New Study Confirms Clinical Test, Cap-Score™, Capable of Predicting and Ranking a Man’s Fertility

Data Shows Fourfold Increase in First-Attempt Pregnancies

A Man’s Fertility Can Now be Measured and Ranked

New Test Has the Power to Predict Pregnancy

MOUNTAINSIDE, N.J., September 25, 2018 – Androvia LifeSciences has announced the publication of a recent prospective study that demonstrates men who had a normal score on a new fertility test, Cap-ScoreTM, had a fourfold increase in pregnancies during the first attempt compared to men with a low score. The study was published in the journal, Molecular Reproduction and Development, a Wiley publication. Equally important, clinical outcomes as measured by pregnancies in couples having difficulty conceiving, clearly show that Cap-Score is a reliable predictor of a man’s probability of generating a pregnancy. A man’s fertility can now be measured and ranked using Cap-Score. There are no such tests readily available to men and clinicians.

“This innovative test appears to be a promising method for assessing the male partner’s potential for achieving a pregnancy; it may enhance our ability to provide more efficient and individualized treatment paradigms for couples with male infertility,” said Zev Rosenwaks, M.D., Director and Physician-in-Chief, Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine.

The results from this proprietary male fertility test provide a solution for many couples, including those who are struggling to conceive and become pregnant. In fact, millions of men seek assistance for fertility each year. Remarkably, more than 50% of male infertility is diagnosed as unexplained by current, inadequate methods. Understanding a man’s probability to generate a pregnancy will help clinicians counsel couples with personalized guidance to shorten their journey to parenthood saving time, emotional distress and money. Whether the couple has decided to delay parenthood or the man is diagnosed with male factor infertility, Cap-Score can assist the couple and the clinician in achieving pregnancy.

“We now have a tool to better assess male fertility. We no longer need to rely solely on a semen analysis. The addition of Cap-Score to the clinical evaluation of male fertility offers a functional measure that will help clinicians better counsel couples on how much intervention may or may not be needed,” said Eric Seaman, M.D., of New Jersey Urology, a leading practitioner of male reproductive medicine.

Cap-Score represents a breakthrough technology that has shifted the focus of understanding a man’s fertility from descriptive measures found with a semen analysis to a functional measure that analyzes the biological process within the sperm cell controlling fertilization. This biological process, known as capacitation, cannot be measured by a semen analysis, but can be quantified by Cap-Score. The published study shows Cap-Score is the best predictor of a man’s fertility.

“Tests of sperm function that provide clinically useful information to help optimize couples path to parenthood are needed and we are optimistic after reviewing the data that Cap-Score has the potential to be a significant contributor in this arena. We are fortunate to be one of the select reproductive centers to currently offer this new tool to help our couples with possible or established male factor infertility fulfill their dreams of establishing a family” said Natan Bar-Chama, M.D., Director of the Center of Male Reproductive Health at RMA of New York.

In the study, Cap-Score and clinical pregnancy outcomes were analyzed for 91 couples. Based on Cap-Score, men were separated into two groups. The newly published data showed that men with normal Cap-Scores generated four times the number of pregnancies in the first attempt than men with low Cap-Scores. The data also yielded dramatic and consistently high pregnancy rates in the second and third attempts for men with normal scores.

For access to the complete publication please visit: https://onlinelibrary.wiley.com/doi/10.1002/mrd.23057.

“The ability to determine the man’s probability of generating a pregnancy is a substantial advance for all couples when planning their families. This is particularly important when childbirth is being delayed resulting in an increased likelihood of encountering potential problems,” said Gianpiero Palermo, M.D., Ph.D., Director of Assisted Fertilization and the Andrology Laboratory at the Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine at Weill Cornell Medicine. Dr. Palermo is a member of Androvia LifeSciences’ Clinical Advisory Team.

“Cap-Score also addresses the many questions about what may have a positive or negative effect on a man’s fertility. Similarly, since we now know how to measure the process that controls fertility within the sperm cell, we also may have the foundation for a novel approach to male contraception. This technology can also be applied to important aspects of animal health care and particularly the breeding of livestock. The benefits are quite expansive,” said Michael V. Novinski, CEO of Androvia LifeSciences.

Androvia LifeSciences is a NY-based, privately held company focused on developing new diagnostics that provide a higher level of patient management of male fertility for use by clinicians to counsel couples. The company’s objective is to understand male fertility at its most fundamental level – how it occurs, how it’s measured, and how it can be applied to improve outcomes.

