There’s still room for upstarts with solid technology and a winning value proposition to take on the orthopedic industry’s heavyweights. ODT profiles four up-and-comers with their eyes on the prize.
The orthopedic market, while one of the largest sectors in the medical device industry, also happens to be among the most challenging. That doesn’t mean, however, that growth and opportunities for innovation are nonexistent. Companies continue to innovate and the past year has seen robust acquisition activity.
In the past year, we’ve seen a significant number of deals in orthopedics, internationally and here at home—ranging from multibillion-dollar buyouts to smaller deal-making. Stryker Corp. recently bought Small Bone Innovations for $375 million in cash. Biomet Inc. bought spine firm Lanx Inc. late last year. This spring, Biomet was the target, with its planned purchase by Zimmer Holdings Inc. for $13.4 billion (the deal has not yet closed). Wright Medical Group Inc. shed its large-joint holdings last year and is bulking up its extremities business. To that end, Wright purchased small extremities firms OrthoPro LLC and Solana Surgical LLC, for $32.5 million and $90 million, respectively. Last spring, NuVasive Inc. purchased one of its suppliers, small Ohio-based spinal implant maker ANC LLC for $4.5 million. And, Smith & Nephew plc is preparing to close on its $1.7 billion purchase of ArthroCare Corp.
Analysts and other industry-watchers predict continued orthopedic market growth, with a focus on international opportunities, minimally invasive technologies and an expanding extremities market. And, of course, as the industry adjusts to new healthcare sector demands, any system, any technology or procedure that reduces costs, increases efficiency and decreases hospital time will have an edge. The timing is right for smaller companies with transformative ideas.
This is the fifth year, as part of our Top Company Report issue, that Orthopedic Design & Technology has profiled small and midsize emerging growth firms positioning themselves alongside (perhaps with the goal of overtaking or being acquired by) larger market leaders. This year’s installment provides an overview of four orthopedic companies vying for rank, digests their technologies, examines their sectors and what’s kept them busy during the past year.
• Robert Weigle, CEO
• Laurent Schaller, Founder & Chief Technical Officer
• Jeffrey Jones, Chief Operating Officer
• Victor Barajas, VP of Operations
• Barbara S. Lindsay, VP, Clinical, Regulatory and Quality Affairs
Sector: Spine/Vertebral Compression Fractures
Location: Santa Clara, Calif.
Founded in 2004, private-equity-backed Benvenue Medical Inc. develops minimally invasive expandable implants for the spine. The Northern California firm, based in the south Bay Area in Santa Clara, has made its business tackling the treatment of vertebral compression fractures (VCFs).
According to the American Association of Neurological Surgeons, VCFs occur when the body in the spine collapses, which can lead to pain, deformity and loss of height. These fractures more commonly occur in the thoracic spine—the middle portion of the spine—the lower part, in particular. Osteoporosis is the most common cause of VCF, but the fractures also may be caused by trauma or tumors.
According to figures cited by Benvenue, there are 750,000 osteoporosis-related vertebral compression fractures annually in the United States, which is expected to grow as the population ages.
Surgical treatment options for VCFs include:
- Vertebroplasty. Bone cement is injected into cracked or broken vertebrae. The cement hardens, stabilizing the fractures;
- Balloon kyphoplasty. The procedure is similar to vertebroplasty except kyphoplasty inserts a small balloon into the fracture. The balloon is inflated to create a space that is filled with bone cement to help restore vertebral height and reduce spinal deformity, according to the website Spine Universe. It also allows a thicker cement to be used, which has less risk of leaking out and causing complications, the website noted; and
- Spinal fusion, which bonds two or more vertebrae together using bone graft (naturally and artificially derived) and small spacers/cages often are used as well.
