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INDI, world’s first 100% dairy free, soy-free infant-formula.

Periodic Reporting for period 1 - INDI (INDI, world’s first 100% dairy free, soy-free infant-formula.)

Reporting period: 2018-01-01 to 2018-04-30

Infant formulae are specialized products designed for the dietary management of babies aged 0–12 months. Specific formulations are needed to fulfill different nutritional needs of infants. Two major types of infant formulae are available: Cow Milk fomula and soy-based formula.
Cow milk protein-based formulae. Most infant formula is made with cow's milk that's been altered to resemble breast milk. This gives the formula the right balance of nutrients — and makes the formula easier to digest. Most babies do well on cow's milk formula. Some babies, however — such as those allergic to the proteins in cows’ milk — need alternative types of infant formula. Indeed, cow’s milk allergy or intolerance result in severe diarrhea. If affected infants are not given a milk-free infant formula, they may develop severe dehydration and weight loss.
Soy-based formulas. Soy-based formulas exclude animal proteins from the child's diet. Soy-based infant formulas are an option for babies who are intolerant or allergic to cow's milk formula or to lactose, a carbohydrate naturally found in cow's milk. However, the safety of soy infant formula has been debated for years because it typically contains a class of compounds called isoflavones. Isoflavones are naturally occurring compounds found primarily in beans and other legumes, including soybeans, peanuts, and chickpeas. These isoflavones are referred to as phytoestrogens because they are found in plants (phyto) and because of their ability to act like the hormone estrogen in the body. It is recognized that infants go through developmental stages that are sensitive to estrogens. Therefore, infants are more likely than adults to be vulnerable to the estrogen-like effects of the phytoestrogens in soy. In some cases, the health effects resulting from a soy-based diet (such as early onset of puberty in females and alterations in development of breast tissue) may not be apparent until years later.

INDI is the world’s first 100% dairy and soy free formula. The patented INDI formula matches the Gold Standard of breast milk in regards to composition and performances without the harmful effects of dairy and soy-based products. Being breast milk equivalent, INDI can be used as the sole food source of an infant.
The main findings of the study are listed below:
- Analysis of current stage of development of the powder and liquid form led to definition of MVP development roadmap. The project is at a mature stage and the tasks identified are:
1) Finalization of the development of the liquid form
2) Production scaling-up and industrialization
3) Clinical validation of the infant formula
- Clinical validation roadmap was defined with the key objective of demonstrating that infants thrive on an INDI-based diet and, therefore, that INDI meets the nutritional requirements and safety standards set by the ESPGHAN in Europe and FDA in the USA. To this purpose, GH consulted with Prof. Ron Shaoul (Rambam Hospital), and with different European and Israeli CROs. The protocol synopsis was outlined, together with a plan to complete the pre-clinical tests (PER study) required to start the clinical trial.
- Multiple contract manufacturers in EU were contacted and interviewed. INDI industrialization plan was then reviewed on the basis of the main findings resulting from such conversations and on-sites visits. Risks and mitigation measures related to contract manufactured were identified and addressed in detail.
- Detailed analysis of the potential business models revealed that online B2C sales could initially lower the market barriers and facilitate INDI’s penetration in the European and American markets. We reviewed our financial projections and pricing strategy accordingly.
- We planned the go-to-market strategy and internalization plan together with the main dissemination and exploitation activities.
100% vegan, INDI is hormones, antibiotics, GMO, and gluten free. The formula fully meets the international food standard of the WHO/FAO for infant nutrition (Codex Alimentarius ) in terms of nutritional values, and is medically endorsed by leading paediatric experts (Prof. Ron Shaoul, Paediatric Gastroenterologist at Meyer’s Children’s Hospital in Haifa and Brigitte Cochavi, senior Dietitian at Edmond&Lily Safra Children’s Hospital in Tel Hashomer).
INDI Innovative Non-Dairy Infant Formula