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AcuFocus Inc. has received approval from Health Canada to market and sell the Kamra inlay, an innovative corneal inlay to treat presbyopia, within Canada.
Irvine, CA-AcuFocus Inc. (www.AcuFocus.com) announces that it has received approval from Health Canada to market and sell its corneal inlay for the treatment of presbyopia (Kamra) within Canada.
The company announced further that it has received a certificate of free sale, which will now open up additional markets, such as Argentina, Russian Federation, Venezuela, Peru, Mexico, India, and Colombia. The inlay is a unique treatment option that uses small-aperture optics to restore near and intermediate vision.
“We are excited to bring the [inlay] to surgeons in Canada so they can offer a sound solution to their [patients with presbyopia],” said Ed Peterson, AcuFocus president and chief executive officer. “We are striving to make the [inlay] available . . . around the world; with our CE Mark, certificate of free sale, and now approval from Health Canada . . . , we are one step closer to achieving that goal.”
To date, the inlay has been implanted in more than 15,000 patients and is now available in more than 40 countries worldwide. The inlay has received the CE Mark and is available in select markets across Europe, the Asia‐Pacific region, the Middle East, and South America. The company anticipates submitting for FDA Approval for distribution in the United States this year.
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