Pediatric cancer is a global problem that children and their families struggle with. Almost 500,00 children will be diagnosed with cancer this year and nearly all of the will experience pain during their first year. Pain management in children remains an enormous unmet medical need that is not currently served by current practices. Because of the relative homogeneity of pain in cancer (procedural pain and pain from cancer itself), Nen Evidence-Based Solution S.L.U. (nen), a clinical-stage company is developing evidence-based digital therapeutics to help kids fighting cancer, their families and their doctors manage pain.
Pain management is addressed through play, by leveraging gamification of cognitive behavioral therapy to modulate pain and improve a child’s overall well-being and outcomes. Through validated outcome measures, both families and physicians can provide insightful and tailored pain management support to children who currently lack alternative means to express their needs.
With the support of Francesca Domenech Wuttke (Founder & CEO) and Xènia Riasol Cercos (COO), nen is a mission-driven profit-for-purpose company to democratize pain management at scale to all kids who are in pain, wherever they are.
Let’s dive in to learn about Nen’s operations in meeting its objective.
What inspired you to establish Nen Health?
When I started thinking about my next steps, I wanted to do something with a more direct patient impact. I put my consulting hat back on and did a scan of the whole of the digital health market to identify gaps. I wanted to know what those gaps are and if can they be filled with a digital solution or service but more specifically with a digital therapeutic.
I feel strongly that DTx is the fourth wave of medicine: small molecules, biologics, cell and gene therapy, and now digital therapeutics. I was surprised by the dearth of activity in the pediatric digital health space and had worked on a DTx for pain in adults and saw how readily the CBT modules could be translated to a digital platform and thought why not apply that to kids that were the genesis of nen.
What are the core values of the company? How are you driving the company to achieve its mission and vision statement?
nen is focused on developing kid-centric care designed for their minds- because kids matter and we are committed to kids.
How big is the addressable market?
Pain management in children remains an enormous unmet medical need that is not currently served by current practices. To date, no current solutions exist to moderate pain designed specifically for kids. The current modalities including pain assessment and then treatment scales are incredibly subjective and not appropriately modified for use in children, particularly in small children.
nen offers a novel mission-driven approach to address pain management through play leveraging gamification approaches and cognitive behavioral therapy (CBT) to modulate pain and improve their overall well-being and outcomes. We are creating an app-based platform for smartphones/tablets. The CBT modules will be age appropriate and designed for children to be engaging and enjoyable for them.
Who are your target customers?
nen’s first indication is for school-aged children from 7-12 years old, as they have more developed neurodevelopmental skills where CBT is considered a clinically validated and well-established therapy. After we have established a solid and tested the regular nen solution (with proven efficacy and learnings) nen will continue to develop the platform to serve patients from 2-6 as this age group remains a huge unmet need as very few digital solutions for pain management are addressed specifically to them and yet they too suffer from pain (both physically and psychologically). We will then expand to adolescents.
As an experienced leader, what advice would you like to give to aspiring entrepreneurs and enthusiasts who wish to venture into the competitive industry that you are serving?
Patience and resilience. There will be a lot of no’s along your path but if you stay true to your mission and vision you can achieve great things.
What are the future goals of the company? How does it envision scaling up its operations and reach in 2023 and beyond?
We have designed our business model with flex so that we are not reliant on the ever-changing regulatory landscape.
B2C: The first iteration is a pediatric oncology patient support tool, designed for GDPR/HIPAA and ISO compliance at inception and with parallel development in US and Europe in English (UK and American) Spanish, French, Italian, German, and Dutch. This tool will initially be targeted to parents so we can beta-test the outcomes. We expect to launch this product in late 2023 and then after it is clinically validated, we will offer a premium product (identical to the PDT) with robust medical claims at a higher price point.
B2B: Next, we will continue to forge research collaborations with academic institutions to generate clinical evidence while gaining champions.
Rx: Standalone Prescription Digital Therapeutic (PDT.) Once registered as SaMD, or under DiGA or similar laws, we will seek reimbursement as a standalone PDT across various payor systems, models and geographies.
About the Founder
Francesca Wuttke is the CEO and Founder of nen-bringing evidence-based Digital Therapeutics (DTx)pain solutions to kids with cancer. Dr. Wuttke brings broad drug development and healthcare expertise in both the US and Europe, with nearly 30 years of clinical, commercial, strategic and transactional experience. She has worked with diverse organizations including start-ups, consulting, large and specialty pharma as well as academia. Formerly the Chief Digital Officer of Almirall where she created the Almirall Digital Garden to accelerate and incubate digital health startups. Previously she led European investments as Managing Director for the MSD Global Health Innovation Fund, LLC. Prior to that, Dr. Wuttke led Almirall ́s Corporate Development Strategy team to transact on both med device and pharma M&A opportunities with a new and targeted focus for the company. Dr. Wuttke worked at Novartis where she was responsible for two Cell and Gene therapy opportunities that were successfully brought into the organization as well as managing the strategy and commercialization for the existing portfolio of cell therapy assets. Dr. Wuttke holds a Ph.D. in Pharmacology from Weill Cornell Graduate School of Medical Sciences and a BA from Cornell University College of Arts and Sciences.
About the COO
Xènia Riasol is the Chief Operating Officer of nen. She is experienced in launching digital therapeutics across Europe and in creating and deploying customer-centric digital solutions globally. Xenia is a digital innovation and strategy expert with a focus on commercialization models and global solution deployment. She has extensive experience in Pharma, where she was bringing digital innovative solutions to patients and managing strategic digital marketing campaigns globally. As Chief Operating Officer, Xenia is responsible for leading the product planning and evolution, marketing strategies and for the everyday running of the business, turning industry knowledge into actionable business channels and revenue streams for the company. She works with investors, partners, advisors and patients to manage the strategy and path forward for nen.