Fziomed Hits Million-Patient Mark, Eyes New Surgical Standard

SAN LUIS OBISPO, CA – February 18, 2026 – Medical technology firm Fziomed, Inc. today announced a significant milestone: its proprietary adhesion barrier technology has been used to treat over one million patients worldwide. The achievement, accumulated over more than two decades, highlights the growing adoption of the company's synthetic, absorbable gel designed to prevent one of surgery's most common and debilitating complications—internal scarring.

The announcement positions the San Luis Obispo-based company's dual-polymer platform not just as a successful product, but as a contender for a new standard of care in postsurgical recovery. Fziomed's gels are used in a wide array of procedures, from complex spine surgeries to delicate pelvic and intrauterine operations, to improve patient outcomes.

"This is a tremendous achievement for the Company and especially impactful for the patients who have benefitted from surgeons utilizing our adhesion barrier products across multiple specialties," said Jim Feeney, Vice President, International Sales. "This milestone provides convincing evidence of the long-standing safety and effectiveness of our adhesion barrier products over the past two decades in an ever-growing number of patients around the world, now including the United States."

The Unseen Complication of Surgery

Every time a surgeon makes an incision, the body’s natural healing process kicks in. While essential for recovery, this process can also lead to the formation of adhesions—bands of scar tissue that can cause organs and tissues to stick together abnormally. These internal scars are a frequent, yet often overlooked, consequence of surgery, capable of causing chronic pain, infertility, small bowel obstruction, and neurological issues. In some cases, they necessitate complex and risky repeat surgeries.

Fziomed's technology directly confronts this problem. The company's clear, absorbable gels are based on a proprietary dual-polymer platform combining carboxymethylcellulose (CMC) and polyethylene oxide (PEO). When applied during surgery, the gel acts as a temporary, lubricious barrier that physically separates tissues during the critical 5-7 day healing period when adhesions are most likely to form.

The CMC component allows the gel to adhere to tissue surfaces, ensuring it stays where it is needed, while the PEO provides a protective function that disrupts the formation of fibrin bridges—the scaffolding for scar tissue. The gel remains at the surgical site for up to 30 days before being naturally and safely absorbed by the body. This synthetic, biocompatible approach avoids materials derived from human, animal, or bacterial sources, minimizing risks of immune reactions.

Clinical data gathered over two decades supports the efficacy of this approach. For example, a 352-patient U.S. pivotal study on Oxiplex, Fziomed's product for spine surgery, demonstrated a 35% greater reduction in leg pain and a 28% greater reduction in back pain for the treatment group compared to controls at six months post-surgery. In gynecological applications, studies have linked the use of the gel to reduced adhesion scores and, in some cases, improved chances of conception for women undergoing fertility-related procedures.

A Two-Decade Journey to a New Standard

While the one-million-patient milestone is a recent announcement, Fziomed's journey began in 1996, with its products first used clinically in 2002. For years, the technology, marketed under various brand names like Oxiplex and Intercoat, has been a staple in operating rooms across more than seventy countries in Europe and Asia. This long-term international use has built a substantial body of evidence for its safety and effectiveness.

The most significant recent development, however, has been the company's breakthrough into the lucrative and highly regulated U.S. market. In July 2025, the U.S. Food and Drug Administration (FDA) granted De Novo classification and marketing authorization for Oxiplex gel. This designation, reserved for novel, low-to-moderate-risk devices with no existing predicate, made Oxiplex the first and only FDA-authorized intraoperative gel for reducing postoperative leg pain and neurological symptoms in adult patients after lumbar spine surgery.

Achieving De Novo status is a rigorous undertaking, requiring Level 1 clinical evidence from randomized trials. This FDA authorization validates Fziomed's long-held claims and provides a powerful platform for its ambition to establish its technology as a standard of care.

"We are well on our way to establishing our unique adhesion barrier technology as a standard of care adjunctive therapy for nearly any surgical procedure," commented Paul Mraz, President and CEO. He credits the company's vertically-integrated structure and dedicated associates for the achievement.

The term "standard of care" is not used lightly in medicine. It signifies a treatment that is widely accepted by the medical community and integrated into official clinical guidelines. While Fziomed's gel is not yet universally mandated, the combination of extensive global use, robust clinical data, and a first-in-class FDA authorization for a key indication makes a compelling case for its trajectory.

Navigating a Competitive Landscape

Fziomed is not alone in the market for postsurgical adhesion prevention. The space is populated by a variety of technologies, including films, fabrics, and other gels, each with its own advantages and drawbacks. Competitors include products based on hyaluronic acid (HA), oxidized regenerated cellulose (ORC), and polyethylene glycol (PEG).

Some barrier products, like Gore-Tex Surgical Membrane, are effective but non-absorbable, sometimes requiring a second procedure for removal. Others, like the widely known Seprafilm, have demonstrated efficacy but have also been associated with certain risks in specific surgical contexts.

Fziomed's dual-polymer gel differentiates itself through its unique combination of features: it is synthetic, fully absorbable, ready to use without mixing, and has a formulation specifically designed to be both adherent and protective. Its gel consistency allows it to conform to complex anatomical structures where rigid films or fabrics may be difficult to apply. This ease of use and targeted mechanism of action have been key to its adoption by surgeons globally.

The company’s singular focus on adhesion prevention since its founding has allowed it to develop a specialized portfolio for different surgical needs, including spine (Oxiplex), tendon/nerve (Dynavisc), and abdominal/pelvic procedures (Oxiplex/AP). This specialization further distinguishes it from larger competitors with more diversified product lines.

With the million-patient milestone reached and a key FDA approval in hand, Fziomed is poised to build on its two decades of work. The company will be showcasing its Oxiplex gel at the upcoming 2026 Spine Summit in Phoenix, Arizona, a clear signal of its intent to deepen its penetration into the American surgical market. As surgeons and hospitals increasingly focus on long-term patient outcomes and the avoidance of costly complications, technologies that promise a smoother, less painful recovery are gaining significant attention. Fziomed's journey from a niche biomaterials pioneer to a global player suggests that the next million patients may be treated in a fraction of the time it took to reach the first.