
28 Nov Ep 28 Lessons Learned in Innovation & Launching Products
Uterine cancer rates in the United States are rising. Yet uterine exams rely on expensive, difficult, and painful procedures developed decades ago. North Carolina-based Luminelle has developed an office-based alternative that could revolutionize women’s health.
In Episode #28 of the MedTech Speed to Data podcast, Andy Rogers of Key Tech talks with Allison London Brown, Luminelle’s Chief Executive Officer, about her company’s innovation journey.
Need to know
According to American Cancer Society reports, uterine cancer is growing 2% a year while overall cancer rates are going down.
African American and Hispanic women are more likely to die of uterine cancer.
Endoscopes provide live video during colonoscopies, guiding physician observations, sample collection, and lesion removal.
Uterine diagnostic and treatment procedures are simpler but provide no visual feedback.
The nitty-gritty
While developing other office-based medical technologies, Luminelle’s team wondered why endoscopy is not standard practice in gynecology. With existing methods, Brown explained, “there’s a camera helping to guide the physician to know where to look and what samples to take.”
However, gynecologists use different equipment to collect samples. “They use this very simple device that’s like a straw with a suction bulb or a syringe, and you have no idea that the straw is going where you think it’s going.”
Finding little data in the literature, Brown’s team interviewed physicians, learning that standard endoscopy is too expensive and complicated to perform in the office. Furthermore, an endoscope’s large diameter places painful pressure on the patient’s cervix, requiring anesthesia and an extended outpatient procedure.
Feedback from laboratory groups, however, revealed something else. “They would tell us that between fifty to seventy percent of their lab samples were inadequate.”
“We saw this insight,” Brown said, “the opportunity and where the market could go and that nobody was playing in that space… and just pivoted.”
Data that made the difference
Luminelle developed its DTx Hysteroscopy System, comprising an easily maneuverable 2-millimeter endoscope and a processor, to transform uterine exams into 10-minute office-based procedures. The initial system cost is half what a clinic would spend on an ultrasound system with recurring costs for thin single-use sheaths.
“We have a range of rotosheaths that slide over the scope itself and allow people to do a variety of things. It controls the fluid. It allows you to do operative procedures. It allows you to deliver drugs. And then the Luminelle BX takes that same kind of idea of a sampling tool and incorporates it into our sheath.”
Given the millions of uterine exams performed every year in the United States alone, the market potential is enormous. Luminelle’s challenge is convincing doctors to change. Market research data is essential to meeting this challenge. Brown’s company analyzes multiple sources to understand the psychographics of gynecologist offices in specific territories.
“It’s a smarter and more cost-effective play, especially for a startup,” Brown said. Clinical equipment sales ordinarily require a three to six-month cycle. “Our goal is to really get that down so a rep never goes into an office until the physician is ready for a demo.”
Watch the video below to learn more about Luminelle’s solution and Brown’s approach to startup leadership and mentorship.
The American Cancer Society (cancer.org) reports 2% annual increases in uterine cancer rates.
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