In the US, one in seven couples are infertile, resulting in approximately six million couples seeking assisted reproduction procedures. In over 50% of infertile couples, the problem is with the male.
The current best practice is for the male semen to be collected in the clinic, using a common specimen cup. The use of the ProteX, in place of the common specimen cup, can allow the couple to collect the sample at home, although the process can be altered to fit the clinics needs. The use of ProteX will result in significantly higher viability of semen, which can result in couples being eligible for lower cost procedures, intrauterine insemination (IUI) and/or achieving success with a reduced number of In Vitro Fertilization (IVF) cycles; the average cost is $12,000 per IVF cycle.
The ProteX medical device consists of three injection molded components whose designs provide an environment conducive to the preservation of the viability of the semen collected. The size of the assembled device is approximately equal to a 4-ounce specimen cup.
The results from FDA approved initial clinical trials, indicated significantly higher viability (37%) of semen. Using the common specimen cup, the percentage of pregnancies derived that carried to term and delivered a heathy baby was 40%, as compared to 100%, when ProteX was used. Fertility clinics are required to publish their success rates. It is projected that the use of ProteX will improve a fertility clinic’s success rate by 20 percentage points.
Information gathered through potential customer segment interviews, conducted during participation in the National Science Foundation Regional i-Corps program, confirms the market, problem and opportunity.