Key points:
- Kimberly Langdon’s own battle with a medical condition inspired her to develop a natural, drug-free device to treat vaginal infections effectively.
- Her company, Coologics, uses patented cooling technology to treat infections faster, safer, and more effectively than traditional medicines.
- Kimberly built a powerhouse team of experts, including specialists in intellectual property and medical practice, to bring her vision to life.
Kimberly Langdon, M.D., the founder and inventor of Coologics, is a true innovator. Her work is not just about solving problems but creating new ways to think about them. Like Santiago in The Alchemist, who followed the signs to find his treasure, Langdon followed her instincts to challenge old ideas and find better solutions. Her journey from being an Obstetrician and Gynecologist to a medical device inventor is a story of purpose, persistence, and the power of simplicity.
The turning point in her life didn’t happen in a medical lab or a corporate boardroom. It happened at home when she was dealing with a condition that regular treatments couldn’t fix. Instead of relying on standard medicines, she looked for an answer based on how the body naturally works. This idea led to Coologics and its flagship product: a first-of-its-kind vaginal device that addresses infections faster and more effectively than traditional drugs.
This story is about how Kimberly used her years of medical knowledge, strong will, and clear vision to change women’s healthcare. From creating safe, drug-free treatments to building a team of people who share her goals, Kimberly shows us what is possible when science and determination come together.
The USA Leaders: What inspired you to pursue a career in medicine, particularly obstetrics and gynecology?
Kimberly: Interestingly, I initially wanted to become a veterinarian. However, I discovered that gaining admission to veterinary school required experience with large animals, which I didn’t have. While studying on a swimming scholarship at the University of Cincinnati, I began to reassess my career path.
After earning my degree, I worked for an airline but felt unfulfilled. I wanted to pursue something more meaningful. Through self-reflection, mentorship, and exploration, I realized that medicine was my true calling. Specifically, I was drawn to obstetrics and gynecology because of my natural interest in women’s health.
What appealed to me most about OB/GYN was its multifaceted nature. It’s a field where you deliver babies, perform surgeries, and offer preventative and educational care during office visits. That combination of dynamic responsibilities and the opportunity to impact lives on multiple levels solidified my decision.
Each step in my journey—from exploring different careers to finding mentors—helped shape my path, leading me to where I am today. It’s been a rewarding experience that continues to inspire me daily.
The USA Leaders: Briefly share the origin story of Coologics. What was the pivotal moment that sparked the idea for Coologics?
Kimberly: The idea came during a personal experience with an acute onset of a yeast infection at home when I had no medication available. I decided to create a specialized cold pack, inspired by what I often recommended to my patients. But instead of relying on the usual frozen peas or corn, I took it a step further. The specific details of how I developed the cold pack are top secret, but it was a game-changer for me—it eliminated the symptoms, and I never needed medication afterward.
That experience motivated me to delve deeper into understanding why it worked, how it worked, and how I could develop it into a device that not only relieved symptoms but also addressed the infection itself.
The process wasn’t easy. My first challenge was deciding what materials to use and figuring out how to manufacture the device. I went through six prototypes to perfect their size, aesthetics, functionality, and ease of use. Each iteration brought me closer to creating a product that could truly make a difference for others facing similar challenges.
It’s been an incredible journey, combining medical insight with innovation to create something both practical and transformative.
The USA Leaders: Could you provide a brief overview of your innovative product, VLISSE? How it works?
Kimberly: VLISSE is built on patented, controlled-cooling technology designed to treat localized infections effectively and safely. Our first product is a disposable vaginal device that is used for 30 minutes, bringing tissues to a safe cooling temperature while the woman sits or lies down. This innovative method addresses the infection and symptoms simultaneously, offering faster relief and better outcomes.
What sets VLISSE apart is its multifaceted action. The device cures infections by returning fungal hyphae—the root cause of yeast infections—to a dormant state while killing the fungus outright. It also normalizes pH levels by encouraging lactobacillus growth, which thrives in cooler temperatures. Additionally, it reduces biofilms through three mechanisms, leading to faster recovery and a significantly lower recurrence rate.
In comparison, traditional oral drugs, which were once nearly 100% effective, now only offer a 60-75% success rate due to rising drug resistance. These drugs come with systemic risks, side effects, and delayed symptom relief. Physicians often hesitate to prescribe them, as yeast infections are localized conditions better suited for topical treatments. However, topical creams have become less effective over time and often cause severe side effects.
VLISSE is a game-changer, delivering results faster than drugs—by a factor of nearly 100-200%—and with nearly 100% effectiveness against both yeast and bacterial infections. Unlike drugs that rely on a single mechanism of action and are prone to resistance, VLISSE uses four mechanisms, making it a robust and reliable solution.
Additionally, our future devices for conditions like fungal nail infections and diaper rash will have their own specific configurations.
The USA Leaders: The development of VLISSE marks a breakthrough in healthcare. Can you walk us through the manufacturing process and the innovative thinking behind its creation?
Kimberly: VLISSE’s design and manufacturing are rooted in proven technologies, using materials commonly found in fluid-filled baby teethers, sports mouthguards, and teeth-whitening trays. The materials and manufacturing process are proprietary and rely on multiple steps to ensure safety and efficacy.
