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A Platform for Early Detection of the Adverse Effects from Toxic Stress

We provide a tool for rapid, objective, clinically relevant identification of children suffering the adverse effects of toxic stress.

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Updates: How has your idea changed or evolved throughout the Prize? What updates have you made to this submission? (1500 characters)

I am making revisions to the application to focus the story of what we are doing in the context of what is happening in the rest of the ecosystem. I decided to make these changes as a result of mentor feedback.

Name or Organization

Recalibrate Solutions, PBC Cofounder: Bryon Bhagwandin, Ph.D. has 20 years’ experience in medical device development and diagnostics design. Bryon possesses a unique combination of leadership, technical expertise, and business acumen. Cofounder: Sarah Watamura, Ph.D. is an internationally recognized researcher and scholar in potential lifelong consequences of early life stress for health, achievement, and well-being.

Geography

Denver, Colorado, United States of America.

What is your stage of development?

  • New Innovator, with less than one year of experience in ECD

Type

  • For-profit

What is the stage of your proposal?

  • Prototyping: I have done some small tests or experiments with prospective users to continue developing my idea.

Describe how your solution could be a game-changer for your selected Opportunity Area (600 characters)

Chronic or severe exposure to childhood adversity can compromise brain development, achievement, the immune system, & mental health. Currently, there is no objective tool to evaluate if a child’s exposure to trauma or stress is producing adverse consequences. Recalibrate Solutions is developing a non-invasive, diagnostic system to screen for adverse consequences from high levels of childhood stress. Early detection of dysfunctional stress response can lead to earlier implementation of supportive, family-based interventions which changes the life-trajectory of a child’s health and wellbeing.

Select an Innovation Target

  • Product: A new or enhanced physical product that creates value for end beneficiaries.

Tell us more about your innovation (1500 characters)

The first step in the path toward interrupting adverse effects of early childhood trauma is detection. The ability to detect who is being adversely affected, the ability to detect when intervention is best initiated, the ability to detect how well an intervention is working are critical to changing the status quo. Researchers are continually evaluating the efficacy of intervention methods. In a standard research project, saliva samples are collected from participants (children and care-providers), returned to the research team by mail or in person, pre-processed within 12-48 hours of collection, frozen, then analyzed in batches by an outside clinical-lab. This process limits evaluation of test results until a study is complete; in some cases, this can mean years later. Unfortunately, if a child was being treated with an ineffective intervention, they may be left with the long-term adverse consequences. Imagine if a researcher could meet with study participant, collect saliva samples, transfer samples to a small, disposable cartridge, place the cartridge into a portable analyzer and have results in less than 5-minutes. Then, if a treatment plan is seen to be ineffective, modifications could be made in real time. The system Recalibrate Solutions is developing will provide a researcher clinically equivalent data from saliva-based biomarkers in a more time-relevant fashion. In the future, physicians and health care providers can use the same system in their practice.

What problem are you aiming to solve? (3 sentences)

Problem: there is no tool available that allows quantitative monitoring of the stress response system for children who are at risk of suffering the adverse consequences of chronic or severe stress. Problem: there is no tool to objectively detect the onset of adverse effects from childhood trauma or stress. Problem: there is no tool available to objectively evaluate the efficacy of an intervention plan aimed at countering the adverse effects from childhood trauma and stress

Explain your idea (5000 characters)

