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NanoVibronix, Inc. (NASDAQ: NAOV) is a forward-thinking medical device company specializing in the development and commercialization of innovative products that leverage its proprietary low-intensity acoustic technology. Located in Elmsford, NY, with a subsidiary, NanoVibronix Ltd., based in Nesher, Israel, the company aims to revolutionize the medical field with cost-effective therapeutic ultrasound applications.
NanoVibronix's groundbreaking technology enables the creation of miniature transducers that transmit low-frequency, low-intensity ultrasound through flexible material surfaces. This unique feature is integral to a range of products designed for various medical applications, particularly those requiring noninvasive methods.
The company's flagship products include:
- PainShield®: A patch-based device carrying FDA clearance, designed for pain management through the delivery of therapeutic ultrasound.
- UroShield®: A device aimed at preventing biofilm formation and reducing urinary tract infections associated with catheter use.
- WoundShield®: A device that promotes wound healing by transmitting low-frequency ultrasound waves to stimulate tissue regeneration.
NanoVibronix's products are designed for home use, enabling patients to receive therapy without the need for medical professionals. This approach not only enhances patient convenience but also reduces healthcare costs.
In addition to its direct-to-patient sales, NanoVibronix partners with distributors to expand its market reach. The company's recent achievements include securing FDA clearance for PainShield® and forming strategic partnerships to enhance product distribution.
Overall, NanoVibronix, Inc. stands out for its innovative approach to medical device technology, focusing on noninvasive solutions for pain management, biofilm prevention, and wound healing, making significant strides in improving patient outcomes.
NanoVibronix (NASDAQ: NAOV) reported significant business advancements, including CMS reimbursement approval for its PainShield product, launch of the PainShield Plus, and expanded distribution with UPPI. The company is enhancing its manufacturing processes to reduce costs and increase capacity while being sufficiently capitalized for growth. A proposal to increase common shares authorization from 24.1 million to 40 million is set for a stockholder vote on August 17, 2021, aimed at meeting conversion obligations and supporting strategic opportunities.
NanoVibronix, Inc. (NASDAQ: NAOV) announced the adjournment of its Special Meeting of Stockholders to May 6, 2021, at 10:00 a.m. Eastern time, allowing more time for stockholders to vote. During the adjournment, the Company will continue to solicit proxies for the proposals in its proxy statement. Stockholders are encouraged to vote by May 5, 2021, at 11:59 p.m. Eastern time. The Company filed a definitive proxy statement with the SEC and urges shareholders to read all relevant documents before voting.
NanoVibronix, Inc. (NASDAQ: NAOV) has announced a significant milestone as the U.S. CMS has added its PainShield device to the Durable Medical Equipment (DME) reimbursement schedule. This approval allows reimbursement under a unique HCPCS code K1004 for low-frequency ultrasonic diathermy treatment at home. NanoVibronix anticipates increased demand and further market penetration due to this change, which enhances its ability to distribute PainShield more broadly. CEO Brian Murphy highlighted the potential for expanding their traditional healthcare market presence.
NanoVibronix, Inc (NASDAQ: NAOV) has initiated an independent real-world patient study for its UroShield device at Southampton University Health Sciences in partnership with Southern Health NHS Foundation Trust. The 16-week study aims to assess UroShield's effectiveness in reducing catheter-associated urinary tract infections among patients reliant on indwelling catheters. With an estimated 100,000 patients at risk in community settings, this study marks a significant opportunity for broader commercialization of UroShield. Interim results are expected in October 2021, with full results anticipated in early 2022.
NanoVibronix, Inc. (NASDAQ: NAOV) has announced the adjournment of its Special Meeting of Stockholders, now set to reconvene on April 27, 2021, at 10:00 a.m. Eastern time. This decision allows additional time for stockholders to cast their votes. Proxies already submitted will be voted in the reconvened meeting unless revoked. The Company urges all stockholders to vote before April 26, 2021. NanoVibronix focuses on developing medical devices utilizing proprietary low intensity surface acoustic wave technology, targeting applications such as pain relief and disrupting bacteria.
NanoVibronix, Inc. (NASDAQ: NAOV) has announced the adjournment of its Special Meeting of Stockholders originally scheduled for March 31, 2021. The meeting will reconvene virtually on April 14, 2021, at 10:00 a.m. Eastern time. This extension allows more time for stockholders to cast their votes on proposals outlined in the proxy statement. Stockholders are encouraged to vote by April 13, 2021, and proxies submitted will be counted unless revoked. The company specializes in medical devices using low intensity surface acoustic wave technology for various medical applications.
NanoVibronix, Inc. (NASDAQ: NAOV) has announced that its UroShield device is now added to the Federal Supply Schedule through a service-disabled veteran organization, improving access for Veterans. UroShield is designed to prevent Catheter Associated Urinary Tract Infections (CAUTI), which affects millions annually, causing significant health risks. With UroShield, Veterans can benefit from a non-invasive solution that reduces infection risk and hospitalizations, particularly crucial during the COVID-19 pandemic. CEO Brian Murphy stated this development expands their market reach, emphasizing the importance of innovative healthcare solutions for Veterans.
NanoVibronix, Inc. (NASDAQ: NAOV) announced receiving a review timeline from the National Institute for Health and Care Excellence (NICE) for its UroShield device, aimed at reducing catheter-associated urinary tract infections. The review's publication, expected in March 2022, is seen as a precursor to a positive recommendation, which would enhance NHS adoption and access for patients. The independent study highlighted significant benefits, including reduced UTIs and improved patient well-being, supporting commercialization efforts.
NanoVibronix, Inc (NASDAQ: NAOV) announced on February 2, 2021, that it has regained compliance with Nasdaq's minimum bid price requirement under Listing Rule 5550(a)(2). This follows a notice received on January 4, 2021, confirming compliance with the equity requirement under Rule 5550(b)(1). The company faced a potential delisting due to previous non-compliance with these rules. All matters related to compliance have now been resolved, allowing the company to maintain its listing on the Nasdaq Capital Market.
NanoVibronix, Inc (NASDAQ: NAOV) reflects on 2020 successes and sets a promising outlook for 2021 in a recent shareholder letter. The company enhanced its product portfolio, secured a distribution agreement with Ultra Pain Products, and raised approximately $11.2 million in capital. Notably, the FDA allowed the distribution of its UroShield device during the pandemic, addressing urinary tract infections in COVID-19 patients. With a stronger financial position and expanded manufacturing capabilities, NanoVibronix aims for notable growth in 2021.
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