ORGO — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-07

• Local Coverage Determinations (LCD) and CMS Proposed and Final Rules

• On April 25, 2024, seven MACs published new proposed LCDs for skin substitute grafts/CTPs for the treatment of DFUs and VLUs in the Medicare population. These LCDs were finalized by the MACs on November 14, 2024, and were originally set to become effective on February 12, 2025. However, on January 2…

• On November 5, 2025, CMS released a final rule adopting policy changes for Medicare payments under the PFS and other Medicare Part B issues, effective on or after January 1, 2026. On November 25, 2025, CMS issued a final rule that adopted policy

• changes for Medicare payments under the Hospital OPPS, effective on or after January 1, 2026. For calendar year 2026, under the PFS and OPPS final rules, CMS will pay for certain skin substitute products, at a payment rate of approximately $127.14 per square centimeter (prior to the application of t…

• On January 1, 2026, CMS began testing the WISeR Model which uses technology-enabled prior authorization services on select Medicare services, including the use of skin substitutes. The WISeR Model will run in six states for five years and, according to CMS, is intended to reduce waste. Implementatio…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• As previously disclosed, manufacturing of Dermagraft was suspended in the fourth quarter of 2021 and sales of Dermagraft were suspended in the second quarter of 2022. We currently plan to transition our Dermagraft manufacturing to our newly-leased biomanufacturing facility in Smithfield, Rhode Islan…

• ReNu is a cryopreserved suspension derived from human amniotic membrane and cells derived from amniotic fluid. The initial target indication for ReNu is for the management of symptoms associated with knee osteoarthritis (“OA”). We are in the planning

• stages for clinical studies of ReNu to support the management of symptoms associated with hip OA, and we believe ReNu may have potential as a treatment for additional OA and tissue regeneration applications, which would need to be clinically evaluated further before any such approved uses. As used h…

• We completed a Phase 3 prospective, multicenter, double-blind, randomized, saline-controlled clinical trial to evaluate the efficacy of amniotic suspension allograft (“ASA”) in patients with knee OA, and completed topline analysis in the second quarter of 2024. We reported results consistent with th…

• On September 25, 2025, we announced an update on our second Phase 3 Randomized Controlled Trial (RCT) of ReNu. This second Phase 3 trial was a prospective, multicenter, double-blind, randomized, saline-controlled, parallel group clinical trial to evaluate the efficacy of ASA in patients with symptom…

Text added vs the prior filing · source: 10-Q · 2026-05-07

• We and each of our executive officers entered into a Key Employee Retention Agreement (the “Key Employee Agreement”) effective May 6, 2026. The Key Employee Agreements supersede and replace the Change in Control Retention Agreements between us and each of our executive officers. The Key Employee Agr…

• Pursuant to the Key Employee Agreement, if the executive’s employment is terminated during the twenty-four month period following a “Change in Control” (a) by us without “Cause” or (b) by the executive upon the occurrence of an “Event of Constructive Termination” (as those terms are defined in the K…

• Also pursuant to the Key Employee Agreement, if the executive’s employment is terminated prior to a Change in Control or after the 24-month anniversary of a Change in Control (a) by us without Cause or (b) by the executive upon the occurrence of an Event of Constructive Termination, the executive wi…

• Our obligation to provide the foregoing benefits is subject to the executive entering into a new noncompetition agreement with us and the effectiveness of a release of claims executed by the executive in favor of us.

• Copies of the Key Employee Agreement with Mr. Gillheeney and the form of Key Employee Agreement with our executive officers other than Mr. Gillheeney are attached as Exhibit 10.1 and Exhibit 10.2 to this Report. The foregoing summaries of these Agreements are qualified in their entirety by reference…

Text removed vs the prior filing · source: 10-Q · 2025-11-06

• During the three months ended September 30, 2025, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-rule 10b5-1 trading arrangement,” as each term is defined in item 408(a) of Regulation S-K.

• On October 31, 2025, the Company entered into the October 2025 Amendment to the 2021 Credit Agreement. The October 2025 Amendment (a) reduced the Revolving Facility from $125,000,000 to $75,000,000, (b) removed the Consolidated Fixed Charge Coverage Ratio covenant, (c) added a minimum Consolidated I…

• The foregoing description of the October 2025 Amendment is not complete and is qualified in its entirety by reference to the October 2025 Amendment, which is attached to this Current Report on Form 10-Q as Exhibit 10.2 and incorporated herein by reference.