Baxano, based in San Jose, Calif., was founded in 2005 by Dr. Jeffery Bleich, who had the vision to create flexible tools to provide precision lumbar decompression from the “inside out.” Baxano’s mission is to develop innovative tools that restore spine function, preserve healthy tissue, and enable a better quality of life for the patients it serves.
Recupero brings over 20 years of experience in the medical device industry to Baxano. Prior to Baxano, Recupero led one of the largest and most effective direct sales forces in the spine market as vice president of sales for Kyphon Inc. Prior to Kyphon, Recupero was the national sales manager for Sulzer Spine-Tech Inc. He began his medical device career in sales and sales management with United States Surgical Corporation. Recupero is a graduate of The General Management Program at Harvard Business School and holds a bachelor’s degree in communications from State University of New York at Albany.
Q: Share with me a short history. What first brought you to Baxano?
A: I have been in spine technologies for the last 12 years and have gravitated to the introductions of revolutionary technologies. First, with Sulzer Spine-Tech and then with Kyphon, a local company that was acquired by Medtronic in 2007. I have always looked for technologies that represent advancements in care as opposed to “me-too” products.
I ran into Dr. Jeff Bleich, who is the founder of Baxano, a few years ago, in 2006. I saw the potential that the technology had – not only to provide patients with degenerative spinal stenosis a less invasive treatment but to potentially address a large subset of patients undergoing fusion today.
I have always been attracted to technologies that represent a leap forward and doing less invasive surgery with patients that help them recover faster. Ultimately, that is what attracted me to the company.
Q: How would you describe the focus of Baxano?
A: We are very focused on developing less-invasive, cost-effective technologies that can provide surgeons, patients and payors with options that will hopefully provide better patient care, while being cost-conscious because there is obviously a lot of stress on the healthcare system right now.
Q: Your product is aimed at patients with lumbar spinal stenosis. Talk about the product and what it is addressing in the marketplace?
A: There are 225,000 lumbar decompressions done in the U.S. every year. The procedure is typically done for patients that have lumbar spinal stenosis. That is the removal of some bone and some soft tissue that is creating pressure on nerve roots in and as they exit the spine.
There are also many spinal fusions done each year, and many of those fusions are done for spinal stenosis as well. Probably, at least another 250,000 fusions are done for a variety of reasons – a large subset is spinal stenosis.
What our device enables a surgeon to do is, instead of having to go from the outside in, they can go from the inside out so that it preserves tissue. We thread a wire through that space where the nerve lives, and it comes back out through the skin. We can then pull through thin, flexible devices that enable the surgeon to remove the tissue that’s pressing on the nerve without having to do as much unnecessary tissue removal.
Q: What sort of data are you gathering around your devices?
A: We have clinical trials that are enrolling right now that are single-arm trials that evaluate the use of the iO-Flex system and compare the outcomes to historical controls.
Basically, we are looking at standard spinal patient outcome measurement tools. There are four different measurement devices that are used to tell everything from patient pain to mobility. We also are studying the economics of it: the potential to save hospitals money by reducing operative time and length of stay, while improving long term outcomes.
The reality is that with devices these days, you just can’t simply add cost to a procedure; you have to demonstrate that your device either provides better patient care or that it somehow removes cost from the system.
We believe that we have potential to reduce operating time, but we are backing that up with clinical studies.
Q: When does that data come out?
A: We think we will finish enrolling the first of two studies in late 2011 and we will submit for publication the following year, so we have one year of data. So we would hope that we would have published data by 2012.
Q: How has the company been financed to date?
A: Last year, we closed a $30 million round of financing from some really top-tier investors, led by CMEA out of San Francisco. What was also validating for us is that one of the new investors is Kaiser Permanente Ventures. Kaiser, as a healthcare system, is typically very cost-focused, so for them to invest, it really made a statement that this is the technology with potential.
Q: Tell me about some of the company’s goals for the near future.
A: Our goal is to begin enrollment of a clinical trial that will demonstrate the utility of the device in lumbar spinal stenosis, as compared to some of the other techniques that are being done to treat the condition right now.
We also have goals set around numbers of surgeons that we want to train to use the devices.
We plan to expand our commercialization and we want to be able to, at the appropriate time, provide information to patients so that that they know there are alternative technologies and procedures that can help them.
Q: How well is Baxano positioned to fit within the parameters of healthcare reform?
A: We are really well positioned to address where healthcare is going. Payors are becoming more critical of technologies and procedures that do not have evidence of efficacy. Comparative effectiveness is the new direction in healthcare.
So, we think that this technology fits well with where healthcare is headed – less invasive, less cost.
This interview has been edited for length from its original version.
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