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FAQs

I’ve heard that using Prolact+ H2MF® can actually save hospitals money. Is that true?

Yes. A study in the Journal of Breastfeeding Medicine found that extremely premature infants fed an exclusively human milk diet including the only human milk-based HMF, Prolact+ H2MF®, had lower expected costs of hospitalization, resulting in net direct savings of $8,167.17 per infant. The study also found that extremely premature infants who were not diagnosed with NEC spent approximately 3.9 fewer days in the NICU than infants who were diagnosed.

Is Prolacta Bioscience a for-profit company?

Yes. We have invested over 40 million dollars in research, clinical studies and facilities to develop and test our human milk derived products. This world class research and development would not have been possible in a non-profit business model.

Is Prolacta a milk bank?
Prolacta has set up a network of affiliated milk collection organizations. These organizations can be found in hospitals, birthing centers, or associated with charities. Depending on the organization, they share the responsibilities of qualifying the donors and collecting the milk with Prolacta. All affiliated milk collection organizations have all milk sent to Prolacta for processing.

What does Prolacta do with the milk they collect through the affiliated milk banks?
The milk that is collected through affiliated milk banks is tested, pasteurized and formulated into nutritional products exclusively for in hospital use. The formulations are made specifically to feed critically ill premature babies that are in the NICU. The donations do not serve as substitutes for mother’s milk if a baby is not under hospital care.

What are your products?
Prolacta’s commitment to Advancing the Science of Human Milk® has led us to develop and offer the only liquid HMF derived from 100% human milk, as opposed to other HMFs, which are derived from cow’s milk. Our line of liquid human milk-based fortifiers, Prolact+ H2MF®, provide Very Low Birth Weight (VLBW) premature infants with the nutrition necessary to support appropriate growth and development. Prolacta’s human milk-based products have been formulated to deliver exact caloric and protein levels every time. These products are critical to premature infants in the NICU who require higher levels of protein and calories than can be provided by mothers’ milk alone.

Where are your products being used?
Prolacta’s completely human milk formulations are used in hospitals throughout the world, for the most fragile babies.

How do I know my preemie will benefit from Prolacta’s fortifier products?
A recent study published in the Journal of Pediatrics showed that when added to human milk, Prolact+ H2MF® clinically reduced the odds of developing NEC by 77% in premature infants weighing 500 g – 1250 g at birth, when compared to infants receiving a cow’s milk-based HMF (also commonly called breast milk fortifier) or, when mother’s milk was unavailable, preterm infant formula. Earlier studies have also demonstrated that for infants in the NICU, human milk decreases the incidence of diseases such as necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD), and sepsis (infection).

Why does my baby need a human milk fortifier?
Premature babies, especially babies that weigh 2 pounds 12 ounces or less at birth, have very special nutritional needs. For example, premature babies need more energy to grow than term babies. Premature babies also grow at a rapid pace, so they need more protein than term babies. Prolact+ H2MF® is the only human milk fortifier (also commonly called breast milk fortifier) made from breast milk, and it helps provide the additional nutrients your baby needs.*
*Kleinman R, ed. Pediatric Nutrition Handbook. 6th ed. 2009: 31-39

If a baby is prescribed Prolacta’s human milk products, how much does it cost a parent?
Prolacta never charges a parent for product. The cost of Prolacta products is, in most cases, under two percent of the total cost of care for a VLBW infant. Prolacta’s products are treated in the same manner as most products used to provide patient care in hospital. In many cases medical insurance covers the cost of the products. In other cases hospitals are willing to absorb the cost. In fact, hospitals and the health care system save money using Prolact+ H2MF® because of the cost savings realized due to the reduced incidence and severity of NEC seen in our clinical trial.

What does Prolacta do?
Prolacta is a research driven company dedicated to advancing the science of human milk. We produce and sell specialty nutritional formulations made exclusively from human milk for critically ill premature infants in the NICU. All our products are clinically proven to meet the needs of these infants. Prolacta is the first and only company to produce an HMF made from 100% human milk, Prolact+ H2MF®. It is added to mothers’ own milk or to donor milk.

