Hollo (Digi-ACT)

Despite Rare Diseases being uncommon, patients with such conditions face various difficulties in their everyday life, hindered quality of life, difficulties in access to care, mobility, job opportunities, and difficulties with social conditions. Even though the world becoming an increasingly accessible community in highly developed cities, the difficulties Patients with Rare Diseases face continue to be an issue for low to moderate income countries and cities.

Many of these factors contribute to poor mental health for Rare Disease Patients. Within the spectrum of rare diseases, studies looking at over 300 participants with 79 varying rare diseases have found that around 42% of participants had shown signs of depression and anxiety (N. Uhlenbusch, et al., 2019). Like chronic patients, depression impacts these patient’s adherence to their physical medical treatments less; require more emergency visits to clinics and hospitals, and incur higher cost per patient for Hospitals and supporting Organizations.  

Even within a highly developed city like Hong Kong, access to mental health resources is considerably low compared to the total population (4.5 Psychiatrists per 100,000 people (Hong Kong Statistics, 2020), showing a lack of access, and lack of integration for psychological services, extending this problem to rare disease patient populations as well. This issue finds itself at scale where patients with depression have no clear services or integrated solutions targeting the comorbidity of mental health issues in Rare Diseases.

Our company is building a pipeline of clinically validated and groundbreaking technology focused on: 1) improving how mental health is detected and diagnosed in modern, multimorbid patients; and 2) improving how mental health is treated through automated digital therapy. 

Our Screening Technology utilizes AI for multiple roles: 1) Detecting through alternative media (like patient videos for facial, vocal, semantic recognition of unconscious signals of mental health (biomarkers), 2) allowing a multi-layered patient profile that considers: physical symptoms, mental health reported data, background behavioral data (from wearables and mobile sensors like: Sleep, Lifestyle patterns, exercise, etc.). We utilize smart phones due to their widespread penetration and increasing accessibility for collecting our data, since our models are device agnostic. 

This model allows for more accurate diagnostic frameworks that are inclusive, less linear, and more accurate - reducing inequalities and inefficiency in the diagnostic process. We can work together with frontline providers on applying this actionable data through our therapeutics as well as implementing meaningful outcomes to their service models. 

Our Therapeutic products are digitized and gamified versions of evidence-based interventions, for example our flagship product to undergo our first clinical trial in October (2022) will be an automated Acceptance Behavioral Therapy for Cancer Patients in Hong Kong. As a blend of educational content, we provide gamified training and exercises for patients to work through over 5 weeks of their prescription to enhance several perspectives/ideals that will ultimately lead to bettering their lives (by alleviating depression and anxiety symptoms). For example, leading mindfulness and valued living goal setting will allow patients to become more accepting of their life conditions, focus on more positive aspects of their lives, and help return them to communities and connect with others. ACT is widely applicable and considered 'trans-diagnostic' allowing it to be used for alleviating depression and anxiety in general populations, comorbid chronic populations as well as rare disease management. 

Currently, we are working with the Cancer population in Hong Kong (where our company is based) for our proof of concept and initial test bed for our technology. Cancer patients, alike other Chronic and Rare Disease patients, find themselves needing increased hospitalization, treatment from health services, increased monitoring and changes to their lifestyles which can be difficult to manage without multi-disciplinary healthcare resources. Emotional well-being is priortized last, especially in Asian Cultures, despite it being a large contributing factor to disease management, adherence and recovery rates. Disease management has evolved in the modern day to include comprehensive and multidisciplinary teams, however in Hong Kong and many South East Asian cities (as well as many under privileged nations), this is impossible without appropriate funding and resources that do not exist. 

The combination of Objective Digital Biomarker Data and Digital Intervention allows for preventative care, scalable and able to target larger populations, appropriate diagnostics and triage allow for care re-distribution and reduces stress on the healthcare system. This benefits Patients by improved mental health; increasing disease treatment adherance; providers spend less on cost of care; payors like insurers or project funders may save money as well. This advocates for our missions of increased accessibility to care, increased efficiency of healthcare systems, and sustainable care.

By enabling a scalable, autonomous, inclusive, and clinically validated solution for mental health management and treatment in communities like these; we can build on communities with limited resources, provide adequate healthcare solutions, and create long lasting impact through sustainable improvements to healthcare structures. Especially, with technology that addresses limited internet connection, performance of smart devices, and incurs less burden on frontline workers. 

