Prolacta Bioscience
Prolacta Bioscience is a private life sciences company that develops 100% human milk-based nutritional fortifiers for premature and critically ill infants in hospital NICUs, sold prescription-only to US hospitals with growing international distribution in Japan and Australia.
- Company typePrivate
- Founded1999
- HeadquartersCity Of Industry, United States
- Headcount251–500
- GTM typeB2B
- OfferingHardware or Manufacturing
What Prolacta Bioscience does
Prolacta Bioscience is a privately held life sciences company founded in 1999 and headquartered in Duarte, California, that develops and manufactures 100% human milk-based nutritional products for premature and critically ill infants in neonatal intensive care units (NICUs). The company's core technology is its patented vat pasteurization process, operated in what it describes as the world's first pharmaceutical-grade human milk processing facilities (two locations in California, including City of Industry), supplemented by DNA-matching donor verification modeled on plasma and blood industry standards. Its product portfolio includes Prolact+ H2MF (the original 100% human milk fortifier for extremely premature infants weighing under 1,250g), PreemieFort (the world's first human milk-based fortifier approved as a prescription drug in Japan), Surgifort (the first FDA-approved human milk-based fortifier for term infants recovering from gastroschisis surgery), Humavant (Australian market), and Prolact CR cream supplement.
Prolacta generates revenue through exclusive B2B sales to hospitals under prescription-only distribution, with more than 50% of US Level III/IV NICUs using its products as of 2024. Pricing is quote-based via hospital contracts; the company describes an approximately $10,000 incremental spend per infant over ~60 days of use, offset by roughly $8,167 in hospital cost savings through reduced complications such as necrotizing enterocolitis (NEC). The go-to-market model is enterprise field sales with multi-year contracts, complemented by full implementation services including clinical outcome identification, feeding protocol design, coding/billing/reimbursement support, and staff training. International distribution is channel-based, notably through the Clinigen Group partnership for Japan (Marketing Authorization Holder for PreemieFort) and regional partners for Australia.
The company has raised approximately $78 million in disclosed venture funding across multiple rounds since 2004, with notable participation from Health Evolution Partners, Essex Woodlands Healthcare Partners, Aisling Capital, Alta Partners, and DFJ Mercury. Prolacta has grown to over 300 employees and has supported nutritional care for 125,000+ premature and critically ill infants worldwide since 2007, supported by 30+ peer-reviewed clinical studies including the 2025 JASMINE randomized trial. The company holds FDA food manufacturer registration, state tissue banking licenses (California, New York, Maryland), and the world-first regulatory approvals for human milk-based fortifiers as both a prescription drug (Japan MHLW, late 2025) and a term-infant fortifier (US FDA, Feb 2025).
Prolacta Bioscience firmographics
Firmographics- Name
- Prolacta Bioscience
- Legal name
- Prolacta Bioscience, Inc.
- Website
- https://prolacta.com
- Company type
- Private
- Founded year
- 1999
- Operating status
- Operating
- Headcount range
- 251–500 employees
- Short description
- Prolacta Bioscience is a private life sciences company that develops 100% human milk-based nutritional fortifiers for premature and critically ill infants in hospital NICUs, sold prescription-only to US hospitals with growing international distribution in Japan and Australia.
- Ownership category
- akta.pro rank
Prolacta Bioscience industry classification
Industry- Product category
- Neonatal Nutritional Products
- NAICS
- Dairy Product Manufacturing (3115), Dairy Product (except Frozen) Manufacturing (31151), Dry, Condensed, and Evaporated Dairy Product Manufacturing (311514)
- SIC
- Dairy Products (2020)
- akta.pro primary industry
- Infant Formula & Specialized Dairy Nutrition Manufacturing (AFAKAKAJ)
- akta.pro secondary industries
- Premature & Low-Birth-Weight Infant Formula Manufacturing (AFAHAHAE), Specialized Dairy Nutrition Base Powder & Premix Manufacturing (Vitamin/Mineral/Functional Premixes) (AFAHAHAJ)
Keywords
Where Prolacta Bioscience is headquartered
LocationHeadquarters
- HQ city
- City Of Industry
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Prolacta Bioscience business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Personnel, Supply Chain, Operations, Technology or R&D, Marketing or Sales, Infrastructure
Revenue model
- Hospital Product Sales: Prolacta sells its 100% human milk-based nutritional products exclusively to hospitals for use in NICU settings. Products are prescribed by neonatologists and administered in hospital settings. The company has achieved market penetration with over 50% of Level III/IV NICUs in the US using their products. Pricing is quote-based through hospital contracts.
