NanoVibronix Issues Letter to Stockholders
NanoVibronix (NASDAQ: NAOV) issued an update on its business developments and financial performance for Q1 2024. The company reported record first-quarter revenues of $921,000, but also a loss from operations of $568,000. Cash reserves stand at $2.7 million with $2.6 million in inventory. Domestic sales, particularly within the Veterans Affairs (VA) and worker’s compensation markets, are seeing growth, aided by a new General Services Administration (GSA) grant effective May 1, 2024. Internationally, the company has made strides in the UK, Australia, and New Zealand. A significant research study on UroShield by the University of Michigan is underway, potentially bolstering FDA approval efforts. The company is also focused on improving existing products and exploring new opportunities. Key goals include expanding distribution channels and achieving broader market coverage.
- Record first-quarter revenues of $921,000.
- Strong balance sheet with $2.7 million in cash and $2.6 million in inventory.
- Growth in domestic sales, especially in the Veterans Affairs and worker’s compensation markets.
- Awarded a GSA grant effective May 1, 2024, expected to boost product adoption and sales.
- Progress in UK market with NHS contract and increased sales.
- Potential expansion in Australia and New Zealand pending reimbursement approval.
- University of Michigan conducting a Randomized Control Trial on UroShield, supporting FDA clearance.
- Efforts to improve existing products and explore new product opportunities are underway.
- Operational loss of $568,000 in Q1 2024.
- Uncertain timing for reimbursement approval in Australia and New Zealand.
- Evaluation with Apogepha Pharmaceutical is still ongoing, with no final decision yet.
- COVID-19 pandemic interrupted business momentum.
Insights
Revenue Growth: The company has reported revenues of
Veterans Affairs (VA) Progress: The award of a General Services Administration (GSA) contract is a significant milestone, potentially accelerating product adoption within VA facilities. This could translate to higher sales and market penetration. Long-term revenue from the VA could stabilize the company's income streams and offer a competitive edge.
Market Segments: The company's focus on the Veterans' Health System and worker's compensation markets has begun to show increased revenues, particularly with the PainShield product. The trend away from opioid use suggests a growing market for non-invasive pain relief solutions, making PainShield a potentially valuable asset.
Clinical Research: The upcoming Randomized Control Trial (RCT) study by the University of Michigan for UroShield is a notable step towards solidifying the product's clinical credibility. RCTs are the gold standard in evaluating medical interventions and positive results could pave the way for FDA clearance, bolstering the product's marketability. This could enhance investor confidence and justify future product development investments.
Patient Outcomes: The focus on improving patient outcomes, such as reducing urinary tract infections and catheter blockages, could make UroShield a preferred choice in long-term care facilities. This aligns with healthcare providers' goals to enhance patient care while reducing healthcare costs, potentially driving demand for the product.
Product Improvement: The company's commitment to enhancing existing products aims at improving therapeutic efficacy and reducing costs. These improvements could make their products more competitive in the market, leading to higher adoption rates and better patient satisfaction.
International Market Expansion: The company's progress in Australia, New Zealand and the UK demonstrates its strategy to diversify and grow its international market footprint. Full reimbursement for UroShield in these regions would significantly boost demand. The collaboration with Peak Medical Limited to expand inventory and market opportunities in the UK is promising.
Distribution Strategies: NanoVibronix's efforts to establish solid distribution channels, such as the exclusive distribution agreements and private label partnerships, aim to create forecastable revenue streams. These strategies, if successful, could provide stability and long-term growth potential, making the company more attractive to investors.
Regulatory Approvals: The company’s ability to secure approvals and reimbursement from several healthcare systems underscores its product efficacy and market readiness. This regulatory backing can increase consumer trust and drive market penetration.
To Our Stockholders:
We are committed to our strategic vision of developing, improving and commercializing our distinct and effective therapies, which we believe enable healthcare providers to treat patients in need and fill a void in the market, which has the potential to increase value for our stockholders. We are focused on several areas that we believe will have a substantial impact on our growth and product adoption. Many of these areas of focus have begun showing positive results, as reflected in our most recent quarterly financial results. Our products continue to deliver impressive results with high patient satisfaction, with no demonstrated adverse events. We are also investing in sales improvement and long-term opportunities with all of our products.
