NanoVibronix, Inc. - NAOV STOCK NEWS

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.

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.