New Trak® Male Fertility Testing System Empowers Men to Measure, Track and Improve Sperm Count from the Comforts of Home

Innovative Device Represents the Only Comprehensive At-Home Approach to Managing Male Reproductive Health

LIVERMORE, CA – Sandstone Diagnostics, a diagnostic and digital health company developing sophisticated connected wellness products for home-health testing, today announced the launch of its Trak® Male Fertility Testing System. As the first-of-its-kind, comprehensive in-home male fertility test, the Trak system allows men to conveniently measure and track their sperm count over time using a straightforward, easy-to-read test. Additionally, its interactive mobile app provides personalized feedback, tips and tools to help improve reproductive health. The innovative device fulfills a significant unmet need for the millions of men who struggle with infertility, enabling them to conveniently measure their sperm count from the comfort and privacy of their own home, generating results in mere moments.

Cleared by the U.S. Food and Drug Administration (FDA) for over-the-counter use, the Trak system is now available for purchase at www.trakfertility.com.

“Unfortunately, there is a certain stigma and silence associated with male infertility, which often precludes men from seeking proper and timely evaluation and treatment,” said Dr. Jamin Brahmbhatt, urologic surgeon and infertility specialist with Orlando Health in Orlando, Fla. “However, the advent of the Trak system turns this very premise on its head, disrupting the status quo by empowering men to take that first important step in managing their fertility health in a conducive and comfortable manner that works for them.”

Trak is the first and only FDA-cleared device that classifies 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. In fact, a large, multicenter clinical trial demonstrated that the Trak system produces results that are as precise and accurate as the gold-standard laboratory fertility test conducted in a physician’s office.i The easy-to-use device applies centrifugal force to isolate and quantify sperm cells using specially designed disposable cartridges, which in turn produces lab-quality sperm count measurements. It also comes with several disposable test kits for repeat testing.

As the only fully-integrated digital health platform of its kind on the market, the Trak system pairs with the Trak mobile app, which allows men to compare their results to population statistics via a cloud-based community of users and clinical databases, and receive personalized

feedback on steps they can take to help boost their sperm count. Since sperm count can be impacted by a multitude of lifestyle factors, including weight, sedentary activity,ii stress,iii toxinsiv, v and heat exposure,vi Trak can help identify potential barriers to conception and urge men to take action to improve their chances of fatherhood.

“Trak represents a major step forward for men’s reproductive health, as it revolutionizes the way we approach this all-too-common, yet significantly undervalued condition,” said Karen Drexler, CEO, Sandstone Diagnostics. “While there are several at-home sperm tests currently on the market, Trak is set apart in offering a comprehensive approach to male reproductive management, with its holistic platform, superior precision, unique design, robust data analytics and personalized educational tools – all backed by peer-reviewed clinical research.”

The Trak system does not “replace” clinical evaluation, but rather helps couples test sooner and track progress as men make health and lifestyle changes that can improve sperm production. Fortunately, male infertility is often treatable, with studies showing that 76 percent of couples who sought treatment had a potentially correctable condition.vii

“Nearly half of fertility problems originate with the male partner, however, couples have had very few options for tackling the male half of the conception equation,” said Dr. Brian Levine, New York practice director for the Colorado Center for Reproductive Medicine, a multistate fertility practice. “The launch of the Trak Male Fertility Testing System can provide would-be parents with earlier male fertility evaluation, which could lead to earlier medical intervention and conception.”

“Infertility can be overwhelming for couples. Historically, it’s been viewed as a woman’s condition, all-too- often leaving men out of this important reproductive health equation, which can hinder timely treatment and ultimately slow the conception process,” said Ken Mosesian, Executive Director, Path2Parenthood, a nonprofit organization committed to helping hopeful parents find the most streamlined path to having a child. “Trak, an FDA approved home test, can help men to be proactive in addressing fertility concerns, providing them with an easy, discreet way to evaluate sperm count prior to a comprehensive evaluation by a reproductive urologist.”

About Male Infertility

Male infertility is a common, yet significantly undervalued condition that is growing in prevalence. Data suggest approximately 15 percent of couples experience infertility and that men contribute to up to half of all infertility cases.v,viii The majority of men have sub-optimal sperm counts, which can lead to infertility and longer time to pregnancy.ix Average sperm counts have fallen significantly and continuously over the last several decades due to biological, environmental and lifestyle shifts,x, xi , xii and there is a significant need for advanced options that can help tackle the male half of the conception equation.

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, visit www.trakfertility.com and www.sandstonediagnostics.com.

i U.Y. Schaff et al, Novel Centrifugal Technology for Measuring Sperm Concentration in the Home. Fertility & Sterility 2016 (in press). http://www.fertstert.org/article/S0015-0282(16)62948-5/abstract.

ii Excess weight may affect sperm production, reduce fertility in men. Harvard School of Public Health (2012).

iii Jurewicz J, et al. The effect of stress on the semen quality. Polish. Med Pr. 2010;61(6):607-13.

iv Santos EP, et al. Impact of spontaneous smoking cessation on sperm quality: case report. Andrologia. 2011 Dec;43(6):431-5.

v La Vignera S, et al. Does alcohol have any effect on male reproductive function? A review of literature. Asian J Androl. 2013 Mar;15(2):221-5.

vi Shefi, S., et al. Wet heat exposure: a potentially reversible cause of low semen quality in infertile men. Int. Braz J Urol 33, 50–57 (2007).

vii Sandlow, J.I. Shattering the myths about male fertility. Postgraduate Medicine. May 2002. 107(2). Accessed at https://consumer.healthday.com/encyclopedia/fertility-19/infertility-news-412/male-infertility-646199.html.

viii 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.

ix Jørgensen, N. et al. Human semen quality in the new millennium: a prospective cross-sectional population-based study of 4867 men. BMJ Open 2012;2:4.

x Rolland, M. et al. Decline in semen concentration and morphology in a sample of 26 609 men close to general population between 1989 and 2005 in France. Human Reproduction, 28(2), 2013, p.462-470.

xi Huang, C et al. Decline in semen quality among 30,636 young Chinese men from 2001 to 2015. Fertility and Sterility (2016) in press. 

xii Adiga S K, et al. Declining semen quality among south Indian infertile men: A retrospective study. J Hum Reprod Sci 2008;1:15-8.