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 and commercially but no product has been built that satisfies basic requirements -- to collect accurate tissue information over the entire cervix at precisely known locations, to provide immediate diagnosis, to be used by an operator with minimal skills, and to employ a disposable probe that can be manufactured 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 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 disposable probe tip can be modified to include a guide tube for a biopsy forceps. This associated application could receive FDA approval within a year after the prototypes are built. This product could then be sold sooner than the Pap test replacement and would provide data for the clinical trials of the bioprobe. 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 65 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 a replacement for the Pap test could be accomplished in less time than FDA approval. The world market for a cervical screening system is 1 billion tests per year, assuming retesting every two years.