Sandstone Diagnostics, a healthcare startup that seeks to make it easier for men to track their sperm count, secured 510(k) clearance from the U.S. Food and Drug Administration for its Trak Male Fertility Testing System, according to an emailed company statement.
The company views male infertility as a significant and underreported problem because it’s perceived as an embarrassing subject. Greg Sommer, Sandstone CEO, sees its diagnostic kit and companion apps as a way to provide men and couples in particular a way to track semen count at home and contribute data to improve the research of this subject.
“Male infertility is a dramatically under-appreciated condition affecting millions of couples every year,” Sommer said. “Trak is a complete system that not only gives couples the ability to conveniently measure semen quality at home, but also provides digital health tools and population-based data to help men take charge of their reproductive health in a whole new way.”
The test classifies sperm counts as low, moderate, or optimal using World Health Organization guidelines and clinical studies that correlate higher sperm counts with faster time to pregnancy, a statement from the company said. It also includes disposable cartridges for repeat testing.
The kit includes an engine, a disposable test plate and seal, a sample collection cup and a dropper. A semen sample is collected in the cup, swirled around, put in the test plate with the dropper and sealed. Then it’s loaded into the centrifuge, which spins the sample for several minutes. Sperm cells collect at the end of the test plate, which is calibrated like a thermometer to deliver a sperm cell count reading. When the kit is launched in October this year, app users will be able to factor in these results to their app.
It apps its help users track aspects of their health that could impact sperm count such as diet, exercise, stress, heat exposure, toxin exposure and general wellness. It gives users a score for each category each time they make an entry. It also provides feedback based on responses with the goal of improving sperm health. Users can track their sperm count score over time and determine if there is any correlation to the choices they make and improvements to their sperm count. It launched an Android app in October last year and an iOS version in November.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
What makes Sandstone’s approach interesting is that while there are many digital health and diagnostics companies in the fertility space, few have focused on male fertility — they’ve simply added apps to their product portfolios. SpermCheck Fertility received a greenlight from the FDA in 2012.
Sommer and Ulrich Schaff, CTO and co-founder, developed the Trak Fertility system when they were research scientists at Sandia National Laboratories.
