Byonyks Medical Devices, Inc.
Byonyks Medical Devices is a Chicago-area medical device company founded in 2019 that develops FDA-cleared, needle-free automated peritoneal dialysis cyclers for home treatment of end-stage kidney disease, serving dialysis providers, nephrologists, and healthcare systems across the U.S., South Asia, and other international markets.
- Company typePrivate
- Founded2019
- HeadquartersItasca, United States
- Headcount51–100
- GTM typeB2B
- OfferingHardware or Manufacturing
What Byonyks Medical Devices, Inc. does
Byonyks Medical Devices, Inc. is a privately held medical device company founded in 2019 and headquartered in Itasca, Illinois, that develops automated peritoneal dialysis (APD) cyclers for home-based treatment of end-stage kidney disease (ESKD). Its flagship product, the X-1 APD Cycler, received FDA 510(k) clearance in May 2025, making Byonyks only the third company globally to obtain this clearance. The device delivers bloodless, needle-free dialysis with a touchscreen interface, battery backup, and built-in safety systems including pressure monitoring, leak detection, and emergency shutdown; the company is also developing X2 and X3 next-generation devices featuring biocompatible, acid-free dialysate technology. Byonyks has assembled a leadership team drawn heavily from the dialysis industry, including Rod Kenley (100+ dialysis patents, 40+ years of experience) and other veterans whose prior work contributes to devices used by 62% of U.S. peritoneal dialysis patients.
The company operates an ISO 13485-certified manufacturing facility in Punjab, Pakistan, with R&D centers in Chicago and Lahore, and planned dialysate and tubing/assembly plants in Hyderabad and Gujarat, India. Its revenue model combines hardware sales of the X-1 cycler, recurring revenue from consumables and dialysate, and international licensing, the last of which has supported 10,000+ overseas therapies to date. Distribution follows a dual approach: direct enterprise field sales for the U.S. market (initial rollout in California, Texas, and Illinois beginning February 2026) and channel/licensing partnerships for international markets across South Asia, the Middle East, East Africa, and Europe. Target customers are dialysis providers, nephrologists, and healthcare systems seeking cost-effective home dialysis technology, supported by the U.S. federal mandate to move 80% of ESKD patients to home dialysis or transplant.
Byonyks has raised approximately $21.6M across five funding rounds between 2021 and 2025, including a $1M Form D debt offering in January 2023. The company holds Scientific Advisory Board relationships with former International Society for Peritoneal Dialysis (ISPD) presidents and a clinical partnership with Dr. Andrew King's Home Dialysis Therapies for early U.S. adoption. Strategic positioning targets the $120B global dialysis market and $44B U.S. market, where Byonyks contends that only 13% of U.S. dialysis patients are currently on home therapy despite government targets of 80%, and where it competes against a historical two-player duopoly of incumbent providers.
Byonyks Medical Devices, Inc. firmographics
Firmographics- Name
- Byonyks Medical Devices, Inc.
- Legal name
- Byonyks Medical Devices, Inc.
- Website
- https://byonyks.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Byonyks Medical Devices is a Chicago-area medical device company founded in 2019 that develops FDA-cleared, needle-free automated peritoneal dialysis cyclers for home treatment of end-stage kidney disease, serving dialysis providers, nephrologists, and healthcare systems across the U.S., South Asia, and other international markets.
- Ownership category
- akta.pro rank
Byonyks Medical Devices, Inc. industry classification
Industry- Product category
- Medical Devices
- NAICS
- Surgical Appliance and Supplies Manufacturing (339113), Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)
- SIC
- Surgical & Medical Instruments & Apparatus (3841), Electromedical & Electrotherapeutic Apparatus (3845)
- akta.pro primary industry
- Peritoneal Dialysis (PD) Systems & Supplies (HLAHAKAB)
- akta.pro secondary industries
- Home Dialysis Equipment & Remote Monitoring (HLAHAKAG), Kidney & Dialysis Remote Care (CKD/ESRD monitoring, home dialysis support) (HLALAFAC)
Keywords
Where Byonyks Medical Devices, Inc. is headquartered
LocationHeadquarters
- HQ city
- Itasca
- HQ country
- United States
- HQ region
- North America
Offices6 records
Markets served
Byonyks Medical Devices, Inc. business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Supply Chain, Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure
Revenue model
- Medical Device Sales: Sale of X-1 APD Cycler and future X2 & X3 devices for home peritoneal dialysis. The devices are sold directly to healthcare providers and dialysis centers.
- Consumables and Dialysate: Recurring revenue from consumables including dialysate solutions and tubing for dialysis treatments. The company is also developing on-demand dialysate production technology.
