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Concept Medical Receives USFDA IDE Approval For MagicTouch AVF Indication

AHMEDABAD: Gujarat based Concept Medical, a leading company in innovative medical device technology, has announced approval of an Investigational Device Exemption (IDE) for its US FDA breakthrough designated MagicTouch AVF for the treatment of stenotic lesions of Arteriovenous Fistula (AVF) in the Haemodialysis management of Chronic Renal Failure.

The Company has been granted four other US FDA IDE approvals for its MagicTouch product portfolio for different indications.

The latest IDE approval for the AVF indication is their 5th in quick succession.

This US FDA IDE approval allows Concept Medical to conduct pivotal clinical studies to gather safety and efficacy data for the Magic Touch Sirolimus Coated Balloon in A.V. fistula and support a future pre-market approval (PMA) application in the USA.

The multiple haemodialysis procedures necessary for the management of chronic renal failure patients often result in repeated blockages of the arteriovenous fistula used for the procedure. MagicTouch AVF is proposed for managing such stenotic lesions of arteriovenous fistula, offering a novel approach that could potentially enhance patient outcomes in haemodialysis, a life-sustaining treatment for those with renal failure.

Dr Manish Doshi, Founder of Concept Medical said, "This approval is not just a testament to our pursuit of innovation but also marks a pivotal moment in our journey to redefine the treatment landscape for haemodialysis patients. We look forward to MagicTouch AVF's positive impact on patient care and are excited about the upcoming clinical trials."

The Company anticipates initiating the AVF IDE clinical trial for MagicTouch SCB in the coming month and are on track to begin enrolment for the currently approved other IDE trials of the MagicTouch product in the US.

Concept Medical is headquartered in Tampa, Florida, and has a global presence with a manufacturing facility in Gujarat. It is engaged in developing innovative drug delivery technology for vascular and non-vascular diseases, utilizing a unique combination of technology and products with proprietary coating technology that delivers pharmaceutical agents across luminal surfaces of blood vessels. Apr 2, 2024

Warburg Buys Majority Stake In Ophthalmic Device Company Appasamy

The latest deal follows Warburg Pincus acquiring about 67% stake in Coimbatore-based bath fittings brand Watertec India at ₹2,600-₹2,800 crore (about $340 million) valuation in 2023. The PE firm's other investments in the Indian healthcare sector include Meril Life Sciences, MedPlus, Laurus Labs, and Metropolis Healthcare.

New Delhi: US private equity firm Warburg Pincus has bought a majority stake in Chennai-based Appasamy Associates, India's largest maker of ophthalmic equipment and intraocular lenses (IOLs). Financial details of the transaction were not disclosed. Appasamy operates across the entire value chain of ophthalmic devices - diagnostic, surgical equipment, and IOLs, according to company statement.

ET was the first to report last July that Warburg Pincus was in advanced stages of talks to acquire Appasamy, having signed an exclusivity agreement, and started due diligence of the company.

Promoters of Appasamy were expecting a valuation of ₹3,000- ₹3,200 crore, ET reported at the time. Warburg planned to buy a 60-70 per cent stake in the company and the business would continue to be run by the current management, ET reported. Post the deal, Appasamy will continue to be led by recently appointed CEO, Senthil Kumar who will drive the business going forward with support of the promoter family and in partnership with Warburg Pincus, according to the statement. Appasamy is also the exclusive distributor for Canon medical equipment in India.

"The promoters and the management team have a distinguished history of successfully running businesses in the ophthalmic industry. Senthil brings great strengths in building and scaling teams and products across geographies, and we are excited to collaborate with him in Appasamy's next phase of growth," said Narendra Ostawal, head of India private equity, Warburg Pincus. Nuvama Investment Banking acted as the exclusive financial advisor to the transaction.

The latest deal follows Warburg Pincus acquiring about 67 per cent stake in Coimbatore-based bath fittings brand Watertec India at ₹2,600-₹2,800 crore (about $340 million) valuation in 2023. The PE firm's other investments in the Indian healthcare sector include Meril Life Sciences, MedPlus, Laurus Labs, and Metropolis Healthcare.

Appasamy started operations in 1978 by introducing India's first low-cost cryo surgical equipment for ophthalmology at ₹1,800, compared to an equivalent imported unit costing ₹20,000.

"It is a matter of great pride for us to witness the evolution of Appasamy, from being just an idea of PSN Appasamy, the founder, to becoming a leading player in the Indian and global ophthalmic space, with remarkable growth over the last 40+ years," said Arvind Kasthuri, from Appasamy's promoter family. The Indian intraocular lens market is dominated by global brands such as Alcon, Bausch Health, Biotech Healthcare Holding GmbH, Carl Zeiss AG, Hoya Holdings, Johnson & Johnson and French lens maker EssilorLuxottica SA.

Among Indian brands, Appasamy is the market leader with about 75 per cent market share. , Apr 12, 2024

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