Today, a new treatment launches for osteoporosis patients worried about developing severe spine curvature.
Spine tech startup Benvenue Medical, based in Santa Clara, Calif., announced the full commercial launch of its Kiva VCF treatment at the Society for Interventional Radiology (SIR) Annual Scientific Meeting. The medical device tech is implant-based and intended for use in patients with vertebral compression fractures. Patients with osteoporosis are at risk for these types of fractures, which, if left untreated, can be painful and cause severe curvature of the spine.
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The device is a cylindrical medical-grade polymer implant that’s passed over a wire into the vertebra, and the coils stack upon themselves, CEO Robert Weigle said. “Therefore you get a very predictable implant every time.”
Watch how it works in the video above.
Benvenue also announced results from a randomized trial that put its treatment on par with the current standard of care: balloon kyphoplasty.
Medtronic (MDT) is a leader in this space. Its Kyphon uses “orthopaedic balloons to restore vertebral body height and correct angular deformity” then bone cement is inserted in the resulting cavity, according to the company’s website.
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“When we developed this system the reason we developed it was there were unmet needs in this space, primarily around reducing the effects of adjacent fractures. . . to keep some of these patients at least off the slippery slope of future fractures,” Weigle said.
The trial (KAST) results discussed at SIR compared the product’s outcomes to balloon kyphoplasty’s. Here are the highlights, according to a Benvenue company statement:
- Both provided “essentially the same amount of pain relief and improvement in daily function.”
- Biggest of all: “… the implant patients were less likely to suffer a fracture in adjacent vertebra. This latter finding is despite the fact that the 153 patients who received the implant had higher risk predictors for future fractures.”
Results like these set the company up to take on a big chunk of the spine market.
Though the device does have a learning curve, Weigle said that curve is “very short,” as this treatment uses the same access and imaging tech as kyphoplasty.
Benvenue is already at work on another implant solution for spinal issues, which Weigle said he hopes to have cleared by year’s end. The company will submit its next product, the Luna treatment system, for FDA 510(k) clearance later this spring, Weigle said. Luna is a treatment for degenerative disc disease.
Though the company’s old for a startup — about a decade old, Weigle has experience working at startups with novel treatments that take longer to develop. He came to Benvenue from TherOx. And, after all these years, the company’s still venture-backed.
Current investors include DeNovo Ventures, Domain Associates, Technology Partners and Versant Ventures.
Weigle said Benvenue is “blessed to be fully funded to the point where we don’t need to raise money ever again.” (Must be nice, huh?) And added the company will be announcing “very significant” financing in the near future.
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