Latest news with #diabeticretinopathy
Globe and Mail
17-07-2025
- Business
- Globe and Mail
Ainnova Tech Reaches Major FDA Milestone in AI-Powered Diabetic Retinopathy Detection
Revolutionary Vision AI platform moves closer to US market approval following successful FDA pre-submission meeting The healthcare technology landscape took a significant step forward this week as Ainnova Tech, Inc., in partnership with Avant Technologies Inc. (OTCQB: AVAI) announced the successful completion of a crucial milestone meeting with the U.S. Food and Drug Administration (FDA). This pivotal moment brings the company's groundbreaking Vision AI platform one step closer to revolutionizing early diabetic retinopathy detection in the United States. FDA Guidance Paves the Way Forward The pre-submission meeting represented a critical juncture for Ainnova and its Contract Research Organization (CRO), Fortrea. During this session, the team presented their comprehensive clinical trial plans for the Vision AI platform, focusing exclusively on diabetic retinopathy detection within the United States market. The FDA's response has been overwhelmingly constructive, providing essential guidance across multiple aspects of the clinical trial process. The regulatory body offered specific recommendations regarding clinical protocol development, the optimal number and types of clinics required for a successful trial, and the necessary number of retinologists needed to examine images generated by the AI platform. This detailed feedback enables Ainnova to accurately plan and budget for the complete clinical trial process, creating a clear pathway to their ultimate goal: FDA 510(k) submission and clearance to market Vision AI technology in the United States. A Game-Changing Approach to Diabetic Eye Care Vinicio Vargas, Chief Executive Officer at Ainnova and Board member of Ai-nova Acquisition Corp. (AAC), expressed enthusiasm about this next phase of development. "We're truly excited about this next phase. We're getting ready to begin data collection across primary care clinics in the U.S. with a study that is simple, yet rigorous - comparing our AI-based retinal screening to the readings of three retinologists." The clinical trial design reflects Ainnova's commitment to both simplicity and scientific rigor. By comparing AI-generated results directly with expert retinologist evaluations, the study will provide compelling evidence of the technology's effectiveness and reliability. Beyond Current Technology: The Automated Retinal Camera The Vision AI platform represents just one component of Ainnova's comprehensive technology portfolio. Vargas highlighted the upcoming approval of their automated retinal camera, which he believes will be truly transformative for the industry. "This milestone not only brings us closer to validating our platform in the world's largest healthcare market, but it also paves the way for the upcoming approval of our new automated retinal camera, which we believe will be a game changer - making diabetic retinal screenings faster, more accessible, and available from virtually any point of care." This automated camera technology promises to democratize diabetic retinopathy screening by making it available across diverse healthcare settings, potentially reaching patients who might otherwise lack access to specialized retinal examinations. Strategic Partnership Unlocks Global Potential The partnership between Avant Technologies Inc. and Ainnova Tech has created AAC (Ai-nova Acquisition Corp.), which holds worldwide licensing rights for Ainnova's entire technology portfolio. This strategic arrangement is particularly significant given the FDA's regulatory authority over drug and medical device development in the United States. Success in the U.S. clinical trial will unlock substantial commercial potential, with the early FDA engagement ensuring that AAC can enter the market with speed, credibility, and a thoroughly validated product. The U.S. healthcare market represents the world's largest opportunity for medical technology companies, making FDA approval a crucial milestone for global expansion. Innovation Rooted in Experience Ainnova Tech brings impressive credentials to this endeavor. Based in Nevada with headquarters spanning San Jose, Costa Rica, and Houston, Texas, the company was founded by an experienced team dedicated to leveraging artificial intelligence for early disease detection. The company's track record includes multiple global awards and established partnerships with hospitals and medical device companies worldwide. This recognition underscores the quality and potential impact of their technological innovations. The Broader Vision: Preventing Blindness, Detecting Disease The Vision AI platform represents more than just a diagnostic tool—it embodies a proactive approach to healthcare that prioritizes prevention over treatment. By enabling early detection of diabetic retinopathy, the technology has the potential to prevent blindness while simultaneously facilitating early diabetes detection. This dual benefit aligns with broader healthcare trends toward preventive medicine and early intervention, potentially reducing long-term healthcare costs while improving patient outcomes. Technology Partnership Driving Innovation Avant Technologies Inc., Ainnova's partner in this venture, brings complementary expertise in artificial intelligence and biotechnology solutions. As an emerging technology company focused