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Petros Pharmaceuticals Strengthens Partnership with Market Leading Big Data Provider Implementing Key Enhancements to its AI Platform

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Petros Pharmaceuticals (NASDAQ:PTPI) has enhanced its AI platform with key improvements to support its SaaS-based technology for Rx-to-OTC drug switches. The upgrades include Deep Fake detection, improved facial and ID recognition, and enhanced image auto capture features.

The company's SaaS and Software as a Medical Device (SaMD) solutions aim to facilitate the transition of prescription drugs to over-the-counter status, aligning with President Trump's Executive Order for greater Rx-to-OTC switch efficiency. Petros is developing this technology in accordance with FDA guidance and targeting the self-care market, valued at over $38 billion with an expected 5.6% annual growth rate over the next decade.

Petros Pharmaceuticals (NASDAQ:PTPI) ha potenziato la sua piattaforma di intelligenza artificiale con miglioramenti chiave per supportare la sua tecnologia SaaS dedicata alla conversione di farmaci da prescrizione a da banco. Gli aggiornamenti comprendono rilevamento di Deep Fake, riconoscimento facciale e di documenti d'identità migliorati, e funzionalità avanzate di acquisizione automatica delle immagini.

Le soluzioni SaaS e Software as a Medical Device (SaMD) dell'azienda mirano a facilitare il passaggio dei farmaci da prescrizione a quelli da banco, in linea con l'Executive Order del Presidente Trump per una maggiore efficienza nelle conversioni Rx-to-OTC. Petros sta sviluppando questa tecnologia seguendo le linee guida della FDA e puntando al mercato dell'autocura, valutato oltre 38 miliardi di dollari con un tasso di crescita annuale previsto del 5,6% nel prossimo decennio.

Petros Pharmaceuticals (NASDAQ:PTPI) ha mejorado su plataforma de inteligencia artificial con actualizaciones clave para respaldar su tecnología SaaS para la conversión de medicamentos de receta a venta libre. Las mejoras incluyen detección de Deep Fake, reconocimiento facial y de identificación mejorados, y funciones avanzadas de captura automática de imágenes.

Las soluciones SaaS y Software como Dispositivo Médico (SaMD) de la empresa buscan facilitar la transición de medicamentos con receta a venta libre, alineándose con la Orden Ejecutiva del Presidente Trump para una mayor eficiencia en los cambios Rx-to-OTC. Petros está desarrollando esta tecnología conforme a las directrices de la FDA y apunta al mercado de autocuidado, valorado en más de 38 mil millones de dólares con una tasa de crecimiento anual esperada del 5.6% en la próxima década.

Petros Pharmaceuticals (NASDAQ:PTPI)는 처방약에서 일반의약품으로 전환하는 SaaS 기반 기술을 지원하기 위해 AI 플랫폼을 주요 기능으로 강화했습니다. 업그레이드에는 딥페이크 탐지, 향상된 얼굴 및 신분증 인식, 그리고 고급 이미지 자동 캡처 기능이 포함됩니다.

회사의 SaaS 및 의료기기 소프트웨어(SaMD) 솔루션은 처방약을 일반의약품으로 전환하는 과정을 촉진하는 것을 목표로 하며, 트럼프 대통령의 행정명령에 따라 Rx-to-OTC 전환 효율성을 높이고자 합니다. Petros는 FDA 지침에 따라 이 기술을 개발 중이며, 향후 10년간 연평균 5.6% 성장률이 예상되는 380억 달러 이상의 셀프케어 시장을 목표로 하고 있습니다.

Petros Pharmaceuticals (NASDAQ:PTPI) a amélioré sa plateforme d'IA avec des améliorations clés pour soutenir sa technologie SaaS dédiée à la conversion de médicaments sur ordonnance en médicaments en vente libre. Les mises à jour incluent la détection de Deep Fake, une reconnaissance faciale et d'identité améliorée, ainsi que des fonctionnalités avancées de capture automatique d'images.

Les solutions SaaS et Software as a Medical Device (SaMD) de la société visent à faciliter la transition des médicaments sur ordonnance vers le statut de vente libre, conformément à l'Ordre exécutif du Président Trump visant à accroître l'efficacité des conversions Rx-to-OTC. Petros développe cette technologie en accord avec les directives de la FDA et cible le marché de l'autosoins, évalué à plus de 38 milliards de dollars avec un taux de croissance annuel prévu de 5,6 % au cours de la prochaine décennie.

