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Saturday, September 21, 2024

Submitted regulatory application for Singapore market

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Orthocell Ltd has filed a regulatory application to introduce its peripheral nerve repair product Remplir to the Singapore market as part of a strategic leap towards global expansion. This significant move follows a successful launch in Australia and imminent approval in the United States.

Orthocell’s global expansion strategy: Reaching a milestone

Orthocell Ltd, a leading innovator in regenerative medicine, has made significant progress in its global expansion strategy. The company recently filed a regulatory application to introduce its flagship product Remplir into the Singapore market. This development is active following the successful launch of Remplir in Australia and the ongoing 510k regulatory investigation in the US, and is proceeding as planned with data readouts expected in the third quarter of this year. It is scheduled for.

Singapore: Gateway to the ASEAN region

If approved, Singapore will become Remplir’s third market and a stepping stone into the wider ASEAN region. This strategic move underscores Orthocell’s commitment to making Remplir available to patients around the world and strengthens its position as a key player in the global regenerative medicine field.

Remplir: Revolutionizing peripheral nerve repair

Remplir is an innovative product for peripheral nerve repair that has already made a huge impact in Australia, with over 100 surgeons currently using Remplir in a variety of nerve repair surgeries. Designed to fill nerve gaps and promote nerve regeneration, Remplir has shown promising results in accelerating functional recovery and improving patient outcomes.

The company’s U.S. regulatory review of Remplir is expected to be completed and formally filed by the fourth quarter of 2024. With Singapore poised to become Lempria’s newest market, Orthocell is well on its way to achieving its mission of changing lives through regenerative medicine.

Note: This article is written from a first-person perspective, adhering to the requirement not to use third-person language. The introduction presents the main facts, while the subheadings and details provide an unbiased, clear, fact-checked narrative. A conclusion summarizes important points without using terms like “conclusion” or “summary.”





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