The company operates at the highest standard of laboratories which is CLIA compliant, New Jersey DOH approved, certified by the College of American Pathology and licensed by New York State as both a facility and as an approved Laboratory Test. Cornell University has licensed the Cap-Score technology to Androvia LifeSciences for development into a commercially practical diagnostic assay. The company has analyzed over 1300 men since late 2016, has published five peer reviewed articles and has made multiple invited presentations on its cutting-edge technology. Couples and clinicians who are interested in learning more about the Cap-Score and the probability of a man’s ability to generate a pregnancy can click here or visit www.androvialifesciences.com. The Cap-Score test is currently available to physicians and couples.

Contact information:
Alana Simpson
646-747-9105
asimpson@androvialife.com

Androvia LifeSciences Study Reveals New Evidence for Men Experiencing Fertility Problems

Timing for Sperm Maturation and Capacitation Differs Dramatically in Men

Mountainside, NJ, April 3, 2018- Androvia LifeSciences, a company dedicated to the development of male fertility solutions, announced today a newly published study in the Journal of Molecular Reproduction and Development, a Wiley publication. The study shows that in a significant number of normal fertile men, it takes more time for sperm to mature and undergo capacitation to be able to fertilize the egg.  Altering insemination timing can improve a couple’s ability to conceive, either naturally or through assisted reproduction. The study showed that in 44% of normal fertile men, it took much longer (24 hours) for sperm to mature post ejaculation and gain the ability to fertilize the egg than previously thought.

Once ovulation occurs, the egg is only receptive to sperm for fertilization for a short period of time, 12-24 hours.  To fertilize, sperm must mature and undergo capacitation once in the female reproductive tract. The time it takes post ejaculation for sperm to mature has been identified as the capacitation rate, or Cap-Rate™.  Conventional thought has been that sperm mature quickly (i.e. within 12 hours) following ejaculation. However, in this study of 123 samples from 54 fertile men, 44% (54/123) of this fertile population required 24 hours to reach peak levels of maturation and capacitation. Inseminating too late, whether naturally or artificially, would greatly reduce the probability of conception for couples. If sperm are not given appropriate time to mature and capacitate while in the reproductive tract, fertilization of the egg will not happen. Inseminating earlier for certain men may dramatically improve the probability of conception. In the same study, it was found that Cap-Rate was consistent in men who required more time for their sperm to capacitate and in men with sperm that capacitated readily after ejaculation. When samples obtained from men questioning their fertility were analyzed for Cap-Rate, 29% (5/17) of this population was designated to the late capacitation group which is not different than the late capacitation phenomena observed in the fertile population.

“Understanding how each man’s sperm mature and capacitate will help improve the probability for pregnancy. This will allow physicians to personalize the treatment strategy and adjust thought processes and improve a couple’s chances for pregnancy” said Gianpiero Palermo, MD, PhD, a world expert in the fertility field and Director of Assisted Fertilization and the Andrology Laboratory at the Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine.

Over the last year, Androvia has analyzed samples from almost 1000 men at eight major reproductive centers in the US using the newly introduced clinical Cap-Score™ Sperm Function Test (Cap-Score SFT). Currently, the company is providing the test at no charge while collecting these data. The company has released four major publications to date since 2017 regarding male infertility, improving diagnosis and treatment for couples experiencing fertility problems by analyzing sperm function and more specifically, capacitation.

Couples and/or clinics interested in the Cap-Score SFT should visit www.androvialifesciences.com to find a list of clinics offering the Cap-Score SFT and/or to inquire about adding the Cap-Score SFT to your clinic’s menu of male fertility testing and evaluation.

To read this study in its entirety, please visit the following:

Infertility
Approximately 73 million couples experience infertility globally. At least 6.7 million infertile couples live in the United States. Male factor infertility contributes to roughly half of all cases of infertility, and 50% of male infertility cases are unexplained by traditional semen analysis.

About Androvia LifeSciences
Located in Mountainside, NJ, Androvia LifeSciences is a CLIA registered and CAP accredited laboratory. The company’s first product, the Cap-Score SFT, has been developed to empower couples and clinicians with critical information, helping them to achieve more personalized fertility solutions.  For more information on Androvia and the Cap-Score SFT please visit www.androvialifesciences.com.