Petros Pharmaceuticals (NASDAQ:PTPI) hat seine KI-Plattform mit wichtigen Verbesserungen erweitert, um seine SaaS-basierte Technologie für die Umstellung von verschreibungspflichtigen auf rezeptfreie Medikamente zu unterstützen. Die Upgrades umfassen Deep Fake-Erkennung, verbesserte Gesichts- und Ausweiserkennung sowie erweiterte automatische Bilderfassung.

Die SaaS- und Software-as-a-Medical-Device (SaMD)-Lösungen des Unternehmens zielen darauf ab, den Übergang von verschreibungspflichtigen zu rezeptfreien Medikamenten zu erleichtern und entsprechen der Executive Order von Präsident Trump für eine effizientere Rx-to-OTC-Umstellung. Petros entwickelt diese Technologie gemäß den FDA-Richtlinien und richtet sich auf den Selbstpflege-Markt, der mit über 38 Milliarden US-Dollar bewertet wird und in den nächsten zehn Jahren eine jährliche Wachstumsrate von 5,6 % erwartet.

Positive
  • Development of proprietary SaaS and SaMD technology platform for Rx-to-OTC switches
  • Alignment with recent Trump Executive Order supporting Rx-to-OTC switch efficiency
  • Enhanced AI capabilities including Deep Fake detection and improved ID verification
  • Targeting growing self-care market valued at $38 billion with 5.6% CAGR
Negative
  • Platform is still in development phase with no immediate revenue generation
  • Success depends on FDA approval and market adoption
  • Potential competition in the Rx-to-OTC switch technology space

Insights

Petros enhances AI identity verification technology to facilitate prescription-to-OTC drug switches, aligned with regulatory trends but still in development phase.

Petros Pharmaceuticals has implemented several strategic upgrades to its developing AI platform focused on identity verification—including deep fake detection, improved facial recognition, and enhanced ID matching capabilities. These technological advancements directly address a critical regulatory challenge in the Rx-to-OTC switch process: ensuring proper patient screening without physician oversight.

The company's platform represents a technological solution to the FDA's "Additional Condition for Nonprescription Use" (ACNU) pathway, which allows medications to move over-the-counter with appropriate safeguards. By developing sophisticated identity verification and potentially user assessment algorithms, Petros is creating digital infrastructure that could replace the traditional physician gatekeeping role.

Their collaboration with an unnamed "big data provider" suggests they're incorporating large datasets to potentially improve decision-making algorithms and establish patterns for safe medication use. This approach could help pharmaceutical companies overcome regulatory hurdles for switching their products to OTC status.

The $38 billion self-care market (with projected 5.6% CAGR) represents a substantial opportunity, though Petros would capture value through enabling technology rather than direct pharmaceutical sales. However, several key uncertainties remain: the platform is still in development with no announced pharmaceutical partners or FDA approvals, and no specific commercialization timeline is provided.

While aligned with favorable regulatory trends, including a recent Executive Order promoting Rx-to-OTC switches, the ultimate success depends on regulatory acceptance, pharmaceutical company partnerships, and consumer adoption—all significant execution challenges that lie ahead.

Petros advances AI verification technology for Rx-to-OTC switches; strategically positioned but commercialization timeline and partnerships remain undefined.

Petros Pharmaceuticals is strategically positioning itself at the intersection of pharmaceutical regulation and healthcare technology with its enhanced AI platform. The company is developing specialized infrastructure designed to solve a significant industry challenge: facilitating prescription-to-OTC switches while maintaining medication safety standards.

The announced technological enhancements focus heavily on identity verification capabilities—deep fake detection, facial recognition, and ID validation—addressing key regulatory concerns for allowing medications to transition to over-the-counter status without physician oversight. This aligns directly with the FDA's ACNU (Additional Condition for Nonprescription Use) guidance and recent executive orders promoting greater medication access.

