IVF success the first time
Currently 12% of women and 9.6% of men are clinically infertile. This infertility rate is on the rise as younger generations are intent on having children later in life in addition to exposure to environmental toxins including but not limited to pesticides, pollution, and micro-plastics. Despite the increasing rate of infertility, 80% of infertile couples never receive any treatment due to the prohibitive nature of the costs. For those that do begin the IVF process, 34% have to cease the process due to costs. These costs are primarily due to the medication and testing required for ovarian stimulation to produce excess oocytes, intercytoplasmic sperm injection (ICSI) which is used for almost 90% of cases despite only being necessary for 20%, and the manual labor involved in the oocyte collection, selection, and transfer. On average the cost for IVF is $19,000 and the success rate is 30% which further exacerbates the difficulty in affording such a risky process. Ravata's automated in vitro fertilization, incubation, and embryo selection platform would complement low stimulation IVF processes (mini-IVF) which are currently being used to drastically reduce the cost of medication and lab tests for patients undergoing IVF. Currently for any sort of IVF treatment patients must visit specialized clinics and pay all expenses out of pocket with no low cost option available to them via their healthcare providers. Our platform would enable IVF to be performed at any hospital without requiring ICSI or an embryologist to manually handle and evaluate embryo quality.
The current standard of care is for patients struggling to conceive with either primary or secondary infertility to visit an IVF specialist where the cause of infertility can be diagnosed. Whether the infertility is due to male or female factor however the subsequent steps are standard practice. The female donor is started on medication to stimulate follicle development and oocyte maturation so as many oocytes as possible can be collected. For some patients this results in ovarian hyperstimulation syndrome which makes subsequent attempts at conception even more difficult. Sperm from a male donor is also collected and a few motile and normal morphology sperm are used to perform ICSI. Despite being necessary for only 20% of IVF patients, and having a peer reviewed lower rate of IVF success, the technique is used so IVF clinics can claim the highest rate of fertilization possible despite the detrimental effects to live birth rates. Following fertilization embryos are cultured in time-lapse incubators where images are collected of embryos to assist embryologists in their selection process prior to transfer. Ravata's platform would complement either the conventional stimulation techniques used or the lower stimulation techniques however the primary difference would be oocytes and sperm are inserted into our platform after which microfluidics would enable the fertilization of embryos. Once embryos are fertilized our sensors can detect the physiological change and embryos would be transferred to a culture chamber which would evaluate embryo development over 7 days. Following development the system would advise on embryo quality.
We have entered into a strategic agreement with the Jackson Labs in which they pay for our device, chips, and software to perform fertilized and unfertilized selection for their $100M+ production pipeline. Furthermore, any co-developed intellectual property will be split such that we retain access to all applications of the technology outside of mouse. This benefits us to continue developing the platform sold to Jackson Labs in line with predicting which embryos are most likely to implant and result in offspring because it will dramatically reduce their production costs and allow us to bring our technology to the FDA. By developing in conjunction with Jackson Labs we can collect the pre-clinical efficacy data required with mice, while generating revenue, and have a partner to assist in the development and any patent costs. Furthermore we are collaborating with the UC Davis School of Vet Med and UCD Mouse Biology Program to fulfil SBIR research.