The French company said that the new CMS C-code covering HIFU ablation of prostate tissue procedures will take effect July 1. The code will cover procedures performed by its HIFU devices, including whole primary gland prostate ablation, partial prostate ablation or whole and partial salvage ablation.
“We are elated by CMS’s decision. This is another key milestone in the acceptance and recognition of HIFU technology in the U.S. as reflected by CMS’s celerity in addressing the dossier, establishing a c-code and assigning a competitive coverage level. It will provide a choice between recognized therapies based solely on clinical need and evidence. The C-code is a significant achievement and opens the door to broader coverage from different payers, including private and commercial payers. We will now transition our efforts toward expanding coverage and physician education to make our innovative technology available to all patients in the U.S. I would like to thank Jerry Stringham, president of the reimbursement strategy consulting firm Medical Technology Partners for all of his hard work. Jerry has been instrumental in directing our efforts towards reimbursement. We look forward to continuing to work with his experienced team while we pursue additional reimbursement for HIFU procedures,” EDAP CEO Marc Oczachowski said in a prepared statement.
Last April, EDAP inked an agreement with institutional investors for the placement of 3.3 million shares at $3.50 a piece, bringing in an estimated $11.5 million for the company.
Investors in the round received warrants to purchase up to 3.3 million shares at an exercise price of $4.50 per share, exchangeable beginning 6 months from the date issued and for a period of 2 years after, Edap said.
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