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The company believes SMT is the ideal partner for the Australian market, with its established relationships with oral surgeons and a successful track record driving market entry of high-quality products.
The company believes the new principal investigators’ clinical experience in psychedelic-assisted therapies will help develop its evidence-based and scalable clinical services for patients with major mental health concerns.
Twelve months on from Orthocell’s CelGro® nerve regeneration trial, a data readout has indicated more than three-quarters of all nerve repairs conducted during the clinical study resulted in functional recovery.
The patents cover the method of using CelGro® to repair a defect in soft tissue, such as tendons, ligaments and nerves, avoiding the use of damaging sutures.
Patents were filed after signal analysis of Emyria’s clinical data, one of the largest trials-grade clinical registries for medicinal cannabis, and extensive review of the global literature and patent landscape.
The data show that on average opioid consumption reduces after commencing care at Emerald Clinics from a previous 12 month steady-state of opioid use.
China and Hong Kong have granted patents to the product, which is used to augment ligament repair surgeries.
A Class IIa classification applies to software that is intended to provide information used to make decisions with diagnostic or therapeutic purposes.
The company has been granted a trading halt by the ASX pending an announcement and securities will remain halted until Thursday, May 13 or when the announcement is released to the market.
EMDMA-001 has been modelled on a major Phase III clinical trial developed by the Multidisciplinary Association for Psychedelic Studies (MAPS).
Orthocell is well-positioned to establish CelGro® as the best-in-class membrane for bone and soft tissue repair and to realise multiple commercial partnering opportunities.
EMD-003 is being developed to reduce anxiety, depression and stress symptoms while the company is also advancing EMD-004 targeting irritable bowel syndrome.
The breakthrough results position CelGro® as the potential market leader in nerve regeneration and restoration of voluntary muscle control in patients with tetraplegia or paralysed upper limbs with a strategic evaluation of medical device U
The company is now well placed to achieve current milestones for its registration plans for EMD-003 targeting mental health concerns and EMD-004 for irritable bowel syndrome (IBS) which is under development.
Under the agreement, Emyria’s EMD-003 drug development program will use Cann Group’s proprietary Gelpell microsphere technology, to seek a Schedule 3 registration for treating unmet needs in mental health.
In 2021, the company is focused on delivering and completing the required pivotal clinical trials required to successfully register EMD-003 and further expanding its clinical services nationally to meet demand.
The prostheses list defines the minimum value of benefit private insurers pay for CelGro® Dental used in approved dental bone and soft tissue repair procedures.
The expansion comes off the back of record patient appointments in January 2021 and a recently announced expansion in Victoria.
Buoyed by its financial and operational strength, the company is focused on advancing the development and commercialisation of its treatments for mental health conditions and IBS.
The appointment of highly acclaimed and experienced Dr Karen Smith boosts the company’s global clinical trial and regulatory approval expertise to accelerate drug registration initiatives.