Contact information:
Alana Simpson
646-747-9105
asimpson@androvialife.com

Androvia LifeSciences Announces Results from a Health Economics and Outcomes Research Study Highlighting the Potential Cost Impact of the Cap-Score™ Sperm Function Test

The Cap-Score™ is projected to improve pregnancy rates and save couples time and money

The cost savings as a result of the Cap-Score™ may lead to more infertile couples seeking infertility treatments

MOUNTAINSIDE, N.J., Oct. 18, 2017 (GLOBE NEWSWIRE) — Androvia LifeSciences, a company devoted to the development of infertility solutions, announced today the publication of a paper presenting the potential economic impact of the Cap-ScoreTM in the Journal of Assisted Reproduction and Genetics, a Springer International Publishing AG publication.

“The Cap-Score™ has the potential to change the management of male factor infertility and infertility of unknown origin by increasing access, improving outcomes, and saving money,” said Joseph B. Babigumira, Associate Professor, Global Health and the lead author of the study.

The study’s objective was to evaluate the differences in outcomes and financial expenditures when using the Cap-ScoreTM with timed intrauterine insemination (IUI) versus standard of care (SOC).  To assess the potential benefit of adding the Cap-Score™ to the SOC, researchers at the Global Medicines Program at the University of Washington utilized decision-analytic modeling methods, sensitivity analysis and estimates of the cost of fertility treatments to demonstrate that compared to SOC, utilizing the Cap-ScoreTM in conjunction with timed IUI has the potential to dramatically reduce medical costs associated with IUI and in vitro fertilization (IVF) when combined with SOC vs SOC alone. The study also projected a reduction in the cumulative number of IUI and IVF procedures as well as the total costs of fertility treatment across all age groups studied.

Data from this study projected that mean IUI cost savings varied from $595 in couples with women under 35 years of age to $1,366 in couples with women over 42 years of age. Mean IVF cost savings were projected to vary from $3,410 in couples with women under 35 years of age to $17,823 in couples with women over 42 years of age. Mean total cost savings were projected to vary from $4,000 in couples with women under 35 years of age to $19,100 in couples with women over 42 years of age.

Notably, the cost savings attributable to Cap-ScoreTM usage consistently increase with maternal age because of decreasing probability of clinical pregnancy with age. Therefore, implementation of the Cap-Score™ SFT can potentially increase the clinical and economic value propositions for older couples with difficulty conceiving.

“The Cap-Score™ is a potentially valuable clinical tool which allows the physician and infertile couple to select the best cost effective option for their treatment.  By using the Cap-Score™ we may be able to reduce the time to achieve a clinical pregnancy and thus save the couple time and money,” said Dr. Fady Sharara, one of the leading fertility specialists in the country and one of the first to offer the test at his practice, the Virginia Center for Reproductive Medicine and also an author of this publication.

“From what we have seen to date, the Cap-Score™ is a valuable tool and a step towards a couple’s personalized treatment which should result in a cost savings and positive outcome in an accelerated fashion,” said Michael V. Novinski, CEO of Androvia LifeSciences.

An on-going company-sponsored multi-site investigation has shown so far that Cap-Score™ results are highly predictive of negative outcomes related to use of IUIs when reviewed along with other semen analysis parameters, and is predictive of positive fertility outcomes. The company is looking to increase the positive predictive value of this test by integrating more data and the influence of insemination timing on positive predictive outcomes along with other factors.

To read this publication through open access, please visit the following:
Projecting the potential impact of the Cap-ScoreTM on clinical pregnancy, live births, and medical costs in couples with unexplained infertility
https://doi.org/10.1007/s10815-017-1021-4

Infertility

Approximately 73 million couples experience infertility globally. At least 6.7 million infertile couples live in the United States. Male factor infertility contributes to roughly half of all cases of infertility, and 50% of male infertility cases are unexplained by traditional semen analysis.

