Vertiflex closed a $40 million financing round, which will fund the commercial expansion of its minimally invasive spinal stenosis implant in the U.S.
The Superion Indirect Decompression System is indicated for the treatment of moderate lumbar spinal stenosis, or the narrowing of the open spaces within the lower spine. Spinal stenosis can put pressure on the spinal cord, causing pain, numbness, muscle weakness or problems with bladder and bowel control, according to the Mayo Clinic.
The system earned PMA approval in May 2015 as the Superion Interspinous Spacer System. The FDA nod came after a 470-patient pivotal trial and a 391-patient trial. Designed to decrease pressure on the affected nerves, the implant is delivered through a small incision in the patient’s back.
“Vertiflex has seen tremendous early success in the commercialization of the Superion System,” said Vertiflex CEO Earl Fender in a statement. “With favorable long-term clinical outcomes, a new Category I AMA CPT code and broad reimbursement in place, adoption of Superion has continued at a rapid and steady pace.”
New investors Endeavour Vision and H.I.G. BioHealth Partners led the round, with participation from existing backers New Enterprise Associates, Alta Partners and Thomas, McNerney & Partners.
In January 2016, Vertiflex raised $26.8 million of a proposed $45.7 million in a financing. The company also markets the Totalis Direct Decompression System, a suite of instruments to perform minimally invasive procedures for the direct decompression of the lumbar spine.