Mumbai,
June 11, 2025: In a significant leap for India’s medical device
sector, Renalyx Health Systems Pvt.
Ltd., a healthcare technology innovation company, has unveiled RENALYX – RxT 21,
the world’s first fully indigenous, AI-enabled smart hemodialysis machine. The
company announced plans to invest ₹800 crore over the next four years
to build robust manufacturing capacity and expand access to affordable dialysis
across the country.
Priced competitively at ₹6.70 lakh, RxT 21 is significantly more affordable than imported machines and is designed to bridge the vast demand-supply gap in renal care, particularly in semi-urban and rural India. The machine features real-time remote monitoring, clinical connectivity, cloud integration, and AI-based decision support, setting a new benchmark in dialysis technology.
“With RxT 21, we aim to redefine renal care in
India by making dialysis affordable, accessible, and smarter. Our goal
is to bring this critical service closer to patients and build a globally
competitive medical device ecosystem out of India,” said Dr. Shyam Vasudeva Rao, Founder and
Director, Renalyx Health Systems.
RxT 21 is entirely designed and manufactured in India,
making Renalyx the first Indian company
and the sixth globally to develop an advanced dialysis machine with EU CE certification. The machine
integrates features such as cloud-based Nephrology
Information System (NIS), Electronic
Medical Records (EMR), AI-driven
algorithms, remote diagnostics, and Internet of Medical Things (IoMT) capabilities for 24/7
performance monitoring and clinical oversight.
Expansion
Plans and Global Footprint
Renalyx aims to
manufacture 5,000 units by FY2025-26,
and an additional 1,500 units by FY2027-28
across its manufacturing sites in Bengaluru,
Mysuru, and Mumbai. The
company is also planning indigenous production of dialysis consumables.
To fund its
expansion, Renalyx is in the process of raising equity capital from both Indian
and global investors, alongside promoter investments and debt financing. The
company also plans to explore an IPO route within the next three years.
Initial deployment
of the RxT 21 machines will take place in Maharashtra and Karnataka, followed by a pan-India rollout and exports. Renalyx has already secured
international orders from South Africa,
the USA, and Europe.
Collaborations
and Licensing
Renalyx has
partnered with Bharat Electronics Ltd.
(BEL) to manufacture 6,000 units
of its previously launched model, RxT 17, over the next three years. RxT
17 offers standard dialysis features and will complement the advanced
capabilities of RxT 21 in creating a scalable renal care infrastructure.
The company is also
working on developing a home dialysis
model, reinforcing its commitment to innovation in patient-centric
kidney care. Renalyx will set up franchise
centres across India and overseas in collaboration with partners, and
will install machines at Primary Health
Centres (PHCs), Community Health Centres (CHCs), private centres, and hospitals.
Local service teams and technician training programs have been established to
ensure smooth operations.
Regulatory
Approvals Underway
The CDSCO approval for RxT 21 is in the
final stages and expected by July 2025,
while U.S. FDA clearance is
anticipated by March 2026.
Market
Context
India adds over 2.2 lakh new ESRD (End-Stage Renal Disease)
patients annually, creating a demand for approximately 3.4 crore dialysis sessions, according
to data from the Pradhan Mantri
National Dialysis Program (PMNDP). The launch of an affordable,
indigenous solution like RxT 21 is expected to ease the pressure on India's
renal care ecosystem.
