Seeing the Undetectable
Exploratory surgery remains the gold standard for diagnosing endometriosis, but it is far from golden. Misdiagnosis rates and delays in diagnosis represent a huge unmet need, and more often than not, patients are left suffering the consequences. FemLUNA is poised to revolutionize the standard of care with definitive, non-invasive, lesion-level clarity.
Endometriosis has long lacked a definitive, non-invasive diagnostic. Blood and saliva tests may one day offer a simple yes or no, but they rarely provide enough information to act. They don’t tell a patient where the lesions are, how severe they are, whether the organs are fused, or what symptoms might be caused by their location.
That missing detail often leads to diagnostic limbo. Exploratory surgery becomes the next step, yet even that is far from conclusive. One in three women comes out of surgery without a diagnosis. Some are misdiagnosed. Others have lesions that are missed entirely. And in many cases, the patient did not have endometriosis at all.
The consequences of this are serious. Many women undergo invasive procedures expecting clarity, only to return home with the same uncertainty they started with.
Accurate, lesion-level imaging has the potential to change everything. The location of lesions directly affects symptoms. Endometriosis on the bowel presents differently from disease on the ovary or diaphragm. Some patients are told their fertility is at risk when it is not. Others live for years with malignant endometriomas that go undetected. In the worst cases, women are prescribed hormone suppressants that actually worsen the disease because the location and nature of the lesions were never identified.
Targeted FemLUNA offers unprecedented clarity, enabling the definitive detection of sub-millimeter endometriosis lesions that are otherwise undetectable by existing imaging technologies.
Surgical outcomes also depend on imaging. A planned surgery, with a trained excision team prepared for the full extent of disease, results in far better outcomes than an exploratory procedure with limited visibility. Most recurrences happen not because the disease is uncontrollable, but because the original lesions were never fully removed.
That is why EndoCyclic developed FemLUNA, a targeted imaging peptide with the potential to locate every lesion, whether superficial, fibrotic, or deep infiltrating. It does not simply confirm disease. It identifies where it is, what symptoms it may be causing, and how best to treat it.
Conventional MRI agents, based on heavy metals, are not ideal for reproductive or sensitive populations. More importantly, they cannot visualize the fibrotic or superficial subtypes of endometriosis, which together account for more than 80 percent of disease burden. Ultrasound offers even less accuracy. It is highly dependent on the skill and experience of the technician, and many lesions, especially those behind the uterus or involving the bowel, bladder, or deep pelvic structures, are difficult or impossible to detect with standard transvaginal or abdominal ultrasound.
FemLUNA is designed to address this gap. By being absorbed only by endometriotic lesions, it highlights even the smallest areas of disease. It is not just an imaging agent. It is a clinical roadmap that offers clarity before a decision, not just confirmation after one.