Current healthcare tech solutions are built by Scientists and Doctors with mostly practitioners' perspectives in mind when developing solutions - this leads to poor patient retention on these apps, and therefore lack of effective use-case in real life. Typical solutions like Huma or remote care like MyDoc, facilitate hospital at home or telehealth solutions, which generally target single segments of the healthcare journey. These processes are clunky, have poor integration with offline services, which leads to poor usage in real-life practices. At Hollo, we’ve taken the stance of Patient-first in our product development, centering on the pillars of Design Thinking. However, as a tech-first company, our approach crosses disciplines of Design Thinking, Agile Software Development, and the Scientific Process of Clinically Validating interventions and technology (Clinical Trials, Randomized Controlled Trials, FDA Approvals, etc.). This way, we target the patient’s core issues, retaining them longer; quickly pushing new researched features; providing more value for practitioners; all the while, enabling a validated model through Clinical Trial protocols.

Our company is able to stand out from other Digital Therapeutic or Mental Health tech companies for several reasons: 1. Therapeutic Target Specificity, currently other companies target other diseases e.g. mental health in psoriasis patients (Happify Health), ADHD (Akili Interactive), opioid addiction (Pear Therapeutics), psychosis (Oxford VR), or IBS (Nerva) whilst our flagship targets cancer and soon other chronic diseases that require pain management. 2. Standout technology, other startups use baseline questionnaires through apps, whilst we use a cohort of questionnaires, AI generated biomarkers, and personalized gamified interventions. 3. Regulatory Approvals: 96% of mental health apps publicly downloadable are not regulated by any authority (FDA, CE, or otherwise), Hollo is clinically validating our technology, intervention and service models through research partnerships with CROs and Universities. 4. Business Model & Delivery, by delivering products through clinical relationships, the product is directly marketed to our target users, benefitting from potential reimbursable pathways, as compared to direct to consumer subscription models. Additionally, the majority of the US and EU based startups are building therapeutics based on Western Culture and Healthcare systems, which are both inaccessible and non-applicable to Asian contexts. By curating Chinese and Asian-value based technology, we are able to have stronger considerations and penetration in Asia.

The key Growth Outcomes the company is exploring over the next two years are focused in developing more treatments and detection models in our Clinical Product Pipeline (R&D and Commercialization); Talent Acquisition & Retention; working closely with the customers and stakeholders on a product-market fit with the commercialization of our product models. 

Long Term Milestones: Our company splits our product roadmap into 4 Phases, blending UX / Design Thinking, Agile Software Development, and Clinical Approval milestones. Phase 0 focuses on the Product Discovery Process, identifying key technology, psychological content, and market analysis. Phase 1 builds a prototype, drafting initial protocols, exploring literature, and quality assurance. Phase 2: builds Beta version, user feedback, feasibility studies, piloting in real clinics, and small scale RCTs. Phase 3: builds large scale product clinical trials, readying products for regulated market (FDA), and generating evidence of scalable impact. Phase 4: Product enters product-market fit, scaling distributions with FDA approvals, and minor UX improvements. This process allows for validation of product from both User, Customer and clinical perspectives; whilst ensuring clear roadmaps for Investors and Regulatory Agents.

Within the support of this prize, our company aims to continue building our pipeline of products, and begin the process of scaling up the business model. The varying levels of Medical Device regulation around the world allows us to have our product launched locally in Hong Kong, whilst we pursue full approval from the FDA for distribution in other Asian and Western countries. Other products on our roadmap include translations of our product into English (culturally and linguistically); further targeting other Non-Communicable Diseases (NCDs), like chronic pain, heart disease, Rare Diseases.; new AI models for digital biomarkers; and building outcome based business models with our unique diagnostic processes. We can bring these models and scale them into other low income communities by working closely with NGOs and other organizations, to deliver actionable healthcare outcomes within these cities. 

We are targeted on generating over SG$ 43,371,763 (US$ 31,158,100) recognized revenue by the end of 2024, which 11.17% from hospitals, 11.73% from medical groups, and 77.09% from clinics. It is projected that Hollo can serve over 66,000 Cancer patients by 2024, generating in Asia within our first 2 years of distribution. Short Term Milestones: Currently the product is nearing the end of Phase 2, which has a solid UX/UI design with planned clinical intervention content. While the in-house team is still co-working with Cybersecurity Consultants and Experienced Developers on the App Development, we are preparing for our first Pilot Randomized Clinical Trial (RCT) for achieving the initial clinical approval milestone. This has been a communicated milestone for Healthcare Venture Capital.