on pushing the boundaries of what's possible in AI and biotechnology, Avant serves diverse industries while driving progress and efficiency through state-of-the-art technology. This partnership combines Ainnova's specialized healthcare focus with Avant's broader technological capabilities, creating a powerful platform for innovation and commercialization. Looking Ahead: The Path to Market With FDA guidance now in hand, Ainnova can begin the detailed planning phase for their clinical trial. The company will work to establish partnerships with primary care clinics across the United States, recruit the necessary retinologists for image evaluation, and implement the clinical protocol refined through FDA feedback. The data generated from this trial will form the foundation of their FDA 510(k) submission, representing the final regulatory hurdle before market entry. Success in this process would establish Ainnova as a leader in AI-powered diabetic retinopathy detection and position the company for significant growth in the expanding digital health market. Conclusion: A New Era in Diabetic Care The successful completion of Ainnova's FDA milestone meeting represents more than a regulatory achievement—it signals the beginning of a new era in diabetic eye care. By combining artificial intelligence with rigorous clinical validation, Ainnova is positioned to make diabetic retinopathy screening more accessible, efficient, and effective than ever before. As the company moves forward with their clinical trial, the healthcare industry will be watching closely. The potential to prevent blindness while enabling early diabetes detection represents a significant advancement in preventive medicine, with implications that extend far beyond individual patient care to broader public health outcomes. The partnership between Ainnova Tech and Avant Technologies, formalized through AAC, demonstrates how strategic collaboration can accelerate medical innovation and bring life-changing technologies to market. With FDA guidance secured and clinical trials on the horizon, Ainnova is well-positioned to transform the landscape of diabetic retinopathy detection and prevention. Other Active healthcare/tech companies active in the diabetes treatment industry include Abbott (NYSE: ABT), DexCom, Inc. (NASDAQ: DXCM), iRhythm Technologies, Inc. (NASDAQ: IRTC), Tandem Diabetes Care, Inc. (NASDAQ: TNDM). Disclaimer: This blog post is for informational purposes only and does not constitute financial advice or an endorsement of COEP or its strategies. FOR EDUCATIONAL AND INFORMATION PURPOSES ONLY; NOT INVESTMENT ADVICE. Please ensure to fully read and comprehend our disclaimer found at has been compensated one thousand dollars by a 3rd party EDM Media for content distribution services on AVAI for July 17, 2025. is neither an investment advisor nor a registered broker. No current owner, employee, or independent contractor of is registered as a securities broker-dealer, broker, investment advisor, or IA representative with the U.S. Securities and Exchange Commission, any state securities regulatory authority, or any self-regulatory organization. This article may contain forward-looking statements as defined under Section 27A of the Securities Act of 1933 and 21E of the Exchange Act of 1934. These statements, often incorporating terms like 'believes,' 'anticipates,' 'estimates,' 'expects,' 'projects,' 'intends,' or similar expressions about future performance or conduct, are based on present expectations, estimates, and projections, and are not historical facts. They carry various risks and uncertainties that may result in significant deviation from the anticipated results or events. Past performance does not guarantee future does not commit to updating forward-looking statements based on new information or future events. 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Globe and Mail
30-06-2025
- Business
- Globe and Mail
Avant Technologies and JV Partner, Ainnova, Prepare for Key FDA Milestone with Next Week's Pre-Submission Meeting
LAS VEGAS , June 30, 2025 /CNW/ -- Avant Technologies, Inc. (OTCQB: AVAI) ("Avant" or the "Company"), and its JV partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced that Ainnova and its Contract Research Organization, Fortrea, will use this week to make final preparations for the company's pre-submission meeting with the U.S. Food and Drug Administration (FDA) next week. The pre-submission meeting with Ainnova's executives and its CRO is set for Monday, July 7. The FDA meeting will allow the Company to discuss its planned clinical trial of Ainnova's Vision AI platform in the early detection of diabetic retinopathy. These meetings will give the team the direction it needs for a successful clinical trial and to support the Company's FDA 510(k) submission to obtain clearance from the FDA to market the Vision AI technology in the United States . Vinicio Vargas , Chief Executive Officer at Ainnova and a member of the Board of Directors of Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova's technology portfolio, said, "We're approaching a key milestone. We've been preparing thoroughly with the support of an experienced CRO and expert regulatory advisors, and we're optimistic about the outcome. "Diabetic retinopathy is the number one cause of preventable blindness worldwide. That's unacceptable—and we believe technology can change that. But this is just the beginning. Retinal screening offers a