gave physicians the okay to implant LOCalizer more than 30 days before breast-conserving surgery, expanding on the clearance it granted the device in 2017.

Now, Hologic has positioned itself to grow sales in the EU by receiving a CE mark clearing the device for use up to 30 days before a procedure. While the time window permitted in the EU is narrower than in the U.S., Hologic thinks it is wide enough to improve workflows at breast health units.   

Conventional localization methods require surgeons to implant a thin wire in the patient on the day of the breast-conserving surgery. Hologic argues this technique causes pain and inconvenience to the patient while also creating scheduling challenges for surgical teams. Giving breast health teams a 30-day window between implantation of the tag and surgery could lessen these challenges.

Once the tag is implanted, the surgical team can use an accompanying handheld reader to locate it and the breast lesion it is marking. Some teams use radioactive seeds for wireless localization but this requires them to comply with regulations on the handling of such materials.

LOCalizer is also up against a radar localization system, Cianna Medical's Savi Scout, in some markets. Cianna's device received FDA clearance before LOCalizer but it is larger than Hologic's device and radioactive seeds.