The product RCT is planned to conduct on cancer patients in Hong Kong hospitals and medical centers for the remainder of 2022. The RCT is a small clinical study in preparation for the FDA medical device approval pathway by obtaining basic clinical data to demonstrate the efficacy and safety of the device. At the same time, the study is also considered as Beta Testing of the product, that helps the team to further understand the user experience of both the patients and healthcare providers, so as to make the final adjustments and finally complete the product design. With the support from DBS, it provides us liquidity for achieving our Milestones as we generate capital through alternative reimbursement grants, look for private capital, etc. Specifically, in the short-run, it provides capital for cooperating with a Contract Research Organization (CRO) and medical institutes on our next clinical milestones: conducting a Large Scale Pivotal RCT for demonstrating the safety and effectiveness of the product.

Our solution can be considered innovative due to several reasons:

• Multiple digital health solutions are unilateral - focused on impact for providers and not patient centric; monomorbid - focused on singular disease management; and poorly integrated with existing healthcare infrastructure. 
  • Hollo Targets these issues with the core of our technology; product focus; and blended design approach considering clinical, user-centric, and software agile frameworks into our development model. 
• Asia has limited Digital therapeutic and diagnostic models being curated due to the lagging healthcare systems and poor integration of startups and software into these communities. We are able to spark this initiative within Hong Kong, collaborate with first movers in this space (Singapore, Taiwan, etc.) and bring these models to collaborate with orgainzations in regions with poor access to healthcare resources. With our Asian focused design lenses and quick startup agility; we are able to localize (in language and more importantly, culture) and contextualize our findings quickly to new systems and easily adapt with local teams on an international scale. 
• Majority (96%) of mental health solutions do not seek clinical validation of their solutions. Hollo looks to validate every part of our AI, Software and treatment models through multiple bodies of authority. Our clinical validation model seeks approval from the FDA, allowing access and monitoring of our development, which is adaptable to majority of Asian Medical device regulators.
• Our Theory of Change model (described in the next question's answer) allows our company to bring sustainable and lasting change to communities. 

“There is no health without mental health” (WHO Director General, Tedros Adhanom Ghebreyesus, 2021).

As mentioned earlier, some of our high level key goals for the next 5 years:

• Treat over 10 million patients in Asia in the next five years
• Improve Health outcomes for patients 
• Serve multiple Chronic Diseases and Rare Diseases and comorbid mental health conditions
• Highly sensitive and selective AI models for detection and treatment of mental health according to disease classification
• Support the Characteristic Diagnosis of mental health (RDOC and HiTOP Frameworks of diagnosis)
• Transform both high and low income communities towards digital first health systems. Working with offline first healthcare frontline companies (like reach52 and others) to reach patients.
• Implement systems of radical transparency in healthcare for patient centric approaches. 

We aim to achieve these by mitigating several go to market risks with digital health:

1. Proving Clinical Efficacy

2. Proving Technological Efficacy

3. Proving Market Need & Feasibility

4. Regulatory Pipeline

By showing clinical efficacy of our treatment and diagnosis modelling, we are enabling scientific and evidence based programs to reach the populations that require proven methodologies to adopt into their healthcare systems. There is a quality assurance behind publishing our findings in both reputable and open source journals and opening our doors to peer review. Without this angle, we cannot prove to stakeholders (both patient and healthcare orientated) that the solution is trustworthy and worth implementing. Furthermore, technoligcal efficacy is important when it comes to User and Patient Centric Design and Service design. Without a clear roadmap, feedback loops, and security audits, products that attempt to go to market and serve multiple nationalities cannot thrive. We are implementing these steps as we co-develop our product closely with the target users. 

Latter risks such as market need and feasibility are addressing the different structures of healthcare systems and digital health in different communities. It is inevitable that different systems will be structured with alternative infrastructure. By enabling the technology and service model to have modular flexibility to adapt to these systems, we can work with local, frontline teams on making sure the solutions work in the communities that need it. Finally, in terms of a regulatory pipeline, to further ensure that not just the theory behind the technology is monitored, but the servicing and practicality of the system can be assessed and monitored by authoritative bodies like the FDA. This will overcome blockers for communities with higher regulation on medical devices, and be a seal of approval for those without much regulation as well. 

By addressing these risks early and engaging in the processes early, companies like ours can bring the solution to communities around the world, enable inclusive design, and be a bastion for credible and scientific resources in the world. 

