Aequus Pharmaceuticals Inc (CVE:AQS) (OTCQB:AQSZF) announced Tuesday a positive update on the regulatory and launch advancement for the Evolve line of preservative-free dry eye products into Canada.
Medicom Healthcare, the UK manufacturer of Evolve products, has received a positive outcome of the audit to meet standards for the Canadian Medical Device Single Audit Program (MDSAP), Aequus said in a statement.
The MDSAP, fully implemented by Health Canada in January 2019, establishes a new audit standard for all medical device manufacturers that distribute in Canada, including those with existing marketed products.
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As a result, there has been a large demand for the completion of audits and delays have been experienced across the industry.
Aequus said it is pleased that the Medicom audit met the Canadian regulatory standards and is "excited to have this important regulatory step achieved for these new-to-the Canadian market medical devices."
As the auditing bodies prepare the formal MDSAP certificate, Canadian launch planning is fully underway. Adaptability to the current and coming circumstances as a result of the coronavirus (COVID-19) pandemic is being integrated into strategic business models, the company said.
These include the development of an e-commerce distribution channel for product access during self-isolation, as well as the establishment of strategic B2B partnerships for clinical distribution as workers return to the healthcare sector, which will bolster existing “boots on the ground” sales infrastructure, Aequus said.
“During this time, Aequus is working diligently to prepare for a new normal, by crafting innovative models that integrate existing retail structures, with more wide-reaching virtual channels,” said Anne Stevens, COO of Aequus.
“These models will virtually support Canadian optometry clinic retailers who have been forced to close during the pandemic, while simultaneously expanding the availability of Evolve products to patients at launch.”
No issues with the supply chain for Evolve products are anticipated, as Medicom continues to manufacture and distribute to 35 countries, and has been further developing and launching new products during this period, the company said
Aequus said it looks forward to providing Canadian patients and clinicians with the Evolve range of dry eye products and expects to file for approval with Health Canada upon receipt of the formal MDSAP certificate, expected in June or the third quarter.
The company added it will be providing separate updates on additional progress and access to new dry eye products in the coming weeks.
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