How do I know that Prolacta’s products are safe?
Our dedication to Advancing the Science of Human Milk® has led us to build a one-of-a-kind, state of the art manufacturing facility. Our products have been safely used in NICUs throughout the United States and Europe. We use the most sophisticated and innovative processes, pasteurization, and filling methods to ensure the highest possible level of product safety and quality. This includes final testing for microbiological and viral contamination. Viruses are detected using polymerase chain reaction, which is a method that can detect as little as one copy of the virus in a sample by amplifying a short sequence of the viral DNA (or RNA) to create many copies.

Is Prolacta regulated by any federal or state agencies?
Yes. Prolacta products are regulated by the FDA. Prolacta’s facility is licensed as a tissue bank by the states of California, New York and Maryland, which require such a license for human milk banking.

How are breastmilk donors screened prior to donating milk?
Breastmilk donations follow a rigorous screening process based on the blood banking model. Prolacta is the only organization that uses these combined safety steps:

  1. Potential breastmilk donors are screened through a medical history survey. After the screening, the donor is entered into Prolacta’s secure database and assigned a donor number.
  2. Once the potential donor passes the medical history survey, she must obtain written approval from her physician and her baby’s pediatrician before she can continue in the donation process.
  3. The potential donor measures the temperature in her freezer with a thermometer provided by Prolacta. The temperature must be cold enough to store human milk or, unfortunately, the potential donor may not donate.
  4. A blood test and a DNA cheek swab are conducted. The blood test screens for several infectious agents including HIV 1&2, HTLV I&II, HBV, HCV, and syphilis. The DNA cheek swab is used to create a donor DNA ID. This DNA ID will be used later to ensure the milk received is from the donor that was blood tested.
  5. If the potential donor passes the screening and meets all of the requirements outlined above, she is qualified to be a breast milk donor for a four month period. After four months, if she wishes to continue donating, she must complete a new medical history survey and have another blood test.

Why is Prolacta no longer co-promoting products with Abbott?

Effective Jan. 1, 2014, Abbott and Prolacta Bioscience will no longer co-promote Prolacta products.

When we first began co-promoting Prolacta products, both companies had relatively small product portfolios for premature babies. Over the years, both of our businesses have grown and we both now have extensive portfolios of products. To provide the best service to our customers, both companies decided it was best to focus on supporting their respective portfolios.

Why should I donate?
If you have excess breast milk, you can donate it to be processed into specialty formulations and sold to hospitals to help meet the nutritional needs of critically ill premature infants in neonatal intensive care units. Many moms donate their extra milk to help babies in need because they have had a preterm baby in the past or know someone who has had that experience. Breast milk donors report a sense of satisfaction knowing they are providing their milk to help provide the added nutritional needs to sick premature infants.

Why do you conduct DNA testing on Donors?
The DNA matching step is necessary so that the milk we receive is matched to our qualified donors. This safety step ensures that only milk from qualified moms is accepted for production.

We start by having the prospective donor provide a sample of cheek cells that we can use to create a unique Donor ID. We extract the DNA from the cheek cells and use it to create a series of 32 numbers that are unique to that donor. Only identical twins share the same profile. Two of the numbers in the profile tell us whether the DNA comes from a man or a woman.

Once the donors milk arrives, we take a sample of the DNA found in the milk and generate a Milk ID. We then look to make sure that the Donor ID and Milk ID profiles match. We can also see if there are multiple Milk ID profiles in the same donation, indicating there are two or more different mothers’ milk is contained in the donation.

The only information that we generate about the donor from her DNA are the Donor and Milk IDs. We do not generate any other genetic information about the donor. The Donor ID contains no information about the donor’s health or heredity. Prolacta does not retain samples of the donor’s isolated DNA once the matching of donor to donation is complete. The only thing that is retained is the 32 number Donor ID.

While there are other ways to match a donor to a tissue sample, this technique is considered the most accurate and is the gold standard.