From a pharmaceutical industry perspective, Rx-to-OTC switches represent significant commercial opportunities. When prescription medications move OTC, they typically gain wider distribution, eliminate insurance requirements, and can extend product lifecycles. Pharmaceutical companies often seek these switches to maintain revenue streams as patents expire. Petros appears to be developing technology that could potentially accelerate and enable these transitions.

However, this announcement represents technology development rather than commercialization. The press release uses forward-looking language ("expected to improve," "being designed to") indicating these capabilities are still evolving. No specific pharmaceutical partners are mentioned, and no timeline for commercial implementation is provided.

While the $38 billion self-care market with 5.6% CAGR presents a substantial opportunity, Petros faces significant execution challenges including regulatory acceptance, pharmaceutical company adoption, and ultimately consumer usage. This represents continued progress on a potentially valuable strategic direction, but with considerable development and commercialization hurdles ahead.

Company continues to innovate and develop its SaaS-based platform to facilitate Rx-to-OTC switch in line with recent President Trump Executive Order

NEW YORK, NY / ACCESS Newswire / May 6, 2025 / Petros Pharmaceuticals, Inc. (NASDAQ:PTPI) ("Petros" or the "Company"), a company focused on expanding consumer access to medication through over the counter ("OTC") drug development programs, today announces it has implemented multiple enhancements to its developing AI platform, which is expected to improve processing and fraud detection and provide a better overall experience. The AI Platform is expected to be a key component of the Company's recently announced SaaS-based technology, integrating Petros' Software as a Medical Device ("SaMD") proprietary solution, which is being designed to help facilitate expanding access for established prescription drugs by bringing them over the counter.

The enhancements include:

  • Addition of Deep Fake detection and mitigation features

  • Improved facial and ID recognition and matching capabilities

  • Enhanced image auto capture feature powered by machine learning technology

Fady Boctor, Petros' President and Chief Commercial Officer, commented, "As we seek to optimize our technology, strengthening our SaaS and SaMD features such as AI identity validation, we are committed to continuous enhancements that meet Rx-to-OTC switch requirements to keep us competitive in this market. With our experience in demonstrating the utility and value of our AI platform, each advancement builds upon an already strong foundation. Collaborating with our partner, a renowned Big Data provider, to integrate with our SaaS and SaMD template platforms is expected to establish commercially viable solutions and enable consistent and reliable results. Further, our commitment is consistent with a recently announced Executive Order from President Trump that calls for greater Rx-to-OTC switch efficiency to help increase the availability of OTC treatment options and reduce drug prices. We are committed to continuing to innovate our technology to help facilitate this demand, with a particular focus on ID verification via advanced AI capabilities, and big data integrations enabling objective qualifiers for safe and appropriate access to key therapeutics. We look forward to continuing to provide updates on all our technology enhancements."

Petros is leading the way in its development of a proprietary SaaS and SaMD technology platform that, based on multiple research studies1, could help pharmaceutical companies pursue Rx-to-OTC switches. The Company believes that further advancement of this technology could provide significant opportunities for future pharma partnerships among companies seeking to extend access and commercial viability of their products through an OTC switch.

Over the course of the development of its technology solution, the Company has been carefully following the direction from recently approved guidance from the Nonprescription Drug Product with an Additional Condition for Nonprescription Use" ("ACNU") by the United States Food and Drug Administration (the "FDA") for companies seeking Rx-to-OTC switch for pharmaceutical products, as well as incorporating periodic feedback from the FDA to address key FDA concerns.

The emerging self-care market is currently estimated to be valued over $38 billion with an expected compounded annual growth rate of 5.6% over the next 10 years.2

About Petros Pharmaceuticals

Petros Pharmaceuticals, Inc. is committed to the goal of becoming a leading innovator in the emerging $38 billion self-care market by providing expanded access to key prescription pharmaceuticals as OTC treatment options. The Company is currently developing a proprietary SaaS platform designed to assist pharmaceutical companies in meeting FDA standards to assist in the Rx-to-OTC switch.

