VertiFlex, Inc. has raised nearly $27 million for its FDA-approved (May 2015) Superion Interspinous Spacer (ISS).
According to a Security and Exchange Commission regulatory filing, the funding consists of $10.5 million in new cash, a $16.2 million debt conversion and another $105, 000 in warrants. Eight unnamed investors participated in the funding.
The Superion Spacer, according to the company, is for the treatment of patients with lumbar spinal stenosis. The device is designed to achieve indirect spinal decompression for patients suffering from neurogenic intermittent claudication due to moderate lumbar spinal stenosis. It is implanted minimally invasively through a cannula designed to be less traumatic to the patient. It can be implanted under general or local anesthesia.
The company submitted the following “Indications for Use” in its PMA (premarket approval) application:
Treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing.
Patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain. The Superion ISS may be implanted at one or two adjacent lumbar (L) levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5.
After the FDA approval, the company’s co-Medical Director, Nick Shamie, M.D., Professor & Chief, UCLA Orthopaedic Spine Surgery, said, “As an early adopter of interspinous spacers, they have provided tremendous improvement for my patients suffering from lumbar stenosis. As a next-generation technology, Superion offers the potential for even greater clinical benefit, with the least invasive indirect decompression possible, and the ability for patients to avoid traditional open spine surgery.”
The company said it intended to follow the IDE (investigational device exemption) subjects for up to five years.
I was recently denied coverage by my Insurance provider. The reasons given were that the procedure is considered Investigational and that I’m had no medical value. I am going to appeal there decision and would like to know if you have any suggestions that I may use in writing my appeal? Your help would be greatly appreciated. My provider is Blue Cross. Thanks.