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.

Androvia LifeSciences to Present Data Focused on Male Infertility At American Urological Association (AUA) 2016 Annual Meeting

MOUNTAINSIDE, NJ, April 4, 2016; PRNewswire — Androvia LifeSciences, a biotechnology company engineering solutions for the advancement of male fertility, today announced that data related to the company’s proprietary technology, the Cap-Score™ Sperm Function Test, will be presented at the American Urological Association (AUA) 2016 Annual Meeting, to be held May 6 – 10 in San Diego, California.

Research Suggests New Insights into Male Infertility

MOUNTAINSIDE, NJ, April 4, 2016; PRNewswire — Androvia LifeSciences, focused on male fertility, today reported results of four new studies that use its proprietary technology to quantify the ability of sperm to fertilize. The Cap-ScoreTM Sperm Function Test offers a ranking where the fertilizing ability of a semen sample is compared to that from a population of fertile men and could potentially have implications for the management of human infertility.

Androvia LifeSciences to Present Four Studies Focused on Male Infertility At 41st Annual Conference of the American Society of Andrology (ASA)

MOUNTAINSIDE, NJ, March 16, 2016; PRNewswire — Androvia LifeSciences, a biotechnology company engineering solutions for the advancement of male fertility, today announced that data related to the company’s proprietary technology, the Cap-Score™ Sperm Function Test, will be presented in an oral session at the 41st Annual Conference of the American Society of Andrology (ASA), to be held April 2 – 5, 2016 in New Orleans, Louisiana. Three additional studies related to the Cap-Score Sperm Function Test will be presented in poster sessions.