Amblyotech Submits 510(K) Documentation with U.S. FDA for Amblyopad to Treat Amblyopia

Boston, MA, March 9, 2017 (Newswire.com) - Amblyotech Inc., an innovative digital therapy company announced the submission of a 510(k) submission to the U.S. Food and Drug Administration (FDA) of its novel Amblyopad device to treat amblyopia.  Embedded within the Amblyopad is the Binocuclear technology incorporated with two games “Dig Rush” and “Monster Burner” which were developed in cooperation with Ubisoft^®.

“This technology is a patented digital therapy embedded within the Amblyopad, has been clinically tested in children and adults to improve the visual acuity of individuals who suffer from amblyopia, also known as lazy eye.  Amblyopia affects up to 3% of children internationally, and if unsuccessfully treated, is a leading cause of blindness,” stated Joseph Koziak, CEO of Amblyotech.

"This technology is a patented digital therapy embedded within the Amblyopad, has been clinically tested in children and adults to improve the visual acuity of individuals who suffer from amblyopia, also known as lazy eye. Amblyopia affects up to 3% of children internationally, and if unsuccessfully treated, is a leading cause of blindness," stated Joseph Koziak, CEO of Amblyotech.

Joseph Koziak, CEO

“The development of Dig Rush and Monster Burner was a great opportunity for us to contribute our knowledge and skills in video game development to help materialize a breakthrough medical treatment. The team from Ubisoft Montreal has been able to create a more engaging and enjoyable experience for patients being treated for amblyopia, and we’re proud to be involved in such a positive illustration of the impact of video game technology,” said Mathieu Ferland, Senior Producer, Ubisoft.

“McGill University has a proud history of innovation and product development in numerous fields, especially in the life sciences.  It is our pleasure to see one of our invented technologies take the next step to commercialization,” stated Rosie Goldstein, Vice-Principal, Research and Innovation.

*Amblyopia is a disorder that involves decreased vision in one eye occurring early in life as the result of a turned eye or unequal refractive error (meaning that one eye is more powerful than the other). Traditional treatments which include patching of the sighted eye have had minimal effect due to compliance difficulties and other issues such as social stigma and a longer treatment time. Accordingly patching has a high relapse rate among children leaving the condition to be unresolved in adolescents and adults.

About Amblyotech Inc.

Amblyotech Inc. was founded by Joseph Koziak and Robert Derricotte to develop and commercialize novel medical treatments using technologies designed for tablet platforms.  The company plans on building a series of therapies using an electronic interface to improve quality of life. To learn more, please visit www.amblyotech.com.

About Ubisoft

Ubisoft is a leading creator, publisher and distributor of interactive entertainment and services, with a rich portfolio of world-renowned brands, including Assassin's Creed, Just Dance, Tom Clancy's video game series, Rayman, Far Cry and Watch Dogs. The teams throughout Ubisoft's worldwide network of studios and business offices are committed to delivering original and memorable gaming experiences across all popular platforms, including consoles, mobile phones, tablets and PCs. For the 2015–16 fiscal year Ubisoft generated sales of €1,394 million. To learn more, please visit www.ubisoftgroup.com.

© 2017 Ubisoft Entertainment. All Rights Reserved. Ubisoft and the Ubisoft logo are trademarks of Ubisoft Entertainment in the US and/or other countries.

About McGill University

Founded in Montreal, Quebec, in 1821, McGill is a leading Canadian post-secondary institution. It has two campuses, 11 faculties, 11 professional schools, 300 programs of study and some 38,000 students, including 8,800 graduate students. McGill attracts students from over 150 countries around the world, with more than 7,700 international students making up 20 per cent of the student body. Almost half of McGill students claim a first language other than English, including 38 per cent who claim French as their first language.

Information:

Joseph Koziak​ ​CEO, Amblyotech Inc. ​Ph. 857 233 2063 ​Email: [email protected] Heather Haefner ​Ubisoft ​Sr. Manager, Corporate Communications ​Ph. 415 547 4045 ​Email: [email protected]

Source: Amblyotech Inc.