Dixon woman lands FDA approval for fertility kit

PherDal is an over-the-counter, sterile, at-home insemination kit.

A PherDal kit, for at-home artificial insemination, is pictured.

DIXON – If you had told Jennifer Hintzsche 10 years ago what she would live through to get to today, she wouldn’t believe you.

A 5-year struggle with infertility? No.

Becoming the mother of two children after that struggle? Nope.

Developing an infertility kit that helped her become a mom, landing two patents and learning she had been granted FDA approval to sell the kit? Never saw it coming.

On Friday, just a day after being notified of the FDA’s nod that her PherDal kit – an over-the-counter, sterile, at-home insemination kit – had met all requirements and now can be sold to the public, she said she was feeling everything that comes with attaining a goal after years of working toward it: joy, relief and excitement with a hint of disbelief.

“I can’t even believe I’m sitting here right now and able to say we are FDA approved,” she said about her PherDal kits, which are made up of three sterile syringes, collector jars and instructions to help infertile couples; the kits also benefit those in the LGBTQ community who want to become pregnant, couples with male factor infertility, and women who are single mothers by choice, she said.

Hintzsche, a native of Hinckley, had always dreamed of a career in biology, studied it, and spent much of her early adulthood earning the degrees that led up to getting her doctorate. But when it came time to transition to family life, she faced another challenge. She and husband, Ryan Westphal, were among the 1 out of every 6 couples who struggle with infertility.

The couple had intended on starting a family right after they got married in 2016. But eight months after her wedding, and with no success, she visited her doctor to find out what was going on. She would have to wait another four months before being referred for testing.

At the time, she was 32 years old and nervous that time was running out.

When the time arrived to be tested, Jennifer and her husband learned that everything was normal and she was diagnosed with unexplained infertility. Their frustration grew when they found out her insurance would no longer cover visits to the specialists. Most insurances will cover up to such a diagnosis, but not past that. Any treatment for it afterward doesn’t get covered, leading to more out-of-pocket costs and more financial stress, all because of the unknown.

She looked into intrauterine insemination and in vitro fertilization, but soon happened upon another idea. Armed with the same determination that helped her earn a Ph.D in biology, she dove in and started doing her own research and development. She learned about intracervical insemination, a more affordable method of artificial insemination. Through her job, she was able to order lab materials and created her own insemination kit. She hoped the device would help do the job that nature wouldn’t, and just before the calendar rolled into 2018, the Westphals were ready to try it out. The first month came and went with no success. The second time was different.

By month 2 of using it, she was pregnant. The couple became parents to their daughter Lois, now 5 years old. A little over a year later she became pregnant with their son, Zack, this time without the kit.

In the years since Lois’ birth, Jennifer met other women who were dealing with infertility. When she told them her story, they also asked for a kit from her, she said. As time passed, Jennifer decided to share their success by putting PherDal on the market. She ordered 200 kits to be made, and she and Ryan put them together, made it available on their website, and marketed it chiefly among an online community of other women facing similar challenges. They sold out in 90 days. While Lois was the first PherDal baby, another 34 PherDal babies have been born since she entered the world.

Instead of ordering more right away, the Westphals wanted to invest in getting the all-clear from the U.S. Food and Drug Administration. A crowd-funding campaign brought in over $630,000, a show of investment that Jennifer said validated her idea to go after FDA approval. The money was spent on the rigorous testing process that confirmed the product’s safety and ability to remain sterile throughout the manufacturing and transportation processes – about 20 tests in all.

The first PherDal kits were sold when the kit was FDA-registered; while awaiting FDA clearance, they were unable to sell or restock their kits. Now that she is FDA-approved, she can immediately start selling kits. With the manufacturing process ready to go, pre-orders at $199 per kit are now being taken through the website, PherDal.com.

“I never guessed my life would be here, ever,” she said. “Never wanted to start a medical device company, never thought I would. I never knew the joy, the satisfaction of helping other people that have been in my situation.”

And for Jennifer, that’s what it’s all about.

“I thought that if I could help get one person pregnant, I will have fulfilled this need I had,” Jennifer said.

Cody Cutter contributed to this article.

Charlene Bielema

Charlene Bielema

Charlene Bielema is the editor of Sauk Valley Media.