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Regulatory

Clinical Data Tells the Story: Commercializing the Kiva

In January 2008, Benvenue Medical released initial details of the Kiva Vertebral Compression Fracture (VCF) Treatment System in an announcement that the company had secured financing to develop the spinal implant technology. What took place in the following six years to March 2014, when the company announced Kiva’s full U.S. commercial launch, was a calculated plan to collect clinical data that would tell a compelling story, build interest in the product and secure a competitive advantage for the company. Robert Weigle, Chief Executive Officer of Benvenue Medical, described the approach.

“We decided from a company perspective that we’re all about clinical data, and every step of the way we felt we were going to take a different approach to the marketplace,” Weigle explained. “Rather than getting a 510(k) on a predicate device with no clinical data, we thought it was important to show the advantages to our system over the current gold standard of care, because no one had done that.”

Kiva is a flexible, cylindrical implant made from PEEK-OPTIMA that represents a departure from the standard balloon kyphoplasty approach. Three comparative studies with a total of more than 500 patients have demonstrated its effectiveness, most notably Kiva System as a Vertebral Augmentation Treatment—A Safety and Effectiveness Trial (KAST). Benvenue’s KAST trial was conducted under an Investigational Device Exemption granted by FDA.



The demand for clinical data for regulatory approval and surgeon acceptance continues to grow. Aside from just showing clinical advantages, though, Benvenue sought to arm itself with the data prior to product launch, enabling the company to leverage the benefits of a competitive strategy, randomized data at hand and attractive recruitment opportunities.

First was competitive strategy. “We believed that the clinical study would set a high bar within this space for anybody that wanted to follow us,” Weigle says. “They, too, would have to conduct a large, randomized study to seek FDA clearance in this space. This gave us not only a clinical advantage, but also a competitive advantage.”

Second, the randomized data sells the technology. “In this day and age, if a company is going to succeed, randomized data is the route you really have to go,” Weigle says. “As we launch into the marketplace, payors and hospital systems appreciate having data to review in their clinical decision making in terms of what new products to bring in. Most certainly, having a product that shows distinct advantages over the current standard of care is a story they want to hear.”

Third, Weigle says, this approach has driven high-caliber industry talent to seek open positions at Benvenue, which grew from 25 employees one year ago to more than 70 and growing today. “There really aren’t a lot of novel technologies out there that have great data in big markets,” Weigle says. “We’re hiring folks who have the same vision and drive as the original 25 people. It hasn’t been hard to attract the talent.”

Returning to the clinical data, three studies showed that Kiva met or exceeded balloon kyphoplasty performance in the reduction of pain and restoration of function in treating VCFs, improved kyphotic angle restoration, reduced the rate of cement extravasation and reduced the rate of adjacent fractures one year after treatment. (In the U.S. alone, 750,000 osteoporosis-related VCFs occur annually.)

Since its announcement in 2008, Benvenue has raised more than $75 million in Series B, C and D funding to support the development, clinical trials and commercialization of Kiva. Weigle described the journey as long but fruitful, as Benvenue works toward its goal of forming a standalone, profitable spine company that offers new technology and believes that clinical data rules the day.

“You need to embrace FDA’s need for clinical data right from the get-go, and you need to be collaborative with them,” Weigle says about creating a positive experience during regulatory approval. “The trap that many companies fall into is that they see FDA as an adversary. We never believed that was the way to go. While they held us to a very high standard, it actually served to benefit the company. Quite frankly, we’re better off for it. “