In Reference to the UN SDG Indicators, Hollo aims to contribute to the following indicators through contributing to any public sustainability reports as well as our own impact reporting. 

3.4.1 Mortality rate attributed to cardiovascular disease, cancer, diabetes or chronic respiratory disease
- Hollo Contributes to reducing mortality rate through treatment adherance and co-morbid mental health treatment

3.4.2 Suicide mortality rate 
- Directly treating mental health will target reducing Suicide Mortality Rate

3.8.1 Coverage of essential health services 
- Contribute to provide accessible and economical health services, enabling and working with Organizaitons in low income communities to provide subsidized services. 

3.8.2 Proportion of population with large household expenditures on health as a share of total household expenditure or income 
- Contribute to this indicator through having price accessible solutions for low income communities. 

Hollo's direct social impact goals will measure through our theory of change. Some indicators:

- Patients served

- Mental Health rate of improvement

- Sustained mental health impact

- Quality of life measurement

- Patient Reported Outcome Measurements (PROMs in Healthcare)

- Hollo treatment adherence

- pharmacological treatment adherence (primary treatment)

- we also measure UX variables to ensure high usability ratings 

- Net promoter score

Through our Theory of Change model, we aim to create lasting impact on both community and policy levels. Patients and other stakeholders benefit from our products directly; these lead to larger social and environmental Outcomes, Primary Impacts and Long Term Impacts. In our big picture, Hollo’s aims to primarily support SDG Goal 3 - Good Health and Wellbeing; we additionally target green energy solutions, inclusive workforces, and lowering inequalities. We aim to achieve this by our Primary Impact Goals: (1) Improving autonomy and access to care, (2) reducing inequalities in healthcare, (3) ethical and clinical/scientific development of core technology that is inclusive of all backgrounds, (4) radical transparency and digitization of healthcare for all, (5) Sustainable technology and cloud computing.

Direct Outcomes from the use of our product’s public launch/distribution (post R&D, Clinical trials/studies) directly contribute to these Primary Impacts. (1) Lower cost barrier to mental healthcare, (2) Increased care accessibility from home, (3) increased safety and reduced risk from validated methodology, (4) improved mental health, (5) faster, empowered chronic condition recovery (having mental health needs addressed in their care), (6) increased transparency due to digital channels of access, (7) improved health literacy. These outcomes happen primarily on our community level. With this evidence in hand, it would be paramount for healthcare systems and professionals to recognize the need for change in their care - we aim to spearhead this with other industry leaders and non-profit organizations in the future. By collaborating with all stakeholders from insurers, providers, patients, and beyond; Hollo aims to create lasting impact through implementing and supporting digital infrastructure and systems in Asia. By ensuring we additionally support green energy in our suppliers for Cloud Computing services and ensuring we have inclusive workplace and recruitment policies, Hollo’s social and environmental impact stems beyond our products and looks inward at our own processes as well.

However, to ensure that we are measuring and reporting our Outcomes, Primary Impacts, and Outputs, Hollo will collaborate with our Impact Partners, Dream Impact Hong Kong to ensure we complete our Social Impact Audits to certify our impact on paper! 

Several milestones allow us to accomplish goals, these can be reflected in our further description of business goals. However, in brief, by continuing our Business Goals: R&D; publishing our findings; clinically trialing our technology; and subsequently launching our services; Hollo will be able to reach our beneficiaries and begin further work on collaborating with stakeholders to create our impact.

Hollo's central technology are modular detection and treatment models, delivered through Apps to our patients. We are developing APIs and a platform for providers and front-liners to contribute, assess, and implement the data and solution into their services.

Our backend consists of multiple AI models that enable us to assess our Digital Biomarkers about our patients. Combining a suite of deep learning and machine learning models, we aim to create comprehensive profiles on our patients, enabling AI-augmented treatment options as well. 

In the near future we foresee including IoT devices such as wearable watches, rings, or earpieces that enable us to further collect biometric and key digital phenotype data about our patients. However, implementing these service models into lower income communities can be explored with more innovative partners. 

In our employment mandate:

- employment opportunity employer: inclusive of all backgrounds, sexual orientation, nondiscriminatory hiring, ensuring gender neutral workplace and will work with consultancies to further implement policies as the startup scales. 

In our service model:

- Developing in multiple languages and cultural contexts. Currently in English and Chinese, but will work with talent on expanding this and our data pools to have inclusive backgrounds. Accessibility and inclusion in our product development is important, to ensure that patients feel represented and included in our design elements. For example, including contexts of disabilities and mobilities are important in our product design, we will strive to create inclusive models that will enable users of all abilities to perform or contribute. 