gateway to detecting many systemic conditions early—like Alzheimer's, cardiovascular disease, and more. "We're committed to pushing the boundaries of preventive care, improving both life expectancy and quality of life for people around the world. That's the mission behind everything we do." Ainnova will use this pre-submission meeting to determine a host of items, including the ideal number of clinical sites, the number of total patients needed, and to learn if the FDA will approve the clinical trial protocol for the planned trial. These are all crucial for both Avant and Ainnova in determining the exact costs and a timetable. AAC has the worldwide licensing rights for Ainnova's technology portfolio. The licensing rights include the U.S., where the FDA regulates drug and medical device development, so the success of Ainnova's interactions with the FDA are paramount to marketing the technology portfolio in the United States. Entering the U.S. market will unlock significant commercial potential, and this early engagement with the FDA ensures AAC can do so with speed, credibility, and a validated product. About Ainnova Tech, Inc. Ainnova is a Nevada -based healthtech startup with headquarters in San Jose, Costa Rica , and Houston, Texas . Founded by an experienced and innovative team that is dedicated to leveraging artificial intelligence for early disease detection. Recognized with multiple global awards and renowned partnerships with hospitals and medical device companies, we proudly introduce Vision AI – our cutting-edge platform designed to prevent blindness and detect the early onset of diabetes. Explore how Ainnova is revolutionizing healthcare through advanced technology and proactive solutions. About Avant Technologies, Inc. Avant Technologies Inc. is an emerging technology company developing solutions in healthcare using artificial intelligence and biotechnologies. With a focus on pushing the boundaries of what is possible in AI and biotechnology, Avant serves a diverse range of industries, driving progress and efficiency through state-of-the-art technology. More information about Avant can be found at You can also follow us on social media at: Forward-Looking Statements Certain statements contained in this press release may constitute "forward-looking statements." Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website ( In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company's ability to raise capital on acceptable terms, if at all, the Company's successful development of its products and the integration into its existing products and the commercial acceptance of the Company's products. The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date after the date of the press release.
Yahoo
24-06-2025
- Business
- Yahoo
Breye Therapeutics announces successful completion of its Phase 1b trial with danegaptide in patients with diabetic retinopathy
Orally administered treatment was well tolerated, with early signs of clinical activity In models of non-proliferative diabetic retinopathy (NPDR), danegaptide has demonstrated protection against retinal capillary loss and vascular leakage Data support continued advancement into Phase 2 clinical evaluation COPENHAGEN, Denmark, June 24, 2025 /PRNewswire/ -- Breye Therapeutics ApS (Breye), a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of vascular eye diseases, today announces the successful completion of its Phase 1b clinical trial evaluating its lead candidate, danegaptide, in patients with non-proliferative diabetic retinopathy (NPDR) with associated edema. Diabetic retinopathy (DR) is a leading cause of vision loss globally, affecting millions of people with diabetes. While there has been successful development of intravitreally administered products, injected directly into the eye, for patients with late-stage disease, treatment options are currently limited for patients in the earlier or moderate stages. The intravitreal treatments are burdensome, often poorly tolerated and associated with low compliance, highlighting the critical need for effective and non-invasive alternatives. Danegaptide is a first-in-class oral small molecule with a novel mode of action, that stabilizes the vasculature and protects from cell-cell uncoupling, retinal capillary breakdown and vascular leakage caused by hyperglycemia. The orally administered treatment was well tolerated across all dose levels in the 24 patients enrolled, with no dose-limiting toxicities reported. Pharmacokinetic (PK) data confirmed that targeted exposures of danegaptide were reached as guided by preclinical data. Early signs of clinical activity were observed, as measured by retinal imaging outcomes, representing reductions in retinal vascular leakage and improvements in anatomical parameters. Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics, said: "These results continue to support danegaptide's potential as an oral, non-invasive therapeutic solution for patients in the earlier stages of diabetic retinopathy. As we now prepare to advance into Phase 2 clinical evaluation, our focus is on validating these findings using regulatory-accepted clinical outcomes to progress our mission of developing safe and effective treatment options for these patients to preserve their vision before the onset of irreversible damage. Additionally, we believe this treatment solution may also support the maintenance of treatment response after induction therapy with intravitreally administered products." Prof. Carl Regillo, MD, Director of Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University in Philadelphia, Member of the Breye Therapeutics Scientific Advisory Board, commented: "An oral approach like danegaptide has the potential to fundamentally shift how we treat moderate to severe-stages of diabetic eye disease, offering patients a much-needed and non-invasive treatment solution for the large group of patients with NPDR." The Phase 1b trial was a multicenter, open-label, dose-escalation study assessing the safety, tolerability, pharmacokinetics (PK) and early signs of biological activity of danegaptide in patients with NPDR and associated diabetic macular edema (DME), a complication of NPDR. Conducted across 11 clinical sites in the UK, Germany and the US, the study confirmed a favourable safety profile, plasma levels within the targeted therapeutic range and early signs of clinical activity. A subsequent Phase 2 trial is planned to evaluate danegaptide in a targeted NPDR patient population using the regulatory endpoint of ≥2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS). Breye is actively fundraising to support this next phase of development. About Breye Therapeutics Breye Therapeutics is a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of vascular eye diseases. Breye is developing a pipeline of oral therapies for diseases of the eye, such as intermediate age-related macular degeneration and glaucoma, so more patients can maintain their sight, autonomy, and quality of life. Its lead candidate, danegaptide, is the first oral drug designed to treat diabetic retinopathy in its earlier stages and has a novel mechanism of action designed to stop and reverse disease progression. It is currently progressing through clinical development, with Phase 1b successfully completed and a Phase 2 trial planned to demonstrate clinical proof-of-concept. Breye is backed by Novo Holdings and Sound BioVentures, and has received financial support from the BioInnovation Institute, the Danish Growth Foundation (Vækstfonden), and the Danish Innovation Foundation (Innovationsfonden). For more information, please visit: View original content: SOURCE Breye Therapeutics
Yahoo
24-06-2025
- Business
- Yahoo
Breye Therapeutics announces successful completion of its Phase 1b trial with danegaptide in patients with diabetic retinopathy
Orally administered treatment was well tolerated, with early signs of clinical activity In models of non-proliferative diabetic retinopathy (NPDR), danegaptide has demonstrated protection against retinal capillary loss and vascular leakage Data support continued advancement into Phase 2 clinical evaluation COPENHAGEN, Denmark, June 24, 2025 /PRNewswire/ -- Breye Therapeutics ApS (Breye), a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of vascular eye diseases, today announces the successful completion of its Phase 1b clinical trial evaluating its lead candidate, danegaptide, in patients with non-proliferative diabetic retinopathy (NPDR) with associated edema. Diabetic retinopathy (DR) is a leading cause of vision loss globally, affecting millions of people with diabetes. While there has been successful development of intravitreally administered products, injected directly into the eye, for patients with late-stage disease, treatment options are currently limited for patients in the earlier or moderate stages. The intravitreal treatments are burdensome, often poorly tolerated and associated with low compliance, highlighting the critical need for effective and non-invasive alternatives. Danegaptide is a first-in-class oral small molecule with a novel mode of action, that stabilizes the vasculature and protects from cell-cell uncoupling, retinal capillary breakdown and vascular leakage caused by hyperglycemia. The orally administered treatment was well tolerated across all dose levels in the 24 patients enrolled, with no dose-limiting toxicities reported. Pharmacokinetic (PK) data confirmed that targeted exposures of danegaptide were reached as guided by preclinical data. Early signs of clinical activity were observed, as measured by retinal imaging outcomes, representing reductions in retinal vascular leakage and improvements in anatomical parameters. Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics, said: "These results continue to support danegaptide's potential as an oral, non-invasive therapeutic solution for patients in the earlier stages of diabetic retinopathy. As we now prepare to advance into Phase 2 clinical evaluation, our focus is on validating these findings using regulatory-accepted clinical outcomes to progress our mission of developing safe and effective treatment options for these patients to preserve their vision before the onset of irreversible damage. Additionally, we believe this treatment solution may also support the maintenance of treatment response after induction therapy with intravitreally administered products." Prof. Carl Regillo, MD, Director of Retina Service of Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University in Philadelphia, Member of the Breye Therapeutics Scientific Advisory Board, commented: "An oral approach like danegaptide has the potential to fundamentally shift how we treat moderate to severe-stages of diabetic eye disease, offering patients a much-needed and non-invasive treatment solution for the large group of patients with NPDR." The Phase 1b trial was a multicenter, open-label, dose-escalation