The Microdose Array Print (MAP) Technology has shown potential in clinical trials, providing the possibility of more accurate ocular drug delivery than traditional eye droppers

NEW YORK - December 22, 2022 - (Newswire.com)

While medical devices have seen incredible advancements over the last 100 years, ocular drug delivery systems have seen minimal progress; the standard eye dropper used today has gone largely unchanged in the last century. Eyenovia, Inc. (NASDAQ: EYEN), a pre-commercial ophthalmic technology company developing a pipeline of late-stage microdose array print (MAP™) therapeutics, is developing one of the first microdosing systems that aims to improve the overall patient experience and streamline practice flow by facilitating digital delivery of eye medications.

The investigational delivery device is currently only used in clinical study settings and has shown promise in delivering cleaner and more efficient ocular drug delivery. "The proprietary Eyenovia device takes a novel approach to administering eye medication via microdosing and does it in a way that should improve the patient experience," said Michael Rowe, CEO of Eyenovia. "Traditional eye droppers are cumbersome, inaccurate, and prone to contamination. Even when handled with care, there's still a significant likelihood that medication patients are paying for gets wasted due to missing drops."

The device is uniquely designed with no protruding parts and a recessed nozzle to not touch patients' eyes, reducing the likelihood of infection. Eyenovia also expects a more gentle dosing experience to create a fundamental paradigm shift in eye care. 

Eye drop innovation has stagnated, in part due to changing medical device regulations that complicate patient access to innovative devices. Safety takes precedence in the medical device industry; however, as digital innovation leaps ahead of bureaucratic regulatory bodies, regulators are challenged to keep pace with the cutting-edge new products that push the boundaries of technology. 

While the world of healthcare looked significantly different 100 years ago, similar paradigm shifts in medical technology through innovations like pacemakers, cochlear implants, 3-D printed body parts, and artificial hearts revolutionized their respective industries, greatly improving quality of life and patient care. With a market share valued at roughly €100 billion in Europe, medical devices make up 7.5% of healthcare expenditure in most publicly funded healthcare systems, and the American ecosystem is taking notice. 

As American private venture capital makes inroads into the digital health market, the total capital investment in medical devices has increased by a factor of five, which portends a promising future for improved patient care. Medical technology device advancement is only expected to increase over the next five years, and Eyenovia is one of those industry leaders in championing innovation. 

"We're proud to be innovating in this space where we have the potential to make lives easier for millions of Americans and people worldwide suffering from chronic eye conditions," adds Rowe.

For more information, visit eyenovia.com. 

About Eyenovia, Inc.

Eyenovia, Inc. is a pre-commercial ophthalmic technology company developing a pipeline of microdose array print (MAP™) therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia and myopia progression. For more information, visit www.eyenovia.com. 

Forward-Looking Statements

Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities for our product candidates and platform technology. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment (which could still be adversely impacted by COVID-19), timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our product candidates; the potential impacts of COVID-19 on our supply chain; the potential advantages of our product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties to develop and commercialize our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our product candidates; intellectual property risks; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and our competitive position. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws. Eyenovia does not undertake any obligation to update any forward-looking statements.

Contact Information:
Norbert Lowe
Vice President, Commercial Operations
[email protected]

Buse Kayar
[email protected]


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Original Source: Eyenovia Aims to Revolutionize Ophthalmology Devices With Microdose Array Print (MAP) Technology

NEWARK, Calif. - December 22, 2022 - (Newswire.com)

EyeQue, the leader in innovative vision testing is proud to announce the donation of 25,000 Personal Vision Trackers to the Oklahoma City Indian Clinic. EyeQue is proud to be able to give back to communities, especially during the most giving time of the year. 

The Oklahoma City Indian Clinic is a 501(c)(3) non-profit established in 1974 to provide excellent health care and wellness services to American Indians in central Oklahoma. The clinic staff cares for more than 22,000 patients from over 200 federally recognized tribes annually. American Indians can receive a range of services, including medical, dental, pediatrics, prenatal, pharmacy, optometry, physical fitness, nutrition, family programs and behavioral health services.

"The use of EyeQue devices will help us meet the vision needs of our growing patient population," said Monica McKee, OKCIC's Vice President of Ancillary Clinical Services.

"EyeQue's solutions allow people to self test their vision, from anywhere at any time. We are delighted to work with and support the OKCIC community in using our technology to improve health care for Native American patients," said Dr. John Serri, Founder and CEO of EyeQue. 

"It's important to pay attention to any changes in your vision," said Byron Bonner, OD, OKCIC's Pediatric Optometrist. "At-home vision tests provide greater accessibility for our patients to monitor their vision, and catch any concerning changes early."

EyeQue believes that clear vision is a right, not a privilege. The company works hard at developing easy to use self-testing ophthalmic medical technologies.

The Company founded in 2015, headquartered in Silicon Valley is dedicated to putting accurate vision tests directly into the hands of people around the world. Based on MIT and EyeQue's own patented technologies, EyeQue's intelligent vision solutions allow people anywhere to self-administer an expanding portfolio of accurate and low cost vision tests using simple passive optical devices, free IOS and Android mobile applications, and a secure HIPAA cloud-based processing and service center. 

