Developer docs
API playgroundTry for free, no card

Search company profiles

Nephrodite

Full company profile

uuid000c4hm

Namestring
Nephrodite
Legal namestring
Nephrodite, Inc.
Websiteurl
nephrodite.com
Company typeenum
Private
Founded yearint
2020
Descriptiontext

Nephrodite, Inc. is a private, pre-clinical medical device company developing Holly™, the first implantable continuous dialysis system designed to replace intermittent, clinic-based hemodialysis for patients with end-stage kidney disease (ESKD). Holly combines a surgically implanted hemofilter placed in the pelvis and connected to larger blood vessels with an external interface and a portable home unit used nightly, eliminating the need for arm grafts, fistulas, and thrice-weekly clinic visits that currently consume 600–800+ hours per patient per year. The system is built on a proprietary hemofiltration membrane platform augmented with edge computing, on-board intelligent sensors, and cloud connectivity that streams patient data for remote physician monitoring and individualized therapy adjustment; biocompatible materials are engineered for long-term implantation with no observed clotting, hemolysis, or leakage in the first successful 72-hour large animal study at the University of Michigan. The intended patient population comprises the 850,000+ US and ~3.5 million global ESKD patients — including bridge-to-transplant and destination-therapy cohorts — served via an enterprise field sales motion into transplant centers, dialysis clinics, and major health systems, with planned hardware sales of the device and a recurring consumables annuity from scheduled cartridge replacement. The company is headquartered in Atlanta, Georgia (with an operations presence in Mumbai, India), was founded in 2020 by Dr. Nikhil Shah and Dr. Hiep Nguyen, has 11–50 employees, and has secured FDA Breakthrough Device Designation (Dec 2025) plus FDA TAP selection (June 2026) — both firsts for an implantable kidney replacement system — while actively raising capital to fund GLP studies and first-in-human trials.

Short descriptiontext

Nephrodite is a private medical device company developing Holly™, an implantable continuous dialysis system for end-stage kidney disease patients. Founded in 2020 and based in Atlanta, the company is pre-commercial, holding FDA Breakthrough Device Designation and TAP selection as it prepares for first-in-human trials.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersAtlanta, United States
HQ citystring
Atlanta
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices2 records

Each record includes

City, Country, Type, Description, Source

Keyword5 values
implantable dialysis device, continuous renal replacement therapy, hemofiltration membrane platform, end-stage kidney disease treatment, portable home dialysis system
Industry3 codes
1Hemodialysis Machines & Systems
CodeHLAHAKAAPrimaryYes
2Home Dialysis Equipment & Remote Monitoring
CodeHLAHAKAGPrimaryNo
3Renal Replacement Therapy Consumables (Bloodlines, Filters, Cartridges)
CodeHLAHAKAHPrimaryNo
NAICS code1 code
  • Electromedical and Electrotherapeutic Apparatus Manufacturing334510
SIC code2 codes
  • Surgical & Medical Instruments & Apparatus3841
  • Electromedical & Electrotherapeutic Apparatus3845
Product category
Implantable Dialysis Devices
Social media profiles2 records
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model2 records
1Holly Implantable Dialysis Device
TypeHardware Sales
Description

Medical device sales model for the Holly implantable continuous dialysis system. The device consists of an internal implant and external interface with portable home unit, along with cartridge-based membrane system for scheduled replacement. Revenue will come from device sales, consumables (replacement cartridges), and associated professional services for implantation and follow-up care.

nephrodite.com
2Cartridge/Membrane Consumables
TypeSubscription Recurring
Description

Recurring revenue from cartridge-based membrane replacement system. The external interface connects to a small portable home unit used nightly, with scheduled cartridge replacement creating a recurring consumables revenue stream.

nephrodite.com
Marketing channels4 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components5 values
Technology or R&D, Personnel, Operations, Marketing or Sales, Others
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Brand1 record
1Holly™
Description

An implantable, continuous dialysis system designed to provide sustained toxin clearance and fluid balance without the burden of intermittent, clinic-based dialysis. Also referred to as Holly™ by Nephrodite.

nephrodite.com
Core offering1 text field

Nephrodite is developing Holly™, an investigational implantable continuous dialysis system for end-stage kidney disease. The product consists of a surgically implanted filter placed in the pelvis area connected to larger blood vessels, paired with an external interface and portable home unit used nightly, along with a cartridge-based membrane system for scheduled replacement. The device is designed to continuously filter waste, balance fluids, and manage electrolytes inside the body without requiring frequent clinic visits, freeing ESKD patients from thrice-weekly dialysis center treatment.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 4 values shown
  • First successful multi-day continuous kidney function replacement in a living organism (72-hour sheep study)
+3 more records
Product overview1 text field

Nephrodite offers the Holly™ platform, a first-of-its-kind implantable continuous dialysis system. The product consists of a surgically implanted filter paired with an external interface and portable home unit. The implantable component is placed in the pelvis area and connected to blood vessels, while the external interface enables nightly dialysis support and remote physician monitoring. The platform is designed as a true kidney replacement therapy alternative for patients with end-stage kidney disease.

