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Zoning In with Robert Weigle

Clinical data continues to be essential for companies to prove a new device’s technological advantages upon market entry. Benvenue Medical, founded in 2004 in an effort to develop an alternative to balloon kyphoplasty, embraced that approach in its full U.S. commercial launch of Kiva Vertebral Compression Fracture (VCF) Treatment System in March of this year. In introducing Kiva, a flexible, cylindrical implant made from PEEK-OPTIMA, Benvenue armed itself with three comparative studies with a total of more than 500 patients to demonstrate its effectiveness. Most notably was the Kiva System as a Vertebral Augmentation Treatment—A Safety and Effectiveness Trial (KAST), which was conducted under an Investigational Device Exemption granted by FDA.

BONEZONE spoke with Robert Weigle, Chief Executive Officer of Benvenue Medical, who described the company’s approach.

BONEZONE: Shed some light, please, on the road to commercializing Kiva.

Robert Weigle: You probably won’t hear this often, but looking back now, we wouldn’t have wanted it to go any other way than it did. We had a good collaboration with FDA. 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. Rather than just getting a 510(k) on a predicate device with no clinical data, we thought it was important to show advantages to our system over the current gold standard of care, because no one has done that.

Based on our initial reports out of Europe on our device, we felt comfortable that we had some distinct clinical advantages. Therefore, we negotiated a Level-1 randomized study. The thought was, let’s prove to the medical community that we’re as advantageous in terms of safety, functional improvement and pain reduction as the current gold standard of care, but let’s also fold in other clinical end points that show that we’re better. That’s what we set out to do.

While it was a long journey, it has been a fruitful one, and it’s paying dividends now. Physicians certainly appreciate randomized data. In this day and age, if a company is going to succeed, that’s the route they have to go. Benvenue has done that. We didn’t just do that in the KAST trial; we also have sister studies performed in Europe that were published in peer-reviewed journals that support the findings from the KAST study. In aggregate, we have three studies with over 500 patients that support and corroborate all of the KAST data, which is gratifying. The other benefit, as we launch into the marketplace, is that payors and hospital systems appreciate having data to review in their clinical decision making in terms of what new products to bring in.

             KIVA WEB

BONEZONE: Your plan from the beginning was to collect extensive clinical data before U.S. commercialization?

Weigle: Yes, it really was. We believed that the clinical study would set a high bar within this space for anybody that wanted to follow us. They, too, would have to conduct a large, randomized study to seek FDA approval in this space. This gave us not only a clinical advantage, but also a competitive advantage.

BONEZONE: When we ask OEMs about their greatest challenge, many times they say regulatory or FDA. What advice can you offer to ensure a positive experience during the regulatory clearance process?

Weigle: You need to embrace FDA’s need for clinical data right from the get-go, and you need to be collaborative with them. 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.

BONEZONE: What is next for Benvenue Medical?

Weigle: Our goal is to create a standalone company and drive toward profitability. We see ourselves in a few years as a breakthrough company in spine, in terms of providing new technologies in the treatment of fracture and degenerative disc disease. That’s our sole focus, and we believe that there is an opportunity for us to have great success in those areas.