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    This CEO Built a Business to Disrupt Reproduction

    By Adrienne Burke | Yahoo Small Business

    Helen Denise is CEO of HiLin Life Products and creator of KNOWHEN

    Helen Denise might be the first entrepreneur to turn an unplanned pregnancy into a business idea. After surviving a near-fatal ectopic pregnancy in 1999 at age 40, Denise, who was unaware that she was fertile at the time she conceived, set out to find a way to give women better insight into their own ovulation cycles.

    The Russian-born civil engineer had already made a fortune in global sales and marketing for a European cookware line. So, when she learned about a little known, highly accurate, and natural method for tracking fertility, she knew she had a winning product idea and dedicated herself to commercializing it.

    After more than a decade of R&D, testing, and clearing regulatory hurdles, and with the support of government grants and the Enterprise Development Center at the New Jersey Institute of Technology, Denise’s company, HiLin Life Products, launched the KNOWHEN saliva fertility monitor this month. It’s a lipstick-sized microscope that tells a user, based on a droplet of her spit, if she is ovulating.

    Considering the accolades HiLin Life Products has won already—including Company Most Likely to Succeed at the NJTC Venture Conference in 2010, First Prize in Health Care at Startupalooza in 2012, and the Sharkette Tank Winner Award at the Own It Ventures Conference in 2013—it’s a safe bet that the long gestation period will pay off.

    Denise calls her product “revolutionary,” although the science behind it is nearly 60 years old. In 1945, a European scientist named Papanicolaou discovered that when estrogen hormone levels increase during the ovulation stage of a woman’s menstrual cycle, fern-like crystals can be detected by microscope in her cervical mucus. Later, scientists realized that the same ferning pattern appears in saliva during ovulation.

    During ovulation, fern-shaped crystals can be seen in saliva under a microscope

    The detection method has been used in clinics, but the tiny, battery-lit KNOWHEN microscope allows women to easily test themselves at home or on the go in minutes. Denise says the $50 device, which can be reused indefinitely, will help women better understand, track, and predict their ovulation cycles, and “empower and guide them with their decision to become or not become pregnant.”

    If a mini ovulation microscope sounds familiar to you, that’s because this is not the first time Denise’s product has appeared on the market. She says she “made a lot of mistakes” when she got her original version under another brand name into big box stores several years ago. She held no patent, lacked marketing support, had an ill-defined business plan, and had too little cash to meet production demands. It was a flop. Denise claims that as many as 25 other saliva-based fertility monitors on the market are also based on her original product.

    This time around she holds the patent, is executing a more careful strategy, and is promoting KNOWHEN as the world’s only FDA approved, clinically proven test. Her brand also comes packaged with an educational CD and a smartphone app available through the iTunes store for keeping users’ personal data secure on the KNOWHEN server.

    HiLin Life’s in-house doctor, Hugh Melnick, founder and director of a New York in vitro fertilization center, says the kit can help with family planning as well as with educating women about their bodies and ovulation cycles. “The most significant advantage of the KNOWHEN system is that it detects the earliest time that the mucus can keep sperm alive,” he says. “If a woman is trying to get pregnant, this gives her the first indication that her egg is ripe and she better get busy.”

    Conversely, for women who are trying to avoid becoming pregnant, like Denise was at age 40, the kit provides a natural, inexpensive birth-control alternative. “I developed KNOWHEN to give women freedom of choice and peace of mind regarding their personal fertility management,” Denise says.

    Of course, other ovulation-monitoring methods exist. But Denise and Melnick argue that saliva monitoring is more reliable. Blood tests and basal body temperature tracking tell women when they have already ovulated, and urine strips that test for the presence of luteinizing hormones are less accurate, they say. Plus, urine-testing strips are costly and stressful for his patients to use, Melnick says. “The monitoring of the saliva ferning pattern is a very accurate and biological test that is very economical,” he says.

    KNOWHEN is already being shipped to distributors in India and a few other Southeast Asian countries. Until it arrives in U.S. stores later this summer, KNOWHEN can be ordered online.

    Estimating the U.S. market for her product, which is assembled in New Jersey and Pennsylvania, Denise points to statistics: 6.7 million women and 2 million married couples in the U.S. struggle with fertility issues, and at least half of all U.S. pregnancies are unplanned. “But I didn’t start this business because I wanted to make money. I had a lot of money,” Denise says. “My goal is to give millions of women peace of mind by helping them know their body. Knowing precisely when they are ovulating will change women’s lives.”

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