Nimble companies easily shift with the environment at hand. Life Spine, Inc., a spinal implant company based in Huntley, Illinois, is doing just that. The company has teamed up with instrument maker Gizmo Medical, LLC of Hoffman Estates, Illinois, to collaborate on a ramp up of vital equipment needed by medical professionals. They are focusing on making large quantities of surgical masks and gowns, along with identifying ways to scale other medical equipment.
“Life Spine and Gizmo have moved to leverage our long-standing relationship and come together to help meet an imminent need for personal protective equipment (PPE) and medical equipment,” said Life Spine President and CEO Michael Butler. “Production is underway, and we look forward to supporting those who are on the front lines and faced with potential shortages.”
“In a time like this it is imperative for companies who can help to find ways to do so. From past experience with manufacturing such products we were able, with our partners at Gizmo Medical, to ramp up manufacturing of PPE. The capabilities were already in place it was just altering lines.”
Medtronic, Inc.’s fourth quarter spine revenue of $811 million was flat, but the company gained market share for the first time since the fourth quarter of 2007. That math doesn’t say much good about the overall spine market.
If you exclude sales of balloon kyphoplasty, the company’s core spine business grew in the low single-digits on a constant currency basis globally and in the U.S. The company believes it outperformed the U.S. market and market share was gained on both a sequential and year-over-year basis.
BMO Capital Market analyst Joanne Wuensch said core spine sales experienced “nice growth” in the U.S. while the company estimated that it has increased its share by 2% in the past year. “In our spine model, which includes Kyphon, the improvement is a bit less pronounced, but still remarkable, as the company gained share for the first time since CY4Q07; we estimate the company’s share increased to 35.1% from 34.7% y/y.”
In a May 21, 2013 announcement, the company said the core spine business continues to see “solid adoption of its new products and procedural innovations.” The company also noted that BMP revenue of $140 million declined by 1% on a constant currency basis. The much anticipated Yale study of the company’s Infuse product is expected to be released in June.
Management pointed out that growth stemmed from new product innovations (e.g., Solera, Bryan Cervical Disc) and pull-through opportunities with its imaging, navigation and powered surgical instruments.
“Considering hospitals are investing in capital equipment in spine surgeries, Medtronic is capitalizing on this opportunity to use navigation to drive implants sales. Case in point, when its O-Arm is placed with an account, the company is seeing implant growth rates that are 10% above those of other accounts, ” said Wuensch.
Wall Street analysts abhor stability (who needs analysts during stable markets?), as for the first time in recent memory analysts didn’t ask one question about spine or Infuse during the quarterly conference call with company CEO Omar Ishrak.
Amendia, Inc., a manufacturer of medical devices used in spinal surgical procedures, announces the commercial launch of its spondylolisthesis reduction system called the Syzygy Stabilization System. The system is configured to provide immobilization and stabilization of spinal segments as an adjunct to fusion. Physicians also use Syzygy in the treatment of instabilities or deformities of the thoracic, lumbar, or sacral spine; and conditions such as fracture, dislocation, scoliosis, kyphosis, spinal tumor, or failed previous fusion.
The Syzygy System is made of implant-grade titanium alloy. It features cannulated and non-cannulated screws, with self-tapping “grip quick” threads for maximum cortical bone purchase. Extended threads allow increased adjustability and control in 5mm increments for accurate reduction of spondylolisthesis. With available medial and cranial couplers, Syzygy facilitates up to 35mm of reduction with ±10° of cranial-caudal adjustment.
Hewatt M. Sims, M.D., a fellowship-trained orthopedic spine surgeon at Orthopedic Spine Center and Tift Regional Medical Center in Tifton, Georgia, performed spine surgeries with Syzygy. He reports that “Syzygy is a unique spinal system, providing quick, precise, and consistent reduction of the spondylolisthesis deformity.”
Lawrence Boyd, Amendia’s executive vice president of Research & Development, said, “In working hand in hand with the medical community and spinal device marketplace, we know how important it is to provide patients and surgeons with a pedicle screw-based solution that consistently and accurately realigns the spine. With surgeons providing care for a large number of patients who engage in athletics and rigorous physical activity, combined with a growing aging population, this critical addition to our line of lumbar fixation products will provide another way for surgeons to evolve their care.”
in Marietta, Georgia based Amendia is a designer, developer, manufacturer and marketer of medical devices used in spinal surgical procedures. Company officials say that the company works to create balanced solutions with disruptive technologies for medical devices paired with biologics and instrumentation. They say that Amendia’s vertically-integrated strategy focuses on improving surgical outcomes and the lives of patients with spinal disorders.
Terry Rich, who played a pivotal role in the turnaround of Alphatec Spine, has been named president of Global Spine at RTI Surgical Holdings, Inc. In addition, Olivier Visa has been promoted to president of Global OEM.
