1. FOR IMMEDIATE RELEASE: 8 a.m. ET, JANUARY10, 2017
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, Calif.,January10, 2017 – Sandstone Diagnostics,adiagnosticanddigital health
companydevelopingsophisticatedconnectedwellnessproducts forhome-healthtesting,today
announcedthe launchof its Trak® Male FertilityTestingSystem.Asthe first-of-its-kind,
comprehensive in-homemale fertility test,the Traksystemallowsmentoconvenientlymeasure
and track theirspermcountovertime usinga straightforward,easy-to-readtest.Additionally,
itsinteractive mobile appprovides personalized feedback,tips andtoolstohelp improve
reproductive health.The innovativedevice fulfillsasignificantunmetneedforthe millionsof
menwhostruggle withinfertility,enablingthemtoconveniently measuretheirspermcount
fromthe comfortand privacyof theirownhome, generatingresultsinmere moments.
Clearedbythe U.S. Foodand Drug Administration(FDA) forover-the-counteruse,the Trak
systemisnowavailable forpurchase at www.trakfertility.com.
“Unfortunately,there isacertainstigmaandsilence associatedwithmale infertility,whichoften
precludes menfromseekingproperandtimelyevaluationandtreatment,”saidDr. Jamin
Brahmbhatt,urologicsurgeonand infertilityspecialistwith OrlandoHealthinOrlando,Fla.
“However, the adventof the Trak systemturnsthisverypremise onitshead, disruptingthe
statusquo by empoweringmentotake thatfirstimportantstepin managingtheirfertility
healthina conducive andcomfortable mannerthatworksforthem.”
Trak is the firstand onlyFDA-cleareddevicethatclassifiesspermcountsas“Low”,“Moderate”
or “Optimal”basedonWorldHealthOrganizationguidelinesandclinicalstudiesthatcorrelate
higherspermcountswithfastertime topregnancy. Infact, a large,multicenterclinical trial
demonstratedthatthe Trak systemproduces resultsthatare asprecise andaccurate as the
gold-standardlaboratory fertility testconductedinaphysician’soffice.i
The easy-to-usedevice
appliescentrifugal force toisolate andquantifyspermcellsusingspeciallydesigneddisposable
cartridges,whichinturnproduceslab-qualityspermcountmeasurements.Italsocomeswith
several disposable testkitsforrepeattesting.
As the onlyfully-integrateddigital healthplatformof itskind onthe market,the Trak system
pairswiththe Trak mobile app,whichallowsmentocompare theirresultstopopulation
statisticsviaa cloud-basedcommunityof usersandclinical databases,andreceive personalized
2. feedbackonstepstheycantake to helpboosttheirspermcount. Since spermcountcanbe
impactedbya multitude of lifestyle factors,includingweight, sedentaryactivity,ii
stress,iii
toxinsiv, v
and heatexposure,vi
Trakcanhelpidentifypotential barrierstoconceptionand urge
mento take action to improve theirchancesof fatherhood.
“Trak representsamajorstepforward for men’sreproductive health,asit revolutionizes the
waywe approach thisall-too-common,yetsignificantlyundervaluedcondition,”said Karen
Drexler,CEO,Sandstone Diagnostics.“Whilethere are severalat-home spermtestscurrently on
the market,Trak is setapart inofferingacomprehensive approachtomale reproductive
management,withits holisticplatform, superiorprecision,uniquedesign, robustdataanalytics
and personalized educationaltools–all backedbypeer-reviewedclinical research.”
The Trak systemdoesnot“replace”clinical evaluation,but ratherhelpscouplestestsoonerand
track progressas men make healthandlifestyle changes thatcanimprove sperm production.
Fortunately,male infertilityisoftentreatable,withstudiesshowingthat76 percentof couples
whosoughttreatmenthada potentiallycorrectablecondition.vii
“Nearlyhalf of fertilityproblemsoriginate withthe male partner, however, coupleshave had
veryfewoptionsfortacklingthe male half of the conceptionequation,” saidDr. BrianLevine,
NewYork practice directorfor the ColoradoCenterforReproductive Medicine,amultistate
fertilitypractice. “The launchof the TrakMale FertilityTestingSystem canprovide would-be
parentswithearliermale fertilityevaluation,whichcouldleadtoearliermedical intervention
and conception.”
“Infertilitycanbe overwhelmingforcouples.Historically,it’sbeenviewedasa woman’s
condition,all-too- oftenleavingmenoutof thisimportantreproductive healthequation,which
can hindertimelytreatmentandultimatelyslowthe conceptionprocess,”saidKenMosesian,
Executive Director,Path2Parenthood,anonprofitorganizationcommittedtohelpinghopeful
parentsfindthe moststreamlinedpathtohavingachild.“Trak, an FDA approvedhome test,can
helpmentobe proactive inaddressingfertilityconcerns,providingthemwithaneasy,discreet
wayto evaluate spermcountpriorto a comprehensive evaluationbyareproductive urologist.”
About Male Infertility
Male infertilityisacommon,yetsignificantlyundervaluedconditionthat isgrowingin
prevalence.Datasuggest approximately15percentof couplesexperience infertilityand that
mencontribute toup to half of all infertilitycases.v,viii
The majorityof menhave sub-optimal
spermcounts,whichcan leadto infertilityand longertime topregnancy.ix
Average spermcounts
have fallensignificantlyandcontinuouslyoverthe lastseveral decadesdue tobiological,
environmental andlifestyleshifts,x, xi , xii
andthere isa significantneedfor advanced optionsthat
can help tackle the male half of the conceptionequation.
About Sandstone Diagnostics
Sandstone DiagnosticsisaBay Areadiagnosticanddigital healthcompanydeveloping
sophisticatedconnectedwellnessproductsthatallow consumerstomeasure,monitor,and
improve keyhealthmarkersathome.The company’sfirstproduct,the Trak® Male Fertility
System,receivedFDA clearance inJune 2016. For more information,visit www.trakfertility.com
and www.sandstonediagnostics.com.
3. ###
i U.Y. Schaff et al,Novel Centrifugal Technology for MeasuringSperm 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 smokingcessation on sperm quality:case
report. Andrologia. 2011 Dec;43(6):431-5.
v La Vignera S, et al.Does alcohol haveany effect on malereproductive function? A review of
literature. Asian J Androl. 2013 Mar;15(2):221-5.
vi Shefi, S., et al.Wet heat exposure: a potentially reversiblecauseof lowsemen quality in infertilemen.
Int. Braz J Urol 33, 50–57 (2007).
vii Sandlow, J.I. Shattering the myths aboutmale 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) PracticeCommittee. Diagnostic evaluation of the
infertilemale: 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. Declinein semen concentration and morphology in a sampleof 26 609 men closeto
general population between 1989 and 2005 in France. Human Reproduction, 28(2), 2013,p.462-470.
xi Huang, C et al.Declinein semen quality among30,636 young Chinese men from 2001 to 2015. Fertility
and Sterility (2016) in press.http://www.fertstert.org/article/S0015-0282(16)62866-2/abstract.
xii Adiga S K, et al.Decliningsemen quality amongsouth Indian infertilemen: A retrospective study. J Hum
Reprod Sci 2008;1:15-8. http://www.jhrsonline.org/article.asp?issn=0974-
1208;year=2008;volume=1;issue=1;spage=15;epage=18;aulast=adiga.