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Primarius portfolio company STAA receives FDA approval for EVO lens.


Summary:

  • Staar Surgical is a commercial stage medical device company that has a product for refractive vision correction (blurred vision).

  • The technology addresses myopic vision correction with a lens-based device using proprietary Implantable Collamer Lenses.

  • The global TAM includes millions of eyes and STAA has executed an initially successful international commercial launch, with significant year over year growth.

  • STAA has demonstrated strong financial performance while still growing over 20% YoY

  • The FDA approval allows STAA to market and sell the newly approved device in the US, which accounts for approximately 910,000 surgeries every year. The company has been investing in bringing awareness to the public about this technology in the US since 2019


Staar Surgical (STAA) recently announced it received FDA approval for its EVO Implantable Collamer Lens for myopia in the US, and will immediately begin sales and marketing efforts. The US is #2 in the lens global market, and the company has seen growth from the EVO launch in China from 2% of market share to 20% of market share. The EVO ICL will replace the legacy technology in the US that only represented less than 1% of market share. The company has been investing in bringing awareness to the US public through a series of campaigns since 2019 in anticipation of approval, and it can be surmised that the company will initially target commercialization in the cities in which the clinical studies were performed.


The EVO ICL has been distributed internationally, with over 1,000,000 lenses implanted

worldwide. The US approval should add significant earnings to STAA's top line throughout the next 2-3 years, and is another long anticipated milestone for the company.


In the Q4 earnings announcement, CEO Caren Mason forecasted another 28% Y/Y sales growth of up to $295M, before the US approval was announced.


While the additional revenue is important to the STAA story, the ability of the management team to execute and consistently obtain FDA approvals on their trials is validating as well.


This a huge and much needed milestone for the commercial stage medical device company. After its market cap increase from $20-30 in early 2020 to trading at over $150 a share in late 2021, the stock price has retreated back to stabilize in the mid $70 range over the past few months. The Q4 earnings call sent shares up 12%, and the FDA approval built on this momentum by adding another 22% gain in one trading day.


We look forward to following STAA's commercial success.

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