INTRODUCTIONPostpartum depression (PPD) is common, persistent, and stigmatized. There are insufficient trained professionals to deliver appropriate screening, diagnosis, and treatment.AREAS COVEREDWB001 is a Software as a Medical Device (SaMD) based Agent-Guided Cognitive-Behavioral Therapy (AGCBT) program for the treatment of PPD, for which Breakthrough Device Designation was recently granted by the US Food and Drug Administration. WB001 combines therapeutic alliance, human-centered design, machine learning techniques, and established principles from CBT and interpersonal therapy (IPT). We introduce AGCBT as a new model of service delivery, whilst describing Woebot, the agent technology that enables guidance through the replication of some elements of human relationships. The profile describes the device's design principles, enabling technology, risk handling, and efficacy data in PPD.EXPERT OPINIONWB001 is a dynamic and personalized tool with which patients may establish a therapeutic bond. Woebot is designed to augment (rather than replace) human healthcare providers, unlocking the therapeutic potency associated with guidance, whilst retaining the scalability and agency that characterizes self-help approaches. WB001 has the potential to improve both the quality and the scalability of care through providing support to patients on waiting lists, in between clinical encounters, and enabling automation of measurement-based-care.

03 Apr 2022·Expert Review of Medical Devices

RETRACTED ARTICLE: Anatomy of a Woebot® (WB001): agent guided CBT for women with postpartum depression

Article

Author: Goodwin, Kim ; Darcy, Alison ; Beaudette, Aaron ; Mariano, Timothy Y. ; Daniels, Jade ; Wicks, Paul ; Robinson, Athena ; Chiauzzi, Emil

INTRODUCTIONPostpartum Depression (PPD) is common, persistent, and stigmatized. There are insufficient trained professionals to deliver appropriate screening, diagnosis, and treatment.AREAS COVEREDWB001 is a Software as a Medical Device (SaMD) based Agent-Guided Cognitive Behavioral Therapy (AGCBT) program for the treatment of PPD, for which Breakthrough Device Designation was recently granted by the US Food and Drug Administration. WB001 combines therapeutic alliance, human-centered design, machine learning techniques, and established principles from CBT and interpersonal therapy (IPT). We introduce AGCBT as a new model of service delivery, whilst describing Woebot, the agent technology that enables guidance through the replication of some elements of human relationships. The profile describes the device's design principles, enabling technology, risk handling, and efficacy data in PPD.EXPERT OPINIONWB001 is a dynamic and personalized tool with which patients may establish a therapeutic bond. Woebot is designed to augment (rather than replace) human healthcare providers, unlocking the therapeutic potency associated with guidance, whilst retaining the scalability and agency that characterizes self-help approaches. WB001 has the potential to improve both the quality and the scalability of care through providing support to patients on waiting lists, in between clinical encounters, and enabling automation of measurement-based care.

News (Medical) associated with WB001

22 Jul 2021

·www.nsmedicaldevices.com

Woebot wins $90m funding for AI-based mental health platform

The funds will be used to boost further development of the firm’s relational platform and technologies Woebot Health has secured $90m funding for AI-based mental health platform. (Credit: VSRao from Pixabay) Woebot Health has secured a $90m funding in Series B round for its artificial intelligence (AI) based mental health platform. Co-led by existing investors JAZZ Venture Partners and Temasek, the financing round saw participation from funds and accounts managed by BlackRock Private Equity Partners and Owl Ventures. The round also included additional participants such as Mirae Asset Capital, Kicker Ventures, Alumni Ventures and Gaingels, as well as existing investors NEA and AI Fund. Woebot Health will use the funds to boost further development of its relational platform and technologies and advance its digital therapeutic candidates. The funds will also help the company to expand its team and go-to-market activities to meet the increasing global demand for mental health care. Woebot Health CEO Michael Evers said: “We’re at a moment when mental health issues are front and center in a global conversation, and there’s incredible momentum to apply cutting-edge approaches to help solve real human problems. “It’s gratifying that some of the world’s leading investment groups see the same potential for relational technologies to deeply engage people in their mental health at scale, and to transform care.” Established in 2017, Woebot Health is engaged in the development of relational tools and technologies for mental health. Woebot, a relational agent, is the core to its AI-powered health platform. Woebot is demonstrated to create a human-level therapeutic bond with users. It is said to translate proven therapeutic approaches into engaging, responsive and scalable software applications. In May this year, the company secured breakthrough device designation from the US Food and Drug Administration (FDA) for its WB001 digital therapeutic to reduce the burden of postpartum depression, During the same month, the company also announced a large-scale study which offered evidence that Woebot creates a therapeutic bond with users.

27 May 2021

·www.nsmedicaldevices.com

Woebot Health gets FDA breakthrough device status for digital therapeutic to treat postpartum depression

Woebot’s digital therapeutic, a prescription-only treatment, is provided over eight weeks through a patient’s smartphone The digital therapeutic features the firm’s advanced relational agent Woebot. (Credit: StockSnap from Pixabay) Woebot Heath has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its digital therapeutic to treat postpartum depression (PPD). WB001 is an investigational digital therapeutic that integrates cognitive-behavioural therapy (CBT) and elements of interpersonal psychotherapy (IPT) with a deep understanding of the lived experience of PPD to minimise symptoms of depression. Woebot’s digital therapeutic, which is a prescription-only treatment, is provided over eight weeks through a patient’s smartphone. Designed to use under the supervision of a clinician, the digital therapeutic features the firm’s advanced relational agent Woebot. In a recent study, the relational agent was demonstrated to have a capability to form a bond with patients to facilitate meaningful engagement and improved outcomes. Woebot is part of the company’s AI-powered platform that offers the foundation for the development of digital therapeutics and tools, the company said. As per the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, PPD is a major depressive episode with symptom onset during pregnancy or within four weeks of delivery. Woebot Health chief clinical officer Dr Athena Robinson said: “The odds are truly stacked against women who are hit with barriers to treatment right after childbirth, especially those of lower socioeconomic status and/or minority populations who are at a higher risk for PPD but face ongoing and concerning care disparities that pervade the mental healthcare system. “WB001 is designed to significantly reduce barriers to PPD care that often thwart help-seeking and treatment engagement behaviors—including lack of time, childcare issues, stigma and fear of loss of parental rights.” WB001 has been designed to enhance patient motivation and treatment efficacy in a noninvasive way, said the company.

100 Deals associated with WB001

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Indication	Highest Phase	Country/Location	Organization	Date
Lung Cancer	Preclinical	CN	Hangzhou Weiben Pharmaceutical Co. Ltd.	29 May 2023
Stomach Cancer	Preclinical	CN	Hangzhou Weiben Pharmaceutical Co. Ltd.	29 May 2023
Pancreatic Cancer	Preclinical	CN	Hangzhou Weiben Pharmaceutical Co. Ltd.	12 Oct 2022

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