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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) announced positive evaluation results for its UroShield device at a recent medical conference. The report, conducted by clinicians from the Royal National Orthopaedic Hospital, indicates a decrease in blockages and infections, as well as increased patient satisfaction with catheters. The device is believed to improve quality of life and reduce healthcare costs for patients with spinal cord injuries. CEO Brian Murphy emphasized the significant market opportunity, as approximately 285,000 individuals in the U.S. and 50,000 in the UK live with such injuries.
NanoVibronix, Inc. (NASDAQ: NAOV) announced compliance with Nasdaq requirements on February 28, 2023, closing a prior listing matter regarding the $1.00 bid price. The company was granted an extension by the Nasdaq Hearings Panel on October 17, 2022, to regain compliance by February 23, 2023. NanoVibronix specializes in portable medical devices like UroShield® and PainShield® that utilize patented surface acoustic wave technology. These devices are designed for at-home use and aim to provide therapeutic benefits for various medical applications.
NanoVibronix, Inc. (NASDAQ: NAOV) has announced the launch of a month-to-month rental program for its medical devices, PainShield and UroShield, effective March 1, 2023. This initiative aims to improve patient accessibility and convenience, allowing individuals with valid prescriptions to rent these devices at affordable rates. The CEO, Brian Murphy, expressed confidence that the program will qualify for Medicare reimbursement, with additional supplies available for purchase separately. The company has applied for Medicare reimbursement, expecting a decision by May 2023 and implementation by October 1, 2023.
NanoVibronix, Inc. (NASDAQ: NAOV) announced a 1-for-20 reverse stock split effective on February 8, 2023, at 4:05 PM. The common stock will start trading on a split-adjusted basis on February 9, 2023. The reverse split reduces outstanding shares from approximately 32.9 million to about 1.6 million, while the share par value remains unchanged. This decision follows stockholder approval received on December 15, 2022, granting the board discretion to execute a reverse split within specified ratios. Stockholders’ percentage interests will remain unaffected.
NanoVibronix, Inc. (NASDAQ: NAOV) announced positive interim results from lifecycle testing of its PainShield product. This follows a setback where the Centers for Medicare & Medicaid Services (CMS) denied reimbursement due to insufficient life expectancy testing. The company has commissioned Carmel Labs to conduct this testing and will submit the positive results to CMS.
Additionally, the potential enactment of the bipartisan NOPAIN Act could significantly increase demand for PainShield by allowing separate Medicare reimbursement for non-opioid pain management alternatives. This legislative effort aims to expand access to devices like PainShield, which are designed for home use.
NanoVibronix, Inc. (NASDAQ: NAOV) held its 2022 annual stockholder meeting virtually, where several resolutions were passed. The Board of Directors now consists of eight members for a one-year term. A significant resolution passed allowing a reverse stock split of shares at a ratio between 1-for-2 and 1-for-50. Additionally, the 2014 Long-Term Incentive Plan was amended to increase the number of shares reserved by 1,518,000 shares. However, proposals to classify the Board and increase authorized shares were rejected.
NanoVibronix, Inc. (NASDAQ: NAOV) has partnered with Peak Medical, Ltd. to enhance distribution capabilities for its continence care products in the UK. This collaboration follows NHS Supply Chain Approval, allowing Peak Medical to sell the UroShield device, aimed at reducing risks associated with Catheter Associated Urinary Tract Infections (CAUTIs). With strong demand from the National Health Service, the partnership is expected to boost product uptake and improve patient care.
NanoVibronix, Inc. (NASDAQ: NAOV) has successfully completed a registered direct offering, selling 4,800,000 shares at $0.50 each, generating gross proceeds of $2.4 million. The funds will be utilized for general working capital purposes. The offering was facilitated by H.C. Wainwright & Co. under a shelf registration statement. This transaction allows the company to enhance its financial flexibility and continue developing its proprietary surface acoustic wave technology for medical applications. The offer was conducted under SEC regulations.
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.
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