About the Pathway from Rx to OTC

The process of switching a prescription medication to OTC first involves the design of a Drug Facts Label ("DFL") that is well understood by potential consumers. Then, data must show that consumers can make an appropriate informed decision to use or not to use the product based only upon the information on the DFL and their personal medical history. Then consumers must demonstrate that they can properly use the product based upon the information on the DFL. To accomplish this, the FDA ordinarily requires a consumer tested OTC DFL. Such testing includes conduct of iterative Label Comprehension Studies (LCS) in the general population, Self-Selection Studies (SSS) in a population interested in using the product and in specific populations who may be harmed if they use the product, and usually one Actual Use Trial (AUT) demonstrating safe and appropriate use by consumers in a simulated OTC setting.

The regulations that the FDA is currently in the process of finalizing introduced Additional Conditions for Nonprescription Use ("ACNU") criteria that enable correct self-selection by consumers and may expand OTC access to medications that formerly could only be available by prescription. An ACNU may be an innovative computerized tool, or the additional conditions may use other approaches that support the switch process. Petros is developing a technology platform (SaaS) to assist companies in navigating this pathway.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are based upon Petros Pharmaceuticals, Inc.'s ("Petros," "we," "our," "us" or the "Company") management's assumptions, expectations, projections, intentions, and beliefs about future events. In some cases, predictive, future-tense or forward-looking words such as "intend," "develop," "goal," "plan," "predict", "may," "will," "project," "estimate," "anticipate," "believe," "expect," "continue," "potential," "opportunity," "forecast," "should," "target," "strategy" and similar expressions, whether in the negative or affirmative, that reflect our current views with respect to future events and operational, economic and financial performance are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. Such forward-looking statements are only predictions, and actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of risks and uncertainties, Petros' ability to execute on its business strategy, including its plans to develop and commercialize its proprietary Rx-to-OTC switch technology Petros' ability to comply with obligations as a public reporting company; Petros' ability to maintain compliance with the Nasdaq Stock Market's listing standards; risks related to Petros' ability to continue as a going concern; risks related to Petros' history of incurring significant losses; and risks related to Petros' ability to obtain regulatory approvals for, or market acceptance of, any of its products or product candidates, including its proprietary Rx-to-OTC switch technology. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in the Company's periodic reports and in other filings that the Company has filed, or may file, with the U.S. Securities and Exchange Commission (the "SEC") under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and elsewhere. The Company cautions readers that the forward-looking statements included in this press release represent our beliefs, expectations, estimates and assumptions only as of the date of hereof and are not intended to give any assurance as to future results. New factors emerge from time to time, and it is not possible for us to predict all these factors. Further, the Company cannot assess the effect of each such factor on our business or the extent to which any factor, or combination of factors, may cause actual results to be materially different from those contained in any forward-looking statement. Accordingly, you should not unduly rely on any forward-looking statements.

The Company undertakes no obligation to update or revise any forward-looking statements contained in this press release, whether as a result of new information, future events, a change in our views or expectations or otherwise, except as required by federal securities laws.

Contacts

Investors:
CORE IR
ir@petrospharma.com

Media:
Jules Abraham
CORE IR
917-885-7378
pr@coreir.com

1 8 completed studies (Formative Human Factors Studies '23 & '24, Application Comprehension Studies '24, Two Arm All Comers Self Selection Study '24) - Data on file

2 Rx-to-OTC Switches Market Size, Trends & Forecast 2033 | FMI (futuremarketinsights.com)

SOURCE: Petros Pharmaceuticals, Inc.



View the original press release on ACCESS Newswire

FAQ

What new AI features did Petros Pharmaceuticals (PTPI) add to its platform?

Petros added Deep Fake detection and mitigation, improved facial and ID recognition and matching capabilities, and enhanced image auto capture feature powered by machine learning technology.

How does PTPI's technology align with Trump's Executive Order?

The technology aligns with Trump's Executive Order by facilitating efficient Rx-to-OTC switches, aiming to increase OTC treatment options availability and reduce drug prices.

What is the market size for the self-care industry that PTPI is targeting?

The self-care market is currently valued at over $38 billion and is expected to grow at a 5.6% compound annual growth rate over the next 10 years.

What is the purpose of Petros Pharmaceuticals' SaaS and SaMD platform?

The platform is designed to help pharmaceutical companies facilitate the transition of prescription drugs to over-the-counter status through advanced AI-powered identity validation and verification systems.

Is Petros Pharmaceuticals' AI platform currently generating revenue?

The press release indicates the platform is still in development phase and does not mention current revenue generation from this technology.
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