The Aroa Biosurgery Ltd (ASX: ARX) share price has closed 7.69% higher today after announcing it has secured United States Food and Drug Administration (FDA) clearance for one of its products, 'Symphony'. In addition, the company received European approval for its product, 'Myriad', and released an investor presentation today.
The New Zealand-based Aroa is a soft tissue regeneration company focused on improving the rate and quality of healing in complex wounds and soft tissue reconstruction.
Symphony FDA clearance
Symphony is designed to reduce complex wound healing time in the proliferative phase where normal healing is impaired due to disease.
Its pending commercial launch in 2021 presents a major expansion in Aroa's product portfolio in the US. Pleasingly, the launch will take the company's addressable market to more than $2.5 billion, up from $1.5 billion previously.
Aroa CEO Brian Ward said "Symphony will give clinicians a new option to treat some of their most hard to heal patients, in what we estimate is a US market size of US$1.15 billion for the product".
European approval for Myriad
Aroa's product, Myriad, has received the 'CE mark' to allow commercialisation in the European Union. Myriad supports rapid tissue growth for dermal tissue reconstruction. The company expects the launch of the product to occur in 2021.
The FDA clearance in June 2017 led to first sales earlier this year. Additionally, it is estimated the total addressable market size for the product globally is US$350 million.
July investor presentation
According to its investor presentation, all Aroa's products are based on its proprietary Endoform platform technology which is a unique Extracullular Matrix (ECM) derived from sheep forestomach.
Additionally, the company says its technology offers superior regenerative performance at a significantly lower cost than other biologics enabling more patients to have access to the benefits of regenerative healing.
The company's products have competitor protection due to the patents it owns. This includes 10 patents and 25 pending patent applications across 6 patent families. Aroa has 5 patented products selling across the US alone.
Pleasingly, the company's revenue has grown from $8.43 million in FY18 to $21.92 million in FY20. Furthermore, its product gross margin of 71% in FY20 has expanded compared to 36% in FY18. It is earnings before tax, depreciation and amortisation (EBITDA) positive in FY20 on a proforma basis.
Aroa Biosurgery share price performance
The Aroa Biosurgery share price closed today's trade at $1.54 which represents a 14.07% increase since it listed on the ASX just last Friday.