Product and service1 record
1Holly™ Implantable Continuous Dialysis System
CategoryImplantable Dialysis Devices
Description

An implantable, continuous dialysis system for end-stage kidney disease patients that combines a surgically implanted hemofilter placed in the pelvis and connected to larger blood vessels with an external interface and portable home unit used nightly, plus a cartridge-based membrane system for scheduled replacement. The device continuously filters waste, balances fluids, and manages electrolytes inside the body, freeing patients from thrice-weekly in-center dialysis, needle sticks, and arm grafts while enabling at-home or on-the-go treatment with remote physician monitoring. It is designed as a true kidney replacement therapy alternative for use as continuous therapy, bridge-to-transplant, or destination therapy.

Scale indicator7 records

Each record includes

Type, Value, Description, Source

Partnership6 partners
Strategic tierCoreTypeStrategic or Co-development PartnerAnnounced on2026-03-20
Description

ATDC is Georgia Tech's technology business incubator. Nephrodite joined ATDC's HealthTech portfolio and received coaching, programming, regulatory guidance, and access to Georgia Tech labs, facilities, prototyping support, and clinical advisors. The company was selected from thousands of applicants for CDL Rockies Prime stream. ATDC's HealthTech vertical is sponsored by Catalyst by Wellstar and includes medical devices, biotech, and digital health companies.

2Center for MedTech Excellence (Georgia Tech)
Strategic tierMinorTypeStrategic or Co-development Partner
Description

Georgia Tech program providing additional support and resources for medical technology development alongside ATDC participation.

nephrodite.com
Strategic tierMinorTypeStrategic or Co-development Partner
Description

State program providing manufacturing expertise and support for product development and commercialization.

4Conrad Jobst Vascular Research Laboratories, University of Michigan
Strategic tierCoreTypeStrategic or Co-development Partner
Description

Conducted the successful 72-hour multi-day large animal study demonstrating continuous kidney function replacement in a living sheep model. This critical preclinical milestone validated the Holly device's safety and performance.

nephrodite.com
Strategic tierCoreTypeStrategic or Co-development Partner
Description

Seed-stage program for science-based companies providing objectives-based mentoring over nine months. Nephrodite was selected from thousands of applicants for the Rockies Prime stream and graduated in 2022, gaining access to experienced entrepreneurs, investors, and scientists for mentorship and guidance.

Strategic tierMinorTypeStrategic or Co-development Partner
Description

Technology business incubator at University of Texas where Nephrodite was added to its client portfolio as a life science company developing innovative implantable dialysis technology.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight6 records

Each record includes

Type, Description

Peers8 records
TypeBroad incumbent
Description

World's largest dialysis services and products company, operating thousands of dialysis centers and manufacturing dialysis machines and consumables. A potential strategic acquirer and the dominant incumbent Nephrodite must displace or partner with in the U.S. ESKD market.

TypeBroad incumbent
Description

Global medical device and pharmaceutical company with a significant peritoneal dialysis (PD) portfolio and renal care franchise. A potential strategic acquirer and incumbent in the broader renal replacement therapy market Holly targets.

TypeDirect peer
Description

Maker of the Tablo Hemodialysis System, a console-based home and in-clinic dialysis device targeting the same ESKD patient population as Nephrodite's Holly. Most directly comparable as a venture-backed disruptor pursuing simpler, patient-friendly dialysis outside the clinic.

4Wearable Artificial Organs Inc. (WAK)
TypeEmerging player
Description

Developer of the Wearable Artificial Kidney, a wearable dialysis device targeting continuous ambulatory dialysis. Closely comparable as an early-stage alternative modality pursuing freedom from chair-based dialysis for the same ESKD population.

TypeEmerging player
Description

Developer of the SC+ portable hemodialysis system, a compact device for home and clinic use targeting the same patient population as Holly. A direct emerging competitor pursuing simpler, portable dialysis outside traditional centers.

