News

Summary: Legacy Medical Consultants (LMC), a leading provider of allografts for the treatment of hard-to-heal chronic wounds, has acquired the U.S. rights to sell ActiGraft® wound care treatments, expanding its portfolio beyond allografts.

LMC reached agreement with RedDress, an Israel-based company, to exclusively market the product in the U.S. ActiGraft Pro is at the forefront of personalized and autologous wound care management, providing solutions for patients’ most challenging chronic wounds.

The terms of the deal include exclusive agent status across all care settings, including hospitals, physician office, Veteran Affairs (VA) and Department of Defense (DoD) facilities, and outpatient wound-care centers. RedDress and Legacy will collaborate on payer‑coverage expansion, GPO contracting, and investigator‑initiated research to further validate ActiGraft’s benefits.

Known as the silent epidemic, approximately 6.5 million – or 1 in 38 – adults are affected by chronic wounds each year in the U.S.1 An aging population and the increase in rates of diabetes and obesity are major contributors to the dire need for continued innovation in the wound care space.

“As a leader in wound care, our mission at Legacy has always been to address unmet clinical needs. Through the evolution of science and innovation, we’ve been able to improve and expand treatment options for these patients to improve their quality of life,” said Jonathan Knutz, LMC’s Chief Executive Officer. “Patients shouldn’t have to worry about having an amputated limb due to a chronic wound – they should have access to the best treatments. This is why our partnership with RedDress is so crucial. ActiGraft provides an option for patients, in addition to our high-quality allografts, that might not otherwise be available.”

RedDress developed the innovative autologous solution, ActiGraft Pro, which offers a personalized approach to healing. Its technology uses a patient’s own blood to create a whole blood clot, replacing a dysfunctional extracellular matrix (ECM) responsible for stalled wounds. This supports the reactivation of the innate healing process and the facilitation of a natural healing cascade. The ActiGraft can be used on patients who are taking a blood thinner and have exposed bones and tendons.

“Legacy Medical Consultants’ high-quality team and Allograft portfolio is a powerful complement to our state-of-the-art autologous ActiGraft,” said Alon Kushnir, Chief Executive Officer of RedDress. “We are excited and proud to partner with Legacy to provide the best options to those who are suffering from chronic, non-healing wounds.”

LMC’s portfolio already includes six products, Zenith Amniotic Allograft, Impax Amniotic Allograft, Orion Amniotic Allograft, Complete ACA Allograft, SurGraft FT Allograft, and Reeva FT Allograft.

Summary: Legacy Medical Consultants (LMC) announces its newest product portfolio addition with the recent Q code approval for Reeva FT™, a terminally sterilized, full-thickness, dual-layered amnion/chorion allograft designed for covering and protection during advanced wound treatment.

“There is a critical need in the wound care space for these advanced allograft products,” says Jonathan Knutz, CEO of Legacy Medical Consultants, “and we continue to deliver solutions that innovate while advancing a well-established and proven medical technology.”

About Reeva FT
Reeva FT is a lyophilized human placental-based allograft consisting of amnion and chorion membranes, with the retention of the intermediate layer. Reeva FT provides a protective covering to the surrounding environment in acute and chronic wounds. The graft also introduces a naturally derived extracellular matrix that acts as a scaffold to support native tissue during treatment. Reeva FT hydrostatically adheres to wounds and has a 5-year shelf life when stored at ambient temperature.

Reeva FT is offered in a variety of sizes: 2×2 cm, 2×3 cm, 4×4 cm, 4×6 cm, 4×8 cm, and 10×15 cm. Reeva FT is confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act as defined in 21 CFR Part 1271.

In the most recent HCPCS announcement by CMS, Reeva FT was assigned a new HCPCS Level II code of Q4314.

Summary: In April 2024, all seven Medicare Administrative Contractors (MACs) proposed a new Local Coverage Determination (LCD) – Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers.

If implemented, the LCD will put thousands of lives at risk, including a disproportionate number within marginalized communities. The LCD has the potential to put wound care providers out of business and sets a dangerous precedent for Medicare coverage of other types of devices.

LMC is urging CMS’s Medicare Administrative Contractors (MACs) to reconsider the LCD, including issuing a 24-month extension before it goes into effect.