The company said it is slated to submit an investigational new drug application with the FDA and begin a study of a new implant using its Durasert technology to treat severe osteoarthritis pain in the knee.
Psivida claims the new device would be surgically implanted in the knee and provide sustained delivery of a corticosteroid directly to the joint for approximately 6 months.
“With over 10 million cases of knee osteoarthritis and 700,000 knee replacement surgeries last year in the U.S. alone and a population that is aging and increasingly overweight, a product that would offer a new treatment alternative for the pain of severe osteoarthritis of the knee would be a very welcome clinical development,” CEO Dr. Paul Ashton said in prepared remarks.
For the quarter, pSivida reported losses of $5.1 million, or 17¢ per share, on sales of $409,000 for the 3 months ended June 30.
That amounts to a 29.7% increase in losses on sales growth of 40.1% compared to the same period last year. Losses per share were off from analysts expectations by 4¢ for the quarter.
For the year, the company reported profits of $6.3 million, or 22¢ per share, on $25.6 million worth of revenue for the fiscal year ended June 30.
That amounts to an enormous transition from a $13.4 million loss reported last year, and sales growth of over 600% compared to last year. Earnings per share beat estimates with analysts expecting a loss of 45¢.
Shares have stayed steady with the news, rising a slim 0.3% as of mid-day trading.