1. Why hasn't MrMedTech already launched sales of the test as a "testosterone level tracker" wellness product prior to FDA approval?

 

While we are within our legal right to do so, we have intentionally delayed launching as a "testosterone level tracker", prior to securing adequate funding, to ensure robust intellectual property protection for our proprietary formulation and app technology. Without sufficient capital, we wouldn't be positioned to effectively safeguard our IP or prevent potential reverse engineering of our company's core science and software. Protecting our unique science and technology is paramount, given the significant revenue potential and strategic advantage our test provides. While we anticipate successful FDA approval, this groundbreaking capability makes us the first in existence to offer instant, at-home testosterone monitoring—FDA cleared or otherwise.

 

2.  Does MrMedTech have contingency plans if initial FDA clearance timelines extend or costs increase?

 

​Yes—our team has proactively built conservative budgets and timelines to account for potential FDA delays, additional study requirements, and regulatory complexity. In the meantime, we are legally permitted to market our product in the U.S. as a “Testosterone Level Tracker,” even prior to FDA clearance.

 

However, under this classification, we are not allowed to position the product as a diagnostic device, use the term “testosterone test,” or prescribe testosterone based on the results. Despite these limitations, the wellness market for men is growing rapidly, and our product’s affordability, simplicity, and innovative design position us for strong early adoption.

 

We have significant opportunities to drive revenue through strategic partnerships with supplement brands, nutrition companies, and health and fitness influencers—many of whom already have large, loyal audiences. By leveraging affiliate marketing programs and influencer-driven campaigns, we can generate rapid brand awareness, viral engagement, and substantial sales—all at very minimal customer acquisition cost.

 

This pre-clearance strategy allows us to build meaningful revenue, brand equity, and a database of loyal customers while we continue pursuing full FDA approval.​​

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3. In what ways will obtaining FDA clearance influence MrMedTech's revenue potential and overall company valuation?

 

​1. FDA clearance significantly enhances the marketability and licensing value of our technology, positioning us to create robust, high-margin B2B revenue streams. However, any licensing agreements with major men's health platforms offering testosterone prescriptions will only proceed upon collective investor approval to ensure optimal strategic alignment.

 

​2. Before securing FDA approval, we possess the immediate flexibility to generate substantial revenue through two primary strategies:

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• White-Label Partnerships: We can offer white-label versions of our non-FDA-cleared testosterone level trackers, enabling large-scale supplement companies, health companies, celebrities, and social media influencers - that already have databases with millions of existing customers—to seamlessly integrate and sell our technology under their own established brands.

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• Affiliate Marketing Programs: In addition or alternatively, we can rapidly generate revenue, build our customer database, and expand our brand presence by partnering with the same previously mentioned large-scale companies and influential celebrities—both domestically and internationally—by offering them a small commission from each sale through an affiliate marketing program. This strategy enables us to achieve rapid market penetration, brand visibility, and highly cost-efficient customer acquisition.

 

3. ​Upon FDA approval, we will carefully evaluate the strategic advantage of retaining exclusive rights to our fully cleared testosterone testing technology, potentially enabling us to dominate the multi-billion-dollar men's health diagnostics market and capitalize on our unique first-mover advantage.

 

• Crucially—and as a key component of our comprehensive strategic approach—customers must download our app to access their testosterone level results. Our user agreements will transparently disclose our intention to securely retain customer data and contact information (whether the users are acquired through white-label partnerships, affiliate programs, or direct sales channels). Explicit consent is clearly obtained within the app to ensure compliance and transparency. This carefully structured approach allows us to efficiently build a valuable proprietary customer database, significantly enhancing future market opportunities and customer relationships.

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• This carefully planned customer-acquisition strategy ensures that immediately upon achieving FDA clearance, MrMedTech can directly engage millions of customers, rapidly converting this extensive database into substantial revenue, brand dominance, and accelerated growth in the men's health and wellness marketplace.​​​

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​4. What FDA approval pathway is MrMedTech pursuing for the testosterone test?

 

We plan to pursue the FDA 510(k) pathway, leveraging existing analytical predicate devices and supplementing these with targeted usability studies and clinical validation specifically tailored to home-use scenarios. If no direct home-use predicate exists, we are fully prepared to engage with the FDA proactively through pre-submission consultations and provide additional data to establish the safety, accuracy, and efficacy of our innovative home-based diagnostic approach.

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5 What are the main regulatory risks or challenges and how are you mitigating those challenges?

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1. Avoiding timeline extensions and increase costs:​

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• Regulatory Advisor: Adding a specialized FDA regulatory expert to our team—or partnering closely with an experienced regulatory consultant is crucial to efficiently identify a suitable predicate device, which reduces the scope of required testing, potentially eliminates the need for large-scale clinical trials (typically 200-500 participants), and dramatically streamlines the FDA clearance process and avoids cost increases.

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• Clinical Trials: Designing robust clinical and analytical studies.

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• Early FDA Meetings: Conducting early pre-submission (Q-Sub) meetings with FDA to align expectations and proactively resolve potential concerns.

 

​2. Clearly aligning our test results with existing blood-based FDA standards and predicates by ensuring robust analytical accuracy and precision, particularly considering variations in customer environments, including differing lighting conditions, device types, camera settings, testing windows, distances, and angles. It's critical to standardize testing protocols and provide clear instructions and automatic calibration features within our app to mitigate these risks effectively and ensure consistently reliable results. 

