SEC 8-K filings with transcript text
May 17, 2022
2 ex99-1.htm
Exhibit 99.1
Expanded Distribution, Entry into New Geographic Markets and Regulatory Approvals Advancing Efforts Towards Full Commercialization
N.Y., May 17, 2022 — NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company utilizing the Company’s proprietary and patented low intensity surface acoustic wave (SAW) technology, today reported its financial results for the quarter ended March 31, 2022.
First Quarter 2022 Financial and Recent Business Highlights
● Revenue of $272,000, an increase of 164% compared to the prior year period
● Significant backlog of orders to be filled in Q2
● Supply chain challenges are expected to abate moving into the second half of 2022
● Submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for PainShield® MD PLUS
● Engaged a prominent researcher to facilitate a “gold standard” study for UroShield to submit to FDA for full 510k clearance
● Received published recommendation guidance from the National Institute for Health and Care Excellence (NICE) to advance efforts to achieve NHS approval of UroShield
● Received licensing approval from Health Canada / Santé Canada for PainGuard and UroGuard
● Signed a Provider Agreement with EZ Health Care to advance position in workers’ compensation market
● Continued to broaden the PainShield footprint in the VA system nationwide through Delta Medical
● Entered into an International Marketing, Sales and Clinical Management Agreement with leading commercialization firm to extend reach of UroShield and PainSheild
● Filed three U.S. patent applications related to SAW technology and indwelling medical devices
● Expanded Board of Directors with appointment of two new independent directors
● Balance sheet remains strong with $6.0 million in cash and $0 long-term debt as of March 31, 2022
“We continued our efforts to expand distribution of our products through new partnerships in the workers’ compensation market and by securing regulatory approvals both domestically and in the U.K. and Canada,” stated Brian Murphy, CEO of Nanovibronix, Inc. “First quarter sales were up significantly year-over-year despite component sourcing challenges that caused a delay in first quarter order shipments of approximately $300,000. We expect that the delay will only impact the timing of revenue recognition as demand for our products remains robust. We continue to improve our approved reimbursement channels and are working to further enhance them going forward. We believe our manufacturing is stable, and we do not expect our supply chain to be an issue for the remainder of the year.”
Murphy added, “Our balance sheet remains strong with $6.0 million in cash on hand and zero debt at the end of the first quarter of 2022. We believe we are in a solid position to fund our growth and continue to advance our products towards full commercialization. We continue to be optimistic about the future of NanoVibronix.”
First Quarter 2022 Financial Summary
Revenues were $272,000 for the first quarter of 2022, up 164% compared with $103,000 for the first quarter of 2021. The increase was primarily due to increased orders from the Company’s largest customer as well as the addition of selling to veteran affairs facilities, which was limited to available finished goods.
Gross profit was $106,000, or 39.0% of revenue, in the first quarter of 2022 compared with $77,000, or 74.8% of revenue, in the 2021 period. The increase in gross profit was primarily driven by sales to veteran affairs facilities and sales of products to distributors at higher margins.
Total operating expenses were $1.2 million in the first quarter of 2022 compared with $1.4 million in the prior year period. The decrease was mainly due to a decrease in selling and marketing expense due to decreased salaries and a decrease in options expense.
Net loss was $1.1 million for the first quarter of 2022 compared with a net loss of $4.9 million for the previous quarter. The three-month period ended March 31, 2021 included a non-cash loss of $1.9 million related to a change in the fair value of derivative liabilities and a non-cash loss of $1.6 million of warrant modification expense related to warrants held by a certain investor that were repriced.
About NanoVibronix, Inc.
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including for disruption of biofilms and bacterial colonization, as well as for pain relief. The devices can be administered at home without the assistance of medical professionals. The Company’s primary products include P
Aug 17, 2021
2 ex99-1.htm
Exhibit 99.1
Significantly Increasing Revenue Opportunities with Planned Launch of First OTC Product, Expanded Distribution and Additional Applications for Regulatory Approval and Medicare Reimbursement
N.Y., August 16, 2021 (Business Wire) — NanoVibronix, Inc., (NASDAQ: NAOV), a healthcare device company that produces the UroShield® and PainShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today reported its financial results for the quarter ended June 30, 2021 and provided a business update.
Financial and Business Highlights
● Revenue increased 18% to $318,000, which included the first shipment of products to Ultra Pain Products, Inc. (UPPI) under its amended contract which extended terms and increased minimum purchase requirements to $8 million over three years
● Launched OTC pain management device, PainShield RELIEF
● Submitted request to CMS for reimbursement code(s) for UroShield and PainShield Plus
● Received registration approval for UroShield from Therapeutic Goods Administration (TGA) in Australia
● Balance sheet remains strong with $5.7 million in cash and $0 long-term debt as of June 30, 2021
“We made great strides in the first half of 2021, accelerating our progress towards full commercialization of our products with expanded distribution, clearance of regulatory approvals, the launch of PainShield Plus and the planned launch of PainShield RELIEF, which is expected to be available over-the-counter, significantly expanding our addressable market,” stated Brian Murphy, CEO of NanoVibronix. “Our entire product portfolio has been redesigned to improve appearance, functionality and efficiency, and we have submitted patent applications to protect our intellectual property, both for our existing brands and technology as well as products under development. Our robust business model is comprised of innovative products that are clearing regulatory approvals, a high-quality manufacturing partner and global distribution channels. Importantly, we believe that we are operating in a market environment of increasing demand and that we can continue to grow.”
