Firm Aims to Market Its Human Milk as Next Best to Mother’s

Elena Medo envisions one day selling pasteurized human milk to children with cancer, heart conditions or AIDS.

But for now, Medo’s company, Prolacta Bioscience Inc., is focused on providing human milk to the tiniest infants born prematurely in the U.S. each year.

Next month, Prolacta plans to begin processing milk donated by nursing mothers and selling it to hospitals with intensive care units for newborns. Backed by some well-known Silicon Valley investors, Medo aims to make milk donation as commonplace as giving blood.

Hospitals now use formula when mothers -- because of stress, illness or other factors -- cannot supply milk for their babies. Less frequently, hospitals tap nonprofit milk banks for donor milk when an infant can’t tolerate formula.

Medo wants to turn that low-key work into a booming business. It’s founded on her belief that human milk -- despite being sterilized and frozen for shipment -- is the next best thing to a mother’s own milk.

But her business faces some challenges. Among them is research by New York neonatologist Richard J. Schanler, who found that infants on donor milk in the first few weeks of life fared no better than babies on formula. His four-year study of 243 premature babies appeared this month in the journal Pediatrics.

Schanler, a professor at Yeshiva University’s Albert Einstein College of Medicine, concluded that valuable substances that protect infants from infection were destroyed when human milk was pasteurized.

Schanler said it was possible that donor milk conferred advantages he didn’t measure. Still, he said, “it sort of makes you wonder.”

Medo, 52, however, is optimistic. Leading a tour of her Monrovia factory last week, she showed off two gleaming stainless steel tanks, similar to those found in dairy plants. The equipment can process enough milk in a year to feed 100,000 hospitalized infants for two months.

Taking a page from the dairy industry, Medo plans to produce two breast milk formulations: regular and high fat for babies who need extra calories. Her products will be packaged in syringes -- premature infants are tube-fed -- and will come with nutrition labels. Under development is a breast-milk-derived “protein booster” to supplement regular feedings.

Some academics, including Ruth Lawrence of the University of Rochester in New York, applaud Medo’s efforts. In fact, her university’s Strong Medical Center is lined up to become Prolacta’s first customer.

“There have been times in the past when [donor] milk has not been available or we have not been able to get as much as we need,” said Lawrence, an advisor to Prolacta. “Now there will be much more milk available.”

As a for-profit venture, Prolacta is causing a stir. The company has received a cool reception from the nine nonprofit milk banks that serve the U.S. market. Laraine Lockhart Borman, director of a nonprofit milk bank in Denver, said Prolacta was poaching on her turf and trying to steal her customers. “They’re being very pushy,” she said.

Others in the breast-feeding community said they were worried that commercialization could lead some mothers to sell their milk.

“I’m very concerned about mothers not giving their babies the benefit of their own milk,” said Nancy Wight, a neonatologist at Sharp Mary Birch Hospital for Women in San Diego.

Medo said she was eager to work with the nonprofits, perhaps by processing their milk. And she insisted that Prolacta would not purchase milk from mothers. But Prolacta is compensating hospitals an undisclosed amount for the donated milk they collect.

Prolacta’s business plan calls for establishing human milk depots at hospitals. As part of the agreement, hospitals would recruit and screen volunteer donors for disease and collect and ship donated milk to Prolacta for processing. Prolacta in turn would provide hospitals with all necessary equipment -- including refrigerators, temperature-controlled shipping cartons and tracking software -- plus payments linked to the volume of milk they provide.

Prolacta also plans to provide hospitals with a public relations program to attract donors. Nursing mothers who agree to donate any amount of milk would receive a free motorized breast pump, a device for siphoning milk.

Despite all the incentives, Strong Medical Center doesn’t believe it would make money from human milk. Hospital staff members must thoroughly screen prospective donors, a process that includes a 40-minute interview. And medical center employees would be responsible for bar-coding, freezing and shipping the donated milk.

“We’re hoping to break even,” said Maureen Freedman, one of the nurses who will manage the program. She said the hospital was participating to benefit its community.

Medo’s interest in breast-feeding began with the births of her four children, now adults. As a nursing mother, Medo became frustrated when she couldn’t find a comfortable breast pump. So she designed one for her own use. Encouraged by friends in the late 1980s, she started a small company in Temecula to manufacture and sell her pumps.

Before long, Medo found herself in a nasty tiff with Medela Inc., a competitor. In 1994, she sued Medela and more than a dozen breast-feeding advocates, including Marianne Eg Neifert, the author of the popular Dr. Mom book series. Medo accused them of badmouthing her product, allegations they denied, according to two people familiar with the litigation. The suit ended in a confidential settlement in 1996, but the spat ruined Medo’s business, she said.

In 1999, she started Prolacta, inspired by her visits to maternity wards when she was selling breast pumps. “I witnessed with my own eyes that babies thrived on human milk,” she said. “I saw a real need.”

Medo did some research and concluded that physicians would welcome a fortified product because milk donated by women with healthy children often lacked sufficient calories for preemies. She drew up an ambitious plan to establish milk depots at every hospital with a neonatal intensive care unit, where low-weight infants -- those under 3 pounds -- were treated during their first weeks of life. Later, as the business grew, she hoped to sell her fortified milk to older children who were sick.

But Prolacta -- the name derived from prolactin, the hormone that stimulates milk production -- was a tough sell to investors, Medo said, particularly those who fed their children formula. Her luck changed in June, when a venture group led by affiliates of Draper Fisher Jurvetson of Menlo Park, Calif., invested $4 million.

David Cremin, founder of DFJ Frontier, says Prolacta is creating a whole new market, as formula makers did a generation ago. The company could become profitable in six months, he said.

“Parents want to give their children healthy food,” he said. “This is the way America is going.”