In this interview, we speak with Jeff Bennett, CEO of Morari Medical, about the challenges and strategies in developing a wearable patch for enhancing or improving sexual performance. The discussion covers regulatory hurdles, data privacy, clinical evidence, and the broader implications of sexual health and wellness.
Moe Alsumidaie: What regulatory challenges has Morari faced with the patch?
Jeff Bennett: Our product targets premature ejaculation, defined clinically as ejaculation within two minutes of penetration. A challenge is obtaining FDA indication for this specific condition. To make this claim in our marketing, we need to conduct a clinical study, which we plan to do post-market. Initially, we aim for a broader claim of enhancing or improving sexual performance, allowing us to market without directly treating a disease. This approach helps us enter the market sooner while collecting post-market data to support an indication expansion for premature ejaculation. When we first formed the company, we conducted a pilot proof of concept with five individuals using commercially available transcutaneous electrical nerve stimulation (TENS) units, which yielded favorable results.
We then moved to a feasibility study with ten couples, all of whom reported increased ejaculation time. However, recruitment was challenging at that time due to social media restrictions on sexual content, limiting our advertising options on platforms like Facebook, Twitter, and Reddit. Additionally, involving both partners in the study required consent and buy-in, which can be sensitive given the nature of the condition.
Moe Alsumidaie: How do you ensure data privacy and security in your app?
Jeff Bennett: We adhere to FDA cybersecurity guidelines, which constantly evolve. As part of our product testing submitted to the FDA, we conducted cybersecurity assessments to ensure compliance. We’ve had to update our assessments as guidelines changed. Importantly, we do not save any personally identifiable information. Instead, we collect session data such as date, time, duration of intercourse, and satisfaction levels. This approach ensures user privacy while allowing us to gather necessary data for product improvement and regulatory purposes. By focusing on non-identifiable data, we maintain a high level of privacy for our users, which is crucial given the sensitive nature of the information involved. This strategy aligns with regulatory requirements and builds trust with our customers, who can be assured that their personal information is protected.
Moe Alsumidaie: What evidence supports neurostimulation’s effectiveness?
Jeff Bennett: We’re not alone in this market; Virility Medicalhas published data showing the effectiveness of neurostimulation. We’re using their product as a predicate device for our FDA submission. Their work has shown significant results in delaying ejaculation through neurostimulation. From Morari’s standpoint, there’s no reason to believe our technology can’t achieve similar or even better results. We plan to conduct a formal clinical study post-market to gather effectiveness data. Neurostimulation has been safely used in various medical applications, such as pain management and Parkinson’s treatment, which gives us confidence in its potential effectiveness for our product. This background provides a solid foundation for our approach, allowing us to focus on ensuring safety and gathering post-market data to support our claims. By leveraging existing research and technology, we can expedite our product’s development and market entry while maintaining high efficacy and safety standards.
Moe Alsumidaie: How will you assess adherence?
Jeff Bennett: User adherence is challenging since the patch is intended for single use. We emphasize this in our documentation, but some users might reuse it. While we haven’t developed technology to prevent reuse, we ensure our instructions are clear. The patch’s workflow is similar to a condom—use once and dispose of it. This analogy helps users understand the intended use and the importance of following guidelines to ensure safety and effectiveness. By clearly communicating the single-use nature of the patch, we aim to minimize misuse and ensure optimal performance. Additionally, we are exploring future technologies that could further enforce single-use adherence, but for now, our focus is on education and clear instructions. This approach helps us manage user expectations and maintain product integrity, which is crucial for safety and effectiveness.
Moe Alsumidaie: What usability findings have emerged about the patch?
Jeff Bennett: Comfort and fit are crucial. The patch is placed on the perineum, requiring some hair removal for proper contact. We collaborated with companies to find an adhesive that holds well but is gentle to remove using a product from 3M. Feedback from our feasibility study was positive, with participants rating comfort and fit on a scale of one to five. While not perfect, comfort wasn’t a significant concern, indicating that our design considerations were effective. Ensuring the patch doesn’t cause discomfort during removal was a key focus, given the area’s sensitivity. By prioritizing user comfort and ease of use, we aim to enhance the overall experience and encourage adherence to the product. This focus on usability is essential for gaining user trust and ensuring the product’s success in the market.
Moe Alsumidaie: What strategies do you have for scaling trials and recruitment?
Jeff Bennett: Post-market, we plan to collect data from existing customers to support our indication for premature ejaculation. This approach leverages users already interested in enhancing their sexual performance. We believe this strategy will simplify recruitment, as these customers have an inherent desire for the product. We might conduct solo masturbation studies if partner involvement proves challenging, but ideally, we’d include partners in our studies. This flexibility allows us to adapt our approach based on recruitment success and regulatory discussions with the FDA. We can efficiently gather data by focusing on existing customers while minimizing recruitment challenges. This strategy streamlines the process and ensures that we collect relevant and meaningful data to support our claims and improve our product.
Moe Alsumidaie: Anything to add about the sexual health and wellness industry?
Jeff Bennett: Sexual health and wellness is a rapidly growing field with limited regulatory oversight. Many products lack FDA clearance, which is concerning given potential safety issues. We’re committed to ensuring our product’s safety and efficacy through proper testing and regulatory compliance. Sexual health significantly impacts overall well-being, and more clinical studies are needed to support this connection. For example, the female vibrator market is a multi-billion industry with few FDA-cleared products, highlighting the need for regulatory guidance. Our approach includes thorough safety testing, such as biocompatibility assessments, to ensure our product meets high standards. By prioritizing safety and regulatory compliance, we aim to set a new standard in the industry and provide consumers with reliable and effective products. This commitment to quality and safety is essential for building trust and advancing the field of sexual health and wellness.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
