Contrario Medical 的 Cyperus 精子分离设备获 FDA 510(k) 许可

Single-use device prepares motile sperm for IVF, ICSI and IUI, giving fertility labs the next evolution in sperm separation technology with advanced capabilities.

, /PRNewswire/ -- Contrario Medical, Inc., a Houston-based medical device company developing next-generation sperm separation technology, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Cyperus. Cyperus is a sterile, single-use device that prepares motile sperm from semen for use in in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI) and intrauterine insemination (IUI).

"FDA clearance of Cyperus is the culmination of a lot of creative and hard work by our talented team," said Albert Huang, MD, CEO of Contrario Medical. "We built this technology to improve the experience for healthcare providers and for the patients who depend on them in the fertility space."

Leading clinicians in reproductive medicine advised Contrario Medical as it brought Cyperus to market.

"Sperm preparation methods have barely evolved in years. Cyperus changes that with an innovative design that delivers a high-quality sperm sample with just a few simple steps," said Anthony Anderson, DHSc, ELD (ABB), founder and CEO of IVF Academy USA and an advisor to Contrario Medical. "I believe it will set a new standard, and I can't wait for embryology labs to experience the difference."

"At Pozitivf, our rule for innovation is simple: lower the price, never the bar," said Francisco Arredondo, MD, MPH, co-founder and chief medical officer of Pozitivf Fertility and an advisor to Contrario Medical. "Most new fertility technology fails that test by adding cost. Cyperus passes it, giving labs a better way to select high-quality sperm at a competitive price. That matters, because parenthood is a universal human right, not a luxury."

About the device

Cyperus is a compact, sterile, single-use device used by embryology and andrology lab staff to simply and efficiently process semen samples with fewer steps than on market devices. The Cyperus device is a closed system with a unique two membrane system that generates active flow that sperm instinctively swim against in the same way they do in the female reproductive tract. This flow allows the sperm to efficiently separate, while at the same time the flow has been shown in studies to minimize the presence of microparticles such as microplastics in the separated sperm sample.

Availability and Contact

Availability: To learn more or request a demonstration, please visit www.contrariomedical.com 

Indications for Use: Cyperus is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.

About Contrario Medical, Inc. Contrario Medical, Inc. is a Houston-based medical device company developing next-generation sperm separation technology for use in assisted reproductive technologies. Learn more at www.contrariomedical.com.

Media contact Albert Huang, CEO Contrario Medical, Inc. [email protected] 

SOURCE Contrario Medical Inc.