Gynesonics - 2014 Fierce 15

CEO: Chris Owen
Based: Redwood City, CA
Founded: 2005
Website: www.gynesonics.com

The scoop: The cancer scare over power morcellation has set off a scramble to find alternative methods of removing fibroids--such as Gynesonics' VizAblate. The handheld device combines ultrasound and radiofrequency ablation to destroy fibroids in a minimally invasive, incision-free procedure that leaves the abdominal space within the uterus intact, eliminating the risk of spreading uterine sarcoma.  

What makes Gynesonics Fierce: Gynesonics offers the only transcervically delivered treatment for noninvasive removal of intramural fibroids (those located within the uterine wall), Vice President Rich Lanigan said in an interview. Hysteroscopic myomectomy also uses the transcervical approach but cannot eliminate intramural fibroids, which Lanigan said account for 60% of all fibroids. Gynesonics aims to stop fibroids' main symptom, heavy menstrual bleeding.

A model of a procedure that treats uterine fibroids using the VizAblate--Courtesy of Gynesonics

VizAblate offers a much less invasive approach to both open surgery and less invasive but risky laparoscopic surgery requiring power morcellation. Lanigan said the procedure will require only a day's stay at the hospital in the U.S., with complete recovery occurring in zero to four days. The FDA estimates that power morcellation poses a 1-in-350 chance of upstaging the often-hidden cancer uterine sarcoma to potentially fatal levels. The FDA is considering banning power morcellators, and market leader Johnson & Johnson ($JNJ) recalled all its drill-like morcellators.     

"With all the publicity morcellation's gotten, that's really just no longer going to be an option," Lanigan predicted.

Gynesonics offers a high-tech alternative. "Our engineering team has advanced ultrasound into a place it's never been before, and that allows us to perform this incision-free procedure," Lanigan said. The 8-millimeter device includes an ultrasound probe and radiofrequency ablation tool. The device rests at the end of a rigid handle. It is delivered into the uterus via the cervix through a small opening created by a minor dilation procedure.

The imaging and ablation device comes with a smart targeting guide that provides a graphical overlay of the real-time ultrasound image of the fibroid, so that the surgeon can control the ablation zone and "aim" at the right spot. In addition, "we've got our own specific algorithm for temperature control to obtain consistently optimal ablation," Lanigan said.  

Last year Gynesonics closed on a $21 million Series D financing that included longtime investor Abingworth.

Meanwhile, industry bigwig Boston Scientific ($BSX) is also looking to capitalize on the power morcellation controversy with its May purchase of IoGyn. Unlike VizAblate, IoGyn's hysteroscopic device focuses on submucosal fibroids, according to Boston Scientific's website (though Boston Scientific told FierceMedicalDevices that some of those fibroids may be considered intramural as well).  

What to look for: Lanigan said Gynesonics is aiming for FDA clearance of the VizAblate system in the first half of 2018. Even though the device is aiming for a 510(k), it still requires a pivotal trial, explaining the lengthy time frame to commercialization. 

"As they [FDA] become aware of it and understand it, I think when they see the preliminary clinical results, they'll understand what a wonderful option it is to be able to provide women as clinicians are searching for alternatives to be able to treat these intramural fibroids," Lanigan said. The company is also developing a clinical evidence plan to prepare for the reimbursement challenge. 

Although Lanigan believes the procedure preserves fertility, Gynesonics will run a separate trial to prove that following FDA clearance, per the agency's specifications. 

Having received a CE mark for the updated version of the device this year, the immediate commercialization plans are focused on Europe. The vice president believes the market is promising because of the popularity of hysteroscopic myomectomy, which does not remove intramural fibroids. 

Lanigan hopes the European operations will allow the company to achieve profitability by the time the VizAblate receives FDA clearance. He's also aiming to sell the device in Asia, especially China. 

Finally, there is potential for Gynesonics' novel use of ultrasound within the uterus to be used in other applications, according to Lanigan: "We anticipate there will be other diagnostic applications for uterine therapies based upon this ultrasound platform." -- Varun Saxena (email | Twitter)

For more:
Gynesonics aims for $35M for minimally invasive uterine fibroid device
FDA prepares to weigh risks of uterine fibroid removal tool
Gynesonics draws in $21M Series D to advanced uterine fibroid ablation device

Gynesonics - 2014 Fierce 15
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