- International Distribution: Products are distributed internationally through partnerships. Japan market access achieved through Clinigen Group as exclusive licensee and Marketing Authorization Holder. Products also distributed in Australia, Europe, and Middle East.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Prolact+ H2MF for extremely premature infants |
Go-to-market motion3 records
Distribution channels4 records
Marketing channels8 records
Prolacta Bioscience product offering
Product offeringCore offering
Prolacta Bioscience manufactures and sells 100% human milk-based nutritional fortifiers and enteral products (Prolact+ H2MF, PreemieFort, Surgifort, Humavant, Prolact CR Cream) for premature and critically ill infants in NICU settings. The products are made from carefully screened donor breast milk processed in two pharmaceutical-grade manufacturing facilities using vat pasteurization and a patented manufacturing process that retains bioactive components. Products are sold exclusively to hospitals through prescription-based, neonatologist-administered distribution channels in the U.S., Japan, Australia, and other international markets.
Product overview
Prolacta Bioscience offers a portfolio of 100% human milk-based nutritional products for premature and critically ill infants. The core product line includes PreemieFort Enteral Solution (prescription drug for VLBW infants in Japan), Surgifort (FDA-approved for term infants post-gastroschisis surgery), Humavant (for Australia/New Zealand markets), and Prolact+ H2MF (the original human milk fortifier for extremely premature infants). These products are used as part of an Exclusive Human Milk Diet (EHMD) protocol and are supplemented by Prolact CR Cream. All products are made from donor human milk and processed using vat pasteurization to ensure pathogen inactivation while preserving bioactive components.
Differentiator
Problem solved
Functional benefit
Brands
- PreemieFort: 100% human milk-based fortifier approved as prescription drug in Japan and used for vulnerable premature infants
- Humavant
- Surgifort
- Prolact+ H2MF
- Prolact CR
Products and services
- Prolact+ H2MF The first and only human milk fortifier made from 100% human milk for extremely premature infants weighing 2 pounds 12 ounces (1250 grams) or less at birth. A concentrated breast milk-based fortifier with added essential minerals, used in NICU settings as part of an Exclusive Human Milk Diet protocol. Designed for prescription use under neonatologist authority.
- PreemieFort Enteral Solution A 100% human milk-based nutritional fortifier for very low birth weight infants, infants with congenital gastrointestinal disorders, congenital heart diseases, and post-surgical recovery cases. It is the world's first human milk-based nutritional product to receive prescription drug status, achieved in Japan in 2025. Used in NICU settings as part of an Exclusive Human Milk Diet protocol.
- Surgifort The first and only 100% human milk-based fortifier approved by the US FDA for term infants with gastroschisis who have undergone corrective surgical procedures. Supports healing and growth during post-surgical recovery. Made from 100% donor breast milk with essential minerals. Used in NICU and pediatric surgical settings.
- Humavant 100% human milk-based fortifiers available to hospitals in Australia and New Zealand as an alternative to cow milk-based nutritional fortifiers for premature infants. Used as part of the Exclusive Human Milk Diet (EHMD) protocol. Products comply with FSANZ regulation.
- Prolact CR Cream Human milk cream supplement used as part of an Exclusive Human Milk Diet to improve growth outcomes and reduce NICU costs for preterm infants. Provides additional calories and nutrients for very low birth weight infants in NICU settings.
Quantifiable outcome
- 77% reduction in NEC odds for infants 500-1250g when fed human milk with Prolact+ H2MF vs cow milk-based fortifier
- +5 more outcomes
Companies that use Prolacta Bioscience
Customer profileNamed customers5 records
Segments3 records
Ideal customer profiles4 records
Prolacta Bioscience technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Prolacta Bioscience partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core and minor.
- Clinigen GroupcoreClinigen K.K. serves as exclusive licensee and Marketing Authorization Holder for PreemieFort products in Japan. Partnership enabled world-first regulatory approval for human milk-based fortifiers as prescription drugs. Clinigen handles distribution and market access for Japan's specialized neonatal nutrition market.
- Susan G. Komen for the CureminorCharitable partnership through Helping Hands Milk Bank where Prolacta donates $1 to Susan G. Komen for every ounce of qualified breast milk collected. Donations exceeded $406,000 since 2010.
- Make-A-WishminorAnnual sponsorship through Milk for Wishes Milk Bank. Prolacta donates $1 per ounce of qualified breast milk collected. Total donations exceeded $61,000 since 2011 with minimum annual commitment of $30,000.
- International Breast Milk ProjectminorPartnership for international milk donations. Prolacta contributions exceeded $567,000 since 2007. Milk collected through IBMP Milk Bank is primarily shipped to Africa for infants suffering from HIV/AIDS, malnourishment, poverty and disease.
- National Milk BankminorAffiliate milk bank partner that recruits potential breast milk donors for Prolacta. Previously affiliated from 2006-2009; renewed exclusive agreement in September 2011.
- Helping Hands Milk BankminorAffiliate milk bank collecting breast milk from overproducing mothers. For every ounce donated through HHMB, $1 is donated to Susan G. Komen. Has facilitated over $75,000 in donations.
