Allegra Orthopaedics Limited (ASX: AMT), the provider of a wide range of orthopaedic products including the Active Total Knee, is also the exclusive distributor of Waldemar Link Gmbh &Co. KG products in Australia. Link has an extensive range of solutions covering right from complex lower limb solutions, to the hip and knee replacements and the varied oncology solutions. The extensive set of products of Link together with the AMT’s wide range of products supports the distribution of the products from international suppliers that cover solutions for right foot and ankle to upper limb. AMT with its strong existing research relationship with the companies, universities and surgeon inventors along with its global license for the composite biocompatible ceramic material known as Sr-HT-Gahnite is working towards the construction of its extensive portfolio of patents.
AMT had a meeting with the USA’s Food and Drug Administration (FDA), in Washington DC on November 7, 2018. The meeting was held with regards to the discussion for the approval process needed for the release of Sr HT-Gahnite spinal cage device into the USA.
Sr-HT-Gahnite spinal fusion device is used for the regeneration of the bones under spinal load conditions which are completely resorbed by the body, making body free from any kind of foreign entity. Recent animal studies have concluded that, being the first degradable structural porous biocompatible ceramic material that is available for medical implant, the device has the capability to achieve spinal fusion in the absence of added bone grafts recording a reduced operative time taking into consideration the clinical limitations associated with the existing spinal fusion device. The limitation associated with the device is minimal bone integration and contribution to infection. Extensive design of the device has a network of 3D-printed pores that allow bone growth and does not need a large central cavity to hold bone graft.
In this meeting, FDA has clearly indicated that a large animal, study conducted for a period of 6 months to 12 months will be sufficient to reach to a conclusion and prove the success of this device without a large central hole. FDA will require to carry a small human confirmatory study to ensure that the results from the large animal, study are representative of clinical benefits in the human population.
On November 21, i.e. today, AMT has provided an update in line with the recent meet organized on November 7, 2018. AMT has released a media update announcing the positive response made by FDA towards the small human study that is taking place in Australia. Chief Executive officer, Jenny Swain, mentioned this recent update from FDA as a significant milestone for Allegra which will further provide a regulatory approval into the US markets. With this update AMT shares have made a new 52 week high and lastly traded at $0.22. The group is now eyeing the USA market with the above developments.
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