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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) has announced the launch of a new CBD gel designed for the topical treatment of pain and inflammation. This product aims to expand the market for NanoVibronix's PainShield line, providing an additional revenue stream. The gel features nano-cannabidiol sourced from High Purity Natural Products, an FDA-registered manufacturer. The company anticipates product availability by mid-2022, positioning it as a complementary option for common ailments like arthritis, while still maintaining the efficacy of existing pain management devices.
NanoVibronix, Inc (NASDAQ: NAOV) held its Annual Meeting of Stockholders virtually. Key resolutions adopted include the election of six director nominees, an amendment to increase the number of authorized shares, the ratification of Marcum LLP as independent auditor, and advisory approvals for executive compensation.
The company focuses on medical devices like UroShield® and PainShield®, utilizing patented low-intensity surface acoustic wave (SAW) technology, aiming for applications in pain relief and biofilm disruption.
NanoVibronix, Inc. (NASDAQ: NAOV) announces its entry into the Over-the-Counter (OTC) pain relief market with the launch of PainShield RELIEF™, a non-prescription ultrasound device aimed at providing rapid pain relief for soft tissue and nerve damage. CEO Brian Murphy notes this significant market expansion opens new revenue opportunities for the company. Plans are in place for a U.S. launch and trade show reveals in early to mid-2022. The company is also preparing to submit a regulatory application to the FDA and protect its trademark.
NanoVibronix, Inc. (NASDAQ: NAOV) has secured regulatory approval from Australia's TGA for its PainShield device, following the recent approval of UroShield. This allows for distribution in Australia through their new partnership with DukeHill Healthcare Pty Ltd, enhancing access to their ultrasound-based therapeutic devices. PainShield offers treatment for acute and chronic pain, while UroShield aims to reduce urinary catheter infection risks. The strategic partnership positions NanoVibronix to effectively meet market demands in Australia.
NanoVibronix, Inc. (NASDAQ: NAOV) announced it completed the application process for a CMS reimbursement code for its UroShield and PainShield Plus devices. CEO Brian Murphy stated this initiative aims to significantly expand the market for these therapies, particularly among Medicare beneficiaries. The UroShield is designed to prevent urinary tract infections, while PainShield Plus provides ultrasound therapy for pain treatment at home. Approval of the reimbursement code is seen as a catalyst for increasing revenue opportunities for the company.
NanoVibronix, Inc (NASDAQ: NAOV) announced the fulfillment of its first order for the PainShield Plus®, a next-generation pain management device. This device covers double the area of its predecessor and offers a higher gross margin. Expected revenue recognition from this sale is anticipated in Q3 2021. The PainShield Plus utilizes ultrasound therapy to alleviate pain and allows patients to self-administer treatment at home, thus helping to reduce reliance on opioids. CEO Brian Murphy highlighted positive responses from the launch and increasing distributor interest.
NanoVibronix, Inc. (NASDAQ: NAOV) announced significant findings from a study published in The Journal of Medical & Surgical Urology, confirming the effectiveness of its UroShield device in real-world settings. The study showed that 100% of participants reported ease of use and significant health benefits, including a reduction in urinary tract infections and pain. Conducted with 23 patients over 12 weeks, researchers concluded that UroShield is an appropriate treatment for persistent UTIs. The study aims to support future NICE Guidance for the device.
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.
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