VERIGRAFT's 'Living Vein' Trial Aims to Cure Chronic Venous Disease

GOTHENBURG, Sweden – March 25, 2026 – Swedish biotechnology firm VERIGRAFT has launched a pivotal Phase II/III clinical trial for a groundbreaking therapy that could offer the first-ever cure for Chronic Venous Insufficiency (CVI), a debilitating condition affecting millions worldwide. The study, supported by a fresh $10 million in financing from existing investors, will test a personalized, tissue-engineered vein (P-TEV) designed to permanently restore normal blood flow in patients' legs.

This milestone moves the company significantly closer to its goal of achieving market approval in the United States and Europe by 2028, potentially transforming the treatment landscape for a progressive disease that currently has no curative options.

A Widespread Condition Without a Cure

Chronic Venous Insufficiency is a pervasive and often under-recognized vascular disease where the veins in the legs, specifically their internal valves, fail to work properly. Instead of efficiently pushing blood back toward the heart, gravity causes it to pool in the lower limbs. This leads to sustained high pressure in the leg veins, triggering a cascade of symptoms that worsen over time.

The condition is remarkably common, impacting an estimated 25–40% of women and 10–20% of men globally. Driven by an aging population, rising obesity rates, and increasingly sedentary lifestyles, CVI represents a massive and growing healthcare burden. In the United States alone, the disease affects up to 40% of the population, with annual care costs exceeding $1 billion, largely due to treating its most severe complications.

Patients in the early stages may experience leg heaviness, swelling, and the appearance of spider veins. As the disease progresses, it can lead to painful varicose veins, persistent edema, skin discoloration, and ultimately, severe, difficult-to-heal venous ulcers. Beyond the physical pain, CVI significantly diminishes quality of life, often leading to mobility limitations and social isolation.

Current treatments are focused on managing these symptoms. Compression stockings, lifestyle changes, and medications can provide relief, while surgical procedures like vein stripping or minimally invasive ablation can close off or remove damaged veins. However, these methods do not restore the natural, physiological function of the venous system and recurrence is common. They are palliative, not curative.

The Promise of Personalized Regeneration

VERIGRAFT’s P-TEV technology represents a radical departure from symptom management. It is designed to replace the diseased vein segment with a new, fully biological, and functional one. The process uses a vein from a deceased donor, which is put through a proprietary process called decellularization. This gently removes all the donor's cells, leaving behind a natural, non-immunogenic collagen scaffold that retains the vein's original structure, including its crucial valves.

This scaffold is then personalized by infusing it with the patient's own blood. Over a rapid 10-day manufacturing period, the patient's cells repopulate the scaffold, creating a living, personalized vein graft. Because the resulting P-TEV is made from the patient's own biological material, it is not recognized as foreign by the body, eliminating the need for lifelong immunosuppressive drugs and their associated health risks.

Once prepared, the P-TEV is surgically implanted. The new vein segment, with its functioning valves, is intended to restore normal venous hemodynamics—a concept previously considered unattainable in advanced CVI.

“This is truly restorative, unlike so many of the available tools,” commented Dr. Bryan Kluck, an Interventional Cardiologist at Lehigh Valley Hospital who is familiar with the technology. “Patency of the venous system, along with functional vein valves, has the potential to revolutionize venous therapy. This technology restores normal venous hemodynamics, a concept that, heretofore has been unimaginable.”

Navigating the Path to Market

The initiation of a combined Phase II/III trial is a critical step. It signifies that earlier-stage studies have provided sufficient safety and efficacy data to warrant a large-scale, definitive study designed to secure regulatory approval. As an Advanced Therapy Medicinal Product (ATMP), VERIGRAFT’s P-TEV is on a rigorous but potentially accelerated regulatory path in both Europe and the U.S., reserved for novel treatments addressing significant unmet medical needs.

The international trial is now underway at sites in Spain, the Netherlands, and Poland, with the company targeting market authorization by 2028.

Dr. Andrés García León, Head of Angiology and Vascular Surgery at Virgen de Valme University Hospital in Seville and the trial's Lead Principal Investigator, highlighted the need for such innovation. “In clinical practice, treatment options for patients with advanced CVI are limited,” he stated. “P-TEV represents a promising and scalable approach with the potential to restore physiological blood flow.”

The Business of a Breakthrough

VERIGRAFT's advancement has not gone unnoticed by investors. The $10 million financing from its existing backers underscores strong confidence in the technology's potential. The company is targeting a vast and expanding market, which is projected to reach nearly $6 billion by 2034.

“This financing enables a critical step forward in our clinical development and is a critical component in our journey to redefine how vascular disease can be treated by restoring natural biological function at scale,” said Petter Björquist, CEO of VERIGRAFT. “With P-TEV, we are addressing a large, underserved patient population with a therapy designed to address the underlying cause of disease, not just manage the symptoms.”

While competitors like enVVeno Medical are also developing novel valve-based technologies, VERIGRAFT's approach as a fully integrated, personalized biological graft sets it apart. The company’s strategy is further fortified by a robust intellectual property portfolio of 92 granted patents, protecting its unique manufacturing process.

If the pivotal trial proves successful, VERIGRAFT will not only be positioned to capture a significant share of the multi-billion-dollar CVI market but will also validate a powerful new platform in the field of regenerative medicine, offering hope that the body's own biology can be harnessed to provide definitive cures for chronic diseases.