TypeBroad incumbent
Description

Large medical device incumbent with renal denervation and broader device franchises, providing a strategic acquirer profile and overlapping expertise in implantable, sensor-enabled therapeutic devices similar to Holly.

TypeEmerging player
Description

Developer of a portable hemodialysis system for use across in-clinic, acute, and home settings. Comparable as a venture-stage competitor pursuing flexible, patient-centric dialysis modalities.

TypeBroad incumbent
Description

Largest U.S. dialysis services provider, operating the majority of outpatient dialysis clinics and increasingly invested in home dialysis modalities. Represents both a major customer channel and a competitive incumbent for any new dialysis technology adoption.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat5 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights7 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment1 record

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile2 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
Yes
API detail
Has APIbool
No

Docs URL, Description

AI capability3 records

Each record includes

Type, Description, Source

AI maturity
App detail

Has app

Feature4 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles3 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Nephrodite

Implantable Dialysis Devicesnephrodite.com

Nephrodite is a private medical device company developing Holly™, an implantable continuous dialysis system for end-stage kidney disease patients. Founded in 2020 and based in Atlanta, the company is pre-commercial, holding FDA Breakthrough Device Designation and TAP selection as it prepares for first-in-human trials.

What Nephrodite does

Nephrodite, Inc. is a private, pre-clinical medical device company developing Holly™, the first implantable continuous dialysis system designed to replace intermittent, clinic-based hemodialysis for patients with end-stage kidney disease (ESKD). Holly combines a surgically implanted hemofilter placed in the pelvis and connected to larger blood vessels with an external interface and a portable home unit used nightly, eliminating the need for arm grafts, fistulas, and thrice-weekly clinic visits that currently consume 600–800+ hours per patient per year. The system is built on a proprietary hemofiltration membrane platform augmented with edge computing, on-board intelligent sensors, and cloud connectivity that streams patient data for remote physician monitoring and individualized therapy adjustment; biocompatible materials are engineered for long-term implantation with no observed clotting, hemolysis, or leakage in the first successful 72-hour large animal study at the University of Michigan. The intended patient population comprises the 850,000+ US and ~3.5 million global ESKD patients — including bridge-to-transplant and destination-therapy cohorts — served via an enterprise field sales motion into transplant centers, dialysis clinics, and major health systems, with planned hardware sales of the device and a recurring consumables annuity from scheduled cartridge replacement. The company is headquartered in Atlanta, Georgia (with an operations presence in Mumbai, India), was founded in 2020 by Dr. Nikhil Shah and Dr. Hiep Nguyen, has 11–50 employees, and has secured FDA Breakthrough Device Designation (Dec 2025) plus FDA TAP selection (June 2026) — both firsts for an implantable kidney replacement system — while actively raising capital to fund GLP studies and first-in-human trials.

Nephrodite firmographics

Firmographics
Name
Nephrodite
Legal name
Nephrodite, Inc.
Website
https://nephrodite.com
Company type
Private
Founded year
2020
Operating status
Operating
Headcount range
11–50 employees
Short description
Nephrodite is a private medical device company developing Holly™, an implantable continuous dialysis system for end-stage kidney disease patients. Founded in 2020 and based in Atlanta, the company is pre-commercial, holding FDA Breakthrough Device Designation and TAP selection as it prepares for first-in-human trials.
Ownership category
akta.pro rank

Nephrodite industry classification

Industry
Product category
Implantable Dialysis Devices
NAICS
Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
SIC
Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)
akta.pro primary industry
Hemodialysis Machines & Systems (HLAHAKAA)
akta.pro secondary industries
Home Dialysis Equipment & Remote Monitoring (HLAHAKAG), Renal Replacement Therapy Consumables (Bloodlines, Filters, Cartridges) (HLAHAKAH)

Keywords

  • Implantable dialysis device
  • Continuous renal replacement therapy
  • Hemofiltration membrane platform
  • End-stage kidney disease treatment
  • Portable home dialysis system

Where Nephrodite is headquartered

Location

Headquarters

HQ city
Atlanta
HQ country
United States
HQ region
North America

Offices2 records

Markets served

Nephrodite business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

  1. Holly Implantable Dialysis Device: Medical device sales model for the Holly implantable continuous dialysis system. The device consists of an internal implant and external interface with portable home unit, along with cartridge-based membrane system for scheduled replacement. Revenue will come from device sales, consumables (replacement cartridges), and associated professional services for implantation and follow-up care.
  2. Cartridge/Membrane Consumables: Recurring revenue from cartridge-based membrane replacement system. The external interface connects to a small portable home unit used nightly, with scheduled cartridge replacement creating a recurring consumables revenue stream.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Nephrodite product offering