Contact Information:
John Serri
CEO and Co-Founder
[email protected]
510-585-7982

Nicole Skibinski
VP of Business Development
[email protected]
510-399-5801


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Original Source: EyeQue Gives Back

Gb Sciences' innovative approach harnesses the power of plant-based treatments as simplified mixtures that target dangerous hyperinflammatory responses to viral infections.

LAS VEGAS - December 22, 2022 - (Newswire.com)

Gb Sciences, Inc. (OTCQB:GBLX), a leading plant-inspired, biopharmaceutical research and development company, is developing cannabis-inspired anti-inflammatory therapeutics that address Cytokine Release Syndrome (CRS) caused by viral infections like COVID-19 and others. Over the two pandemic years, more than 540 million people across the world contracted COVID-19 and 6.3 million died from the hyperinflammatory side effects related to this viral infection, which inspired Gb Sciences to create anti-inflammatory drugs designed to treat future viral outbreaks that elicit these dangerous hyperinflammatory responses. 

The global anti-inflammatory therapeutics market size was estimated at USD 99.6 billion in 2021, according to Precedence Research, and is expected to hit USD 127.5 billion by 2030, with a registered CAGR of 4.5% from 2022 to 2030. Gb Sciences announced in May 2022 that FHI Clinical would consult and write the draft clinical trial protocol for a first-in-human trial of these proprietary cannabinoid-containing formulations. One key differentiator of Gb Sciences' CRS therapeutic is the early-intervention and preventative opportunities for patients when they first discover they have been exposed to a virus that causes hyperinflammation. This therapeutic may also be useful for patients who are experiencing CRS as a side effect of certain new cancer therapeutics, such as Bispecific T-cell engaging (BiTE) single-chain antibody constructs and chimeric antigen receptor (CAR) T-cells.

"Our research shows promise for the potential use of cannabinoids within cannabinoid-containing mixtures as a treatment option for hyperinflammation. There is still a need for effective treatments to combat the hyperinflammatory effects of certain viruses. Our cannabis-inspired therapeutics were designed to reset the immune system after hyperinflammation has been triggered, providing relief by targeting our human immune response to a virus, without being tied to a specific variant or the virus itself," said Andrea Small-Howard, President and Chief Science Officer of Gb Sciences.

Gb Sciences used PhAROS™, its proprietary AI-enabled drug discovery platform, to identify these therapeutic mixtures that were designed to reduce the levels of specific cytokines and pro-inflammatory processes triggered by viruses, while preserving the immune functions and cytokines necessary to fight viral infections. Gb Sciences recently published a white paper on their novel development program titled "Utilizing Proprietary AI/ML Technology, Novel Cannabis-Inspired Mixtures Are Developed as Innovative Anti-Inflammatory Therapeutics"; download it here. 

A proof-of-concept study completed by researchers at Michigan State University in 2021 found that Gb Sciences' proprietary cannabis-inspired minimum essential mixtures (MEM) reduced cytokine release syndrome biomarkers. Gb Sciences' MEM, containing either two or three cannabinoids each, reduced the levels of inflammatory biomarkers more than the sum of the anti-inflammatory effects of the single ingredients tested separately. The ratios of those cannabinoid molecules within the MEM formulations also greatly influenced their anti-inflammatory potential, the study reported. 

To learn more about Gb Sciences, visit www.gbsciences.com.

About Gb Sciences and GbS Global Biopharma

Gb Sciences, Inc. is a plant-inspired, biopharmaceutical research and development company creating patented disease-targeted formulations of cannabis- and other plant-inspired therapeutic mixtures for the prescription drug market through its Canadian subsidiary GbS Global Biopharma, Inc. The "plant-inspired" active ingredients in its therapeutic mixtures are synthetic homologues identical to the original plant compounds but produced under current Good Manufacturing Practices. Gb Sciences' intellectual property portfolio contains six issued U.S. and three issued foreign patents, as well as 17 U.S. and 51 foreign patent-pending applications. In its drug development pipeline, Gb Sciences has five preclinical phase product development programs. Gb Sciences' lead program for Parkinson's disease is being prepared for a first-in-human clinical trial. Gb Sciences' formulations for chronic pain, anxiety, and depression are currently in preclinical animal studies with researchers at the National Research Council Canada. The company also received positive preclinical proof-of-concept data supporting its complex mixtures for the treatment of Cytokine Release Syndrome, and its lead candidates will be optimized based on late-stage preclinical studies at Michigan State University. Gb Sciences' productive research and development network includes distinguished universities, hospitals, and Contract Research Organizations. To learn more, visit www.gbsciences.com.

