Products

Preciva’s primary product will be an electrical device called the bioprobe to detect cancerous and precancerous tissue of the cervix. This device is expected to be an improvement over and a replacement for the nearly universal Pap test. The technology to analyze cervical tissue by electrical response has been established academically but no product has been built that satisfies basic requirements -- to collect accurate tissue information over the entire cervix and at distinguishable depths, to provide immediate diagnosis, to be used by an operator with minimal skills, and to employ a disposable probe that can be made inexpensively. 

The electrodes in the Preciva tip will provide tissue analysis directly. Electrical probes reported in the scientific literature have diagnosed the state of cervical tissue accurately but have been limited to one or two pairs of electrodes which are positioned visually or randomly by the user. Because the tip of the Preciva product contains many electrodes and because the tip position is precisely controlled by a stepper motor in the handpiece, information on tissue state and location is generated. Several frequencies of electrical pulses and several electrode configurations built into the tip will assess the tissue at various depths. Since precancerous lesions of the cervix develop first beneath the surface, detecting deeper changes improves the quality and timeliness of the diagnosis. The mapping application as a diagnostic assist and tissue monitoring system is an intermediate product before the full Pap test replacement device is approved.  This associated application could receive premarket approval within a year after the prototypes are built. This product could then be sold sooner than the Pap test replacement and would help fund the clinical trials and approval process for the bioprobe. In the field, this product would be used to gather data as part of the clinical trial process for the primary product. 

After preclinical testing has established the diagnostic efficacy of the bioprobe, full clinical trials will be undertaken on a large number of patients in order to secure FDA approval. Given sufficient funding, development of the primary product through FDA approval is expected to take about three years. The US market for the Pap test is 55 million tests per year. The European market is similar but government health care systems slow market penetration in some countries. However, private medical services provide about half the gynecological exams in several of the largest Western European countries. Obtaining a CE mark for European distribution as an adjunct to the Pap test could be accomplished in less than a year after clinical trials begin.