Product offering

Core offering

Nephrodite is developing Holly™, an investigational implantable continuous dialysis system for end-stage kidney disease. The product consists of a surgically implanted filter placed in the pelvis area connected to larger blood vessels, paired with an external interface and portable home unit used nightly, along with a cartridge-based membrane system for scheduled replacement. The device is designed to continuously filter waste, balance fluids, and manage electrolytes inside the body without requiring frequent clinic visits, freeing ESKD patients from thrice-weekly dialysis center treatment.

Product overview

Nephrodite offers the Holly™ platform, a first-of-its-kind implantable continuous dialysis system. The product consists of a surgically implanted filter paired with an external interface and portable home unit. The implantable component is placed in the pelvis area and connected to blood vessels, while the external interface enables nightly dialysis support and remote physician monitoring. The platform is designed as a true kidney replacement therapy alternative for patients with end-stage kidney disease.

Differentiator

Problem solved

Functional benefit

Brands

  • Holly™: An implantable, continuous dialysis system designed to provide sustained toxin clearance and fluid balance without the burden of intermittent, clinic-based dialysis. Also referred to as Holly™ by Nephrodite.

Products and services

  • Holly™ Implantable Continuous Dialysis System An implantable, continuous dialysis system for end-stage kidney disease patients that combines a surgically implanted hemofilter placed in the pelvis and connected to larger blood vessels with an external interface and portable home unit used nightly, plus a cartridge-based membrane system for scheduled replacement. The device continuously filters waste, balances fluids, and manages electrolytes inside the body, freeing patients from thrice-weekly in-center dialysis, needle sticks, and arm grafts while enabling at-home or on-the-go treatment with remote physician monitoring. It is designed as a true kidney replacement therapy alternative for use as continuous therapy, bridge-to-transplant, or destination therapy.

Quantifiable outcome

  • First successful multi-day continuous kidney function replacement in a living organism (72-hour sheep study)
  • +3 more outcomes

Companies that use Nephrodite

Customer profile

Segments1 record

Ideal customer profiles2 records

Nephrodite technology and API

Technology

Technology focussed Yes

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature4 records

Nephrodite partnerships and signals

Strategic signal

Partnerships

Six partnerships are on record, tiered core and minor.

  • ATDC (Advanced Technology Development Center) at Georgia TechcoreStrategic or Co-development Partner · 20 March 2026ATDC is Georgia Tech's technology business incubator. Nephrodite joined ATDC's HealthTech portfolio and received coaching, programming, regulatory guidance, and access to Georgia Tech labs, facilities, prototyping support, and clinical advisors. The company was selected from thousands of applicants for CDL Rockies Prime stream. ATDC's HealthTech vertical is sponsored by Catalyst by Wellstar and includes medical devices, biotech, and digital health companies.
  • Center for MedTech Excellence (Georgia Tech)minorStrategic or Co-development PartnerGeorgia Tech program providing additional support and resources for medical technology development alongside ATDC participation.
  • Georgia Manufacturing Extension PartnershipminorStrategic or Co-development PartnerState program providing manufacturing expertise and support for product development and commercialization.
  • Conrad Jobst Vascular Research Laboratories, University of MichigancoreStrategic or Co-development PartnerConducted the successful 72-hour multi-day large animal study demonstrating continuous kidney function replacement in a living sheep model. This critical preclinical milestone validated the Holly device's safety and performance.
  • Creative Destruction Lab (CDL)coreStrategic or Co-development PartnerSeed-stage program for science-based companies providing objectives-based mentoring over nine months. Nephrodite was selected from thousands of applicants for the Rockies Prime stream and graduated in 2022, gaining access to experienced entrepreneurs, investors, and scientists for mentorship and guidance.
  • Austin Technology IncubatorminorStrategic or Co-development PartnerTechnology business incubator at University of Texas where Nephrodite was added to its client portfolio as a life science company developing innovative implantable dialysis technology.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Nephrodite competitors and assessment

Company assessment

Broad incumbents

  • Fresenius Medical Care: World's largest dialysis services and products company, operating thousands of dialysis centers and manufacturing dialysis machines and consumables. A potential strategic acquirer and the dominant incumbent Nephrodite must displace or partner with in the U.S. ESKD market.
  • Baxter International: Global medical device and pharmaceutical company with a significant peritoneal dialysis (PD) portfolio and renal care franchise. A potential strategic acquirer and incumbent in the broader renal replacement therapy market Holly targets.
  • Medtronic: Large medical device incumbent with renal denervation and broader device franchises, providing a strategic acquirer profile and overlapping expertise in implantable, sensor-enabled therapeutic devices similar to Holly.
  • DaVita: Largest U.S. dialysis services provider, operating the majority of outpatient dialysis clinics and increasingly invested in home dialysis modalities. Represents both a major customer channel and a competitive incumbent for any new dialysis technology adoption.

