Boston Scientific has moved to acquire Vertiflex, maker of a minimally invasive vertebrae spacer for treating lumbar stenosis, or the painful narrowing of the open spaces within the lower spinal column.
The deal includes $465 million upfront plus a commitment to additional commercial milestone payments over the next three years to the private, Carlsbad, California-based company.
Vertiflex said it expects to reach at least $60 million in sales this year for its Superion Indirect Decompression System. It estimates that as many as 6 million people in the U.S. may be suffering from the condition, which can pinch nearby nerves and cause lower back and leg pain, numbness and trouble walking.
Boston Scientific, meanwhile, sees the differentiated therapy as slotting in nicely alongside its other procedures for chronic pain in the area and as another option for physicians who perform spinal cord stimulation and radiofrequency ablation.
"The acquisition of Vertiflex and the Superion System will further our category leadership strategy by expanding the breadth of our pain management product offerings," Maulik Nanavaty, president of Boston Scientific’s neuromodulation division, said in a statement.
The system was first approved by the FDA in 2015 for patients with moderate degenerative lumbar spinal stenosis that have not responded positively to firstline therapies such as oral pain medication and steroid injections, but do not yet have severe enough symptoms to require spinal fusion or a laminectomy. The outpatient procedure can be performed under local anesthesia, with a small incision closed with only one suture.
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In the years since, Vertiflex has raised tens of millions in venture capital financing to fund its marketing and commercialization efforts—over $170 million in total, according to Crunchbase—including from New Enterprise Associates, H.I.G. BioHealth Partners and Endeavour Vision.
"Five-year clinical data and real-world experience with the Superion System demonstrate that this minimally invasive and reversable procedure—done without destabilizing the spine—can offer patients safe, long-term pain relief with a relatively rapid recovery time," said Vertiflex President and CEO Earl Fender, who previously served as president of Johnson & Johnson’s DePuy spine business.
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"We are proud of the clinical and commercial successes we've been able to achieve and look forward to continued adoption of the therapy with the global resources and clinical expertise of the Boston Scientific pain management franchise,” Fender added.
Back in 2013, Vertiflex offloaded its noncore spinal implant assets to Stryker for an undisclosed price to raise money to fund the early clinical development of what became its Superion system.
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Its pivotal randomized trial involved 470 patients at 31 U.S. centers, with half receiving Medtronic's X-Stop Spacer interspinous implant. Superion met its primary endpoint, demonstrating a noninferior success rate of 52.7% after two years compared to the X-Stop Spacer’s 50.2%.