Device and disposable – Our business model for LuViva is the familiar razor/razor blade model. Each LuViva scan requires a single-patient-use disposable, called a Cervical Guide (CG). Most commonly, the LuViva device is sold as capital equipment with continuing revenue from the CGs.
Since the Cervical Guide is critical to our business, we have developed anti-counterfeiting and anti-reuse measures employed on each CG. Each CG carries an RFID chip that talks to the LuViva before each use, insuring against reuse and the use of knock offs.
Screening – The LuViva was initially designed to be used with women predetermined to be at risk of cervical cancer after screening – typically Pap smear or liquid-based cytology. This model applies to developed markets with clinical laboratory infrastructure in place. This market represents a portion of all women screened (5% to 10%). However, the larger market opportunity lies with screening. Ministries of Health in some developing countries are using LuViva, in pilot studies, as a primary screener. While the numbers of patients increase exponentially with this use, the cost of the disposable is typically less to compete with Pap and Visual Inspections with Acetic Acid (VIA).
Platform technology – The underlying spectroscopic technology of LuViva is transferrable to the early discovery of other epithelial cancers, or carcinomas. The variables from detecting one type of cancer from another largely rely on access and software. The LuViva is an application of the technology for a specific organ, the cervix. The disposable permits access to the cervix and algorithm provides the result. Other targeted cancers include esophageal, skin, head and neck and biliary.
Healthcare system – LuViva reduces the overall cost of cervical cancer diagnosis by eliminating a percentage of unnecessary and more costly diagnostic procedures. LuViva has been shown to eliminate 35% to 40% of unnecessary colposcopies and biopsies by identifying false positives as a result of screening. This can result in overall savings of about 15% in multi-million dollar cervical cancer prevention programs.
LuViva has also been shown to detect disease missed by colposcopy and biopsy. Early detection not only reduced patient morbidity, but also reduces costs for the healthcare system. For example, if caught in its earliest stages, cervical precancer is treated with cryosurgery which typically costs less than $500. More advanced precancer is treated with cone surgery which removes a significant amount of tissue and costs $1,500 to $2,000. Cone surgery may also have complications for pregnancy. Invasive cervical cancer is treated with hysterectomy, radiation and chemo, which can cost more than $200,000.
The patient – The most common form of diagnosing cervical cancer is the biopsy. Biopsies are painful and can cause complications ranging from excessive bleeding to infection. Results take from several days to weeks to be reported to the patient. As a result, women reported a period of anxiety while awaiting results. The LuViva is painless, takes a little over a minute to scan the cervix and reports results immediately.
The physician – With a negative predictive value of up to 99%, LuViva offers the healthcare provider with the highest level of assurance that a negative result is a true negative. As a screening tool, LuViva provides for potentially higher throughput and see and treat which translates into more women receiving treatment and not being lost to follow up. In terms of triage, the added expense of LuViva exams, is more than offset by reductions in costs and time spent diagnosing healthy women. LuViva’s positive results mean less likelihood of misdiagnosing a true positive.