Benvenue’s technology is a different approach from the options noted above—balloon kyphoplasty, in particular, which is the current standard of care for VCF. Benvenue designs minimally invasive implants and devices for the spine based on proprietary flexible polyetheretherketone (PEEK) and pre-shaped nitinol technologies. The firm’s primary system, called Kiva, is a unipedicular, PEEK-Optima cylindrical implant that the company calls ”a departure from balloon kyphoplasty” and the “first new approach to the treatment of vertebral compression fractures in over a decade.” According to the company, the Kiva implant is designed to provide structural support to the vertebral body and a reservoir to direct and contain bone cement during vertebral augmentation. The implant is delivered percutaneously over a removable guidewire in a continuous loop into the vertebral body through a small diameter, single incision. The amount of the Kiva implant delivered is physician-customized during the procedure. The technology recently was cleared by the U.S. Food and Drug Administration (FDA) and it also has CE mark (received in 2008) in Europe, where it is distributed by Zimmer Spine.
Benvenue also makes the Blazer-C vertebral augmentation system, which is used by physicians to create channels within the vertebral body for bone cement delivery. The Blazer-C is indicated for the treatment of pathological compression fractures of the vertebral body that may result from osteoporosis, benign lesions or malignant lesions, by creating channels in the existing spinal bone structure for the flow of polymethylmethacrylate bone cement.
The firm’s third device is the Luna interbody system, which is used in minimally invasive spinal fusion procedures for degenerative disc disease and incorporates Benvenue Medical’s proprietary implant technology. It has received the CE mark but is not currently available in the United States, though FDA review is pending.
A Good Year
So far, 2014 has been a busy year for the folks at Benvenue Medical, wracking up an FDA nod for its primary technology, securing a new round of funding, as well as the release of important study results.
On Jan. 28, the company reported receiving FDA 510(k) clearance for the Kiva VCF treatment system.
“We are excited to bring the Kiva System and its clinical benefits to the large and growing population of VCF patients in the U.S. market,” said Robert K. Weigle, CEO of Benvenue Medical. ”The VCF segment has little Level I clinical data, and we are proud to have sponsored one of the largest randomized studies in this space to date.”
The Kiva VCF is indicated for use in the reduction and treatment of spinal fractures in the thoracic and/or lumbar spine from T6-L5.
After receiving the FDA’s OK for Kiva, the company presented the results from KAST (Kiva System as a Vertebral Augmentation Treatment: A Safety and Effectiveness Trial). KAST compared Kiva to Medtronic Inc.’s balloon kyphoplasty (BKP) system. The trial results presented by Benvenue officials showed that the Kiva system ”met or exceeded” Medtronic’s system on every endpoint measured.
According to the company, the new implant approach allows the treating doctor to deliver a much more consistent result. In contrast, BKP inserts a bolus of bone cement directly into a vertebral cavity without an implant to hold it.
”The Kiva System was clinically proven in KAST, as well as in several other trials, to be better than or similar to balloon kyphoplasty, which is our most widely offered treatment,” said Sean M. Tutton, M.D., FSIR, co-principal investigator in the KAST study and professor of radiology and surgery at the Medical College of Wisconsin in Milwaukee. ”KAST sets the new standard for future trials in the VCF category. KAST results, in addition to the results of the other trials conducted, demonstrated the Kiva implant has important advantages for our patients and will serve as future guidance in clinical decision-making between VCF treatment options.”
”We are excited to provide a new alternative to the large and growing population of VCF patients in the U.S. market.” said Weigle. ”We believe the enthusiastic response we’re enjoying is a result of, among other things, the fact that government and private payers are pushing to ensure treatment effectiveness in their reimbursement decisions, and we have a growing body of peer-reviewed data that show Kiva’s clinical benefits over BKP.”
The new year also brought a new face in the front office. The company hired Jeffrey Jones as chief operating officer. Jones brings more than 20 years of related operations experience with medical technology startups and Fortune 500 companies to the newly created position for Benvenue. Jones is responsible for working with the senior management team to formulate current and long range plans, objectives and policies, as well as directing the company’s operations, manufacturing, development and quality departments. Previously, he served as vice president of operations at Acclarent, acquired by Johnson & Johnson in January 2010, where he supported sales growth and was responsible for supply chain, manufacturing operations, process engineering, materials, purchasing, facilities, and environmental health and safety. Jones also has held chief operating officer positions at a number of Bay Area medical device startups, including Polyremedy Inc., Reliant Technologies Inc., and Lumend Inc. Earlier in his career, he served as vice president of operations for Boston Scientific Corp. after it acquired EP Technologies, where he also served as vice president of operations. He holds a bachelor of science in engineering from the U.S. Military Academy at West Point and a master of business administration in management from Golden Gate University, and he is Six Sigma Black Belt certified.
