MangoRx Secures DEA Approval for Proprietary HIPAA-Compliant Operating System via Surescripts

Rhea-AI Summary

MangoRx (NASDAQ: MGRX) has secured DEA approval for its proprietary HIPAA-compliant operating system via Surescripts, positioning the company at the forefront of the direct-to-consumer telemedicine market. This authorization allows MangoRx to prescribe controlled medications, including hormone replacement therapies, through the nation's leading health information network.

The approval is expected to drive significant growth by enabling the company to expand its offerings and hyperscale operations. MangoRx's new operating system, developed over nearly a year, aims to revolutionize patient management with features like seamless doctor visits, prescription auto-refills, and personalized healthcare solutions. The company anticipates exponential growth in its subscriber base following this milestone.

Positive

• Secured DEA approval for HIPAA-compliant operating system via Surescripts
• Authorization to prescribe controlled medications, including hormone replacement therapies
• Potential for significant growth and expansion of offerings
• Anticipated exponential growth in subscriber base
• Advanced operating system with real-time data tracking and seamless integration

Negative

• None.

Insights

Healthcare Technology Analyst

MangoRx's recent DEA approval for their HIPAA-compliant operating system via Surescripts marks a pivotal development within the healthcare technology sector. This step enables the company to prescribe controlled substances, such as hormone replacement therapies, directly to consumers. By securing validation from Surescripts, MangoRx demonstrates an enhanced level of regulatory compliance and technological sophistication. For stakeholders, this indicates the company's capability to expand its product offerings and improve service delivery.

In the short term, this approval is likely to drive immediate growth by attracting new patients seeking convenient access to these specialized treatments. In the long run, it aligns MangoRx favorably within the competitive DTC telemedicine landscape.

Understanding HIPAA compliance is important here; HIPAA (Health Insurance Portability and Accountability Act) ensures that any patient information handled by the system remains secure and private. The DEA (Drug Enforcement Administration) approval means that the system has met stringent federal guidelines, which adds significant credibility.

Overall, this milestone not only sets a new standard in telemedicine but also underpins MangoRx's growth trajectory, potentially leading to increased revenue streams and market share.

Financial Analyst

The DEA authorization presents a considerable upside for MangoRx from a financial perspective. With this approval, MangoRx can now include high-margin controlled substances in their offerings, which could significantly boost revenue streams. This is particularly relevant in the areas of hormone replacement therapies, which are in high demand.

While the initial costs for developing and maintaining the proprietary system may be substantial, the efficiency gained from automating processes such as prescription refills and patient management is likely to offset these costs over time. Additionally, having a DEA-compliant system in place could attract institutional investors looking for companies with robust regulatory adherence.

An important financial indicator to consider here is the potential expansion of customer base. With streamlined operations and enhanced service offerings, MangoRx is strategically positioned to capture a broader market share, thus driving revenue growth. However, investors should monitor the cost dynamics closely to ensure the long-term sustainability of these new initiatives.

From a valuation perspective, the DEA approval could lead to a reevaluation of MangoRx's stock, potentially increasing its attractiveness to investors.

DALLAS, TX, July 16, 2024 (GLOBE NEWSWIRE) -- Mangoceuticals, Inc. (NASDAQ: MGRX) (“MangoRx” or the “Company”), a company focused on developing, marketing, and selling a variety of men’s health and wellness products in the areas of erectile dysfunction (ED), hair growth, weight loss, and hormone replacement therapies, is excited to announce obtaining DEA authorization for the company’s groundbreaking HIPAA-compliant operating system through Surescripts. This significant milestone positions MangoRx at the forefront of the direct-to-consumer (DTC) telemedicine market.

Securing DEA clearance to prescribe controlled medications via Surescripts, the nation’s leading health information network, sets MangoRx apart from its competitors, validating its cutting-edge technology and regulatory compliance. This approval aims to give MangoRx’s provider network more flexibility in prescribing custom medication and treatments to include a comprehensive range of controlled substances such as hormone replacement therapies - which they anticipate will drive significant growth in this category. The DEA approval provides a robust foundation for the company's future expansion and success, ensuring adherence to stringent regulatory standards while fostering innovation.