Murphy continued, “The demand we are experiencing exceeds our supply across all of the markets we serve including commercial, insurance and the Veterans Administration (VA). This demand, combined with the energy of our distributors to bring our products to market, reinforces our optimism for continued growth. Given our growing backlog of orders and the submissions we are making for regulatory approval in new markets, we are actively searching for additional manufacturers for our products and are currently engaged with additional contract manufacturers located in the United Kingdom, Israel, the United States and Mexico to expand output.”
Murphy continued, “Another development that we are energized by is our planned entry into the over-the-counter market with the launch of PainShield RELIEF, a derivative of our prescription PainShield that we plan to be available without a clinician’s prescription. Opening availability of our pain management device to the mass market should greatly expand our revenue potential and provide us with the opportunity to scale and leverage our manufacturing and distribution infrastructures.”
“We are aggressively pursuing a reimbursement code from the Centers for Medicare and Medicaid (CMS), which once approved should make the devices more broadly available to millions of Medicare beneficiaries,” added Murphy. “We recently completed the application process with CMS to receive a reimbursement code for our UroShield and PainShield Plus devices and have been granted approval and reimbursement at favorable rates from the Federal Supply Schedule. We are progressing in this realm as expeditiously as possible and are encouraged by the trajectory of our efforts.”
Murphy concluded, “Our balance sheet remains strong, and we are adequately funded for growth and execution of our strategic plans. With $5.7 million in cash at the end of the second quarter and zero debt, we have the capacity to ramp manufacturing as orders accelerate while continuing to invest in product development and expand our sales channels.”
Second Quarter 2021 Financial Summary
Revenues were $318,000 for the second quarter of 2021, up 18% compared with $269,000 for the second quarter of 2020. The increase was primarily due to increased sales of PainShield devices to the company’s distributors.
Gross profit was $208,000, or 65% of revenue, in the second quarter of 2021 compared with $38,000, or 14% of revenue, in the 2020 period. The increases in gross profit and gross margin were primarily driven by increased sales of products to distributors at higher margins and the absence of special discounts in the 2021 period.
Total operating expenses were $1.2 million in the second quarter of 2021 compared with $1.5 million
Nov 17, 2020
2 ex99-1.htm
Exhibit 99.1
NanoVibronix Reports Third Quarter 2020 Financial Results,
Provides Business Update
Gaining Traction with Increased Distribution and Lower Cost Manufacturing
N.Y., November 16, 2020 (Business Wire) -- NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today reported its financial results for the quarter ended September 30, 2020 and provided a business update.
Financial and Business Highlights
●Revenue increased 49% to $150,000
●Expanded offerings with introduction of PainShield Plus
●Received U.S. Food and Drug Administration (FDA) authorization for entry of UroShield into the U.S. during the Covid-19 pandemic
●Completed first shipments of UroShield devices to the United Kingdom
●Signed a two-year, agreement for the distribution of PainShield devices and components by Durable Medical Equipment (DME) distributors throughout the United States
●Expanded license agreement for distribution of UroShield and PainShield in Canada and Turkey
●Secured Medicare reimbursement code from Centers for Medicare and Medicaid Services (CMS) for PainShield
●Received the coveted Plus X Award 2020 for its PainShield PT 100 ultrasound therapy device in the categories of high quality, design, ease of use and functionality
●Strengthened balance sheet with approximately $4.1 million in aggregate net proceeds from two offerings of common stock
“Across the company, we are making great strides towards broader commercialization of our offerings with new and expanded distribution agreements, lower cost manufacturing, clearance of regulatory hurdles and marketing and branding programs that collectively we believe could elevate our business to the next level in the near term and create a strong catalyst for additional growth and broader market penetration,” stated Brian Murphy, CEO of NanoVibronix.
“In the third quarter we delivered increased revenue as a direct result of recently signed agreements,” added Murphy. “At the same time, our sales team is working diligently on a number of potentially new commercial distributor and licensing agreements that represent significant promise for incremental revenue and the opportunity to diversify our revenue sources. In addition, our products have been added to the U.S. Veterans’ Administration Federal Supply Schedule (FSS) and are now reimbursable under CMS Medicare reimbursement codes creating a pathway for uexpanded distribution through government channels.”
Murphy concluded, “The resurgence in Covid-19 cases further reinforces that need for alternative pain therapies that can be administered safely and remotely, despite the uncertainty and potential near-term challenges that may also arise as a result of the global pandemic. Regardless, we continue to execute on our strategy and pursue promising opportunities to expand our reach and establish a framework for long-term growth and attractive returns for our shareholders.”
Third Quarter 2020 Financial Summary
Revenues were $150,000 for the third quarter of 2020, up 49% compared with $101,000 for the third quarter of 2019. The increase was primarily due to increased sales to the company’s distributors.
Gross profit was $99,000, or 66% of revenue, in the third quarter of 2020 compared with $47,000, or 47% of revenue, in the 2019 period. The increases in gross profit and gross margin were primarily driven by more advantageous pricing with the company’s distributors as opposed to discounts given in the prior period.
Total operating expenses were $903,000 in the third quarter of 2020 compared with $840,000 in the prior year period. The increase was primarily due to an increase in selling and marketing expense as a result of the restarting of marketing programs.
Net loss was $922,000, or $(0.10) per basic and diluted share, compared with a loss of $815,000 or $(0.12) per basic and diluted share for the previous quarter. The loss in the third quarter of 2020 includes interest expense of $123,000 compared with $0 in the prior year period. Interest expense in the current period is due primarily to amortization of the full cost of warrants associated with a note payable that was paid in full during the third quarter of 2020.
Balance Sheet
The Company ended the quarter with $3.2 million in cash and cash equivalents, reflecting the two offerings of common stock completed during the quarter, raising net proceeds of $4.1 million.
About NanoVibronix, Inc.
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, in
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