FDA Clears CrossBay Medical’s IVF Embryo Transfer Catheter Set

CrossBay Medical Inc. announced receipt of United States Food and Drug Administration (FDA) clearance of its product, the CrossBay IVF Embryo Transfer Catheter Set. The device has also received clearance to commercialize the product in Europe by obtaining its CE mark. The product is intended for ultrasound-guided transfer of embryos into the uterine cavity following in vitro fertilization. The embryo transfer procedure is the last step in the IVF process and critically important to the success of the procedure.
 
In 2012, there were approximately 1.76 million IVF cycles performed globally. While IVF has become the method of choice for infertile couples and infertility specialists, the average failure rate has remained unchanged over the past decade at approximately 70%. Insertion and delivery problems associated with embryo transfer catheter techniques contribute significantly to this failure rate.
 
“Embryo transfer is one of the most important parts of the IVF procedure, yet the technology has not advanced in 30 years. CrossBay’s IVF Embryo Transfer Set is designed to alleviate many of the issues associated with embryo transfer to try and increase pregnancy rates,” said Piush Vidyarthi, CEO of CrossBay Medical Inc. “With FDA and CE clearance for our IVF Embryo Transfer Catheter Set we can now begin to streamline the way embryo transfer is performed with the ultimate goal of becoming the gold standard.”
 
CrossBay Medical will pursue partnerships globally with entities that are equally driven to improve the IVF process for physicians and patients. In China, the company has entered into an exclusive distribution agreement with Peking Jabrehoo Med Tech Co., Ltd to commercialize the product. 
 
“We’re thrilled to be working with a leading medical distributor in China that will begin commercialization efforts for the product once we receive marketing approval from the Chinese FDA. CrossBay’s goal has always been to offer effective products for the global market. This distribution agreement will be the first step in our entry in the Chinese market,” added Vidyarthi.