Direct peers

  • Outset Medical: Maker of the Tablo Hemodialysis System, a console-based home and in-clinic dialysis device targeting the same ESKD patient population as Nephrodite's Holly. Most directly comparable as a venture-backed disruptor pursuing simpler, patient-friendly dialysis outside the clinic.

Emerging players

  • Wearable Artificial Organs Inc. (WAK): Developer of the Wearable Artificial Kidney, a wearable dialysis device targeting continuous ambulatory dialysis. Closely comparable as an early-stage alternative modality pursuing freedom from chair-based dialysis for the same ESKD population.
  • Quanta Dialysis Technologies: Developer of the SC+ portable hemodialysis system, a compact device for home and clinic use targeting the same patient population as Holly. A direct emerging competitor pursuing simpler, portable dialysis outside traditional centers.
  • Diality: Developer of a portable hemodialysis system for use across in-clinic, acute, and home settings. Comparable as a venture-stage competitor pursuing flexible, patient-centric dialysis modalities.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Nephrodite social profiles

Digital presence

Nephrodite financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Nephrodite leadership team

Management profile

Number of profiles

Profiles3 records

Nephrodite funding detail

Funding detail

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Nephrodite M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Nephrodite

What does Nephrodite do?

Nephrodite is developing Holly™, an investigational implantable continuous dialysis system for end-stage kidney disease. The product consists of a surgically implanted filter placed in the pelvis area connected to larger blood vessels, paired with an external interface and portable home unit used nightly, along with a cartridge-based membrane system for scheduled replacement. The device is designed to continuously filter waste, balance fluids, and manage electrolytes inside the body without requiring frequent clinic visits, freeing ESKD patients from thrice-weekly dialysis center treatment.

Is Nephrodite a public or private company?

Nephrodite is a private company. It is classified as venture growth investor backed and is currently operating.

When was Nephrodite founded?

Nephrodite was founded in 2020. It employs 11 to 50 people.

Where is Nephrodite based?

Nephrodite is headquartered in Atlanta, United States, in the North America region.

How does Nephrodite make money?

Two revenue lines are on record. Holly Implantable Dialysis Device is the primary driver. The others are cartridge/Membrane Consumables.

Who are Nephrodite's main competitors?

Broad incumbents on record are Fresenius Medical Care, Baxter International, Medtronic and DaVita. Outset Medical is listed as a direct peer. Emerging players are Wearable Artificial Organs Inc. (WAK), Quanta Dialysis Technologies and Diality.

Does Nephrodite have an API?

No public API is recorded for Nephrodite.

What industry is Nephrodite in?

Nephrodite's product category is Implantable Dialysis Devices. Its primary akta.pro industry code is HLAHAKAA, Hemodialysis Machines & Systems, with a secondary code of HLAHAKAG, Home Dialysis Equipment & Remote Monitoring. Its NAICS code is 334510 and its SIC code is 3841.

Unlock the full company data

50 free credits on sign-up, no credit card required.