- Overseas Licensing: Revenue from licensing the technology internationally, demonstrated by 10,000+ successful therapies through overseas licenses.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | SEC filing indicates minimum investment of $25,000 |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels6 records
Byonyks Medical Devices, Inc. product offering
Product offeringCore offering
Byonyks Medical Devices designs, manufactures, and distributes the FDA 510(k)-cleared X-1 Automated Peritoneal Dialysis (APD) Cycler for home-based treatment of end-stage kidney disease. The device delivers bloodless, needle-free dialysis with a touchscreen interface, battery backup, and integrated safety systems, targeting dialysis providers, nephrologists, and healthcare systems. The company is also developing next-generation X2 and X3 devices featuring biocompatible, toxin-free dialysate and on-demand dialysate production technology.
Product overview
Byonyks Medical Devices, Inc. is a medical device company focused on home-based peritoneal dialysis solutions. The company has developed the X-1 APD Cycler as its flagship FDA 510(k)-cleared product, an automated peritoneal dialysis machine designed for home use that offers needle-free, bloodless dialysis therapy. The company is also developing X2 and X3 devices as next-generation products to further advance peritoneal dialysis technology. Together, these products aim to disrupt the $120 billion dialysis industry by offering more affordable, patient-friendly, and biocompatible dialysis solutions.
Differentiator
Problem solved
Functional benefit
Products and services
- Byonyks X-1 APD Cycler FDA 510(k)-cleared automated peritoneal dialysis (APD) cycler designed for home use by ESKD patients. Warms dialysis fluid to body temperature, operates needle-free, includes battery backup for uninterrupted therapy, features a touchscreen interface with built-in safety systems (pressure monitoring, leak detection, intelligent alarms, emergency stop), and is sold to dialysis providers, hospitals, and home dialysis programs.
- Byonyks X2 & X3 Next-Generation Peritoneal Dialysis Devices Next-generation peritoneal dialysis devices in development designed to deliver ultra-pure, biocompatible, non-inflammatory dialysis solutions. The combination of X2 and X3 devices is intended to reduce proven inflammatory mediators, allow customization of glucose and bicarbonate concentrations, reduce peritonitis risk, and significantly reduce plastic medical waste compared to typical home PD systems.
- Dialysate Solutions and Dialysis Consumables Recurring consumables for dialysis treatments, including dialysate solutions and tubing used with the X-1 APD Cycler. Includes development of on-demand dialysate production technology aimed at lowering per-treatment cost and supporting home PD adoption in markets with limited supply chains.
- Overseas Dialysis Technology Licensing International licensing of Byonyks' dialysis technology to regional partners and distributors, evidenced by 10,000+ successful therapies delivered through overseas licenses before U.S. commercialization. Provides access to South Asia, Middle East, East Africa, and European markets where APD availability has historically been limited.
Quantifiable outcome
- 10% higher survival rate with peritoneal dialysis vs in-center hemodialysis (U.S. Renal Data System)
- +3 more outcomes
Companies that use Byonyks Medical Devices, Inc.
Customer profileNamed customers2 records
Segments4 records
Ideal customer profiles3 records
Byonyks Medical Devices, Inc. technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
Byonyks Medical Devices, Inc. partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core and minor.
- Home Dialysis TherapiescoreDr. Andrew King, Byonyks' Chief Medical Officer for North America, founded Home Dialysis Therapies in San Diego. This partnership provides clinical expertise and early adopter validation for Byonyks' APD technology, with Denise Barnes R.N. helping establish home-only facilities under this partnership.
- Kidney Beyond BordersminorPartnership with Dr. Irfan Munir, Founder & President of Kidney Beyond Borders, for expanding access to dialysis care globally through collaborative initiatives and shared learning.
- SGS (Geneva)coreObtained official IEC certification from SGS in October 2023, an essential regulatory milestone for international market access and product safety compliance.
- TUV SUD MinnesotacoreObtained IEC approval from TUV SUD Minnesota in 2023, supporting regulatory compliance for the X-1 APD Cycler.
- FiLab (France)coreFiLab France approved biocompatibility tests in July 2023, a critical step in regulatory approval process for medical devices.
- HTW (China)coreHTW China electrical testing lab approved in September 2023, supporting global regulatory compliance for the X-1 device.
Scale indicators9 records
Recent moves9 records
Expansion highlights6 records
Byonyks Medical Devices, Inc. competitors and assessment
Company assessmentDirect peers
- Baxter International: Baxter is the dominant U.S. APD cycler manufacturer (HomeChoice, Amia systems) and the primary incumbent Byonyks must displace. Same product category (home peritoneal dialysis cyclers), same target customers (dialysis providers, nephrologists, ESKD patients), and overlapping direct-sales channels to hospitals and clinics.