What happens in early childhood can matter for a lifetime. Children are especially vulnerable to the harmful effects of chronic, severe, and unmitigated stress exposure; also known as toxic stress. For many children who are repeatedly exposed to stress, their “fight or flight” system is activated so often it stays on, or more concerning, it becomes dysfunctional. These high levels of emergency hormones can lead to changes in the structure and function of children’s developing brains and bodies. Children who experience toxic stress are at higher risk for long-term social problems, like asthma, diabetes, and obesity, as well as learning difficulties. Toxic stress may also make it difficult to sit still in school or to control emotions in challenging situations. If left untreated, toxic stress can lead to increased risk of adult diseases including heart disease, and cancer, and ultimately in untimely death. Currently, there is no objective quantitative measurement for the adverse effects of toxic stress. In this early stage IDEO Prize application Sarah Watamura, Ph.D. from the University of Denver and Bryon Bhagwandin, Ph.D. from Recalibrate Solutions, PBC, propose to leverage existing assay technologies toward development of a rapid, low-cost, portable, test for toxic stress screening. This test will maintain high correlation to current clinical standards for detection of abnormal salivary cortisol levels in children. Salivary cortisol levels are known to reflect the state of the human stress response system. Dr. Watamura contributes data and knowledge used to establish diagnostic thresholds and Dr. Bhagwandin contributes expertise in medical diagnostic development. The final medical-device will be comprised of a saliva-sample collector, integrated with a disposable lateral-flow test cartridge, and an automated test analyzer. The first phase of development will be to create a breadboard testing system to demonstrate feasibility of the chemical assay using lateral-flow technology, and to show correlation between the new disposable test format and the current clinical test assay. Following these milestones, a product can be designed for the initial research market. Research applications represent a significant initial market for this innovation. In the last 5-years there have been more then 50,000 scholarly citations containing the word “cortisol”. If each of those citations required 100 samples in the data-set, it represents, on average, a million samples tested each year. Currently, cortisol testing costs between $10-$30 per sample. The expected cost to the user implementing the Recalibrate Solutions platform is expected to be under $3 per sample. Following development of the research product, Recalibrate Solutions will use inputs from the breadboard and research product to design an FDA cleared medical device that can be used by health care workers and physicians. All development efforts will be carried out under an ISO 13485 compliant quality system. This will ensure compliance with FDA regulations as well as Medical Device Regulation (MDR) for potential EU clearance and distribution. There is currently no individualized and clinically relevant testing system for toxic stress screening. The pressing public health concern of toxic stress has motivated business, legal, government and philanthropic efforts. The Recalibrate Solutions’ screening platform would provide a transformational tool for research and clinical applications.

Who benefits? (1500 characters)

There are many beneficiaries from this innovation. First and foremost are the children. With no objective tool to detect the adverse effects of toxic stress, interventions are delayed, ineffective interventions may be deployed, and children are thrown off normal developmental pathways. Lack of identification and intervention, result in adverse health outcomes. An effective detection tool for adverse effects of childhood stress with appropriate early intervention can changes children’s lives incalculably. Researchers also benefit from the Recalibrate Solutions’ product. The ability to objectively identify specific children adversely affected by exposure to toxic stress will allow earlier deployment of intervention therapies. The ability to quantitatively monitor stress biomarkers in a timely way after an intervention has been deployed to determine if the intervention is appropriate and effective will allow a much more efficient development of intervention plans. The availability of a low-cost test platform for rapid, quantitative detection of saliva-based stress hormones may also attract more research and researchers with a focus on toxic stress. Physicians and healthcare workers will benefit from the FDA cleared version of this technology. Having a rapid, low-cost test platform to evaluate the health of a child’s stress response system could be incorporated into pediatric practices and community health care practices allowing early intervention to be deployed.

What kind of impact will your idea have? (1500 characters)

A screening system for toxic stress will lead to very long-lasting outcomes and will catalyze positive change in the lives of children and families. Toxic stress is the greatest unaddressed public health problem of this generation. It is undisputed that unaddressed childhood adversity leads to some of the greatest problems we have in our educational and healthcare systems: learning disabilities, attention deficit disorder, behavior issues, obesity, diabetes, and other chronic diseases. Imagine if we could disrupt a major cause of all these problems during early childhood. Many effective stress-buffering interventions are available and have been proven to be effective. Unfortunately, an objective, cost-effective, detection system to identify children who need such supportive interventions does not exist. Interventions currently are implemented based on subjective evaluations of a child’s circumstances, but how many are we missing? What if stress-system monitoring were understood to be a vital sign. A system to be monitored on a regular basis; at home, at school, in the clinic. With so much at stake, we must start by developing tools that allow us to objectively detect and evaluate the stress response system to monitor the wellbeing of every child. It’s a wellness paradigm-shift, and it begins with a diagnostic assessment tool.

How does or how could your idea impact low-income children? (1500 characters)

A toxic stress screening tool will have a major impact on children from low-income children and their families. The original research study correlating Adverse Childhood Experiences (ACE) with negative health outcomes, was conducted by the Center for Disease Control (CDC) and Kaiser Permanente (KP). In that study, 17,500 participants’ health data were used to show the strong correlation between ACEs and negative later-life health and wellbeing outcomes. Many of the events considered in the CDC-KP ACEs study are prevalent among low-income households. Examples include substance abuse in the household, incarcerated family member, food insecurity, and housing insecurity. The availability of a detection tool for identifying children in low-income environments who need supportive intervention plans to mitigate adverse effects of toxic stress has huge implications for positive impact. The wide-ranging health and social consequences of ACEs underscore the importance of preventing them before they happen. Providing a means to identify and monitor negative sequala from toxic stress together with the deployment of effective intervention plans will have a meaningful impact on children from low-income families because they represent a high-risk population.

