dimecres, 4 de novembre del 2015

Allergan acquires EarFold ear implant assets

AllerganAllergan (NYSE: AGN) said today it agreed to acquire Northwood Medical’s EarFold implant technology designed to correct prominent ears, with or without asymmetry, in patients 7 years or older.

The device from London-based Northwood is a small implantable strip of nitinol metal alloy that is inserted under the skin and grips ear cartilage, enhancing or creating the shape of the anti-helical fold and reducing ear prominence, the company said.

“EarFold technology adds another innovative product to our medical aesthetics product portfolio, especially for the plastic surgeons we serve today, and has the potential to expand the number of patients interested in corrective surgery as it provides an alternative treatment that may appeal to those who have been reluctant to undergo traditional surgical procedures. Many of Allergan’s plastic surgery customers currently perform otoplasty procedures, emphasizing our commitment to serving the unmet needs and practice of plastic surgery,” Allergan international brands prez Paul Navarre said in a press release.

The EarFold device won CE Mark approval in the European Union in April this year, Allergan said.

Upon the closure of the acquisition, Allergan intends to commercialize the product “widely across Europe,” and will continue to explore regulatory pathways and requirements to commercialize the device in other countries, including the U.S.

Also following closure of the deal, Allergan will “establish a standarized training program” for surgeons using the EarFold to expand the treatment option availability and “ensure effective and safe outcomes,” the company said.

“Following a complex outcome after a standard otoplasty procedure, early in my career, I was motivated to develop an alternative approach to correcting prominent ears. In my clinical practice, there are a significant number of patients who are reluctant to undergo surgery and so put up with accepting the social hindrance of prominent ears. The beauty of the earFold™ treatment system is that it offers an evidenced-based alternative to standard otoplasty surgery that may meet the needs of a wider range of patients, by delivering immediate and predictable results, without the risks associated with general anaesthetic,” EarFold creator Norbert Kang said in prepared remarks.

Last month, Allergan said it closed its $300 million, all-cash acquisition of AqueSys and its Xen soft glaucoma stent, in a deal that also includes unspecified milestone payments.

The device made by Aliso Viejo, Calif.-based AqueSys is designed to treat glaucoma by shunting intra-ocular fluid from the anterior chamber of the eye into the sub-conjunctival space. The company raised a $43.6 million Series D funding round and closed enrollment in U.S. clinical trial of the Xen Gel stent in January 2014. Allergan announced the deal last month.

The post Allergan acquires EarFold ear implant assets appeared first on MassDevice.



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