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Hot Pursuit News

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(16 Jan 2025, 11:13)

Shalby gains on USFDA clearance for knee replacement device

Shalby rallied 3.50% to Rs 230.60 after its step down subsidiary, Shalby Advanced Technologies (SAT) Inc., USA, received U.S. Food and Drug Administration (FDA) 510(k) premarket notification clearance for Duraniom on 14 January 2025.


Duraniom is the company’s primary total knee replacement device with TiNbN coating.

Based on the safety and effectiveness data, the US drug regulator has determined the device is substantially equivalent to legally marketed predicate devices.

Shalby is the largest chain of multi-specialty hospitals in Western and Central India. It was founded by arthroplasty specialist, Dr. Vikram Shah. It performs more than 14,000 joint replacement surgeries a year and in the last 29 years has performed more than 1,45,000 joint replacements. It operates under three main verticals, namely, hospital business, Shalby Orthopedics Centre of Excellence (SOCE) franchise and implant business.

The company’s consolidated net profit dropped 87.71% to Rs 3.39 crore despite 12.42% increase in revenue from operations to Rs 267.53 crore in Q2 FY25 over Q2 FY24.

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