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• Device and Environment Optimization: To ensure consistent accuracy across diverse smartphone models and testing environments, our app will automatically detect the user's phone type and surrounding conditions. It will dynamically optimize camera settings—such as aperture, shutter speed, ISO, and white balance—specifically tailored to each device's make and model. This ensures reliable, precise, and standardized test results under all usage conditions.​

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• Standardized Testing Setup: To achieve consistent positioning and precise results, our test kit packaging will be designed either to fold into a standardized stand or to include a compact fold-out plastic stand. This stand securely holds the test cassette beneath it and places the user's smartphone at an exact, fixed distance and angle, ensuring consistent and accurate measurements for every test.​

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• Automated Precision Timing: Our app will soon include an integrated, automated 15-minute timer activated by the user, immediately after the user applies three blood drops onto the test cassette, positions it under the stand, and securely places the smartphone on top. At exactly 15 minutes, the app automatically captures images of the cassette, ensuring precise timing and maximum accuracy for every test result.

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• AI-Enhanced Accuracy and Early-Adopter Strategy: While our proprietary technology already meets the FDA's accuracy requirements, our app further enhances precision through advanced artificial intelligence and continuous learning. By comparing our test results directly with traditional lab results provided by users, the software consistently improves its accuracy. To accelerate data collection and maximize efficacy prior to FDA approval, we can launch our product as the previously mentioned "Testosterone Level Tracker," offering significant discounts, rebates, or incentives for early adopters who share their lab results. Users who provide lab-drawn blood results and perform our test within strict, clearly defined parameters will particularly enhance our dataset quality. This collaborative approach not only rapidly improves our test's accuracy but also positions these early adopters as credible advocates who can genuinely attest to our product’s quality, accuracy improvements, and collaborative approach—thus driving word-of-mouth promotion and customer trust upon securing FDA clearance.​

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6. What are the expected regulatory costs for MrMedTech’s FDA clearance?

 

We estimate total FDA clearance costs at $1M–$2.5M, accounting for clinical validation studies, regulatory consultants, FDA application fees, analytical testing, and contingency for additional studies or FDA queries.

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7. How long will FDA clearance realistically take for MrMedTech’s testosterone test?

 

Given the novel technology, we realistically anticipate the FDA clearance process to take approximately 24–36 months. This includes clinical validation, FDA review, responding to questions, and final labeling approvals.

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8. Has the FDA previously cleared any at-home testosterone test that provides immediate diagnosis and prescription without needing lab processing?

 

No, our test will be the first FDA-cleared solution that enables instant testosterone diagnosis and same-day prescription entirely at home.

 

9.  What clinical studies are required for FDA clearance?

 

FDA typically requires accuracy studies, precision testing, analytical validation, interference studies, and usability/human factors testing for diagnostic devices.

 

10. . Have you completed clinical validation yet?

 

We've completed feasibility and preliminary accuracy testing, and we are currently preparing comprehensive clinical validation studies.

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11. What potential regulatory issues might you encounter during the FDA review?

 

Common issues include additional requests for clinical data, analytical validation clarity, user-interface adjustments, and device labeling clarifications.

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12. . Are there plans to seek CLIA waiver status?

 

Yes, securing CLIA waiver status is a strategic priority, enabling broader use in pharmacies, clinics, and homes, significantly increasing market potential.

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13. How long does it take to obtain a CLIA waiver after FDA clearance?

 

Typically, obtaining CLIA waiver takes an additional 3–6 months post-FDA clearance.

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14. Can the testosterone test be commercialized for diagnosing and prescribing testosteroneest outside the U.S. before FDA clearance?

 

Yes, certain international markets have different regulatory standards, allowing earlier commercialization. We are exploring CE marking for Europe and other international regulatory pathways to generate early revenue.

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15. How will FDA approval impact your exit strategy?

 

​Approval will position us for acquisition by telehealth giants (e.g., Teladoc) or an IPO, leveraging a $1B+ market and targeting a 50-150x return for investors.

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16. What if funding falls short for regulatory costs?

 

​We are currently raising a Seed round intended to fully cover FDA regulatory approval costs, manufacturing, distribution, marketing, and all essential activities required to efficiently launch operations, generate revenue, and rapidly build a strong customer base—while adhering strictly to high standards without compromising quality or compliance. However, if costs exceed projections or if revenue generated from pre-FDA "Testosterone Level Tracker" sales (should investors approve an early market entry) falls short of our funding needs, we will strategically initiate a Series A funding round. This subsequent round would be carefully structured to secure additional capital while minimizing dilution, ensuring optimal terms and preserving value for our existing investors and stakeholders.

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17. Once cleared, how will MrMedTech stay compliant with ongoing FDA requirements?

 

​1. FDA Regulatory Guidance and Reporting: Our Medical Director and Regulatory Advisor will ensure our team remains continuously informed about critical FDA guidelines, compliance requirements, and reporting obligations.

 

​2. Rigorous Compliance and Quality Assurance: We will proactively implement ongoing compliance monitoring, comprehensive quality assurance procedures, and robust quality management systems to consistently uphold regulatory standards and product excellence.

 

​3. Continuous App Improvement and Trust Building: We will regularly integrate strategic app updates and improvements, proactively enhancing user experience, fostering customer satisfaction, and building strong regulatory confidence.

 

18. How will we manage ongoing investor communication about regulatory progress?

 

Investors will receive transparent quarterly updates on regulatory milestones, including clinical trial progression, FDA communications, and critical validation results, ensuring informed decision-making throughout the regulatory journey, test and technology updates, as well as the men's health platform build process.​