On the heels of their recent CE Mark announcement, we spoke with Mirabilis Medical’s CEO, Jens U. Quistgahttps://www.fusfoundation.org/news/1896-mirabilis-medica-awarded-ce-mark-for-uterine-fibroidsard, to learn more about the company, its device, and what’s on the horizon. “This technology has the promise of helping a large number of women worldwide, and I’m glad to be involved with it,” says Quistgaard.
Q & A with Jens U. Quistgaard, CEO of Mirabilis Medical
Q. How did you get involved in Mirabilis?
I have spent my entire career in medical ultrasound, beginning at ATL ultrasound in the early 1990s. I started as an engineer, became Chief Scientist, and then transitioned to the business side. After ATL, I was one of the founding employees of SonoSite, starting as VP of Product Development and Operations and then moving to Chief Product and Marketing Officer. I then became CEO of LipoSonix, an aesthetics company, which was successful, and we ultimately sold to Medicis Pharmaceutical Corporation. After taking some time off, a Mirabilis investor asked me to join their Board of Directors. I was Chairman for about a year leading fundraising efforts, and I then transitioned to the CEO role.
Q. In general, what is the current status of your company?
We are an early commercial stage company. We expect to start both European commercial operations and our US pivotal study this year.
Q. How many years has your treatment platform been in development, and what are its origins? Does it have a name yet?
The original idea came from a group at the University of Washington. The company was founded in 2004 and then funded in 2006. Mirabilis is the name for the company, the procedure, and the device.
Q. What are some of the technical challenges your group has to overcome to develop a fully noninvasive system?
The company originally wanted to use a transvaginal approach for treatment, but it was too challenging from a use standpoint. Shifting to the trans-abdominal approach to allow better access to more types of fibroids was a huge undertaking, but ultimately the right decision. The addition of a robotic system to dramatically improve usability was also quite challenging, but we believe that it contributes a lot toward a practical procedure.
Q. What other challenges will you have to tackle moving forward?
We believe the technology is solid, so the upcoming challenges are largely related to commercial launch, regulatory matters, and reimbursement.
Q. Given that there are already multiple focused ultrasound companies with commercial devices for uterine fibroids, what are the benefits of your technology over them? What are the benefits of being ultrasound guided?
Key advantages in my opinion are speed of treatment, relatively low cost, and ease of use. At the 2014 ISTU meeting, we highlighted that we are able to treat significant volumes relatively quickly. Ultrasound guidance allows for a smaller, less expensive device. Robotic assistance and substantial attention to the user interface contribute to ease of use.
Q. Have you learned any lessons from watching the experience of the other companies involved in using focused ultrasound for fibroids?
Sure. The first lesson is that it works. Others have done great work in pushing this technology forward and showing that it can be an effective intervention in the treatment of fibroids. So we hope to make this a more commonplace procedure than it already is.
Q. Tell us about your company structure: ownership, lead executives, and their roles.
Mirabilis is a venture funded company – our main investors are GSR Ventures and Charter Life Sciences. Dr. Michael Lau is the gynecologist who founded the company. He has been involved since the very beginning and is currently Chief Medical Officer. Pat Martin is our VP of Clinical and Regulatory Affairs, and Greg Darlington is our VP of Product Development and Operations.
Q. Are you looking toward treating any other women’s health conditions? Other diseases?
Yes, we are certainly considering it, but at this point our IDE and CE Mark are limited to treatment of uterine fibroids, and that is what we are focusing on.
Q. Does your shell ablation method create an infarct pain sensation like with uterine artery embolization (UAE)?
Not in our experience. We are not targeting the uterine artery, so the mechanism of action of the Mirabilis System is very different from that of UAE. UAE treats the fibroid by occluding the uterine artery, which can result in ischemia of the myometrium. Mirabilis can be much more localized, and treatment is targeted to the fibroid, which tends to be more poorly innervated than the surrounding myometrium.
Q. Do you have to be selective with which patients or types and size of fibroids that you treat?
As with any other medical device, treatment with the Mirabilis System is not for every patient. There are indications and contraindications in the product labeling and in the study protocol. In the pilot study, we treated quite a range of fibroids, up to 7+ cm. The inclusion criteria included women aged 18 to 55 who were seeking relief from fibroid symptoms. We excluded patients with scars or foreign objects in the treatment path.
Q. Final thoughts?
This is an exciting area to work in. This technology has the promise of helping a large number of women worldwide, and I’m glad to be involved with it.