The real breakthrough, however, was rethinking the conventional reliance on drugs as the only solution. Sometimes, the simplest answer is the most effective one. Cooling has been used for over a century to alleviate symptoms like itching, burning, swelling, and pain—commonly applied to injuries caused by physical trauma. However, infections, too, cause biochemical changes that damage tissue, primarily through immune responses. Cooling directly addresses this type of tissue damage, making it a powerful yet underutilized approach.
By applying controlled cooling to treat infections, we’re leveraging a natural, side-effect-free solution that addresses both symptoms and the root cause. This shift in perspective—moving beyond medications to embrace simpler, safer alternatives—has been key to VLISSE’s success.
The USA Leaders: Building a successful venture often involves assembling the right team. How did you approach finding the experts who became pivotal to Coologics’s journey?
Kimberly: One of my primary responsibilities has been identifying and collaborating with the right experts to bring this vision to life. Early on, I knew that securing strong intellectual property protection was essential. That led me to Dale Hunt, Ph.D., a molecular biologist, and an exceptionally talented IP attorney. Dale not only believed in the novelty of VLISSE but also had the expertise to articulate its mechanism of action. His confidence in the product’s potential was so strong that he handled all the patent work in exchange for equity, which speaks volumes about his belief in our mission.
As the journey progressed, I connected with Dr. Nicole Williams, an OB/GYN who began using VLISSE in her practice. The outstanding results she observed with her patients were transformative. Her enthusiasm for the product and its impact motivated her to join us as Chief Medical Officer.
Bringing these experts on board has been instrumental in shaping VLISSE into the groundbreaking solution it is today. Their deep expertise and shared passion for innovation have made all the difference in our journey.
The USA Leaders: Navigating regulatory approval is critical for medical innovations. How has your experience with the FDA shaped Coologics’s development journey?
Kimberly: Our interactions with the FDA have been constructive and insightful. They’ve guided us toward the De Novo pathway since there isn’t a predicate device. This pathway is appropriate for novel medical devices that are low to moderate risk, similar to intravaginal devices like tampons and menstrual cups, which are typically classified as Class II.
To meet the requirements, we need to conduct just one clinical trial to demonstrate safety and efficacy. Encouragingly, we already have promising data. Over 35 women have successfully used VLISSE for yeast, bacterial, or combined vaginal infections, and we’ve also achieved positive results from mouse studies.
These milestones reinforce our confidence in the product’s potential to meet regulatory standards and address a significant unmet need in women’s health. The journey has been challenging but incredibly rewarding as we move closer to making this innovative solution widely available.
The USA Leaders: What were some of the challenges you faced while developing your product, and how did you overcome them?
Kimberly: One of the biggest challenges was convincing engineers, mostly male, that a simple solution was often the best one. There was a tendency to overcomplicate the design, but I knew from my understanding of female anatomy that a simpler approach would be more effective.
I had to be firm and insist on my vision, even when faced with resistance. It was important to trust my knowledge and experience and not let unnecessary design changes hinder the product’s potential.
The USA Leaders: What’s the most significant impact you hope Coologics will have on women’s health?
Kimberly: The past few years have been both challenging and incredibly rewarding. Bringing VLISSE to market is my greatest achievement, as it has the potential to alleviate significant suffering for countless women and their unborn children.
While yeast infections may seem like a minor inconvenience to some, they can have serious consequences. Both bacterial and yeast infections, along with associated inflammation, are linked to premature births and premature membrane rupture.
VLISSE offers a unique solution that targets both types of infections and addresses inflammation. Unlike traditional treatments, it can reduce the risk of preterm birth by up to 66%. Additionally, by targeting biofilms and pH imbalances, VLISSE helps prevent recurrent infections.
The USA Leaders: How have you managed to balance your entrepreneurial pursuits with your personal life?
Kimberly: After 19 years in clinical practice, I made the decision to retire and dedicate myself fully to Coologics. It was a pivotal change that allowed me the time and focus to drive the research, networking, and trial-and-error processes required for this innovation. The deep understanding of the disease, the intricate anatomy, and the patient’s perspective were crucial to this innovation. No amount of money could have replaced my firsthand knowledge and passion.
This transition also gave me the opportunity to be present for my children as they navigated college and beyond. Balancing personal and professional fulfillment has been a rewarding aspect of my journey.
When I’m not working, I enjoy spending time with my kids, reading, cooking, traveling, hiking, and swimming. I also have a soft spot for animals.
The USA Leaders: What are your next steps for bringing your groundbreaking technology to market?
Kimberly: Our immediate goal is to bring VLISSE to market as quickly as possible. We’re currently in discussions with several companies that specialize in women’s and infant health. These companies have expressed significant interest in our technology, as it addresses three major areas of concern in OB/GYN. We’re confident that we’ll find the right partner to help us bring this innovative product to market and improve the lives of countless women.
Quotes
“Sometimes, the simplest answer is the most effective one.”
“Innovation isn’t just about solving problems—it’s about rethinking them entirely to find better, smarter solutions.”
Also Read: Innovators in Medical Devices: Shaping the Future of Healthcare in 2025
