LUMINELLE, a medtech company based in North Carolina, has developed a suite of endoscopic tools that allow clinicians to perform visually guided gynecological procedures right from their office. At present, the majority of uterine biopsies taken to investigate the cause of abnormal uterine bleeding are taken blind, with no visual guidance at all. This leads to suboptimal outcomes, and the frequent need to repeat the biopsy procedure because the first attempt did not yield an adequate sample.
To address this, LUMINELLE has developed the LUMINELLE SUSTAINE system and the LUMINELLE Bx (Biopsy) device. These technologies are designed to allow clinicians to visualize the biopsy process without the need for extra tools. The system includes an on-board camera and light, and it automatically adjusts viewing parameters such as image focus, light intensity, and exposure to enhance image quality.
Here’s a short company video presenting the LUMINELLE Bx:
Medgadget had the opportunity to speak with Allison London Brown, CEO and co-founder of LUMINELLE, to get an overview of the technology.
Conn Hastings, Medgadget: Please give us an overview of uterine cancer, and its current prognosis and prevalence.
Allison London Brown, LUMINELLE: The latest data states that we have a growing prevalence of uterine cancer and other uterine disorders. In fact, since 2017, the prevalence of uterine cancer amongst African American women has increased 8% year-over-year and 5-6% in Hispanic women.
Now, uterine cancer is the fourth leading type of cancer in women and the sixth leading cause of death. And unfortunately, we have not changed how these disorders are diagnosed, despite an early warning sign of abnormal uterine bleeding (AUB) and the technology for diagnosis. Additionally, there is no blood test for uterine cancer – it must be diagnosed using actual tissue.
Medgadget: How are such cancers detected and diagnosed at present? How is this suboptimal?
Allison London Brown: Abnormal uterine bleeding (AUB) affects about one-third of women annually. It is the primary symptom and a great early warning sign of uterine disease and uterine cancer.
Diagnosis of the source of AUB is a significant clinical need, and can only be diagnosed using actual uterine tissue, not a blood test. A directed biopsy – visually guided, using an endoscope inserted into the uterus, through the vagina and cervix – is the standard of care to diagnose the underlying cause of AUB, yet over 70% of biopsies are completed blindly. A suction curette (straw-like device) is the most commonly used device primarily due to its convenience, cost, and ease of use. And this blind approach results in flawed outcomes.
A suction curette can only sample 4% of the uterus. A positive result is generally correct. However, if negative, the patient will require further evaluation. Unfortunately, according to recent data from lab groups, over 60% of all samples are inadequate – meaning that there is not enough tissue to even determine if there is disease present, and this results in additional costs, visits, and longer time to diagnose. Conversely, the use of a scope and instruments to take a biopsy sample, just like in a colonoscopy, produces an almost 100% accurate outcome (97% sensitivity and 100% specificity).
However, the cost and complexity of using a bulky endoscope system and large diameter scope can be prohibitive in the office setting. It takes extra staff and extra time, and certainly needs appropriate anesthesia for pain management. So, while physicians want to be able to accurately diagnose uterine disorders in the first visit, simply and cost-effectively, there is not the right technology solution that allows for this to easily occur in the office. Until now.
Medgadget: Please give us an overview of the LUMINELLE SUSTAINE System and its features.
Allison London Brown: The patented LUMINELLE SUSTAINE system offers a comprehensive endoscopic office solution that includes a reusable slim-line scope and the LUMINELLE Control Hub with smart-focus technology. The system allows physicians to perform uterine and urological procedures with superior HD visualization employing a novel algorithm that intelligently adjusts light intensity, exposure, and image focus to the specific cavity size – all with an integrated fluid flow system.
LUMINELLE SUSTAINE is customized to the procedure with a portfolio of interchangeable single-use operative and diagnostic RotoSheath including the LUMINELLE DTx (Operative), Dx (Diagnostic), and launching soon, the new LUMINELLE Bx (Biopsy) 360° RotoSheath platform. The LUMINELLE Bx allows a physician to see, diagnose and sample – all with one device, one cervical pass, and accurate diagnosis the first time.
Medgadget: How does the LUMINELLE Bx (Biopsy) work, and what are its advantages?
Allison London Brown: LUMINELLE Bx (Biopsy) device is our major foray into truly solving the challenges with endometrial cancer diagnosis. A directed biopsy (visually guided) is the standard of care to diagnose the source of AUB, yet over 70% of biopsies are completed blindly, using a suction straw-like device, primarily due to the challenges that physicians may face using biopsy instruments. Again, this blind approach results in flawed outcomes.
LUMINELLE Bx enables physicians to conduct a directed biopsy, while still employing the technique with which they are already familiar. This is the first and only device affording physicians an accurate method to simultaneously visualize and sample tissue without extra instruments (e.g., scissors, graspers). It has continuous flow and a small diameter that may minimize the anesthesia needed. The design allows a physician to actually see the tissue that they want to collect and watch while they are collecting it, plus allowing for visual confirmation that they did get adequate tissue. The LUMINELLE Bx allows a physician to see, diagnose and sample – all with one device, one cervical pass, and accurate diagnosis the first time.
Using our LUMINELLE System now with the simple LUMINELLE Bx RotoSheath allows physicians to meet today’s standard of care and provides a prompt diagnosis of cancerous tissues while replacing the over 6 million inaccurate procedures.
Medgadget: What inspired you to develop this system?
Allison London Brown: I have worked in women’s health since my early days at J&J, so over 25 yrs. I joke sometimes that I feel like I touched every single woman’s brand when I was there. But it was a great training ground and learning opportunity. It gave me the opportunity to learn about some of the greatest physicians out there, like Dr. Amy Garcia, Dr. Malcolm Munro, and Dr. David Robinson. And these relationships translated into our company today. In fact, Dr. Robinson is our chief medical officer, Dr. Garci is the chair of our medical advisory board, and Dr. Munro is on the advisory board. They were so gracious in their willingness to work with us in our startup.
I definitely think understanding the market is critical – what gynecologists are doing, what they are not doing, and what they want to do. Listening and observing, coupled with an understanding of epidemiology and recent data to see what “should be seen today” is really part of it.
However, what drives me is a deeper, underlying passion. I have felt since I was in college that there was a calling for me to do something significant to transform the lives of women. And it was just for a time such as this for us to understand what the true needs and gaps are. When you spend most of your time looking at the big glaring problems in health care and major surgical interventions, you can easily overlook the simplest but most important clinical gaps. I think it is truly the saying “can’t see the forest for the trees.” There are numerous visual puns that we can make about this.
And of course, it also took the right team to get to where we are. My chief operating officer and partner, Erich Dreyer, is such an important piece of our puzzle. He has created a beautiful, elegant device, which is complex in design but so simple for the physician to use. And most importantly, it gives us an easy solution to an early diagnosis for women.
Medgadget: How do you see this type of technology progressing in the future? Do you have any plans to expand the capabilities of the system further, or any new technologies in development?
Allison London Brown: We are always looking for new ways to improve the current standard of care. Expansion of the LUMINELLE portfolio is intended to meet the needs of smaller or rural offices, offices with reprocessing restrictions, and situations that need immediate care. We will continue to listen to physicians and understand the needs of the office setting as well as urgent care or even trauma situations. So, I anticipate that we will continue to develop innovative solutions by looking at them with a more focused lens.
And I would say our ultimate goal is to provide clinical solutions to problems that need visualization. While the endoscopic system is a great tool, the real magic is in the Rotosheath portfolio and the simplicity of our devices.
Company homepage: LUMINELLE…