About Androvia LifeSciences

Located in Mountainside, NJ, Androvia LifeSciences is a CLIA registered laboratory. The company’s first product, the Cap-Score™ SFT, has been developed to empower couples and clinicians with critical information, helping them to achieve more personalized fertility solutions.  For more information on Androvia and the Cap-Score™ please visit.  http://www.androvialifesciences.com/

Studies Validate Clinical Utility of Cap-Score™ Sperm Function Test

A New Frontier for Semen Analysis and Hope for Infertile Couples

Mountainside, NJ, April 18, 2017 – Androvia LifeSciences announced today the publication of two papers presenting clinical and technology validation studies in the journal Molecular Reproduction and Development, a Wiley publication. These data provide scientific evidence of the clinical utility and value of its breakthrough technology, the Cap-Score™ Sperm Function Test (Cap-Score SFT). A laboratory developed test, the Cap-Score SFT is the only test that can determine if sperm can capacitate, indicating the percentage of sperm that can actually fertilize an egg, and comparing each man’s results to a normal, fertile population.

The Cap-Score Sperm Function Test represents a new frontier in semen analysis and allows us to personalize treatment for couples from the very beginning” said Dr. Fady Sharara, one of the leading fertility specialists in the country and one of the first to offer the test, at his practice the Virginia Center for Reproductive Medicine.

These new publications establish and demonstrate the clinical utility, efficacy and significance of the Cap-Score SFT.  The first paper presents the results of two separate clinical studies, one conducted at Cornell University’s world leading fertility clinic, the other at Androvia’s research lab.  In a trial of men with long histories of unexplained infertility, men with high Cap-Scores above a certain threshold, had a 92% chance of conceiving by natural conception or within three cycles of intrauterine insemination.  Conversely, men with Cap-Scores below that threshold had only a 21% chance.  In the second trial, the Cap-Scores from a group of 76 men with proven fertility were compared against those of 122 men seeking semen analysis because of difficulty conceiving.  A significantly higher percentage of men questioning their fertility (34%) had abnormally low Cap-Scores, compared with only 13% of the fertile men.

These data demonstrate that the Cap-Score strongly reflects fertility, and can provide value as a general screening test for men questioning their fertility. Physicians can now guide couples toward the most appropriate form of assisted reproduction from the start of therapy.

The second paper validated the underlying technology, demonstrating the accuracy, reproducibility and precision of the test.  The Cap-Score is based on the fact that GM1, a lipid on the sperm surface, is found in different regions of the head of a capacitated sperm versus one that can’t fertilize.  Several experimental methods were used to confirm the relationship between these patterns of GM1 localization and the capacitation status of single sperm.  Next, over 100,000 sperm images were used to determine the reproducibility and repeatability of the Cap-Score when read by trained analysts.   Finally, experiments to study the impact of semen handling methods on sperm function demonstrated that chymotrypsin and bromelain, two commonly used agents to facilitate semen analysis and handling had a deleterious effect on sperm function.

Cap-Score reflects sperm fertilizing ability and it provides highly accurate, reproducible, and reliable results.  It helps diagnose the fertility status of individual men, and can be used to assess the impacts of laboratory methods used around the world to improve how assisted reproduction is performed.

The Cap-Score SFT provides a new and promising complement to traditional semen analysis to evaluate male fertility.  Previously, the scores provided by semen analysis gave only descriptive information on how many sperm there are, how well they swim, and how they look.  They failed to identify the majority of men with fertility problems because they provided no information on sperm function—the ability of sperm to actually fertilize an egg.

More accurate testing is the first step towards more effective treatments. The Cap-Score Sperm Function Test can prove to be a game changer for physicians who treat infertility and for their patients” said Dr. Eric Seaman, one of the leading practitioners of male reproductive medicine in New Jersey and whose practice, Urology New Jersey, is the largest urology practice in the state.

“The Cap-Score Sperm Function Test will have an immediate impact on the millions of cases of unexplained infertility with a particular emphasis on men” said Michael V. Novinski, CEO of Androvia LifeSciences.

To read these studies in their entirety, please visit the following:

Infertility

Approximately 73 million couples experience infertility globally. At least 6.7 million infertile couples live in the United States. Male factor infertility contributes to roughly half of all cases of infertility, and 50% of male infertility cases are unexplained by traditional semen analysis.

About Androvia LifeSciences

Located in Mountainside, NJ, Androvia LifeSciences is a CLIA registered laboratory. The company’s first product, the Cap-Score SFT, has been developed to empower couples and clinicians with critical information, helping them to achieve more personalized fertility solutions.  For more information on Androvia and the Cap-Score SFT please visit www.androvialifesciences.com.

