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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 a $6.0 million private placement through the issuance of 8,571,429 shares at $0.70 each. This financing is aimed at general corporate purposes and is expected to close around December 4, 2020. The company is required to file an initial registration statement with the SEC within 10 days and to make best efforts to have it declared effective within 90 days. This offering is not a public sale and lacks registration under applicable securities laws.
NanoVibronix, Inc. (NASDAQ: NAOV) announced positive findings from an independent evaluation of its UroShield® device, utilized by patients for up to two years. Highlights include significant reductions in urinary tract infections, catheter changes, and pain, leading to improved patient well-being. The results have been submitted to NICE for review, with CEO Brian Murphy emphasizing the importance of this guidance for NHS patients. The study, conducted by Coventry University, noted enhanced social engagement and mental health improvements for users. These findings support NanoVibronix's commercialization efforts.
NanoVibronix, Inc. (NASDAQ: NAOV) reported a significant 49% revenue increase to $150,000 for Q3 2020, driven by expanded sales and distribution agreements. The company received FDA authorization for its UroShield and secured reimbursement from Medicare for PainShield. Operating expenses rose to $903,000 due to increased marketing efforts. The net loss widened to $(922,000) or $(0.10) per share. The company strengthened its balance sheet with $4.1 million in net proceeds from stock offerings, enhancing its operational capacity despite ongoing pandemic challenges.
NanoVibronix, Inc. (NASDAQ: NAOV) has launched PainShield Plus®, an advanced ultrasound pain management device enhancing treatment efficiency for multiple pain areas. This device adds a second adhesive patch and transducer, doubling the treatment surface to approximately 40 cm2. The PainShield Plus is designed to minimize opioid usage and can be used by patients in home settings, promoting safety and comfort. Initial feedback from healthcare providers and patients has been positive, indicating potential for broader distribution.
NanoVibronix, Inc. (NASDAQ: NAOV) has filed a U.S. patent application for a new transdermal patch designed to deliver therapeutic agents, including cannabidiol (CBD), in combination with ultrasound technology from its PainShield® device. The innovation aims to enhance drug delivery and absorption, particularly for pain relief and anti-inflammatory effects. CEO Brian Murphy highlighted the potential benefits of this technology in providing alternative pain management solutions. The company aims to expand its patent portfolio and leverage its Surface Acoustic Wave technology for future growth.
NanoVibronix, Inc. (NASDAQ: NAOV) announced an increase in its public offering of common stock to 1,794,783 shares, priced at $1.00 each, due to strong demand. The offering is expected to close around September 25, 2020, raising approximately $1.8 million in gross proceeds before expenses. The funds will be used for working capital, including transitioning manufacturing from China to the U.S. and purchasing inventory. H.C. Wainwright & Co. is the sole book-running manager for this offering.
NanoVibronix, Inc. (NASDAQ: NAOV) announced an underwriting agreement with H.C. Wainwright to offer 1.5 million shares at $1.00 each, aiming to raise approximately $1.5 million by September 25, 2020. The proceeds will support the transition of manufacturing from China to the U.S. and inventory purchases. Additionally, the underwriter has a 30-day option for 225,000 more shares. This is part of a 'shelf' registration effective since August 2020. The offering does not constitute a sale in jurisdictions where it would be unlawful prior to registration.
NanoVibronix, Inc. (NASDAQ: NAOV) has received FDA Enforcement Discretion allowing the distribution of its UroShield device in the U.S. The device, intended to reduce catheter-associated urinary tract infections (CAUTI) and discomfort, addresses a significant healthcare need, particularly during the COVID-19 pandemic. This clearance significantly expands the company's market potential for UroShield, which demonstrates positive clinical evidence in preventing CAUTI. CEO Brian Murphy emphasizes its unique position in the market, given the urgent need for effective solutions amidst increasing urinary catheter use in hospitals.
NanoVibronix, Inc. (NASDAQ: NAOV) has successfully closed its public offering of 4,531,434 shares at $0.75 per share, resulting in gross proceeds of approximately $3.4 million. The offering included the underwriter's exercised option for an additional 198,100 shares. The funds will support working capital and facilitate transitioning manufacturing from China to the United States. H.C. Wainwright & Co. was the book-running manager for this transaction, which was conducted under an effective shelf registration statement.
NanoVibronix, Inc. (NASDAQ: NAOV) announced an increase in its public offering to 4,333,334 shares at $0.75 each due to high demand, with expected gross proceeds of approximately $3.25 million. The offering's closing is set for August 27, 2020, pending customary conditions. The underwriter, H.C. Wainwright & Co., holds a 30-day option for an additional 650,000 shares. Proceeds will support working capital and transition manufacturing from China to the U.S. The offering is made under an effective SEC registration statement.
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