Smile Politely

Epivara Inc. has created a single-injection alternative to spays and neutering

The average dog or cat owner has probably had to go through the surgical process of neutering or spaying their pet. The procedures take up entire days and maybe a week of pain for your pet to recover. With the problem of overpopulation in cats and dogs also looming, Epivara Inc. at Research Park at the University of Illinois is working to create technologies that simplify the process. I was able to speak with Dr. Rex Hess, the Director of Science at Epivara about his new technology using an injection to spay and neuter animals. The technology proved to be so revolutionary that the organization received national recognition and won a $250,000 grant from the National Science Foundation (NSF). 

Smile Politely: Hello! Can you introduce yourself to readers and your role at Epivara Inc?

Dr. Rex Hess: We have three main roles at Epivara.

Dr. Jay Ko is the Founder and CEO of Epivara. He is also Professor of Comparative Biosciences in the College of Veterinary Medicine at the University of Illinois Champaign-Urbana. His expertise is in reproductive biology and molecular mechanisms of ovulation.

Dr. Rex Hess is Director of Science at Epivara and he also comes from the UIUC campus, where he is Professor Emeritus, after 35 years in the Department of Comparative Biosciences. His expertise is in male reproductive biology and toxicology and he provides oversight of the research and relevant literature review.

Dr. Chanjin Park is Vice President of Research & Development and has extensive experience in both male and female reproductive endocrinology and has an Adjunct Research Assistant Professor appointment in Comparative Biosciences. He is responsible for conducting all relevant experiments and data analysis.

SP: Can you explain the focus and main goal of your corporation?

Hess: We are a start-up company whose mission is to make life easier and better for animals through innovative science and compassionate care. The company was started about five years ago, with an initial goal of creating a humane alternative to surgical spaying and neutering of dogs and cats. Thus, our current focus is on animal sterility, primarily dogs and cats, but also other animals as well, such as pigs and cattle, etc.

SP: You’ve recently been awarded a grant for $250,000 to conduct research on developing a single-injection, non-surgical alternative to surgical spaying and neutering. Can you walk me through the steps from how you came up with this idea to how you finally were able to produce it?

Hess: We all also work in the College of Veterinary Medicine and understand the serious problem of overpopulation in some animal species, particular for dogs and cats. Theoretically speaking, just one pair of fertile stray cats can lead to 370,000 homeless cats in seven years and in the U.S. half of those cats will be euthanized. Surgical castration and spaying are very well established and regulated within the profession, but surgery is costly and time consuming in animal shelters, and of course surgery is a stress on the animal, and can lead to occasional complications. Because we already work on reproductive biology problems and chemical toxicology in reproduction, it was natural for us to look at our own research as potential methods for inducing sterility in domesticated animals.

One method that was developed by our research team has tremendous potential because it only requires a single injection of a prepubertal animal to inhibit development of the reproductive system, without impacting the development of other organs. As a consequence, the injected animals grow and reach maturity with normal health and vitality, but they become sterile, meaning that they cannot produce germ cells and do not exhibit mating behaviors. This is the method that is being funded by the NSF grant for a small-scale clinical trial in female dogs. The team has also developed other pipeline methods/products that induce sterility in animals but by different mechanisms. Epivara (originally called Insigna) was founded by Dr. Ko with the goal of commercialization of these new approaches and products for controlling animal fertility.

SP: What are the future steps for the advancement of this product?

Hess: We are currently transitioning from basic research to clinical trials, a necessary and critical step toward commercialization of the injectable sterilizer. The key to future success is in identifying the amount (dosage) of the products to be injected in each species and sex, and the timing of injection that is also different in each species and sex. This type of research is expensive and must be performed under stringent regulations and using rigorous scientific methods and analysis.

SP: Why do you think the cause of simplifying neutering procedures is so important?

Hess: Castration of a single male dog may be fairly simple and quick for most veterinarians, but it still requires sterile surgical methods and is costly and must be performed under general anesthesia. The surgery for the female dog is more invasive and takes even longer time under anesthesia. Thus, simply based on the speed of performance and cost of surgery, the introduction of a one-time injection in a dog, which could possibly be done at the same time as one would give a vaccine, would save time and money and increase the number of animals sterilized in a given time. It would also give an option to owners who simply do not want to put their animals through the trauma of surgery.

Although we are heavily focused on the development of non-surgical sterilizers for dogs and cats, we are also working on extending this methodology to food animals. One of the untold truths in the livestock industry is that all male pigs and beef cattle raised for meat production are castrated soon after birth, without anesthesia and proper post-surgical care. Why is this done? It is done because their testes produce androgens when they reach puberty causing two major problems: Testosterone makes the males aggressive and difficult to handle; and the androgen causes the pork to produce a pungent odor when cooked, which is called “boar taint”. If proper surgical procedures were used for castration in farm animals, the cost of castration would be exceedingly expensive, raising the price of meat to consumers beyond an acceptable level. If successful, our products will prevent boar taint by a humane method (a single injection) at a low cost, which would benefit both animals and humans.

SP: Why is this cause and medical innovation in general so important to you?

Hess: We work in a Veterinary Curriculum and train students to do everything possible to save animal lives and to make animal life better. If we can use our knowledge of reproductive biology and endocrinology for medical innovation by replacing a surgical procedure with an injection method and at the same time help to reduce animal overpopulation, then we are helping to advance veterinary medicine in at least one small area.

SP: How do you plan to spend the money you received from the grant?

Hess: The money will allow us to test the efficiency and safety of our animal sterilizer (EpiFix) in the female dog. Research in dogs is very expensive, as it requires veterinary oversight and special attention to the animals’ health and welfare, all of which must be carried out according to approved protocols. Some of the money will also help to support our research laboratory within the UIUC Research Park EnterpriseWorks.

SP: What was the process like for receiving this award? Did you have to apply, or did someone reach out to you?

Hess: The National Science Foundation supports small businesses with grants and contracts through their Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) programs. Application is open to all small businesses. These grants require the business to make a rather complicated application for these awards through a very competitive process. You first identify a specific area of opportunity that fits your business focus. Then you write and rewrite and rewrite the narrative of the proposal until you feel you have the basic hypotheses and preliminary research data explained sufficiently to convince a panel of scientists to fund your research rather than someone else’s. Just writing the proposal and getting all the needed information ready can take anywhere from one to two months. The supporting preliminary research data may have taken up to two years.

We submitted our first application in 2019. After several months, the submitted application and detailed budget were then reviewed by the NSF Review Panel and given a priority rating. Our first application received a “Competitive” ranking but was not funded. We then re-wrote the proposal titled, SBIR Phase I: Safe and effective injectable alternative to surgical spays in female dogs,” and re-submitted in the Fall 2020. In January 2021, NSF requested further information and answers to various questions, which we supplied and then in the spring 2021 we received notice of funding, which started May 1st.

Learn more about Epivara, Inc. at their website.

Top photo provided by Dr. Rex Hess.

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