Mr. Rich, as a director and CEO of Alphatec Spine, strengthened the organization’s competencies and, according to RTI Surgical, redirected the portfolio with 12 new products and laid the foundation for focused innovation and growth. Before joining Alphatec Spine, Rich was president of Upper Extremities at Wright Medical Group, N.V. Rich had previously held sales leadership positions at Tornier, NuVasive and DePuy Spine.
“This is an important appointment that adds a globally recognized leader to the helm of our spine segment at RTI,” said Camille Farhat, company president and CEO. “Terry has a deep commitment to growth and innovation, as well as exceptional relationships with clinical thought leaders in our market. Our spine business is in the early stages of what we believe is a longer-term transformation with tremendous opportunities ahead. We believe Terry’s leadership will help accelerate the execution of our Novel Therapies commercial channel and multiple product launches planned for 2020.”
According to RTI, “Visa joined RTI in October 2017 as vice president of OEM and has spearheaded the positive performance of this business segment within RTI. Under his leadership, the OEM segment has earned a solid market position serving leading medical technology companies that operate in a diverse set of end markets with attractive growth profiles. Over the past two years the business has returned to growth, driven operational excellence and delivered significant predictable recurring EBITDA.”
Terry Rich told OTW, “I am thrilled to be joining RTI Surgical as the leader of the global spine business with a heightened focus on strengthening our commercial channels, globalizing our portfolio, advancing our product development pipeline and integrating new technologies to enable physician partners to deliver better outcomes. My immediate focus is getting up to speed on our teams, key customers, operating plan, current portfolio, R&D pipeline and international markets. I am eager to meet folks face-to-face over the next few weeks.
How did a 78 bed rural hospital in an economically depressed region of upstate New York end up with a world-class spinal surgeon? The answer lies in the power of human relationships to influence career decisions, the willingness of a hospital administrator and board to invest in equipment for a surgeon who was a continent away and the skills of a Beijing-born doctor, a former molecular biologist, who was just beginning his career as an orthopedic surgeon.
The story began when two orthopedic surgeons approached Lawrence E. Kelly, president and CEO of the Nathan Littauer Hospital in Gloversville. New York. They wanted to increase the coverage in orthopedics they were providing the hospital. To do that they needed a third partner—a spinal surgeon.
“Great, ” Kelly replied. He arranged for the hospital to fund the search and cover the recruitment costs and assigned a staff person to handle the paper work. When the search firm told them about Dr. Jian Shen, a 42-year-old former molecular biologist who was finishing up a residency in orthopedics in North Carolina, they all flew down to meet him.
Something significant happened at that face-to-face meeting. The two upstate New York orthopedists and the hospital administrator found they really liked this novice surgeon. They flew him up to Gloversville to take a look at their hospital and the surrounding Adirondacks. He promised to come but he could not begin work for a year because he had agreed to serve a year-long fellowship in San Francisco.
As Kelly explained, “It was a personal connection that we made. We all hit it off. There was trust there.” Kelly told Shen, “When you get here our commitment to you is we will do everything that is possible to be done to make sure you are a successful spine surgeon.”
Kelly was in constant contact with Shen during Shen’s year in San Francisco. Kelly wanted to know what Shen was learning, what equipment he was using there that he would need in Gloversville. As Kelly explained, “We did not wait until he got here to buy a bunch of stuff for him.
Distal extremity device maker Centric Medical has a new FDA 510(k) clearance for its foot and ankle plating system.
The company, a division of Life Spine, Inc., announced on January 23, 2018, that the FDA clearance offers “multiple surgical solutions” by the company to be used in foot and ankle reconstruction procedures.
“The Centric Medical Foot and Ankle Plating System,” states a company press release, “is comprised of a variety of plates and screws intended to stabilize and fixate bone for a myriad of procedures. The low-profile plates and self-drilling and self-tapping screws were designed to minimize soft tissue disruption and irritation.
“They are offered in non-sterile, single use implantable components and are provided in a multitude of sizes and shapes which include plates specifically designed for metatarsal phalangeal fusions, lapidus fusions, midfoot fusions and calcaneal slide osteotomies.”
“When paired with our recently FDA cleared Cannulated Screw Internal Fixation System, and our existing OSTEO-LINK DBM biologics product, we have the potential for excellent clinical outcomes,” said Life Spine Vice President of Marketing Mariusz Knap. “As one of the fastest-growing, most innovative companies in our space it is crucial to our surgeons and patients that we continue to advance our offerings.”
According to the FDA clearance notification, the system is indicated for use in “stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multifragmentary fractures; revision procedures, joint fusions, and reconstruction of the bones of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used in both adult and pediatric patients.”
The clearance request was received by the agency on November 8, 2017 and cleared by December 21, 2017.
Dr. Barnes has taken office as the 30th president of the American Association of Hip and Knee Surgeons (AAHKS).
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Post time: Apr-28-2020