Q1 2024 Financial Results
We recorded revenues of approximately
Domestic Update
We continue to make progress in several channels of domestic sales and product adoption. Our penetration into the Veterans Affairs (“VA”) continues to improve both in facilities served as well as adoption within those facilities. With our VA partner, Delta Medical, LLC, we were awarded a General Services Administration (“GSA”) grant that provides for an accelerated uptake in product adoption within the Veterans Health facilities. The GSA contract became effective on May 1, 2024. We expect this contract to have a positive impact on both sales and adoption of our products, as well as provide a significant competitive advantage. I am highly optimistic about our sales growth within this important business sector. Additionally, we continue to make progress in the workers’ compensation area of our business, both on a direct basis and through our Durable Medical Equipment (“DME”) exclusive distributor. We are also gratified to see the increase in the adoption of PainShield within both reimbursable market segments. The PainShield product family is quickly becoming a recognizable and acceptable standard for pain relief and the avoidance of opioids.
We recently announced the addition of a distributor for our UroShield within the VA system, CB Medical, LLC (“CB Medical”). VA patients represent a significant opportunity for UroShield due to increased lengths of stay at VA facilities and high acuity. CB Medical is well positioned to establish a foothold in the VA with our product that can benefit its patients.
Reimbursement
Reimbursement is currently approved in the Veterans’ Health System and several worker’s compensation plans, third party administrators and insurance companies. Our revenues in these markets have, and continue to, grow substantially. Through our strategic, exclusive distribution partners for select markets and through our direct sales efforts, we are seeing growth every month. The sales growth follows the payer and patient testimonials that illustrate superior product efficacy.
Reimbursement for UroShield remains in effect for the Veterans Administration segment.
International update
We continue to make progress and generate additional sales in the Australian and
In the
Relative to the broader market in
Research
The University of
UroShield is marketed under the
Product development
We have been working on several exciting improvements to our existing product portfolio, as well as exploring new product opportunities. The goals of the product development are to improve therapy, reduce costs and “future-proof” the componentry. The “kick-off” for the product development project is scheduled for the first week of June 2024.
A look ahead
We remain focused on driving profitable growth by expanding and increasing our distribution and licensing channels, nurturing relationships with new and existing accounts and engaging consumers through a variety of creative mediums. Today, we have initial distribution agreements in place, a solid manufacturing partner and we believe we have the necessary working capital to meet existing and anticipated demand.
We continue to negotiate sector-specific private label agreements. This strategy is intended to develop long lasting, profitable, forecastable revenue. The COVID-19 pandemic interupted our momentum, but we believe that we are on track to aggressively push these discussions forward.
In the near-term, we are primarily focused on achieving the following milestones:
- supplementing distribution to achieve broader geographic coverage in both VA and worker’s compensation channels;
- selection of UroShield distribution for key markets;
-
adding market segment-specific distributions for PainShield in the
U.S. ; -
finalizing a private label partnership for PainShield in the
U.S. ; and -
expanding UroShield distribution in
Europe and theU.S.
Thank you for your continued support. We remain very optimistic and motivated to deliver improved results for 2024.
Kind regards,
Brian Murphy
Chief Executive Officer
About NanoVibronix, Inc.
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in
Forward-looking Statements
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; 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) 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 subcontractor assistance; (viii) insufficient or inadequate reimbursements by governmental and/or other third party payers for our products; (ix) our ability to successfully obtain and maintain intellectual property protection covering our products; (x) legislative or regulatory reform impacting the healthcare system in the
View source version on businesswire.com: https://www.businesswire.com/news/home/20240516840704/en/
Investor Contacts:
Brett Maas, Managing Principal, Hayden IR, LLC
brett@haydenir.com
(646) 536-7331
Source: NanoVibronix, Inc.
FAQ
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