In our technology Model:

- Ensuring non-bias AI by curating diverse datasets from multiple backgrounds that reflect population distribution in the countries and cities we serve. E.g. In Hong Kong we have a distribution of mostly Han Chinese, however we also see large populations of Indian, Pakistani, Middle Eastern, Western, and African populations as well. These are just some examples of potential cultures

Revenue Model

Hollo distributes this product on a Prescription model, where the payors (individuals or insurance reimbursement) pay for a prescription of the current 5-week program. This prescription is currently estimated at US$ 529, around the market rate. Users gain access to screening, treatment, and a dedicated psychologist potentially to monitor the data, only cases labeled as Serious will be referred to an external psychologist, within those 5 weeks. Patients continue to access screening and exercises throughout that year. We will continue to investigate pricing models that are accessible in our product-market fit stage. This pricing model is fitted for Hong Kong, but we are interested in exploring inclusive/economically fitted pricing models for other communities too. 

Channels & Partnerships

Our partnership network will include the healthcare providers; supporting organizations for mental health referrals; insurance partnerships for enabling financial aid for community members; pharmaceutical companies that distribute the primary treatment to the patients; and patient-support groups. To ensure we have a closed feedback loop with our providers and users will be important as we develop our product as well. 

Additionally we will hold a relationship with multiple regulatory bodies (ISO, FDA, HIPAA, GDPR, etc.) this is so that the product can be audited on: Clinical, Technological and social levels. 

Key Activities

Our company focuses on Research and applied research through our business model. Our key activities in research include expanding our clinical pipeline by investigating new interventions that would support chronic and rare patient backgrounds in mental health. For example, at the moment we've developed our ACT for Cancer patients, however we will be exploring applying this treatment manual towards other comobidities. Furthermore we are exploring how our Multimodal AI diagnosis model can apply itself to the HiTOP diagnosis model. 

Segments

Our key customers are the payors in the healthcare system. In Hong Kong, that would be out of pocket and insurance coverage in private clinics and hospitals, but government subsidised in public hospitals. 70% of Healthcare transactions in Hong Kong occur in the Public hospital system. We are exploring potential collaborations with Pharmaceutical companies as the payors for delivering key important healthcare data about patient populations using their drugs or vaccines. Particularly for chronic conditions and rare diseases, these would be key partnerships in delivering effective models for low income communities. 

Key beneficiaries are the patients experiencing mental health issues as comorbid conditions to their chronic condition. We are exploring including healthcare providers in the platform, but requires overcoming the training required to use such platforms in their care programs. 

Cost Structure

Our multidiscplinary team is agile and functional on both operational and research bases. Our core business team comprises of both software and sales/marketing members. Whilst our research is focused on Data Science, Psychology/Cognitive Sciences, and some software members focused on quick deployment and testing. Alternatively, other large costs for our development would be covering our Clinical Trials for the product per therapeutic. Currently we've spent around 150k USD on our first pilot clinical trial (UX research, software development, team, Clinical Research Organization Engagement, deployment, etc.), as a model this can be scaled for other therapeutics as well as higher cost range for a FDA regulated Randomized Control Trial. 

Currently, Hollo has bootstrapped over 3.9 Million HKD (500k USD) with equity-free capital through multiple grant and incubator structures. We are exploring further grants and matching funds from the Hong Kong government, accelerators as well as private investment.

After our first clinical trial in October 2022, we will be fundraising our Pre-seed round of around 2.3 - 2.5 million USD from private capital. Likely to be a combination of Angel investors as well as healthcare venture capital. 

Hollo's aim for financial sustainability is reliant on our business model for the prescription, digital API services for digital health platforms, and working on collaborative grant projects with Non-profit organizations. 

3,910,000 HKD / 500k USD

HK$ 450,000    Microsoft Imagine Cup - Global Champion (2020)

HK$ 100,000   Cyberport Creative Micro Fund (2020)

HK$ 200,000   Good Seed SIE Fund (2020)

HK$ 260,000    Founder Loan (2020)

HK$ 500,000    Cyberport Incubation Programme (ongoing 50%) (2021)

HK$ 1,000,000 Technology Startup Support Scheme for Universities (ITF HK) (2022)

HK$ 600,000    HK WeVenture Gear Up Programme (ongoing 30%) (Gov) (2022)

HK$ 800,000    City I&T Co-Creation Fund (ongoing 60%)