Scientific Data and Presentations

Company announcements:

Press Release: Prospective sudy demonstrates that men who had a normal score on a new fertility test, Cap-Score™, had a fourfold increase in pregnancies during the first attempt compared to men with a low score.
Published Manuscript: Jay Schinfeld, Fady Sharara, Randy Morris, Gianpiero D. Palermo, Zev Rosenwaks, Eric Seaman, Steve Hirshberg, John Cook, Cristina Cardona, G. Charles Ostermeier, Alexander J. Travis. Cap-Score™ prospectively predicts probability of pregnancy. Mol. Reprod Dev. 2018; 1-11.  https://doi.org/10.1002/mrd.23057

Press Release: Study shows that altering insemination timing can improve a couple’s ability to conceive, either naturally or through assisted reproduction.
Published Manuscript: G. Charles Ostermeier, Cristina Cardona, Melissa A. Moody, Alana J. Simpson, Romeo Mendoza, Eric Seaman, Alexander J. Travis. Timing of sperm capacitation varies reproducibly among men. Mol. Reprod Dev. 2018; 1-10.  https://doi.org/10.1002/mrd.22972

Press Release: Study projects the clinical impact of the Cap-Score™ by improving pregnancy rates and saving couples time and money.
Published Manuscript: Babigumira, J.B., Sharara, F.I. & Garrison, L.P. Projecting the potential impact of the Cap-Score™ on clinical pregnancy, live births, and medical costs in couples with unexplained infertility. J Assist Reprod Genet (2017). https://doi.org/10.1007/s10815-017-1021-4

Press Release: Studies validate the clinical utility of the Cap-Score™.
Published Manuscript: Cardona CNeri QVSimpson AJ, et al. Localization patterns of the ganglioside GM1 in human sperm are indicative of male fertility and independent of traditional semen measuresMol Reprod Dev201784:423435. https://doi.org/10.1002/mrd.22803
Published Manuscript: Moody MACardona CSimpson AJSmith TTTravis AJOstermeier GCValidation of a laboratory-developed test of human sperm capacitation. Mol Reprod Dev201784:408-422.  
https://doi.org/10.1002/mrd.22801


Androvia LifeSciences will have a presence at the following scientific meetings in 2018:

ASRM: American Society of Reproductive Medicine
October 6-10, 2018; Denver, Colorado
Booth # 1124

AUA: American Urological Assocation
May 18-21, 2018; San Francisco, CA
Booth # 6075

SSMR: Society for the Study of Male Reproduction
May 20, 2018; San Francisco, CA

ASA: American Society for Andrology
April 21-24, 2018; Portland, OR
Multiple abstracts accepted for poster presentations


Data presented at past scientific meetings:

ASA: American Society for Andrology
April 21-24, 2018; Portland, OR
Multiple abstracts accepted for poster presentations


ASA: American Society of Andrology
April 22-25, 2017; Miami, FL

  • Abstract #P-136Localization patterns of the ganglioside GM1 identify sperm capable of undergoing capacitation and acrosome exocytosis

ASRM: American Society of Reproductive Medicine
October 15-19, 2016; Salt Lake City, UT

  • Abstract #P-354: Capacitation defects are common in men questioning their fertility and are independent of standard semen analysis parameters
    clinical-cohort-study-9-19-16
  • Abstract #P-523: Capacitation timing varies among men, but is consistent among ejaculates within individuals
    cap-rate-asrm-2016-poster

AUA: American Urological Association + SSMR Annual Meeting: Society for the Study of Male Reproduction
May 6-10, 2016; San Diego, CA

  • Abstract #MP70-10: Impacts of common semen handling methods on sperm function
    Slide1

ASA: American Society of Andrology
April 2-5, 2016; New Orleans, LA

  • Abstract #12: Consistent differences among men in capacitation timing could personalize IUI/ART
    Slide1
  • Abstract #138: Normal ejaculates, as defined by WHO, can have abnormal capacitation ability
    Slide1
  • Abstract #140: Sperm from fertile men and those seeking fertility exams differ in their ability to capacitate
    Slide1
  • Abstract #137: Reliability estimates for a test of sperm capacitation, a functional complement to semen analysis
    Slide1

# # #

4 Things Doctors Wish They Knew About Infertility

The Huffington Post, April 25, 2016
About 12 percent of American women of childbearing age have trouble getting and staying pregnant, and about 7.5 percent of sexually experienced men under 44 have seen a fertility doctor, according to the U.S. Centers for Disease Control and Prevention.