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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.
https://timesofindia.indiatimes.com/city/ahmedabad/conceptmedical-receives-usfda-ide-approval-for-magictouch-avfindication/articleshow/108982543.cms
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.
https://health.economictimes.indiatimes.com/news/medicaldevices/warburg-buys-majority-stake-in-ophthalmic-devicecompanyappasamy/109230863?utm_source=top_news&utm_medium=sectionListing
, Apr 12, 2024
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