June not only marked the beginning of summer, but also a new infusion of financing for the company. Benvenue completed a $64 million round of financing, with which it plans to build its U.S. commercial presence, scale up manufacturing, increase administrative functions to support overall corporate growth and provide working capital to fund growth in operating activities.
The financing is a combination of $40 million in Series E equity supplemented with $24 million in debt.The equity financing was led by new investor InterWest Partners with all existing major investors participating and Silicon Valley Bank was the sole debt provider.
”We welcome new investor InterWest Partners, and we’re gratified by the continued support from our existing investors and Silicon Valley Bank, who has been our long-standing banking partner. We believe the large investment in our company is due to Kiva’s successful U.S. launch, the Luna device bearing a CE mark and its upcoming FDA submission. We’re all very excited about the enthusiastic response we’ve received from the spine community,” said Weigle.
Benvenue also added Gil Kliman, M.D., from InterWest Partners to its board of directors.
The company is funded by InterWest Partners, Versant Ventures, DeNovo Ventures, Domain Associates and Technology Partners.
Independent Study Results
In October last year, an independent evaluation of the safety and effectiveness of the Kiva VCF compared with balloon kyphoplasty, found that Kiva delivered significant improvements in back pain, the firm reported. The Kiva system also resulted in significantly fewer new fractures and half the mean cement used as compared to balloon kyphoplasty. The peer-reviewed study results were published online and in the September/October edition of Pain Physician Journal, the official publication of the American Society of Interventional Pain Physicians. This was the second independent study to be published in 2013 providing positive results for the Kiva technology.
”Historically, balloon kyphoplasty has offered my osteoporotic VCF patients benefits. We evaluated Kiva as a new treatment option to see if those benefits were improved,” said Lucia Otten, M.D., of University Hospital in Bonn, Germany, and author of the study. ”Patients in our study treated with Kiva experienced a pronounced improvement in back pain over balloon kyphoplasty. Additionally, patients treated with Kiva demonstrated a lower incidence of newly occurring fractures and we used less than half the cement.”
”This study indicates that using Kiva to treat VCFs offers statistically significant advantages over balloon kyphoplasty in addressing pain, as well as in improving longer-term results by reducing future fractures,” said Robert Pflugmacher, M.D., professor of surgery at the University Hospital in Bonn.
The study, titled ”Comparison of Balloon Kyphoplasty with the New Kiva VCF System for the Treatment of Vertebral Compression Fractures,” was conducted on the basis of matched pairs, with 52 patients suffering from 68 osteoporotic fractures and followed for six months. Patients treated with balloon kyphoplasty were treated with KyphX system by Medtronic, the most common vertebral augmentation treatment in the United States. Outcome measurements used were visual analog scale (a measure of pain), Oswestry disability index (a measure of function), cement usage, cement extravasation (leakage), height restoration, and new fractures.
The study concluded several statistically significant outcomes in favor of Kiva over balloon kyphoplasty: Pain improvement was significantly better with Kiva at six months (p < 0.0001); new fractures following treatment with Kiva were significantly lower, 12 percent, than after balloon kyphoplasty, 54 percent (p < 0.0001); and mean cement used was less than half with Kiva (2.2-2.6 milliliters) vs. balloon kyphoplasty (4.7-7.5 milliliters).
Although not demonstrated in this study to be a statistically significant difference, cement extravasation was less with Kiva (23 percent) vs. balloon kyphoplasty (31 percent). Vertebral height restoration and functional improvement were equivalent in both groups.