Lays out key upcoming milestones for the next 12 months
ELMSFORD, N.Y., Nov. 14, 2018 (GLOBE NEWSWIRE) -- NanoVibronix, Inc, (NAOV), a medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave (SAW) technology, today provided a business update for the third quarter ended September 30, 2018.
Brian Murphy, Chief Executive Officer of NanoVibronix, commented, "When I first joined NanoVibronix as CEO, the Company had developed a potentially breakthrough technology, but lacked the key ingredients for success. The past 12 months have been transformational for the Company, as we have laid the foundation for our commercial launch in each of the key verticals. First, we completed a number of important trials that will be important for expanded regulatory approvals and validation for distributors as well as potential partners. We have a number of additional trials planned that we expect to complete near-term. Additionally, we have put in place the commercial infrastructure necessary to support an aggressive launch. Specifically, we have added a number of key hires to support our global sales and marketing initiatives. We also added a number of distributors in key markets. In the coming months, we plan to announce a number of additional distributors in both the domestic and international markets.
Looking ahead, we are seeking to accomplish a number of major milestones that should help drive value for shareholders, as outlined below:
- Publication of study in International Journal of Urology: Q4 2018
- Trial results compiled and expected 510(K) Class 2 filing to FDA in 1Q 2019
- Target FDA approval of 510K in 3Q 2019
- Projected target US launch in 3-4Q 2019
- Submission for National Health System approval through rapid review process in Q1 2019
- Targeted NHS approval in Q2 2019
- Adding additional domestic and international distributors
- Complete safety & usability studies for clearance without prescription requirement: planned for Q1 2019
- Add additional domestic and international distributors
- License agreements with large scale providers
- License agreements with manufacturer
- Add additional domestic and international distributors
LungShield™ & RenooSkin™
- Active discussions with strategic partners
- Streamlined manufacturing and outsourcing to reduce cost and scale: planned for Q1 2019
Overall, we are building substantial clinical data supporting the clinical efficacy of our devices. To-date, we have now completed the following clinical studies for our UroShield device:
- 56 patient randomized control trial in the U.S.
- 23 patient randomized control in the U.K.
- Economic impact study in the U.K.
- An in vitro study in the U.K. that is nearly complete
- 5 smaller completed studies covering 139 patients
We recently met with the FDA and expect to file a 510(K) Class 2 filing in the first quarter of 2019. Towards this end, we have several smaller studies planned and underway we expect to include in our submission, which we believe will help support our application, including an animal model in sheep, a comparative study of leachables from a urinary catheter with and without UroShield attached, which is already underway, and a small study of patients with neurogenic bladder dysfunction. Given our past clinical data we are quite confident in our FDA submission and our goal is to receive marketing clearance in the U.S. by the third quarter of 2019, which we believe will be a major milestone for the Company. In the meantime, we are in active discussions with a number of potential partners in the U.S. and abroad, all of which should help drive value for shareholders. To-date, we have signed agreements with IMS Medical in the U.K., Instrumed Surgical in Canada and Morulaa HealthTech in India.
Turning to PainShield, we have signed a distribution agreement with Fabrication Enterprises in the U.S., Golfballs.com covering both the U.S. and international markets, IMS Medical in the UK, Morulaa HealthTech in India and M.D.S. Pharm Ltd. in Israel. We are very pleased with the strong support we have witnessed from both potential partners, as well as patients already using the device, including a number of high-profile sports celebrities who have publicly endorsed the product. We currently qualify for reimbursement codes in the United States for clinical use only, which require a prescription. We are currently conducting additional safety and usability studies to secure clearance without a prescription requirement, which we expect to complete by the first quarter of 2019. We believe this will help to dramatically expand the addressable market and remove a major barrier to commercial adoption by consumers. Towards this end and to satisfy the requirements of the FDA, we are completing a usability study to reinforce ease of use for consumers, redesigning the product, and revamping the user manuals and reference guides to meet OTC and FDA requirements. We believe these initiatives will help facilitate our approvals.
In terms of the supporting clinical data for PainShield, we recently completed a double blinded, crossover trial across the US for patients with trigeminal neuralgia, which is considered one of the most chronically painful conditions and is associated with a high suicide rate directly attributable to the condition. As previously disclosed, this trial included 59 patients with a diagnosis of unilateral trigeminal neuralgia; 30 in the active treatment group and 29 in the control group. The treatment group saw a 55.2% improvement in baseline scores vs 2.3% for control group. The treatment group saw a 46.4% reduction in breakthrough pain medication versus 1.5% for the control group. We believe the results of this study are quite compelling, and our plan is to have the final comprehensive data submitted for publication in a leading industry journal.
Finally, we are moving forward with a number of initiatives with WoundShield, LungShield™ and RenooSkin™. In the meantime, we continue to carefully manage our expenses. We have maintained a clean capital structure with sufficient cash to accomplish our near-term goals and have no long-term debt. Overall, we are making tremendous progress and look forward to providing further updates to shareholders in the months ahead.”
The Company filed its Form 10-Q for the period ended September 30, 2018, with the Securities and Exchange Commission on November 14, 2018, which is available on the SEC’s website, www.sec.gov, or the Company’s website, www.nanovibronix.com.
NanoVibronix Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York with research and development in Nesher, Israel, that is focused on developing medical devices utilizing its proprietary and patented low intensity surface acoustic wave technology. The company's 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, (ii) negative clinical trial results or lengthy product delays in key markets, (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 raising 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.