Forward-Looking Statements

This press release may contain statements relating to future results or events, which are forward-looking statements. Words such as "expects," "intends," "plans," "may," "could," "should," "anticipates," "likely," "believes," and words of similar import may identify forward-looking statements. These statements are not historical facts but instead represent only the Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Further, information concerning the Company and its business, including factors that potentially could materially affect the Company's business and financial and other results, are contained in the Company's filings with the Securities and Exchange Commission, available at www.sec.gov. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

Contact Information:
Alexis Quintal
[email protected]


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Original Source: Gb Sciences Identifies Novel Cannabis-Inspired Mixtures as Anti-Inflammatory Therapies Based on Proprietary AI-Enabled Drug Discovery Platform

"Year-after-year of Medicare funding cuts to independent medical practices must be stopped, and we will continue our congressional advocacy efforts to implement long-term solutions, like inflationary adjustments for independent providers," said Bob Still, Executive Director of the Radiology Business Management Association (RBMA).

FAIRFAX, Va. - December 21, 2022 - (Newswire.com)

 This week, Congress passed limited cuts to Medicare payments for independent physician practices but included conversion factor support to limit the severity of these cuts. While these funding cuts will hinder the services provided by independent medical practices across the country, the final 2% cuts are significantly less than the potential double-digit cuts initially proposed by the U.S. Centers for Medicare & Medicaid Services. 

The conversion factor support will aid independent practices that continue to fall further behind other provider types that enjoyed rate increases this year under "market basket" inflationary adjustments. The continued funding infusion is a small step in the right direction towards a much-needed, longer-term reform to the nation's Medicare system, which RPAN will continue to aggressively advocate for. 

"While any Medicare funding cuts are disappointing and will no doubt hurt independent practices, RPAN is encouraged our nationwide advocacy efforts - including over 7,000 phone calls, 38,000 text messages and e-mail correspondence - pressed Congress to shrink the percentage of those cuts as well as include in-conversion factor support in their final funding package. However, there is much more to do. Year-after-year of Medicare funding cuts to independent medical practices must be stopped, and we will continue our congressional advocacy efforts to implement long-term solutions, like inflationary adjustments for independent providers," said Bob Still, Executive Director of the Radiology Business Management Association (RBMA).

"We will be steadfast in our ongoing efforts to reform the Medicare funding system, specifically for independent medical providers who are the only Medicare providers in the country not to receive annual inflationary updates. We are glad to see RPAN's advocacy in the legislative process significantly knock down this year's proposed cuts to our funding, but we are committed to ensuring no future cuts to Medicare funding for America's independent providers and the practices they run going forward," said Shannon Wilson, President of the RBMA.

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About RBMA

The Radiology Business Management Association (RBMA) is an industry-leading organization comprised of more than 2,100 professionals who focus on the business of radiology. RBMA members support diagnostic imaging, interventional radiology and radiation oncology providers in the full spectrum of practice settings. RBMA connects members nationwide to valuable information, education, and practice-related resources and serves as an authoritative industry voice on behalf of shared member interests.

Contact Information:
Will Sweet
RBMA
[email protected]


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Original Source: Radiology Patient Action Network Urges Long-Term Fix for Medicare Payments While Welcoming Limited Support From Congress

PHILADELPHIA - December 21, 2022 - (Newswire.com)

CGFNS International announces that Peter Preziosi, Ph.D., RN, CAE, has become its President and CEO.

Dr. Preziosi previously served as Chief Innovation and Business Development Officer of CGFNS and most recently was at the World Health Organization responsible for establishing the quality and learning standards for its newly established global learning academy as Team Lead for Quality, Standards and Credentials. Dr. Preziosi becomes the fifth CEO in CGFNS's 45-year history. He plans to strengthen its presence in the United States and broaden its global reach as the exemplar in protecting the public by assuring migrating health professionals are eligible to meet standards and practice requirements according to jurisdictional conditions. As an ISO-9001 organization and a member of the Conference of Non-Governmental Organizations (NGOs) in Consultative Relationship with the United Nations (CoNGO), CGFNS is positioned for growth.

Dr. Preziosi said, "I appreciate the opportunity to lead CGFNS into a new era of technology-driven services both in the U.S. and abroad, so as to serve our stakeholders with excellence and state-of-the-art efficiencies. Health professionals' mobility and workforce development are converging, where governments and employers are demanding innovative solutions in addressing health system challenges worldwide. The CGFNS team aims to meet those challenges as we design new solutions in credentialing and other services to meet those in need."

Dr. Preziosi received his BSN at Florida State University and his Masters in Education, Public Administration from Columbia University. He attained from the University of Pennsylvania his Ph.D. in Health Policy and Administration and an MGA in Public Administration.

About CGFNS International, Inc.
Founded in 1977 and based in Philadelphia, CGFNS International is an immigration-neutral, not-for-profit organization proudly serving as the world's largest credentials evaluation organization for the nursing and allied health professions. CGFNS International is an NGO in Consultative Status with the United Nations Economic and Social Council (ECOSOC) and is a member of the Conference of NGOs in Consultative Relationship with the United Nations (CoNGO). For more information, visit https://www.cgfns.org.

Contact Information:
Frank Mortimer
Director of Marketing and Communication
[email protected]


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Original Source: CGFNS International Announces Dr. Peter Preziosi as President and CEO