Contact sales
Live signals
MedicalEconomicsNephrodite’s implantable dialysis system selected for FDA program to advance kidney replacement therapy developmentNephrodite Inc. has been selected to participate in the U.S. Food and Drug Administration’s Total Product Life Cycle Advisory Program (TAP) for its implantable dialysis system, Holly. This selection follows a Breakthrough Device Designation received in late 2025 and aims to accelerate regulatory alignment ahead of planned Good Laboratory Practice studies and early feasibility trials. The program is intended to reduce regulatory uncertainty and support the development of a continuous renal replacement therapy alternative to traditional clinic-based dialysis.The Times of IndiaFor kidney patients, the biggest change may be coming: New artificial kidney implant will filter blood continuosly without regular hospital dialysisAtlanta-based medical device company Nephrodite, co-founded by urologists Dr Nikhil Shah and Dr Hiep Nguyen, has developed Holly, an implantable artificial kidney that filters blood continuously inside the body, and received FDA breakthrough device designation in 2025 following successful sheep studies. The device, which connects to a bedside machine only for water removal, is being manufactured in Kochi, Bengaluru, and Mumbai with human trials expected to begin in India after animal studies in 2027. India bears one of the world's largest kidney disease burdens with over two lakh end-stage kidney disease patients diagnosed annually, of whom only 6-10% access dialysis and barely 1% receive transplants.The Times of IndiaNew kidney implant can do dialysis without needle pricksA new implantable device called 'holly' designed for kidney function has been developed by Nephrodite, a medical device company, and is currently in pre-clinical trials in India. It aims to replace traditional dialysis by continuously filtering waste, potentially improving quality of life for kidney failure patients.NewsBytesNephrodite's Holly implant could help Indians with end-stage kidney diseaseNephrodite's Holly is an implantable artificial kidney surgically placed inside the body, connecting to pelvic blood vessels to filter waste around the clock. It could help more than 200,000 Indians with end-stage kidney disease each year, eliminating regular hospital trips and painful dialysis needles.BriefglanceFDA Fast-Track Signals New Era for Kidney Care with an Implantable DeviceNephrodite, Inc. announced that its Holly™ implantable continuous dialysis device has been selected for the FDA's Total Product Life Cycle Advisory Program (TAP), placing it among an elite cohort of innovators receiving proactive regulatory guidance. The device, designed to free end-stage kidney disease patients from thrice-weekly dialysis clinic visits, received FDA Breakthrough Device Designation in late 2025 and is also aligned with CMS's new RAPID program, which aims to grant Medicare coverage within months of FDA authorization. The company is now preparing for Good Laboratory Practice (GLP) studies and early human trials as it advances toward commercialization.MedicaldesignandoutsourcingFDA picks Nephrodite’s implantable dialysis system for TAP pilotNephrodite has been selected for the FDA's Total Product Life Cycle Advisory Program (TAP) pilot for its implantable Holly dialysis system, which previously received Breakthrough Device Designation. The startup plans to utilize the RAPID pathway to coordinate requests for FDA authorization and Medicare coverage while preparing for early feasibility trials. This regulatory milestone aims to expedite patient access to the device, which serves as an alternative to traditional clinic-based dialysis for end-stage kidney disease patients.Mpo-magNephrodite’s Continuous Dialysis Implant Chosen for FDA’s TAP ProgramNephrodite announced its Holly implantable continuous dialysis system was chosen for the FDA's TAP program. The company will use TAP to align with GLP studies and prepare for early feasibility trials. CEO Nikhil Shah said the recognition supports clinical development and aims to reduce regulatory uncertainty.MedTech IntelligenceTwo GA Tech ATDC Startups — Nephrodite and OrthoPreserve — Secure FDA Breakthrough Device DesignationThe Advanced Technology Development Center (ATDC) at Georgia Tech announced that two of its health technology portfolio companies, Nephrodite and OrthoPreserve, have received FDA Breakthrough Device Designation. The designation provides these startups with accelerated FDA review, including shorter response times, more frequent meetings, and prioritized review, bringing their medical technologies one step closer to market. Nephrodite is developing an artificial kidney technology for dialysis patients, while OrthoPreserve is creating a meniscus implant to address chronic knee pain and potentially prevent knee replacement surgery.News CenterATDC Startups Secure Rare FDA ‘Breakthrough Device’ StatusThe Advanced Technology Development Center at Georgia Tech announced that two of its HealthTech portfolio companies, Nephrodite and OrthoPreserve, received the FDA Breakthrough Device designation, a rare achievement obtained by only about 40% of applicants. Nephrodite is developing a continuous artificial kidney for dialysis patients that is surgically implanted and paired with an external interface, while OrthoPreserve is creating a minimally invasive meniscus implant to address recurring knee pain after surgery. Both companies are raising capital and preparing for human trials, with OrthoPreserve seeking a $2 million seed round and targeting a $1.5 billion U.S. market opportunity.Daily Medical News‘A bridge to transplant’: Implantable dialysis device receives FDA breakthrough statusNephrodite received FDA breakthrough status for its implantable kidney replacement system, the Holly device, aimed at patients with end-stage kidney disease. This device is designed to remove toxins during the day and excess water at night, ultimately aiming to bridge patients to kidney transplants. The company is focusing on developing this technology further to improve treatment for kidney disease.