Amanda Hammer, COO of MangoRx, highlights the system's transformative impact and the significance of the DEA approval: “This authorization through Surescripts marks a pivotal moment for MangoRx. Our system is now capable of supporting hyper growth and has the limitless ability to add new and innovative products. This ensures that we remain at the cutting edge of the telemedicine industry, delivering exceptional value to our patients and stakeholders, all at the same time of maintaining security and regulatory compliance."

Jacob Cohen, CEO and Co-Founder of MangoRx commented, “We anticipate exponential growth in our subscriber base with the launch of MangoRx's new operating system. Our unique proprietary operating system, in development for nearly a year, is designed to revolutionize patient management. Patients can now seamlessly manage their MangoRx doctor visits, prescription auto-refills, and overall health with unprecedented ease and security. This milestone underscores our dedication to leveraging technology for superior patient care, with each individual receiving personalized, efficient healthcare solutions tailored specifically to their needs."

This authorization through Surescripts will enable MangoRx to expand its offerings to include controlled substances, creating new revenue streams while allowing the company to hyperscale operations. The advanced operating system, featuring real-time data tracking and seamless integration, sets a new benchmark for excellence in telemedicine, enhancing patient engagement and satisfaction.

As MangoRx continues to redefine the DTC healthcare experience, we are strategically positioned to significantly impact the market and drive growth. Our proprietary operating system and the DEA's endorsement signal a transformative phase for the Company.

About MangoRx

MangoRx is focused on developing a variety of men's health and wellness products and services via a secure telemedicine platform. To date, the Company has identified men's wellness telemedicine services and products as a growing sector and especially related to the area of erectile dysfunction (ED), hair growth and hormone replacement therapies. Interested consumers can use MangoRx’s telemedicine platform for a smooth experience. Prescription requests will be reviewed by a physician and, if approved, fulfilled and discreetly shipped through MangoRx’s partner compounding pharmacy and right to the patient’s doorstep. To learn more about MangoRx’s mission and other products, please visit www.MangoRx.com or on social media @Mango.Rx.

