Sandstone Diagnostics Announces FDA 510(k) Clearance for the Trak® Male Fertility Testing System

LIVERMORE, Calif.–(BUSINESS WIRE)–Sandstone Diagnostics, a diagnostic and digital health company
developing sophisticated connected wellness products that allow
consumers to measure, monitor, and improve key health markers at home,
announced that the U.S. Food and Drug Administration (FDA) has issued
510(k) clearance for the company’s Trak Male Fertility Testing System.
“This FDA clearance represents a monumental milestone for Sandstone
Diagnostics as we prepare to launch Trak as a radically new approach to
personal fertility management,” said Greg Sommer, Sandstone CEO. “Male
infertility is a dramatically under-appreciated condition affecting
millions of couples every year. 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.”
Data suggest that men contribute to up to half of all infertility cases,
but couples currently have very few options for tackling the male half
of the conception equation ¹. Today’s standard practice of
medical evaluation by clinical semen analysis done in an office setting
is generally viewed as an awkward and embarrassing experience for men,
which further contributes to low rates of male evaluation and treatment.
Trak, which will be available for purchase beginning October 2016, is an
in-home test that allows couples to measure and track sperm count
conveniently and privately as they try to conceive. The innovative
design uses centrifugal force to isolate and quantify sperm cells using
specially designed disposable cartridges. The system includes the Trak
Engine and several disposable test kits for repeat testing.
Trak is the first device cleared by the FDA that provides
semi-quantitative results, classifying sperm counts as “Low”, “Moderate”
or “Optimal” based on World Health Organization guidelines and clinical
studies that correlate higher sperm counts with faster time to
pregnancy. A fully-integrated digital health system, the Trak System
pairs with the Trak mobile app (available free on Google Play, the Apple
App Store and Amazon), to allow men to enter, track and compare their
results to population statistics via the cloud-based community of users
and clinical databases, and receive personalized feedback on lifestyle
and wellness steps that may boost their sperm count.
“This is a game changer for men’s health,” said Michael Eisenberg MD,
director of Male Reproductive Medicine & Surgery at Stanford University
Medical Center. “Sperm count provides a window into a man’s overall
health and it’s very exciting to see a technology that lowers the
barrier for men to get tested, see changes and address fertility
concerns. I believe with the convenience and availability of in-home
testing, we are poised to improve our understanding of male fertility
and empower men to better manage their health.”
About Sandstone Diagnostics
Sandstone Diagnostics is a Bay Area diagnostic and digital health
company developing sophisticated connected wellness products that allow
consumers to measure, monitor, and improve key health markers at home.
The company’s first product, the Trak® Male Fertility System received
FDA clearance in June 2016. For more information, please visit www.sandstonediagnostics.com
1. American Society of Reproductive Medicine (ASRM) Practice Committee.
Diagnostic evaluation of the infertile male: a committee opinion. Fertility
& Sterility 2015 Mar; 103(3):318-25.