This Modern IVF Enterprise Successfully Delivered a Newborn for the Initial Time
Many entrepreneurs liken their companies to their "babies," but for Dina Radenkovic, this took on a whole new meaning on December 7 when the first baby conceived using her firm's in-vitro fertilization (IVF) product, Fertilo, was born in Peru.
"Transitioning from a rudimentary pitch deck in my initial New York rented apartment, to a real-life baby, it's undeniably an intense emotional journey," Radenkovic remarks on this significant milestone.
Since 1978, millions of babies have been born through IVF. In the United States alone, over 2% of all births in 2021 utilized this technique. The process involves injecting oneself with hormones for ten to 14 days, sometimes multiple times a day, to mature eggs that doctors can extract from the body to freeze or fertilize. Once a mature egg is fertilized, it ideally develops into an embryo that can be implanted into the uterus.
While effective, the process is lengthy, expensive, and uncomfortable. The high doses of hormones often result in side effects such as bloating, nausea, and vomiting, and even ovarian hyperstimulation syndrome, Radenkovic points out. Moreover, successful egg extracts only work about half the time for patients under 35 years old (with success rates decreasing significantly for those over 40), necessitating multiple expensive and physically demanding attempts.
These challenges sparked Radenkovic's co-founding of Gameto with Martin Varsavsky in 2021. Both had a background in fertility health. Radenkovic, a physician, had worked in clinical and research roles at institutions such as the National Health Services’ Barts Health and St Thomas'. Varsavsky, a serial entrepreneur, was the founder of Prelude Fertility, North America’s largest chain of fertility clinics.
Gameto aimed to make IVF less invasive, less painful, and more accessible, Radenkovic, a Forbes 30 Under 30 Healthcare awardee, mentions. To achieve this, Gameto raised $73 million in funding, including a $33 million Series B led by Two Sigma Ventures in May 2022, to tackle the $25 billion global IVF market.
"The market is vast," says Dusan Perovic, a partner at Two Sigma Ventures, attributing this to the increasing age at which people are starting families today. "Investors are recognizing the immense unmet need, and better technology is required to address it."
Following Gameto's inception, Radenkovic and Varsavsky collaborated with a lab at Harvard's Wyss Institute, which was researching cell engineering. This resulted in the idea that eggs might be able to mature outside the mother's body, thereby reducing the process's time and invasiveness. This insight led to the development of the company's product, Fertilo.
Using Fertilo, the IVF injection process could be reduced to just two or three days before extracting non-mature eggs. The eggs are then placed in a dish that acts as a synthetic ovary to mature. This method significantly reduces the duration and number of injections, as well as their side effects.
Dr. Brian Levine, the practice director at CCRM, a fertility clinic in New York, explains that reducing hormone injections during the IVF process not only lessens discomfort but also reduces cost and makes it easier for some patients to access IVF.
"Fertilo could help reduce the intrinsic cost of IVF because someone would only need to take medication for a couple of days," Levine says. "If this product could stimulate someone for just three or four days, that could be the difference between providing access to care and no access to care, especially for patients who need to travel for the procedure."
The Gameto team spent years developing the technology through numerous tests to ensure that the eggs and eventual embryos would likely lead to healthy babies. Clinical trials of the technology have shown positive results, and Fertilo is now approved for use in six countries, including Australia, Mexico, Argentina, and Peru. The company is currently preparing to enter the markets in Japan and Paraguay soon.
As of now, there are approximately ten ongoing pregnancies that utilized Fertilo, including a set of twins, Radenkovic reports. Last week, Gameto announced a partnership with IVFAustralia to expand its offerings across that country. Radenkovic claims that these partnerships have helped generate some revenue for the startup, but she declined to disclose the exact amount.
In the United States, Gameto is currently preparing for Phase 3 clinical trials to commence in 2025, with the hope of eventually gaining FDA approval. Meanwhile, Radenkovic is working to persuade the industry that it's ready for disruption.
"We've accomplished so much in the last three years and have stayed laser-focused on execution," Radenkovic says. "I truly believe that exceptional science can be developed in exceptional companies. That's why I entered healthcare, as one can make a positive impact while also building a successful business."
Radenkovic, with her background in healthcare and her experience under 30, has demonstrated significant leadership in the field of IVF, co-founding Gameto to make the process less invasive and more accessible. Despite the challenges and complexities of the $25 billion global IVF market, Radenkovic and her team have developed Fertilo, a product that reduces the IVF injection process to just a few days, making it less uncomfortable and costly, and potentially providing access to care for those who need to travel for the procedure.
