Welcome to the DTx Podcast, where we explore the latest in digital therapeutics. In our previous episode with Mike Pace, we discussed the challenges facing DTx in 2023. Now, with positive developments in 2024, we’re updating our community on the progress in advancing digital therapies.

Host Eugene Borukhovich engages with experts Dr. Jenna Carl, Andy Molnar, Marty Culjat, and Kirsten Tullia to discuss the latest trends, challenges, and opportunities in the DTx industry.

[00:30] Expanding US channels and mental health access

[05:15] Software-wearable integration and commercial models

[12:45] Coverage expansion impact on Medicare and Medicaid

[18:10] Evolution of DTx and reimbursement challenges

[23:30] Investor impatience and R&D impact

[28:00] Medicare reimbursement and investor interest in DTx

Tune in to the DTx Podcast to gain valuable insights into the evolving world of digital therapeutics and stay updated on the latest trends, legislative impacts, and entrepreneurial advice from industry leaders.

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In this episode of the DTx Podcast, Eugene Borukhovich sits down with Mike Pace, CEO and founder of PalmHealthCo, to delve into the latest developments and insights from the DTx industry from 2023 and to discuss what may be in store for 2024.

Eugene and Mike cover various aspects of the DTx landscape, including the growing importance of FDA authorizations, the shift towards non-prescription solutions, and the maturation of the industry into operations and pricing.

Learn more about the impact of FDA authorizations on scalability in the US healthcare system, the strategic integration of digital therapeutics with virtual care models, market consolidation, and the effects of decreased venture funding on the industry.

1. [04:00] What has the industry learned from Pear Therapeutics' initial growth and scaling and, ultimately, its bankruptcy?

2. [10:45] Mike mentions the importance of FDA authorizations for scalability in the US healthcare system. How does he foresee potential FDA approvals shaping the landscape for digital therapeutics in the near future?

3. [15:20] PalmHealthCo has been involved in integrating DTX with virtual care and pushing for a virtual first go-to-market model. How has this approach impacted their journey and success in the DTx space, and what are the potential implications for the industry as a whole?

4. [20:10] What is the importance of high-quality clinical evidence for achieving permanent listing under regulatory laws? How critical is this evidence generation for the future of digital therapeutics, and what challenges does Mike anticipate in this regard?

5. [25:40] Considering the rise of aggregators in the healthcare industry influencing the market for digital therapeutics, what strategies can DTx companies employ to navigate this evolving landscape?

6. [30:15] With the current state of venture funding and market consolidation in digital health, what advice does Mike have for startups in terms of maintaining a focus on positively impacting patients and families while navigating the industry's challenges?

Tune in to the DTx Podcast to gain valuable insights into the evolving world of digital therapeutics and stay updated on the latest trends, legislative impacts, and entrepreneurial advice from industry leaders.

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• Connect with Mike Pace on LinkedIn

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Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:

> Presenting Partner: Amalgam Rx

> Contributing Partners and Sponsors: LSI | Bayer G4A | Lindus Health

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In this episode of the DTx Podcast, Eugene Borukhovich hosts Philip Heimann, CEO of Vivira, a prominent player in the DTx landscape in Germany.

"The genesis of Vivira was the need for personalized movement therapy - we wanted to provide people with a solution that was made just for them," says Philip. 

This necessity led to the development of an innovative digital therapeutic solution that has made a significant impact in the market.

Eugene and Philip dive into the profound impact of the DiGA law in Germany, passed in 2019, on Vivira's market growth. This legislation enabled general reimbursement and physician involvement in prescribing the app, marking a pivotal turning point for the company and the broader DTx landscape in Germany.

In addition, Philip sheds light on the challenges faced by DTx startups in understanding the market complexities and securing suitable funders. He stresses the importance of selecting investors who can offer long-term support and emphasizes the significance of focusing on long-term goals and building high-value companies.

1. [05:30] What challenges did Vivira face in the early stages, being almost exclusively angel-funded, and how did this contribute to the development of their DTx solution?

2. [10:45] What pivotal role has the DiGA law played in enabling Viveira's growth in the market, and what are the implications of this legislation for other DTx companies in Germany?

3. [15:20] How has Vivira's approach of not starting in the direct-to-consumer market and focusing on the DIGA prescription model influenced its journey and success in the DTx space?

