Decentralized dialysis fluid manufacturing

Making life-saving dialysis fluid where it's needed.

Peritoneal dialysis fluid is more than 95% water. So instead of shipping water around the world, Meld Bio is developing a system for producing sterile PD fluid at the point of care.

01  /  The bottleneck

Peritoneal dialysis is crippled by its own weight.

Today's PD fluid is manufactured centrally, then freighted in heavy bags across continents. That weight — more than the mass of an adult, every month, per patient — is the single biggest reason most of the world can't access a therapy that would save them.

500lbs
Water per patient, per month
95%+
Of PD fluid is water
02  /  Our approach

Decentralized manufacturing, near the point of care.

One compact compounder, two simple consumables. Installed at provider locations, the system produces over 100 liters of sterile PD fluid per hour — drawing water from local sources, combining it with premixed APIs, and filling bags through a proprietary contamination-free technology.

I
Compounder
Class I device
Produces water-for-injection from local sources, then mixes and fills. Cleanroom-free. Operator-scale.
II
Premixed APIs
USP API Certification
Concentrated active ingredients, manufactured centrally under USP. Small, light, easy to ship.
III
Bags
Class II device
Sterile packaging filled on demand at the point of care. Shelf stable for months, not hours.
The four steps  /  purify → mix → sterilize → package
I  /  PURIFY
Generate water-for-injection
Purification from any local water source — the 95% of the fluid that used to be shipped.
II  /  MIX
Aseptically combine concentrates
Premixed APIs meter into the purified water under aseptic conditions.
III  /  STERILIZE
Novel non-thermal sterilization
Our proprietary method replaces terminal heat — no degradation, low energy.
IV  /  PACKAGE
Aseptic fill into sterile bags
Contamination-free filling yields fluid stable for months at the point of care.
03  /  What makes this possible

Months of shelf life, without heat.

Existing on-demand compounding methods require fluid to be used within hours. Terminal heat sterilization is costly, energy-intensive, and can degrade the product. Our proprietary non-thermal sterilization is what makes decentralized, high-volume production actually viable.

Existing on-demand compounding
Hours
Fluid must be used immediately after production. No buffer, no continuity, no scale.
Meld Bio sterilizationIP PENDING
Months
Low cost, low energy, no heat damage. Supply chains you can actually build a service around.
Single-operator capacity
1,000 liters per day
Compact, cleanroom-free footprint. One room. Enough fluid to treat dozens of patients every single day.
04  /  Who's building this

Engineering, clinical, and commercial expertise — built for access.

Co-founder  /  CEO
Carolyn Bernemann
MS
Design engineering and medical device development.
Co-founder  /  CTO
Natasha Wright
PhD
Decentralized water and fluid systems.
Co-founder  /  CIO
Ibrahim Yekinni
MBBS, MS
Translational medicine and clinical deployment.
Clinical, Scientific & Commercial Advisors
Michelle Rheault, MD
Clinical
Dennis Schneider
Regulatory
Craig Else, PharmD
Pharmacy
Adam Edwinson, PhD
Microbiology
Martha Sewall, MBA
Commercial