Cautionary Note Regarding Forward-Looking Statements

Certain statements made in this press release contain forward-looking information within the meaning of applicable securities laws, including within the meaning of the Private Securities Litigation Reform Act of 1995 (“forward-looking statements”). These forward-looking statements represent the Company’s current expectations or beliefs concerning future events and can generally be identified using statements that include words such as “estimate,” “expects,” “project,” “believe,” “anticipate,” “intend,” “plan,” “foresee,” “forecast,” “likely,” “will,” “target” or similar words or phrases. These forward-looking statements are subject to risks, uncertainties and other factors, many of which are outside of the Company’s control which could cause actual results to differ materially from the results expressed or implied in the forward-looking statements, our ability to meet Nasdaq’s minimum bid price requirement and other continued listing requirements of Nasdaq; the Company’s stockholders’ equity as of the Company’s next fiscal quarter end, which is required to be above $2.5 million pursuant to correspondence from Nasdaq; our ability to maintain the listing of our common stock on Nasdaq; our ability to commercialize our patent portfolio; our ability to obtain Comisión Federal para la Protección contra Riesgos Sanitarios for our ED product in Mexico, the costs thereof and timing associated therewith; our ability to obtain additional funding and generate revenues to support our operations; risks associated with our ED product which have not been, and will not be, approved by the U.S. Food and Drug Administration (“FDA”) and have not had the benefit of the FDA’s clinical trial protocol which seeks to prevent the possibility of serious patient injury and death; risks that the FDA may determine that the compounding of our planned products does not fall within the exemption from the Federal Food, Drug, and Cosmetic Act (“FFDCA Act”) provided by Section 503A; risks associated with related party relationships and agreements; the effect of data security breaches, malicious code and/or hackers; competition and our ability to create a well-known brand name; changes in consumer tastes and preferences; material changes and/or terminations of our relationships with key parties; significant product returns from customers, product liability, recalls and litigation associated with tainted products or products found to cause health issues; our ability to innovate, expand our offerings and compete against competitors which may have greater resources; our significant reliance on related party transactions; the projected size of the potential market for our technologies and products; risks related to the fact that our Chairman and Chief Executive Officer, Jacob D. Cohen has significant voting control over the Company; risks related to the significant number of shares in the public float, our share volume, the effect of sales of a significant number of shares in the marketplace, and the fact that the majority of our shareholders paid less for their shares than the public offering price of our common stock in our recent initial public offering; dilution caused by recent offerings; conversion of outstanding shares of preferred stock and the rights and preferences thereof, the fact that we have a significant number of outstanding warrants to purchase shares of common stock and other convertible securities, the resale of which underlying shares have been registered under the Securities Act of 1933, as amended, dilution caused by exercises/conversions thereof, overhang related thereto, and decreases in the trading price of our common stock caused by sales thereof; our ability to build and maintain our brand; cybersecurity, information systems and fraud risks and problems with our websites; changes in, and our compliance with, rules and regulations affecting our operations, sales, marketing and/or our products; shipping, production or manufacturing delays; regulations we are required to comply with in connection with our operations, manufacturing, labeling and shipping; our dependency on third-parties to prescribe and compound our ED product; our ability to establish or maintain relations and/or relationships with third-parties; potential safety risks associated with our products, including the use of ingredients, combination of such ingredients and the dosages thereof; the effects of changing rates of inflation and interest rates, and economic downturns, including potential recessions, as well as macroeconomic, geopolitical, health and industry trends, pandemics, acts of war (including the ongoing Ukraine/Russian conflict and war in Israel) and other large-scale crises; our ability to protect intellectual property rights; our ability to attract and retain key personnel to manage our business effectively; overhang which may reduce the value of our common stock; volatility in the trading price of our common stock; and general consumer sentiment and economic conditions that may affect levels of discretionary customer purchases of the Company’s products, including potential recessions and global economic slowdowns. Although we believe that our plans, intentions and expectations reflected in or suggested by the forward-looking statements we make in this release are reasonable, we provide no assurance that these plans, intentions or expectations will be achieved. Consequently, you should not consider any such list to be a complete set of all potential risks and uncertainties.

More information on potential factors that could affect the Company’s financial results is included from time to time in the “Cautionary Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 and our Quarterly Report on Form 10-Q for the three months ended March 31, 2024, and subsequent reports. These filings are available at www.sec.gov and at our website at https://www.mangoceuticals.com/sec-filings. All subsequent written and oral forward-looking statements attributable to the Company or any person acting on behalf of the Company are expressly qualified in their entirety by the cautionary statements referenced above. Other unknown or unpredictable factors also could have material adverse effects on the Company’s future results. The forward-looking statements included in this press release are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these statements after the date of this release, except as required by law, and takes no obligation to update or correct information prepared by third parties that are not paid for by the Company. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.

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FOR INVESTOR RELATIONS

Mangoceuticals Investor Relations
Email: investors@mangorx.com

FAQ

What recent approval has MangoRx (MGRX) received for its operating system?

MangoRx (MGRX) has recently received DEA approval for its proprietary HIPAA-compliant operating system via Surescripts, allowing the company to prescribe controlled medications.

How will the DEA approval impact MangoRx's (MGRX) business?

The DEA approval is expected to drive significant growth for MangoRx (MGRX) by enabling the company to expand its offerings to include controlled substances and hyperscale its operations.

What new capabilities does MangoRx's (MGRX) operating system offer?

MangoRx's (MGRX) new operating system allows patients to manage doctor visits, prescription auto-refills, and overall health with enhanced ease and security. It also features real-time data tracking and seamless integration.

When did MangoRx (MGRX) announce its DEA approval for the operating system?

MangoRx (MGRX) announced its DEA approval for the proprietary HIPAA-compliant operating system on July 16, 2024.