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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, Inc. (NASDAQ: NAOV) has announced a securities purchase agreement with institutional investors for a registered direct offering of 4,800,000 shares at $0.50 each, expected to close around December 1, 2022. The offering aims to generate gross proceeds of $2.4 million, which will be utilized for general working capital purposes. H.C. Wainwright & Co. is the exclusive placement agent for the offering, which is conducted under an effective shelf registration statement with the SEC.
NanoVibronix, Inc. (NASDAQ: NAOV) has achieved a significant milestone by securing FDA 510(k) clearance for its PainShield® MD PLUS, an advanced dual-actuator ultrasound pain therapy device. This approval enhances the device's treatment coverage and opens avenues for future product submissions, including an Over-The-Counter variant, PainShield Relief. The PainShield Plus allows patients to receive ultrasound therapy conveniently at home, addressing chronic pain without opioids, thus expanding the company's product offerings in a growing market for non-pharmaceutical options.
NanoVibronix, Inc. (NASDAQ: NAOV) announced positive interim results from its U.K. clinical study for the UroShield device, conducted by The University of Southampton. Initial findings indicate beneficial effects on patients, showing changes in microbial diversity, fewer catheter blockages, and reduced infections. This study, initiated in April 2021, is pivotal for obtaining FDA clearance for UroShield. The company is optimistic about future expansions in the U.K. market and aims to ramp up production for U.S. distribution.
NanoVibronix, Inc. (NASDAQ: NAOV) provided a business update focused on scaling operations and regulatory progress. With over 90% of sales coming from U.S. distributors, the company is enhancing its presence in the Workers' Compensation and Veterans' Administration sectors. Manufacturing has shifted to Singapore to mitigate supply chain risks. Regulatory efforts continue for PainShield, which has received a reimbursement code, and PainShield Plus is awaiting FDA approval. International partnerships are in negotiation to expand UroShield distribution. Challenges include delays in approvals but management remains optimistic about future revenue growth.
On October 17, 2022, NanoVibronix, Inc. (NASDAQ: NAOV) received a continued listing grant from the Nasdaq Hearings Panel, subject to conditions including a compliance update by December 15, 2022, regarding the $1.00 bid price requirement. The Panel may extend the compliance period until February 23, 2023. Additionally, the Company plans to seek shareholder approval for a potential reverse stock split at the annual meeting on December 15, 2022, to regain compliance. NanoVibronix specializes in medical devices using patented surface acoustic wave technology for various health applications.
NanoVibronix, Inc. (NASDAQ: NAOV) announced that its UroShield device has received approval for sale across the U.K. through the NHS Supply Chain. This contract will enhance distribution, making UroShield available to NHS healthcare providers and patients, thereby improving clinical support. The contract starts in October 2022 and merges with an existing contract in February 2024. UroShield aims to reduce catheter-associated urinary tract infections, enhancing patient outcomes and reducing healthcare costs.
NanoVibronix, Inc. (NASDAQ: NAOV) announced its upcoming virtual Annual Meeting on December 15, 2022, at 10 a.m. ET. Shareholders are advised that the record date for voting is October 17, 2022, with proxy materials expected to be sent out in November 2022.
The company specializes in medical devices utilizing patented low intensity surface acoustic wave (SAW) technology, aimed at pain relief and medical applications. Key products include PainShield® and UroShield®, designed for home use.
NanoVibronix, Inc. (NASDAQ: NAOV) declared a dividend of one one-thousandth of a share of Series F Preferred Stock for each common stock share held by record holders as of 5:00 p.m. ET on October 14, 2022. Distribution will occur on October 17, 2022. The Series F Preferred Stock provides significant voting rights, particularly concerning a potential reverse stock split. Absent stockholder presence during voting will result in automatic redemption of unrepresented shares.
NanoVibronix, Inc. (NASDAQ: NAOV) announced that it received a notice from Nasdaq on August 30, 2022, regarding its non-compliance with the minimum bid price requirement, effective as of August 29, 2022. The company must request a hearing to avoid delisting, which it plans to do. This action will temporarily halt further measures from Nasdaq until the hearing concludes. NanoVibronix develops medical devices utilizing proprietary surface acoustic wave technology aimed at various medical applications, including pain relief.
NanoVibronix, Inc. (NASDAQ: NAOV) has announced a 53% year-over-year growth in Q2 and is making strides in commercializing its PainShield and UroShield medical devices. Sales to VA facilities are increasing despite some administrative challenges. The company submitted a 510(k) application for PainShield MD Plus and is optimistic about FDA approval, which could boost revenue. Efforts for CMS reimbursement codes are ongoing. With a shift in manufacturing to Singapore for efficiency, NanoVibronix aims to enhance its product distribution and market presence.
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