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Leila

Software as a Medical Device for infertility diagnostics

Germany
Market: Medicine
Stage of the project: Prototype or product is ready

Date of last change: 15.06.2021
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Idea

Leila is giving women and gynaecologists the tool stack they need to conduct evidence-based, precision diagnostics. 1/7 couples are struggling to conceive, but only 10% seek medical advice in a fertility clinic. Gynaecologists are not educated to conduct infertility diagnostics, hence a gap in our healthcare system. With Leila we aim to close this gap, automatically diagnosing a women's cause of sterility. In 60% of the cases we can diagnose a women straight away. In 65% of the cases we can support a women through our virtual therapy plans.

Current Status

We are pre-product, in the middle of the product development and certification process to become a medical device.

Market

**Direct to Consumer (D2C) - 2021+:** Our D2C target group is women aged 28-44 who have been trying to get pregnant for more than six months. The size of the target group is 6.1 million in DACH (3.05 million women). On average, a woman spends €460 per pregnancy on fertility-enhancing services, representing a market value of €11.6 billion in DACH. With a price of €199 per patient, Leila creates a potential market value of €600 million. We are starting with D2C in Germany to collect patient data and lay a qualified foundation for machine learning.

**Business to Business (B2B - 2022+):** Fertility clinics can purchase our software as modular web-based software and/or as a white label solution. Initial market research has shown that clinics would like to use the LEILA Fertility Code, on the one hand to standardize diagnostics and preparation for IVF, and on the other hand because they can save a massive amount of time with the software. Reproductive physicians typically spend 85-90% of their working time educating patients, ordering, documenting and storing diagnostic tests, obtaining missing findings and explaining recommended treatments. This time commitment represents only 6% of the economic value, as 94% of a fertility clinic's value comes from reproductive health treatments. With the LEILA Fertility Code, reproductive physicians can spend significantly more time on treatments because diagnostics are automated. This means shorter waiting times for patients and increased profits for fertility clinics.

We will initially offer our algorithm in DACH as SaaS. In Germany alone, there are 131 fertility clinics. Our algorithm will be certified in Europe and will be available in both German and English. This will also allow us to sell the software outside of Germany.

Problem or Opportunity

Although about one in 7 couples in industrialized countries is infertile, it takes an average of 4.5 years for the cause of infertility to be recognized. A major reason for this is that gynecologists are not trained to diagnose infertility by default, lacking in-depth training in endocrinology (the study of the medical aspects of hormones) and reproduction.

Our health care system urges couples with an unfulfilled desire to have children to seek help from experts in fertility clinics, even though studies show that almost 90% of those affected avoid visiting a fertility clinic. Reasons for this include stigmatization, lack of information and high costs. Another reason is the fact that fertility clinics specialize less in diagnostics and more in therapy and often perform invasive in vitro fertilization (IVF) for economic reasons - even when such a procedure would not be absolutely necessary to achieve a pregnancy. A for-profit fertility clinic converts about 70 to 80% of all patients who come to the clinic for an initial consultation to IVF at an average cost of 4,500-5,000 euros per cycle. This discourages many couples. As a result, an offer for these couples has been established on the market that focuses on lifestyle and wellness. A variety of products and services, such as nutritional supplements, fertility trackers, cycle apps, wearables and coaching courses are offered, which are helpful in many cases, but contribute little to the sound diagnosis of the unfulfilled desire to have children. LEILA wants to establish itself in this gap between demand and supply.

Solution (product or service)

The software is web-based, runs on various browsers and is accessible from all devices (laptop, desktop, smartphone, tablet). The product consists on the one hand of a log-in area for patients, a log-in area for doctors & coaches and the algorithm itself. The patient is taken through the dashboard step-by-step. First, a medical questionnaire is filled out, which replaces a 60-minute doctor's consultation. The medical questionnaire is composed of 200 questions, each patient receives an average of 40-60 questions and takes about 10 minutes. On the basis of the answers, the algorithm suggests an individualized blood panel. From about 150 blood parameters, an average of 15-30 blood parameters are recommended. The patient then has the opportunity to speak with Leila's patient care team in a brief phone call about next steps. The patient is asked to take the blood to a laboratory and submit the laboratory results to the company via PDF. The company works with various German lab groups to receive the lab results directly via a digital interface as well. Once the results are submitted, the algorithm can either diagnose directly, make a tentative diagnosis, or recommend further diagnostics. The patient then has the option of a telemedicine consultation with a physician. Leila only acts as an intermediary - the treatment discussion takes place between the doctor and the patient and is billed according to the GÖA. Subsequently, the patient receives a detailed therapy recommendation to increase her chances of pregnancy.

The doctor is voluntarily listed on the platform and receives the information if a patient has booked a consultation. The doctor then gets access to the diagnoses and/or recommendations for the patient and can directly start the video consultation via the dashboard.

The algorithm is in place, the IT infrastructure has been set up and the medical questionnaire has already been developed. Now the user interface and experience (UX/UI) will be created from persona and user behavior to be able to develop the frontend design in the next step. The goal is to complete the dashboards by the end of July in order to be able to conduct various tests on patients throughout August 2021. In parallel to the product development, we are working on the technical documentation for certification, as well as the marketing and sales strategy.

Competitors

Competitors include:- Fertility clinics, which focus on therapy rather than diagnostics, as they cannot otherwise operate cost-effectively due to the high expenses involved (embryology laboratory with cryopreservation, personnel, certifications, etc.). - Lifestyle products designed to increase fertility. These include supplements and fertility trackers (Ovy App, Clue, Natural Cycles, Ovula Ring, Daysy, etc.). - Hormone tests that provide an initial screening but not a diagnosis (Avery, Modern Fertility, etc.)- IVF referral agencies (Dein Kinderwunsch, Apricity, etc.)What differentiates Leila is a medical-diagnostic based offering for couples who do not feel addressed by the existing medical offerings, but are also not looking for wellness and lifestyle products.

Advantages or differentiators

The innovative approach of the LEILA Fertility Code combines the following components:- Several hundred clinical guidelines and studies in the field of fertility are mapped as an electronic decision tree for the first time using more than 20 specially developed algorithms; this not only saves physicians time but also enables individualized diagnostics.
- The software guides doctors and patients through electronic decision trees in real time using personal patient data; this allows patients low-threshold access to evidence-based medical knowledge and shared decision-making between doctor and patient. Since fertility therapy is largely a private service, the LEILA Fertility Code takes into account not only medical data in the decision trees, but also economic aspects.
- Machine Learning: The more data the algorithms receive as input and the more often a diagnosis can be made, the fewer blood tests will be required in the future for rapid diagnosis and the faster risks can be identified.
- The interactive questionnaire developed by LEILA replaces repetitive tasks that otherwise have to be performed by reproductive physicians.
- Telemedical consultations enable time-saving, flexible appointments.

Finance

In 2021, our focus is on D2C and customer growth via organic website searches, social media and smart targeting. Our first four niche target groups have high search volume but rather low cost per click: Women with unmet childbearing needs with a) thyroid dysfunction, b) low egg reserve, c) recurrent miscarriage, and d) polycystic ovary syndrome (PCOS). Our average customer acquisition cost is expected to be €100 per patient and is expected to decrease to €60 by the third year.

The patient pays a one-time fee of €199 for the diagnostic service + telemedicine consultation.

For our B2B strategy, we plan to charge €149 per diagnostic service to the fertility clinic.

Money will be spent on

Finding talents in tech, targeting & data engineering. Key focus is to prepare for successful launch, planned for September.

Offer for investor

€300k at a valuation of €6M via CLAs
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