ELMSFORD, NY / ACCESSWIRE / June 19, 2019 / NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the PainShield® surface acoustic wave (SAW) device, which utilizes the Company's proprietary and patented low intensity, SAW ultrasound technology, announces that on June 12, 2019, the Company had the opportunity to present their signature product, PainShield® surface acoustic wave device, to the Healthcare Common Procedure Coding System (HCPCS) Workgroup at the Centers for Medicare & Medicaid Services (CMS) offices in Baltimore, Maryland.
The HCPCS Workgroup is tasked with evaluating products, supplies, and services that are not included in the Current Procedural Terminology (CPT) codes, such as ambulance services and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) when used outside a physician's office, as well as recommending appropriate payment by the Medicare and Medicaid payment systems. NanoVibronix has previously submitted a Level II HCPCS application for PainShield® with CMS.
Ultrasound has long been used in physical therapy, physical medicine, rehabilitation and sport medicine. Currently, NanoVibronix' PainShield® is working under a general miscellaneous CPT code for reimbursement. The existing payment model does not address the FDA's approved indication for pain management, nor does it facilitate home use of the equipment. The Company aims to receive a HCPCS code designated for PainShield® due to the unique features and additional benefits it provides, especially the role it may play in opioid free pain management.
In general, ultrasound offers many benefits such as increasing blood circulation, promoting protein secretion, and being virtually painless. When compared to standard ultrasound, PainShield® demonstrates additional advantages such as being portable, without the requirement to be plugged into an outlet, covering a wider surface area, and has a low frequency, which means it does not produce heat that can damage tissue. NanoVibronix' products can therefore be self-administered by the patient without the need for direct supervision by a healthcare professional. PainShield® may be applied for a significantly longer period without the risk of tissue damage and does not require the use of gel.
As the United States continues to combat the ongoing opioid crisis, the 2019 CMS challenged providers and healthcare facilities to develop an opioid alternative plan. According to the 2016 Nation Survey on Drug Use and Health, 11.5 million patients misused opioids, there was over 42,000 deaths from opioid misuse and cost the healthcare system $504 billion. Additionally, in 2016 hip and knee orthopedic procedures had 9,000 hospital readmits due to pain. If PainShield were to be provided and reimbursed for these patients, it could generate substantial savings to the healthcare system. More importantly, PainShield® heals the source of pain versus masking the symptoms like opioids. In addition, CMS uses pain as a quality indicator and outcome measurement.
Brian Murphy, Chief Executive Office of NanoVibronix, stated, "We are pleased to have had the opportunity to present the unique features of our product to CMS and the public earlier this week, which is one of the final steps prior to an official decision on our application by CMS. We are cautiously optimistic regarding approval for a Level II HCPCS code based on the responses we have received during the CMS public meeting. If approved, this will build upon our recent success in receiving reimbursement approvals for PainShield® in the United States market through commercial and workman's compensation companies. Due to CMS creating and mandating the use of Pain Management Plans, which encourages new technologies to address pain management, we are encouraged by the feedback we have received and look forward to providing an update regarding CMS' decision."
NanoVibronix Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, which is focused on developing medical devices utilizing its proprietary and patented low intensity surface acoustic wave (SAW) technology. This technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including the disruption of biofilms and bacteria colonization, as well as providing pain relief. The devices can be administered at home without the assistance of medical professionals. The Company's primary products include PainShield®, UroShield™ and WoundShield™. Additional information about the Company is available at: www.nanovibronix.com.
This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products or lengthy product delays in key markets; (ii) negative or unreliable clinical trial results (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital may not be available, or may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
SOURCE: NanoVibronix, Inc.