4. [20:10] What is the significance of high-quality clinical evidence, particularly RCT studies, for achieving permanent listing under the DiGA law?

5. [25:40] What are the challenges and potential solutions regarding the activation of digital therapies prescribed by doctors?

6. [30:15] As a serial entrepreneur, what critical advice does Philip have for DTX startups in navigating the complexities of the market and choosing investors?

Join us on the DTx Podcast for valuable insights into the world of digital therapeutics, covering topics from legislative impacts to entrepreneurial advice. Subscribe now to stay updated on the latest episodes and continue exploring the dynamic realm of DTx.

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Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:

> Presenting Partner: Amalgam Rx

> Contributing Partners and Sponsors: LSI | Bayer G4A | Lindus Health

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In this episode, we hear from Josh Sackman, President and Co-founder of AppliedVR. AppliedVR, in their own words, provide virtual reality-based treatments that represent a comprehensive approach to chronic pain that empowers patients with accessible digital tools self-managed in their own home.

In this episode, we cover:

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Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:

> Presenting Partner: Amalgam Rx

> Contributing Partners and Sponsors: Akili | Big Health | Click Therapeutics | Lindus Health | Orion Pharma

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In this replay episode, we hear from Sylvain Piquet, COO and Co-founder of Five Lives, the app that leverages the new science of brain aging, neuroplasticity, and cognitive reserve to help people improve their brain health and prevent cognitive decline and dementia.

In this episode, we cover:

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Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:

> Presenting Partner: Amalgam Rx

> Contributing Partners and Sponsors: Akili | Big Health | Click Therapeutics | Lindus Health | Orion Pharma

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In honor of Gift of Sight month we're replaying this insightful episode with Mark Wuttke, CEO of Dopavision. In their own words, Dopavision is pioneering the development of innovative solutions that target the eye’s innate dopamine pathway to address unmet needs in ophthalmology using digitally delivered light. 

Topics include:

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Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:

> Presenting Partner: Amalgam Rx

> Contributing Partners and Sponsors: LSI | Bayer G4A | Lindus Health

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In this episode, we hear from Vijay Ravindran, founder and CEO of Floreo. Floreo allows therapy to be more engaging and happen anywhere, assisting people in practicing critical social skills at their own pace through immersive experiences, starting with adolescent Autism spectrum disorder.

In this episode, we cover:

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Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:

> Presenting Partner: Amalgam Rx

> Contributing Partners and Sponsors: LSI | Bayer G4A | Lindus Health

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We're seeing a broader consolidation of digital health solutions this year to bring together the amazing talent and the scientifically validated assets to drive scale in the market and improve unit economics. On the heels of last week's announcement of the merger between Fern Health and BehaVR tune into this replay episode to hear Eugene Borukhovich's conversation with Aaron Gani, Founder and CEO of BehaVR. BehaVR translates proven science into immersive and engaging XR therapeutics for mental and behavioral health.

In this episode, we cover:

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Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:

> Presenting Partner: Amalgam Rx

> Contributing Partners and Sponsors: Akili | Bayer G4A | Lindus Health

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In this episode, we hear from, Rich Brancaccio, Chief Innovation Officer of Revibe Technologies, and Lindsay Ayearst, Chief Scientific Officer of Revibe Technologies.

In their own words, Revibe is a digital therapeutics company fusing behavioral science with technology and currently developing a new digital therapy for ADHD.

In this episode, we cover:

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Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:

> Presenting Partner: Amalgam Rx

> Contributing Partners and Sponsors: LSI | Bayer G4A | Lindus Health

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There are two kinds of people in the world, says Brent Vaughan — those who prefer to make incremental changes with a lower likelihood of failure, and those who aspire to fix (seemingly) intractable problems that have stymied others. Brent falls in the latter category. A serial entrepreneur, former venture capitalist, and current CEO of Cognito Therapeutics (a DTx company that specializes in neurodegenerative diseases), Brent is also uniquely positioned to evaluate the future of next generation digital therapeutics.

Brent and Eugene talk about the differences between prescription and business-to-consumer DTx, the importance of engaging patients and users early on in the development of novel products, and the exciting potential of translational DTx solutions. Eugene’s podcast partner, Brian Dolan, also pops in with a question.

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Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to:

> Presenting Partner: Amalgam Rx

> Contributing Partners and Sponsors: LSI | Bayer G4A | Lindus Health

Follow Digital Health Today:

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