study assessing the safety, tolerability, pharmacokinetics (PK) and early signs of biological activity of danegaptide in patients with NPDR and associated diabetic macular edema (DME), a complication of NPDR. Conducted across 11 clinical sites in the UK, Germany and the US, the study confirmed a favourable safety profile, plasma levels within the targeted therapeutic range and early signs of clinical activity. A subsequent Phase 2 trial is planned to evaluate danegaptide in a targeted NPDR patient population using the regulatory endpoint of ≥2-step improvement on the Diabetic Retinopathy Severity Scale (DRSS). Breye is actively fundraising to support this next phase of development. About Breye Therapeutics Breye Therapeutics is a clinical-stage ophthalmology focused biopharmaceutical company developing oral therapeutics for the early treatment of vascular eye diseases. Breye is developing a pipeline of oral therapies for diseases of the eye, such as intermediate age-related macular degeneration and glaucoma, so more patients can maintain their sight, autonomy, and quality of life. Its lead candidate, danegaptide, is the first oral drug designed to treat diabetic retinopathy in its earlier stages and has a novel mechanism of action designed to stop and reverse disease progression. It is currently progressing through clinical development, with Phase 1b successfully completed and a Phase 2 trial planned to demonstrate clinical proof-of-concept. Breye is backed by Novo Holdings and Sound BioVentures, and has received financial support from the BioInnovation Institute, the Danish Growth Foundation (Vækstfonden), and the Danish Innovation Foundation (Innovationsfonden). For more information, please visit: View original content: SOURCE Breye Therapeutics
Associated Press
06-05-2025
- Business
- Associated Press
Avant Technologies and Partner, Ainnova, Receive FDA Pre-Submission Meeting Date for Company's Vision AI Platform Technology
LAS VEGAS, May 6, 2025 /PRNewswire/ -- Avant Technologies, Inc. (OTCQB: AVAI) ('Avant' or the 'Company'), and its JV partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced that the U.S. Food and Drug Administration (FDA) has scheduled its pre-submission meeting with Ainnova's executives and its CRO, Fortrea, for July 7, 2025, to discuss a range of items related to the Company's planned clinical trial of its Vision AI platform in the early detection of diabetic retinopathy. Vinicio Vargas, Chief Executive Officer at Ainnova and a member of the Board of Directors of Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova's technology portfolio, said, 'We are forever grateful for the opportunity to meet with the U.S. FDA to discuss our planned clinical trial. These meetings will give us the direction that we'll need for success and to support our FDA 510(k) submission to obtain clearance from the FDA to market our technology in the U.S.' 'We will use this pre-submission meeting to determine a host of items, including the ideal number of clinical sites, the number of total patients needed, and to learn if the FDA will approve our protocol for the planned clinical trial. These are all crucial for both Avant and Ainnova in determining the exact costs and a timetable.' AAC has the worldwide licensing rights for Ainnova's technology portfolio. The licensing rights include the U.S., where the FDA regulates drug and medical device development, so the success of Ainnova's interactions with the FDA are paramount to marketing the technology portfolio in the United States. Entering the U.S. market will unlock significant commercial potential, and this early engagement with the FDA ensures AAC can do so with speed, credibility, and a validated product. About Ainnova Tech, Inc. Ainnova is a Nevada-based healthtech startup with headquarters in San Jose, Costa Rica, and Houston, Texas. Founded by an experienced and innovative team that is dedicated to leveraging artificial intelligence for early disease detection. Recognized with multiple global awards and renowned partnerships with hospitals and medical device companies, we proudly introduce Vision AI – our cutting-edge platform designed to prevent blindness and detect the early onset of diabetes. Explore how Ainnova is revolutionizing healthcare through advanced technology and proactive solutions. About Avant Technologies, Inc. Avant Technologies, Inc. is an emerging technology company developing solutions in artificial intelligence in healthcare. With a focus on pushing the boundaries of what is possible in AI and machine learning, Avant serves a diverse range of industries, driving progress and efficiency through state-of-the-art technology. More information about Avant can be found at You can also follow us on social media at: Forward-Looking Statements Certain statements contained in this press release may constitute 'forward-looking statements.' Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website ( ). In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company's ability to raise capital on acceptable terms, if at all, the Company's successful development of its products and the integration into its existing products and the commercial acceptance of the Company's products. The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date after the date of the press release. Contact: Avant Technologies, Inc. [email protected] Video: Logo: View original content to download multimedia: SOURCE Avant Technologies Inc.
