NanoVibronix Inc. (NASDAQ: NAOV) has announced an expansion of the reimbursement approval of its PainShield product by the US Centers for Medicare and Medicaid Services with the addition of the device to the Durable Medical Equipment schedule.
NaniVibronix expands PainShield product reimbursement approval
PainShield will be reimbursable effective immediately as a certified medical device under the CMS-assigned unique code for low-frequency ultrasonic diathermy treatment for home usage. Currently, the device has approval for reimbursement under the distinct HCPCS code K1004 created through the company’s efforts and collaboration with CMS.
Brian Murphy, NanoVibrinix CEO, said, “Receiving CMS approval for reimbursement under the DME schedule is a breakthrough milestone in our efforts to fully commercialize our PainShield product and reach the broader, more traditional healthcare market. This approval expands the original CMS approval to include reimbursement as a device for the many millions of beneficiaries enrolled in Medicare and paves the way for expanded distribution by removing the limitations that we have been operating under until now.”
NanoVibronix closer to product commercialization
Recently, the company offered a business updated indicating that it is at an inflection point in its business, having reaching major milestones that have moved the company closer to full product commercialization.
Murphy said, “Over the last several months, we received approval for reimbursement of PainShield with a dedicated product code from CMS, launched our new product, PainShield Plus, significantly expanded a distribution agreement with one of our primary distributors and refined our manufacturing processes and supply chain to drive our costs down and expand capacity.”
The CEO added, “We are executing against a business plan that we believe will lead to a significant increase in revenue beginning in the second quarter of this year and pave the way for progressively improving financial results throughout 2021 and beyond. “ Towards the end of last year, the company launched PainShield Plus, expanding the core product functionality.