COMPANY
What does Prolacta do?
Prolacta offers the first and only Human Milk Fortifier made from 100% human milk, which is added to a mother's own milk, or to donor milk, for premature and critically ill babies in the neonatal intensive care unit.
Are there other companies or organizations that offer Human Milk Fortifier?
Prolacta is the first and only company to provide a fortifier made from 100% human milk. Prolacta’s products are specialty formulations of human milk that meet the nutritional needs of premature and critically ill infants, as prescribed by neonatologists.
Is Prolacta a for-profit company?
Yes. We would not be able to provide these products under a non-profit business model. We have invested over 10 million dollars in research and facilities to meet the needs of critically ill infants.
Is Prolacta a milk bank?
We assist in the organization of independently run and operated affiliate milk banks. The only exception to this is the International Breast Milk Project Bank (IBMPB), which we organized to support the International Breast Milk Project (IBMP). This organization provides free donor breast milk to infants who have been orphaned by HIV in Africa.
Are you competing against nonprofit milk banks?
We are not in competition with any organization because we are the only company to provide Human Milk Fortifier from human breast milk. We have similar missions but provide different products and services. It is our objective to provide the best possible nutritional products made from 100% human milk for the Neonatal ICU.
PRODUCTS
What are your products?
Prolacta offers the only human milk fortifier derived from 100% human milk, as opposed to cow’s milk. This provides a preemie with the nutrition necessary to support appropriate growth and development. Prolacta also offers human milk products that have been formulated to specific caloric content. These products are critical to premature infants who require food with more protein and calories than mothers' milk can provide.
Where and how are your products being used?
Prolacta's complete human milk solutions are used in neonatal intensive care units for the most fragile babies. Products are being used at NICUs across the nation.
How do you get breast milk for your products?
Similar to the blood donation model, Prolacta collects milk from milk banks that have donors who have been carefully screened and tested donors.
How do I know Prolacta’s products will work?
There has never before been an alternative to bovine fortifier. A growing body of evidence from individual case reports and ongoing clinical trials indicate babies having used Prolacta's Human Milk Fortifier products had positive results. Studies have also demonstrated that for infants in the NICU, human milk decreases the incidence of diseases such as necrotizing enterocolitis (NEC), and sepsis (infection).
PREMATURE AND CRITICALLY ILL BABIES
Why is it vital that premature and critically ill babies are fed specific amounts of calories, fat, protein and minerals?
Critically ill premature babies have special dietary needs requiring higher levels of protein and nutrients than a full term baby would need. These would have been provided by the blood delivered through a mother's placenta during the last weeks of pregnancy -these nutrients are important because the babies' bones and tissues are still developing.
What is the current standard of care for premature and critically ill babies in the NICU?
The current standard of care uses bovine-based milk products for critically ill preemies, who can become intolerant to these preparations.
What is the average size baby that uses Prolacta products?
Under 1500 grams (3.3 pounds)
Can I still try to feed my baby breast milk?
Absolutely. A mother's milk is the gold standard. However, premature babies have special dietary needs that are different than a full term baby's needs. Prolacta's Human Milk Fortifier in combination with your own milk may provide optimal nutrition for these fragile babies.
Does Prolacta have proof that human milk is better than formula?
There are several studies that demonstrate the superiority of human milk over bovine milk, as the best nutrition for babies.
SAFETY & PROCESSING
How do I know the products are safe?
Prolacta uses state of the art formulation, pasteurization, and filling processes to ensure the highest possible level of product safety and quality.
Is Prolacta regulated by any federal or state agencies?
Yes. Prolacta products are regulated by the FDA, as a food. Prolacta's facility is licensed as a Tissue Bank by the State of California.
Are there any side effects?
There are currently no known side effects.
How does Prolacta process breast milk and test for safety?
The initial screen is based on the blood banking industry model: first a general health screening is conducted; then the potential donor must pass various blood tests including those for HTLV, hepatitis B, C, HIV 1 and 2, and syphilis. Donated milk is then tested for drugs of abuse, and for biological contamination (specific types of bacteria). The milk undergoes DNA "fingerprinting" to ensure that it came from the qualified donor. If all tests pass, then milk goes to processing. Prolacta has a proprietary process that kills bacteria and viruses. However, the milk is tested in final container form for the presence of these same bacteria and viruses.
How are Prolacta products different from milk donated without your process and screening?
Prolacta's Human Milk Products are formulated to meet very specific nutritional targets defined as optimal for critically ill, very low birth weight premature infants in the Neonatal ICU. Prolacta's Human Milk Products are labeled with a nutritional facts label to support the precision necessary in feeding these fragile infants.
How is Prolacta regulated?
Prolacta products are regulated by the FDA, as a food. Prolacta's facility is licensed as a Tissue Bank by the State of California.
DONORS
How are donors screened prior to donating milk?
The initial screen is based on the blood banking industry model: first a general health screening is conducted; then the potential donor must pass various blood tests including those for HTLV, hepatitis B, C, HIV 1 and 2, and syphilis. Donated milk is then tested for drugs of abuse, and for biological contamination (specific types of bacteria). The milk undergoes DNA "fingerprinting" to ensure that it came from the qualified donor. If all tests pass, then milk goes to processing. Prolacta has a proprietary process that kills bacteria and viruses. However, the milk is tested in final container form for the presence of these same bacteria and viruses.
Does Prolacta pay donors?
Prolacta does not provide donors with financial compensation.
How does Prolacta find and screen donors?
Prolacta itself does not find donors. Affiliate milk banks work directly with the donors. Prolacta then processes the donor milk.
PRODUCT COSTS
How much does it cost to feed one baby per day?
Price is entirely dependent on the size and gestational age of the baby.
Do Prolacta products cost more than milk from a milk bank?
This is an apples to oranges comparison. We provide human milk preparations that have been formulated to achieve consistent caloric and protein targets. Our best selling product is a Human Milk Fortifier made from 100% human milk, it is the first and only commercially available fortifier made from human milk and is currently only available from Prolacta. Among many other things, targeted formulation, added minerals, proprietary processing, and nutritional facts labeling make Prolacta a pioneer in specialty human milk formulations. For these reasons, our products are not directly comparable to those available from milk banks.
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