Completed BLA Submission for ReNu
On April 28 the company completed its BLA submission to the FDA for ReNu, a potential nonsurgical biologic for symptomatic knee osteoarthritis — a key regulatory milestone supporting future growth in a large unmet market.
Positive Randomized Controlled Trial for PuraPly AM
A prospective, multicenter RCT of 170 patients evaluating PuraPly AM plus standard of care vs standard of care alone met its primary endpoint, demonstrating statistically significant wound closure at 12 weeks (p < 0.0477), reinforcing clinical evidence that may support future coverage.
Evidence of Market Share Gains Despite Market Contraction
Management reported that unit volumes outperformed industry declines and estimated core brands (excluding Apligraf) were down ~22% versus an estimated market contraction of ~63%, indicating relative share gains amid disruption.
Non-GAAP Gross Margin Stronger Excluding One-Time Adjustments
Excluding inventory write-downs, non-GAAP gross profit was $14.8M, or 41% of net product revenue, vs GAAP gross profit of $10.5M (29%), showing underlying margin resilience absent discrete charges.
Cost Reduction Actions and Expected Annualized Savings
A March restructuring (88 employees and closure of St. Petersburg facility) is expected to yield approximately $14M of annualized cost reductions; additional estimated cost savings of ~$7M are expected in 3Q/4Q 2026.
Reduced Operating Expenses Year-Over-Year (Excluding COGS)
Non-GAAP operating expenses (excluding cost of goods sold) were $80.3M versus $89.7M last year, a decrease of $9.4M or ~10% year-over-year, reflecting SG&A reductions.
Improving Sequential Trends and Positive Adjusted EBITDA Target for H2
Management reported month-to-month improvement into April, expects sequential revenue improvement through the year, and continues to target positive adjusted EBITDA generation in the second half of 2026 with normalized profitability in Q4.
Solid Liquidity and No Debt
As of March 31, 2026 the company held $92.1M in cash, cash equivalents and restricted cash (down slightly from $94.3M at December 31, 2025), had no outstanding debt and up to $75M availability under its revolving facility.