Novel OCT Technology for Detection of Occult Sperm in the Testes inNon- Obstructed Azoospermia.

Non-obstructive azoospermia (NOA), a lack of sperm in the ejaculate due to defective
spermatogenesis, affects as many as 100,000 men in the US, and represents an unmet medical
need because many of these men would like to father children, but cannot without surgical
intervention. Current therapy for such men is suboptimal, because it relies upon microsurgical
testicular sperm extraction (micro-TESE), which at best is successful in obtaining viable sperm
50% of the time in these NOA patients. Unasper Inc. was founded to address this unmet medical
need, and consists of a consortium of experienced physician-scientists in male reproduction and
infertility, a prominent academic entrepreneur with a research focus in development of optical
imaging systems, and a urologic surgeon with significant clinical expertise in fertility and practical
experience in isolating sperm from men with NOA. Here Unasper proposes to complete
development, testing and validation of an Optical Coherence Tomographic (OCT) system
specifically designed to visualize sperm in the testis using a chemotherapy induced model of NOA
in rats. We propose two AIMS: AIM 1: Complete the development, testing and validation of OCT
technology for intraoperative detection of sperm in NOA testis. Our prior work with optical imaging
systems combined with our prior experience using an OCT system during acquisition of the
preliminary data for this proposal allows us to readily design a 2-Stage OCT system in the visible
range customized for this purpose. This optimized system involves minor modifications of our
existing experimental systems and can be built within 5 months at low cost. AIM 2: Test and
validate our customized 2-Stage OCT technology in rat NOA testis. Using our 2-Stage OCT in a
rat model of induced NOA, we will assess the sensitivity, specificity, and preliminary safety of our
technology to detect occult sperm pockets in rat NOA testes. Successful attainment of our OCT
technology allowing safe, statistically significant superiority (sensitivity and specificity) of our
system over visual assessment of tubules under the dissecting microscope will justify further
commercialization, where we will test safety in human sperm and clinical (patients with NOA)
feasibility, and plan for regulatory approval for our 2-Stage OCT system. This will represent a
clinically significant major advance in how we currently help azoospermic men with NOA who
wish to father children using IVF.Unasper Inc. in collaboration with scientists at LA Biomed and UC Riverside will develop, test
and validate a novel optical coherence tomography (OCT) technology to locate occult sperm in
the testis for men with no sperm in the ejaculate. Currently, open testis surgery to retrieve testis
sperm is the only option for these men to father children. The OCT technology we are
developing will eliminate the need for the surgeon to cut open the testis to identify and retrieve
sperm; it will increase the accuracy, precision and speed of the procedure and thus have
patient, surgeon and market attractiveness.