VertiFlex raises $27M on heels of PMA approval, reimbursement breakthroughs in 2015

VertiFlex's Superion Interspinous Spacer System--Courtesy of VertiFlex

Minimally invasive spinal startup VertiFlex has raised $26.8 million out of a proposed $45.7 million in a financing, according to an SEC filing. An official announcement is due out shortly, but NEA already has confirmed that a venture round in in the offing for the San Clemente, CA-based company and that it is leading that financing.

Last year was a big one for VertiFlex. In May, it got a PMA approval for its Superion Interspinous Spacer System to treat moderate lumbar spinal stenosis. It's designed to be the least invasive, motion-preserving device among interspinous spacers.

Then in November, the American Medical Association (AMA) defined CPT codes for two levels of insertion of interspinous spacers that are slated to be effective on Jan. 1, 2017. In addition, the Centers for Medicare and Medicaid Services (CMS) added the insertion of interspinous spacers to its list of approved procedures for ambulatory surgery centers with an effective date of Jan.1, 2016.

This latest financing will give VertiFlex some cash to continue to ramp up its marketing of Superion, as well as its Totalis Direct Decompression System, which is CE marked and FDA-cleared, for a procedure to perform minimally invasive direct decompressions of the lumbar spine.

"NEA is enthusiastic to lead this new round of financing for VertiFlex. With its Superion and Totalis product portfolio, the company is establishing itself as a leading partner for spine surgeons and spine interventionalists to treat their patients with spinal stenosis with best-in-class minimally invasive solutions for spine backed by rigorous clinical evidence," NEA Partner Justin Klein told FierceMedicalDevices. Klein is on the VertiFlex board, alongsider other investors from Thomas McNerney & Partners, Aberdare Ventures and Alta Partners.

The Superion Interspinous Spacer is delivered via a small incision in the patient's back using a proprietary access platform. The procedure can be performed under local anesthesia on an outpatient basis and closed with only one suture; it can reduce pressure on the verves that cause pain for lumbar spinal stenosis patients.

The PMA approval for Superion was based on a 470-patient pivotal trial. The system was CE marked in 2007.

"Superion has proven to be a safe, effective and least invasive solution for the treatment of spinal stenosis, in a mostly Medicare-aged population," said VertiFlex President and CEO Earl Fender in a statement at the time of its FDA approval. "Countless numbers of patients in the United States will now benefit from this important technological advancement."

Fender has led the startup since 2008; prior to that he was president of Johnson & Johnson's ($JNJ) DePuy Spine business. He held a series of executive spots there over a 10-year span.

- here is the SEC filing