Irvine-based Viseon Inc., a year-old maker of minimally invasive spine surgery technology, has received regulatory approval of its first product.
The company said last month that it received Food and Drug Administration 510(k) clearance for the Voyant System for Minimally Invasive Spine Surgery.
The device features a reusable controller and a single-use, disposable retractor. It provides enhanced surgical site imaging, and allows surgeons to adjust intraoperative depth of focus.
The product also has a proprietary high-definition imaging sensor and illumination technology.
The 510(k) clearance means the device can be marketed as “substantially equivalent” in safety and effectiveness to an already legally marketed device. Viseon officials say they believe its product represents a clear improvement over others on the market used by spinal surgeons.
“We believe the primary factor contributing to spine surgeons’ slow adoption of minimally invasive spine surgery has been inconsistent outcomes driven by the limited or lack of direct access to and visibility of the surgical anatomy,” Chief Executive Jeffrey Valko said in a statement.
Surgical microscopes and other types of glass-mounted magnifiers are traditionally used in the procedures. Dr. John Liu, professor of clinical neurological surgery at the Keck School of Medicine at the University of Southern California, said Viseon’s device eliminates “ergonomic consequences and multiple scope repositioning maneuvers and refocusing.”
The privately held company closed a $5 million Series A financing round about a year ago. Lead investors in the round included Irvine-based HBM MedFocus, Invus Opportunities Fund and affiliates of Wexford Capital LP.
Viseon was spun out of Irvine-based medical device company Rebound Therapeutics Corp., which raised $16.5 million last year in a Series B financing from the same three firms that invested in Viseon.
Valko also serves as chief executive of Rebound Therapeutics, which was founded in 2015 and makes a product similar to Viseon. He previously served as chief executive of Irvine-based device maker Reverse Medical Corp., which makes vascular-related devices.
Reverse Medical was acquired in 2014 by Covidien PLC on undisclosed terms.
SETing the Standard
Masimo Corp. (Nasdaq: MASI) is making new strides in pediatric care.
It announced last month that it received Food and Drug Administration clearance of its RD SET sensors, which measure oxygen in the blood.
The sensors boast improved accuracy and can be used for patients who weigh less than 6 ½ pounds.
The latest FDA approvals represent “continued innovation in our foundational SET pulse oximetry,” Chief Executive Joe Kiani said in a statement.
“Even though no one has been able to create pulse oximetry that outperforms SET, we have not allowed that to stop us from continuing our pursuit of perfecting the technology.”
The Irvine-based noninvasive patient monitoring device maker received FDA clearance this year to use its RAS-45 acoustic respiration sensor for infants and neonatal patients.
The company has a $6.1 billion market cap.
Urovant Study
The clinical pipeline looks promising for Irvine-based drugmaker Urovant Sciences Ltd. (Nasdaq: UROV).
Urovant, which focuses on developing therapies for urologic conditions, recently announced enrollment has been completed for an international third-phase trial of lead drug candidate vibegron for adults with overactive bladder.
The study of 1,530 patients is randomized across 216 study sites.
The company said it hopes to get data back on the trial in March.
It licensed global rights for development and commercialization of the oral drug, excluding Japan and certain Asian territories.
The drug developer is a subsidiary of Basel, Switzerland-based Roivant Sciences Ltd., which owns a family of clinical-stage drug companies, or “vants,” developing therapies in other areas, including women’s health and neurology.
Urovant went public in September, raising nearly $140 million. Its shares are off more than 40% since the IPO for a market value of about $225 million.