Innovation: What makes your concept innovative? (5000 characters)

There is currently no tool available to objectively detect if exposure to toxic stress is producing adverse effects in children. There is currently no tool available to detect the onset of the adverse effects of toxic stress on children allowing supportive, family-based interventions to be deployed early. There is currently no tool available to quantitatively measure the effectiveness of an intervention plan implemented with a child believed to be suffering from the adverse effects of exposure to toxic stress. The Recalibrate Solutions concept is innovative because it provides an objective, low-cost clinically relevant tool to mitigate the issues articulated above.

Scale: Describe how your idea could reach a significant number of end-users. (1500 characters)

There is a strong, motivated, invested community who understand the community and health threats posed by toxic stress in Colorado. Partners in this community represent medicine, education, government, legal, early childhood, advocacy, research, and philanthropy. Recalibrate Solutions has connections with or is working to partner with several of these organizations. Examples include Colorado Health Foundation, Caring for Colorado, Launch Together, Bright by Three, Colorado Covering Kids and Families, Piton Foundation, Kaiser Permanente, Children’s Hospital Colorado, and others. We believe this statewide ecosystem will allow Recalibrate Solutions to permeate Colorado with our stress response evaluation platform. The first step is working with researchers that are studying toxic stress and its impacts. We are connected to a large, national peer-network of researchers working in this area. As others in Colorado and outside learn about this new tool, we believe it has the potential to spread nationwide. Of course, as we get closer to product launch, we will develop a more detailed strategic plan to foster this growth.

Feasibility: Where are you with understanding the feasibility of your idea? Describe what you’ve done so far and your plans. (3000 characters)

Extensive research conducted by Dr. Watamura, Recalibrate Solutions’ co-founder, has determined infants as young as six months old demonstrate a baseline stress-hormone level that can be monitored to determine dysfunction of the stress response system. After extensive research (>700 companies), Dr. Bhagwandin has identified technology that can be implemented for a low cost, non-invasive, portable, rapid diagnostic test for monitoring saliva-based stress hormones. Recalibrate Solutions has spoken with two potential development partners who have expertise in saliva-based lateral flow assay development. We have created formal specifications and written requests for proposals. We have received quotations for the assay development work. Our discussion with these subject matter experts give us a high level of confidence there will be minimal risks associated with the assay development efforts. Recalibrate Solutions has also received quotations for three generic, off-the-shelf lateral flow research instruments, and a quote from a potential design partner for development of a custom reader instrument. This is also a low-risk development effort. Finally, Recalibrate Solutions has received quotes from two groups to develop a compliant ISO 13485 compliant quality system to meet regulatory requirements for medical product development and design controls. All efforts to date suggest the proposed idea is very feasible and has minimal development risk. Currently, Recalibrate Solutions is planning for a seed round of funding. We are preparing our budgets, proformas, business plan, strategic plans, and due diligence files. We are creating a questionnaire to evaluate platform adoption by researchers and pediatricians. The questionnaire regarding the research tool will be sent out to several prominent researchers in the field. We are working with the American Academy of Pediatrics to send the pediatrician questionnaire to all their members. When the seed round is closed, we will establish a corporate quality system for medical product development and initiate assay development. When a prototype for the test assay has been developed, we will begin correlating results from the Recalibrate Solutions disposable test with results from the standard clinical test assay. This work will form the basis for he design of the research platform.

