AVHHL 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• Repositioning PermeaDerm as an alternative to allograft (cadaver skin), leveraging its clinical, economic, and operational advantages to establish a higher-value role in burn care.

• Complete analysis of the results of the clinical studies for Cohealyx and PermeaDerm and prepare for submission of the data for publication;

• Changes in reimbursement rates and coverage policy by third party payors may place additional financial pressure on hospitals and the broader healthcare system. These changes could reduce demand for our products, particularly if healthcare providers face lower margins or additional administrative bu…

• In July 2026, CMS released the 2027 Medicare Physician Fee Schedule (“PFS”), Hospital Outpatient Prospective Payment System, and Ambulatory Surgical Center (“ASC”) proposed rules addressing Medicare payment for Skin Cell Suspension Autograft, the procedure performed using RECELL The proposed rules r…

• In April 2026, RECELL GO received Therapeutic Goods Administration certification in Australia and was listed on New Zealand's Web Assisted Notification of Devices database by Medsafe, enabling commercialization in both markets. These regulatory authorizations expand the international availability of…

相对上期删除的文字 · 来源:10-Q · 2026-05-14

• Advancing post-market clinical studies for Cohealyx and PermeaDerm to generate additional clinical and health economic evidence supporting adoption;

• Changes in reimbursement rates and coverage policy by third party payors may place additional financial pressure on

• hospitals and the broader healthcare system. These changes could reduce demand for our products, particularly if healthcare providers face lower margins or additional administrative burdens. For example, in 2025 the Centers for Medicare & Medicaid Services (“CMS”) designated pricing responsibility f…

• Results of Operations for the three-months ended March 31, 2026 compared to the three-months ended March 31, 2025.

• Sales and marketing expenses decreased by 13%, or $2.0 million, to $12.8 million, compared to $14.8 million in the corresponding period in the prior year. Lower costs in the current year are due to decreases in salaries and benefits of approximately $0.9 million, selling expenses of $0.6 million, an…