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Devices FDA

 News Release - March 15, 2018

DxNow, Inc. Receives FDA 510(k) Clearance for ZyMōt(TM) ICSI and ZyMōt(TM) Multi Sperm Separation Devices

Novel Devices Advance Fertility Treatment for Millions of Couples Striving to Conceive

GAITHERSBURG, Md., March 15, 2018 -- (Healthcare Sales & Marketing Network) -- DxNow, Inc., a privately held medical device company, announces receipt of FDA 510(k) clearance of its ZyMōt ICSI and ZyMōt Multi Sperm Separation Devices. DxNow is developing novel devices for use in assisted reproductive technology (ART) procedures conducted by fertility clinics and OB/GYN practices. The ZyMōt devices are intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), intrauterine insemination (IUI), and in vitro fertilization (IVF) procedures. These devices will be the first of their kind in the U.S. market.

The ZyMōt devices simulate the cervical and uterine pathway that sperm must navigate to naturally fertilize an egg, recreating a process that has been preserved in nature for millions of years. With the goal of mimicking nature, ZyMōt devices facilitate the separation and preparation of highly-motile sperm with normal morphology for use in ART procedures. Presenting a simple and straight-forward methodology, the ZyMōt devices provide considerable time savings when compared to conventional methods.

"We are excited to announce the achievement of this significant milestone in our company's evolution. This announcement follows CE certification and the introduction of our sperm separation devices in Turkey and several European, Latin American and Asian countries," said Bill Sharp, Co-founder and CEO of DxNow. "We have developed devices that make ART procedures faster and less demanding for reproductive medicine professionals. Equally important, we are offering a new pathway for enabling the selection of stronger and healthier sperm, with the ultimate goal of supporting infertile couples striving to conceive."

"This is an outstanding validation of our core technology platforms," added DxNow Co-founder, Director and Scientific Advisor, Utkan Demirci, Ph.D. "It is very gratifying to know that our devices are now widely available to serve patients through reproductive medicine professionals in the United States. We will continue to drive ourselves with innovations and to advance the development of these innovations that will help deliver what matters most to infertile couples facilitating the possibility to conceive."

Millions of infertile couples worldwide striving to conceive find themselves needing the assistance of ART procedures. More and more, the problem is being attributed to male factor issues. The frequency of male infertility has been steadily increasing, due to environmental, hereditary, lifestyle and dietary factors. Utilizing currently available methods, the embryologist has been challenged to select the "right" sperm for use in ART procedures. Furthermore, current procedures requiring centrifugation cause irreversible damage to the sperm, due to DNA fragmentation and the generation of reactive oxygen species.

About DxNow, Inc.

Leveraging exclusively-licensed technologies developed in the Demirci Bio-Acoustic MEMS in Medicine Labs (BAMM Labs) at Brigham & Women's Hospital and Stanford University School of Medicine, DxNow is developing sperm separation products to assist clinical practitioners in the selection of healthy motile sperm, with the ultimate objective of enabling improved outcomes for couples undergoing ART procedures. Our fertility products eliminate the need and standardize the process for time-consuming sample preparation and sperm-damaging centrifugation. The result is a simple and fast method, enabling the embryologist to consistently select sperm with higher motility, better morphology, lower ROS generation and lower DNA fragmentation.


Source: DxNow

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