Business Viability: How viable is your business model? (5000 characters)

Stress hormones are valid biomarkers throughout life. Targeted market channels include research applications, clinical applications, and the consumer market. The initial market will be for research applications. We believe this is a significant market. Potential researcher-demand for a clinically relevant, stress-monitoring system is evidenced by the 50,500 scholarly citations containing the word ‘cortisol’ since 2012. If each of those citations required 100 samples in the data-set, it represents, on average, a million samples tested each year. Currently, cortisol testing costs between $10-$30 per sample. The expected cost to the user implementing the Recalibrate Solutions platform is expected to be under $3 per sample. When considering the pediatric clinical market, the opportunity is also very promising. Kaiser & the CDC found that, of over 17,000 adults evaluated, 21% were in the high-risk category due to their Adverse Childhood Experiences (ACE score). There are ~ 45 million children under the age of 10 in the US; 700,000 of those are in Colorado (14% of the population), with an additional 66,000 born in the state every year. Our goal is to screen every child and provide intervention before they reach the classroom. Finally, the consumer market recognizes the value of stress-monitoring. In 2016, a company received $10MM in VC funding to develop a wearable sensor using respiratory rate, heart rate, and temperature to report a stress index. As stated, stress hormones are relevant biomarkers throughout adulthood for monitoring overall health and wellness. Adult consumer markets include applications for high-stress professionals, individuals experiencing major depressive disorders (MDD - 3MM/yr), and a treatment monitoring tool for PTSD victims (>3MM/yr).

HCD: How have you used human centered design to build or refine your concept? (5000 characters)

Recalibrate Solutions is too early stage to provide examples of how we have used HCD for our idea. However, we are in the process of collecting input from researchers and pediatricians (end users) to incorporate into our early design concepts. Additionally, when developing a medical device, regulatory requirement (ISO 62366) require extensive, integrated usability engineering in the design process. This will involve asking a user population to provide iterative feedback on the product design. HCD will very much be a part of the Recalibrate Solutions platform design.

Tell us more about you (3000 characters)

I learned about toxic stress in June of 2017 when I participated in a venture generator program called 10.10.10 – 10 wicked health problems, 10 CEOs, 10 days. During that program toxic stress was presented as a wicked problem affecting our communities, with little progress toward a solution. As I considered several other problems present during the program, I kept returning to the upstream root cause – toxic stress. Sarah Watamura, co-founder for this effort, served as the problem expert for this issue. The CDC / Kaiser study was a retrospective tool in the form of a questionnaire given to 17,500 adults. Currently, a handful of research hospitals attempt to screen for toxic stress using a modified questionnaire given to new or expectant mothers. The results are subjective at best. New mothers are not inclined to admit to abuse, drug use, incarceration, etc. in the household. When I learned this was the current screening tool, I immediately saw the opportunity for a rapid diagnostic medical device that objectively monitored a biomarker from the child – no uncomfortable questions to answer, no stigma to deal with – just simple physiological data. This was an obvious solution for me. I have spent 20+ years in medical product development with the last 10 at the executive level. More specifically, I was responsible for engineering development and regulatory compliance of diagnostic equipment.

Do you have the people and partners you need to do what you’ve described? (600 characters)

We currently have the people and partners we need.

As you consider your next steps, what kinds of help could you use? Is there a type of expertise that would be most helpful? (1800 characters)

- Expertise in large health care systems like Mayo - Connections to funders/ early stage medical device venture groups and early-stage impact investors - Expertise in building markets

Would you like mentoring support?

  • Yes

If so, what type of mentoring support do you think you need? (1200 characters)

- Introductions to potential investors for both seed and series A rounds - We have a go-to-market strategy but would be open to advice from a mentor about how to build markets in this space - We welcome mentoring from subject matter experts in Medicaid and insurance billing

Are you willing to share your email contact information submitted on OpenIDEO with Gary Community Investments?

  • Yes, share my contact information

[Optional] Biography: Upload your biography. Please include links to relevant information (portfolio, LinkedIn profile, organization website, etc).

Bryon Bhagwandin, PhD - 20 years’ experience in medical-device development and diagnostics design. https://www.linkedin.com/in/bryonbhagwandin/ Sarah Watamura, PhD - internationally recognized researcher and scholar in potential lifelong consequences of early life stress for health, achievement and well-being. https://www.du.edu/ahss/psychology/facultystaffstudents/faculty-listing/watamura.html https://www.du.edu/ahss/psychology/seedresearch/faculty/watamura.html

Mentorship: How was your idea supported? (5000 characters)

My mentor session was very helpful. The mentors I spoke with helped me see the need to present my innovation in context with the current ecosystem I am working in and to present the application with a focus on our initially targeted market rather than the long-term vision of the company.

Name or Organization

Recalibrate Solutions, PBC 7737 S Poplar Way East Centennial, CO 80112

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