Cognitive Behavioral Therapy (CBT) is a versatile and evidence-based psychotherapy effective across various mental health disorders and chronic conditions. Its structured, goal-oriented approach, along with its focus on core mechanisms and skill-building, makes it adaptable and effective in diverse clinical presentations, particularly given the high mental health comorbidity within chronic conditions.
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Alex Therapeutics and Vicore Pharma today announced FDA Breakthrough Device Designation status for Almee™, a 9-week digital cognitive behavioral therapy (CBT), for the treatment of anxiety symptoms related to PF.
The Access to Prescription Digital Therapeutics Act is a U.S. Bill that aims to amend the Social Security Act and provide Medicare and Medicaid coverage and reimbursement for prescription digital therapeutics (PDTs). If the bill is passed it will help provide improved access to PDTs for patients across the U.S.
There are several approaches to product development, one of which involves the intimate involvement of the end-user in the software design and the development process.
With AI's use becoming so widespread, there are likely going to be an increasing number of ways in which it is used in patient-facing healthcare apps. This article outlines some of the current use cases, and what we expect to see more of in the future.
Next-generation digital patient companion apps offer evolving benefits, reshaping opportunities for the pharmaceutical industry to generate value. Key drivers justify the strategic investment in these apps to support the core business, which is the focus of this article.
Hans-Peter Frank joins Alex Therapeutics as the new Chair of the Board, and brings a wealth of experience from the Pharma, Medtech and BioTech industries.
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A successful partnership that has resulted in the co-creation and clinical validation of Almee, a digital treatment for anxiety in patients with pulmonary fibrosis.
Alex Therapeutics and Vicore Pharma today announced positive results of the COMPANION study, investigating the efficacy of Almee, a 9-week digital CBT intervention accessed through a smartphone or tablet. The study met its primary endpoint, change from baseline in GAD-7 anxiety scores, with a statistically significant 2.7-point improvement compared to control.
Drug-induced nausea and vomiting is a common and debilitating side-effect of certain prescription medications which can have a significant impact on quality of life. In this article we review psychological interventions that can provide patients with effective coping strategies and support to manage these symptoms.
Medication non-adherence is a complex and costly problem. In this article we do a deep, scientific dive into why medication non-adherence is a problem, the factors that influence medication non-adherence, and review the clinical studies examining whether mobile apps can improve medication adherence.
Software as a Medical Device (SaMD) plays a crucial role in diagnostics, treatment, and overall healthcare management. In this guide to SaMD, we’ll explain everything you need to know about SaMD, including its definition, examples of SaMD, the regulatory landscape, development challenges, benefits, and future trends.
This article summarises the recent changes in US Current Procedural Terminology (CPT) codes related to digital CBT and discusses how the US healthcare system is evolving when it comes to incorporating digital health solutions into clinical practice. This comes off the back of evidence from the AMA that physician’s attitudes towards digital health are shifting, with an increased appetite for digital tools.
In this article we break down what the ISO 27001 certification is and why it's important for digital health technology companies to have it.
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The new FDA guidance document Regulatory Considerations for Prescription Drug Use-Related Software describes how the FDA intends to apply its drug labeling authorities to software outputs that are disseminated by or on behalf of a drug sponsor for use with a prescription drug. In this article we give a high level summary of the key points from the guidance.
Drawing from his background of successfully introducing and growing virtual care software and services, alongside managing decentralized trials, Paul enriches the capabilities of the Alex team and its partners.
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Alex Therapeutics’ extends fundraising round to €4.75 million with major investment from Innovestor Life Science. Investing €1.25million, Innovestor joins impressive list top-tier life science and technology venture capital firms, including Hadean Ventures, Scale Capital, Sweet Capital (King founders), and Bonit Capital.
The pivotal study, investigating Alex Therapeutics’ and Vicore’s standalone digital therapy (DTx) treating anxiety in patients with pulmonary fibrosis (PF), has launched in the US. The randomized clinical investigation will evaluate the impact of dCBT-PF Almee™ in adult subjects with PF for 250 patients in a 9-week program.
Alex Therapeutics, together with Pfizer, has reached the first major milestone in a clinical study of a digital therapeutic for the CBT-based treatment of tobacco dependence in Germany.
Alex Therapeutics presents positive results from the pilot phase of a clinical study for one of their digital therapies treating anxiety in patients with the rare disease IPF. The primary objective of the study was to test the functionality, user experience, and safety of the DTx, which were all found to be positive. Additionally, using GAD-7, anxiety symptoms were shown to have been reduced by an average of 4.2 points, a 49% reduction.
Clinical study investigating Alex Therapeutics’ and Vicore’s standalone digital therapy (DTx) treating anxiety in patients with pulmonary fibrosis (PF) has launched in the US. The clinical study consists of two phases; the current pilot study designed to refine the interactive nature of the therapy session, followed by a pivotal study.
Alex Therapeutics raises €3.5M in oversubscribed financing round from top tier VC investors to advance expansion in Europe and the US. This funding round will be used to accelerate Alex's growth in Europe and the US and to develop novel DTx products alongside both new and existing partners, including Pfizer.
The Stockholm-based Digital Therapeutics (DTx) company Alex Therapeutics and world-leading pharmaceutical company Pfizer have joined forces to provide evidence-based, clinically validated, and personalized digital therapies to patients. Together, the companies cover a broad range of expertise in the fields of medicine, marketing, clinical validation, AI, software development, and psychology. The partnership will initially focus on Germany, one of the world's largest unified healthcare markets.
Alex Therapeutics has received approval and funding from Vinnova to develop, optimise and clinically validate an AI-based tobacco cessation treatment tailored to India.
Alex Therapeutics and the world leading pharmaceutical company Pfizer partner to combat the tobacco epidemic and help achieve a smoking-free society. Today, the 31st of May, is the World No Tobacco Day. Alex Therapeutics and Pfizer are seeking to draw attention to the continued global tobacco problem and as well as their collaboration to combat it.
Vicore Pharma, a rare disease pharmaceutical company developing innovative medicines for fibrotic lung disorders such as idiopathic pulmonary fibrosis (IPF), today announces the signing of an agreement with Alex Therapeutics for the development of a clinically validated digital therapeutic (DTx) built on the “Alex DTx Platform”.