Scale indicators9 records
Recent moves8 records
Expansion highlights7 records
Prolacta Bioscience competitors and assessment
Company assessmentDirect peers
- Abbott Nutrition: Abbott Nutrition (a division of Abbott Laboratories) is a direct competitor through its Similac human milk fortifier and extensive NICU nutritional portfolio. Both Prolacta and Abbott serve Level III/IV NICUs with fortification products, but Prolacta differentiates via 100% human milk vs. cow milk-based formulations.
- Mead Johnson Nutrition (Reckitt): Mead Johnson, owned by Reckitt, produces Enfamil human milk fortifier and preterm infant formulas — the principal cow milk-based alternative to Prolacta's products in US NICUs. Both compete for the same neonatal nutrition prescribing decisions and hospital contracts.
Broad incumbents
- Nestlé Health Science: Nestlé Health Science offers a broad portfolio of specialized pediatric and preterm nutrition products (e.g., PreNAN, peptamen) and is a global incumbent in clinical nutrition. It competes with Prolacta at the hospital formulary level for NICU feeding protocols.
- Danone Nutricia: Danone's Nutricia division produces preterm and specialized infant nutrition products (e.g., Infatrini, Nutrilon) widely used in European NICUs. As a broad incumbent with global distribution, it is a comparable — though diversified — competitor in the neonatal nutrition space.
- Perrigo Nutritionals: Perrigo produces store-brand and private-label infant formulas including preterm formulations distributed in US hospitals and retail. As a broad incumbent in value infant nutrition, it is a comparable player in NICU formula markets though it does not offer human milk-based fortifiers.
Emerging players
- NeoKare: NeoKare is a UK-based human milk processing company producing 100% human milk-based nutritional products for preterm and sick infants in European hospitals. It overlaps with Prolacta's human milk-based positioning but operates regionally and at smaller scale.
- Medolac Laboratories: Medolac Laboratories develops shelf-stable human milk products for neonatal and pediatric nutrition. It is one of the few for-profit competitors to Prolacta in donor human milk-based nutritional products, though its commercial scale has been historically limited.
Others
- Human Milk Banking Association of North America (HMBANA): HMBANA is a non-profit network of donor human milk banks that supply pasteurized donor milk to NICUs. While not a direct competitor in fortified products, HMBANA banks supply raw material to Prolacta and represent the alternative donor milk pathway for hospitals.
Market position
Strengths5 records
Weaknesses3 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
Prolacta Bioscience social profiles
Digital presenceProlacta Bioscience compliance and trust
Trust signalCompliance2 records
Prolacta Bioscience financial estimates
Financial estimateRevenue estimate
Valuation estimate
Prolacta Bioscience leadership team
Management profileNumber of profiles
Profiles15 records
Prolacta Bioscience subsidiaries and ownership
Company hierarchySubsidiaries6 records
Prolacta Bioscience funding detail
Funding detailFunding overview
Funding rounds7 records
Investors13 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Prolacta Bioscience M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Prolacta Bioscience
What does Prolacta Bioscience do?
Prolacta Bioscience manufactures and sells 100% human milk-based nutritional fortifiers and enteral products (Prolact+ H2MF, PreemieFort, Surgifort, Humavant, Prolact CR Cream) for premature and critically ill infants in NICU settings. The products are made from carefully screened donor breast milk processed in two pharmaceutical-grade manufacturing facilities using vat pasteurization and a patented manufacturing process that retains bioactive components. Products are sold exclusively to hospitals through prescription-based, neonatologist-administered distribution channels in the U.S., Japan, Australia, and other international markets.
Is Prolacta Bioscience a public or private company?
Prolacta Bioscience is a private company. It is classified as venture growth investor backed and is currently operating.
When was Prolacta Bioscience founded?
Prolacta Bioscience was founded in 1999. It employs 251 to 500 people.
Where is Prolacta Bioscience based?
Prolacta Bioscience is headquartered in City Of Industry, United States, in the North America region.
How does Prolacta Bioscience make money?
Two revenue lines are on record. Hospital Product Sales are the primary driver. The others are international Distribution.
Who are Prolacta Bioscience's main competitors?
Direct peers on record are Abbott Nutrition and Mead Johnson Nutrition (Reckitt). Broad incumbents are Nestlé Health Science, Danone Nutricia and Perrigo Nutritionals. Emerging players are NeoKare and Medolac Laboratories. Human Milk Banking Association of North America (HMBANA) is listed as an others.
Does Prolacta Bioscience have an API?
No public API is recorded for Prolacta Bioscience.
What industry is Prolacta Bioscience in?
Prolacta Bioscience's product category is Neonatal Nutritional Products. Its primary akta.pro industry code is AFAKAKAJ, Infant Formula & Specialized Dairy Nutrition Manufacturing, with a secondary code of AFAHAHAE, Premature & Low-Birth-Weight Infant Formula Manufacturing. Its NAICS code is 3115 and its SIC code is 2020.