Houston, Texas, USA, November 2, 2026
Contrario Medical, Inc. has announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Cyperus Sperm Separation Device, marking an important milestone in reproductive medicine and assisted reproductive technology. The newly cleared device is designed to prepare motile sperm from semen samples for use in in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), and intrauterine insemination (IUI) procedures. The development represents an advancement in laboratory-based sperm preparation technology, providing embryology and andrology laboratories with a sterile, single-use solution designed to simplify sperm processing. Based in Houston, Texas, Contrario Medical focuses on developing next-generation sperm separation technologies to support fertility specialists and patients undergoing assisted reproductive treatments.
Cyperus Introduces an Innovative Sperm Separation Technology
The Cyperus Sperm Separation Device is a compact, sterile and single-use medical device developed to prepare motile sperm for assisted reproductive procedures. According to the company, its design incorporates a closed system with a unique two-membrane configuration that generates an active flow within the device. Motile sperm naturally swim against this flow, following a mechanism inspired by their movement through the female reproductive tract. This process enables laboratory professionals to separate motile sperm from semen samples for subsequent fertility treatments. Unlike conventional sperm preparation approaches that may involve multiple processing steps, Cyperus is designed to make sample preparation more straightforward and efficient. The device is intended for use by trained embryology and andrology laboratory personnel, supporting laboratory workflows in fertility clinics and reproductive medicine facilities. Its single-use configuration also provides a controlled processing environment for individual semen samples.
Supporting IVF, ICSI and IUI Laboratory Procedures
The FDA-cleared Cyperus device is intended for preparing motile sperm from semen for the treatment of infertile couples through IVF, ICSI and IUI procedures. These assisted reproductive technologies are widely used in fertility care, with each procedure requiring appropriate sperm preparation before treatment. In IVF, prepared sperm are used for fertilization alongside retrieved eggs under laboratory conditions. ICSI involves the injection of an individual sperm directly into an egg, while IUI involves placing prepared sperm into the uterus to support fertilization. By providing a dedicated sperm separation solution, Cyperus is designed to support laboratories performing these procedures. Contrario Medical also reports that studies have shown its two-membrane flow system can minimize the presence of microparticles, including microplastics, in separated sperm samples. This potential capability is an additional area of interest for reproductive laboratories, although the company’s reported findings should not be interpreted as proof of improved pregnancy or live-birth outcomes.
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FDA 510(k) Clearance Marks a Regulatory Milestone
The FDA 510(k) clearance represents an important regulatory achievement for Contrario Medical as it advances the commercialization of its reproductive technology. The company stated that the device was developed with input from experienced clinicians in reproductive medicine, including specialists in embryology and fertility care. Albert Huang, MD, Chief Executive Officer of Contrario Medical, described the clearance as the result of the team’s development efforts and highlighted the company’s objective of improving the experience of healthcare providers and patients in fertility care. The company is now making Cyperus available to interested fertility laboratories and healthcare professionals, who can request product demonstrations. The regulatory milestone also highlights continued innovation in medical devices designed for assisted reproductive technology, where improvements in laboratory preparation methods can support clinical workflows.
Source: Contrario Medical press release