- Fresenius Medical Care: Fresenius manufactures the sleep.safe harmony APD cycler and operates the largest U.S. dialysis clinic network (FMCNA), making it both a direct device competitor and a captive customer ecosystem. Directly comparable on product, market, and end-user.
Emerging players
- Outset Medical: Outset Medical's Tablo is a home-use hemodialysis system targeting the same shift to home-based renal care that Byonyks addresses. While hemodialysis rather than peritoneal, both pursue home dialysis economics, payer reform incentives, and inpatient-to-home care migration.
- Quanta Dialysis Technologies: Quanta develops a portable hemodialysis device (SC+) for home and clinic use, targeting the same broader market of patients seeking home-based renal replacement therapy. Comparable on mission and home dialysis focus though different modality (HD vs PD).
- DEKA Research & Development: DEKA partnered with Baxter on APD technology and continues to develop next-generation peritoneal and hemodialysis systems. It represents the type of engineering-driven entrant pursuing innovation in the home dialysis category.
Broad incumbents
- DaVita: DaVita is the largest U.S. dialysis services provider with extensive home dialysis programs. As a key customer of APD cyclers, it is a primary target buyer for Byonyks' X-1 system and benefits from the same regulatory and policy tailwinds.
- B. Braun: B. Braun manufactures the dialog+ hemodialysis system and offers peritoneal dialysis consumables and equipment. While more diversified, B. Braun competes in the renal care space and is a relevant incumbent across PD and HD products.
- NxStage Medical (Fresenius): NxStage pioneered home hemodialysis (System One) and is now part of Fresenius. It represents the home dialysis shift that Byonyks also targets and competes with for clinical mindshare and home dialysis program adoption.
- U.S. Renal Care: U.S. Renal Care is a mid-sized dialysis services provider with growing home dialysis programs, making it a target customer for Byonyks' X-1 cycler and a comparable channel partner in the shift toward home-based renal care.
Regional players
- Terumo: Terumo offers peritoneal dialysis products and dialysate solutions in Asia and other international markets, overlapping with Byonyks' overseas licensing footprint and serving comparable ESKD patient populations in geographies where the U.S. company is also expanding.
Market position
Strengths4 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
Byonyks Medical Devices, Inc. social profiles
Digital presenceByonyks Medical Devices, Inc. compliance and trust
Trust signalCompliance3 records
Byonyks Medical Devices, Inc. financial estimates
Financial estimateRevenue estimate
Valuation estimate
Byonyks Medical Devices, Inc. leadership team
Management profileNumber of profiles
Profiles15 records
Byonyks Medical Devices, Inc. funding detail
Funding detailFunding overview
Funding rounds5 records
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Byonyks Medical Devices, Inc. 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 Byonyks Medical Devices, Inc.
What does Byonyks Medical Devices, Inc. do?
Byonyks Medical Devices designs, manufactures, and distributes the FDA 510(k)-cleared X-1 Automated Peritoneal Dialysis (APD) Cycler for home-based treatment of end-stage kidney disease. The device delivers bloodless, needle-free dialysis with a touchscreen interface, battery backup, and integrated safety systems, targeting dialysis providers, nephrologists, and healthcare systems. The company is also developing next-generation X2 and X3 devices featuring biocompatible, toxin-free dialysate and on-demand dialysate production technology.
Is Byonyks Medical Devices, Inc. a public or private company?
Byonyks Medical Devices, Inc. is a private company. It is classified as venture growth investor backed and is currently operating.
When was Byonyks Medical Devices, Inc. founded?
Byonyks Medical Devices, Inc. was founded in 2019. It employs 51 to 100 people.
Where is Byonyks Medical Devices, Inc. based?
Byonyks Medical Devices, Inc. is headquartered in Itasca, United States, in the North America region.
How does Byonyks Medical Devices, Inc. make money?
Three revenue lines are on record. Medical Device Sales are the primary driver. The others are consumables and Dialysate and overseas Licensing.
Who are Byonyks Medical Devices, Inc.'s main competitors?
Direct peers on record are Baxter International and Fresenius Medical Care. Emerging players are Outset Medical, Quanta Dialysis Technologies and DEKA Research & Development. Broad incumbents are DaVita, B. Braun, NxStage Medical (Fresenius) and U.S. Renal Care. Terumo is listed as a regional player.
Does Byonyks Medical Devices, Inc. have an API?
No public API is recorded for Byonyks Medical Devices, Inc..
What industry is Byonyks Medical Devices, Inc. in?
Byonyks Medical Devices, Inc.'s product category is Medical Devices. Its primary akta.pro industry code is HLAHAKAB, Peritoneal Dialysis (PD) Systems & Supplies, with a secondary code of HLAHAKAG, Home Dialysis Equipment & Remote Monitoring. Its NAICS code is 339113 and its SIC code is 3841.