Impact cervical cancer
Cervical cancer is worldwide the 4th most frequent and the 5th most lethal cancer among women. The incidence is especially high in developing countries.
Dr. Dirk Coeman developed a novel approach for cervical precancer treatment: the Vacuum-Assisted Loop Excisional Biopsy (Valéb). Valéb is an investigational medical device designed to enable a minimally invasive and standardized procedure. It is being developed with the aim of supporting broader accessibility, including potential use by trained healthcare personnel in low-resource settings.
The project seeks to contribute to advancements in cervical precancer treatment, with the long-term goal of reducing the burden of cervical cancer and addressing complications associated with conventional procedures.
Every two minutes a woman is diagnosed with cervical cancer
Cervical cancer remains a major global health concern. It is primarily caused by persistent infection with high-risk strains of the human papillomavirus (HPV). While there is no cure for HPV itself, cervical precancer can be detected and treated before it progresses. It’s estimated that approximately 8 in 1,000 women may experience cervical precancerous changes during their lifetime. Without intervention, progression from HPV infection to cervical cancer can take 10–15 years.
HPV has limited global reach
According to the World Health Organization, HPV vaccination currently reaches only a small portion of the global target population, estimated at 3% worldwide and 13% in high-income countries (HICs). Even in countries with high vaccination coverage, such as those in Scandinavia, a significant reduction in cervical cancer incidence is expected only after a latency period of 10–15 years. Global impact on incidence is not anticipated before 2060.
Current Standard Treatments Present Challenges
The most widely used procedure for treating cervical precancer—loop electrosurgical excision procedure (LEEP) or cone biopsy, can present certain procedural and postoperative challenges. These may include smoke generation, which has raised concerns about occupational exposure, and substantial tissue removal, which may affect the reliability of follow-up testing.
Tissue Removal and Preterm Birth
Cervical conization procedures have been associated with an increased risk of preterm birth in subsequent pregnancies. A Cochrane review has estimated that up to 10% of preterm births may be linked to excisional treatments. Many of these procedures are performed in women of reproductive age, which may carry emotional and physical implications, including distress and anxiety.
Specialized Skills Required
Cone biopsies are typically performed by highly trained gynecologic surgeons. These procedures require significant expertise to avoid complications such as vaginal wall injury or ureteral damage. Smoke generation during the procedure can further obscure visibility, adding to the technical complexity.