Semprus BioSciences has received a $1 million grant from the U.S. Army Telemedicine & Advanced Technology Research Center to develop the world’s first orthopedic devices designed to reduce biofilm formation, which is responsible for most bacterial complications associated with medical device implants.
Semprus BioSciences is a venture-funded biomedical company in Cambridge, Mass. The firm has developed proprietary technology to organize, manage and harness water molecules on a medical device surface. This system creates what the company terms a “highly non-fouling performance” that is intended to reduce the attachment of proteins, cells, bacteria and other biological matter.
According to Semprus executives, the company’s technology can reduce the 56,000 preventable annual U.S. deaths and $11.2 billion cost of infection and thrombus-related complications that often arise when medical devices are implanted in the body.
Gunshot wounds, blast injuries and landmine explosions cause the majority of battlefield wounds to American soldiers. Between 60-70 percent of soldiers who are wounded suffer from orthopedic injuries, which lead to significant morbidity and failure to return to duty. If a bone fracture becomes infected, the patient requires a prolonged course of treatment that can require multiple surgical procedures, long-term antibiotic care and even amputation. Each year, orthopedic device infections cost the U.S. nearly $2 billion and 11,000 deaths, according to the Journal of Wound Care.
Joseph Wenke, Ph.D., an expert on improving outcomes for open fractures at the U.S. Army Institute of Surgical Research, is leading this collaborative effort.
“I look forward to working with Semprus to help resolve a critical issue affecting our wounded warriors,” Wenke said. “We are hopeful that our collaboration with Semprus will yield new orthopedic products that will greatly reduce complications associated with these injuries, and the costs to treat them.”
Semprus BioSciences’ chief technology officer Christopher Loose, Ph.D., is coordinating the research and development to bring technology to the clinic on intramedullary nails. The scope of the work performed in this collaborative effort will focus on adapting the technology to orthopedic substrates, including titanium. According to Loose, Semprus’ Technology has the potential to improve clinical outcomes for soldiers who suffer from extremity trauma.
“Our goal is to dramatically reduce complication rates in orthopedic devices implanted in our men and women in the armed forces,” he said. “We expect our technology to reduce wound complications, amputation and mortality in soldiers with orthopedic injuries.”
Loose added that the benefits of the technology in development would particularly be relevant to military personnel, including: Long-term antimicrobial activity for the multiple months required for fracture healing, as opposed to “slow release” technologies that utilize a drug reservoir with a limited inherent lifespan (one-two weeks); broad spectrum activity against all of the pathogens commonly found on the battlefield, including A. baumannii; and minimal drug resistance because these chemistries use non-specific mechanisms to reduce biofilm formation.
“With widespread use across the military in different combat environments, fracture fixation devices are undoubtedly a permanent aspect of battlefield care,” said Semprus CEO David L. Lucchino. “The reduction of associated infections is critical to streamline the treatment process and minimize recovery time.”
Lucchino added that his firm’s process also could be applied to other orthopedic devices, including external fixation systems, screws and plates.
Semprus BioSciences is a venture-backed biomedical company. In December 2010, the company completed an $18 million Series B financing co-led by SR One, the corporate venture capital arm of GlaxoSmithKline, and Foundation Medical Partners, a national healthcare venture capital investment firm with a strategic relationship with Cleveland Clinic. Combined with previous financing rounds, Semprus has raised a total of $28.5 million in equity.
Medtronic CEO:We’re Keeping Spine
The new head of Medtronic insists he’s not inclined to let go of the company’s spinal unit—a division that has been a bit of a drag on the company’s overall growth.
Rumors that Medtronic would sell its spine unit have been brewing for a while, long before Omar Ishrak took the helm in June from previous CEO Bill Hawkins. Medtronic’s growth has slowed as a result of a decline in medical procedures, product recalls and government investigations into the use of some devices.
A split made sense for Abbott Laboratories Inc., which announced plans earlier this month to separate its drug business from medical products, Ishrak told Reuters, but he sees Medtronic’s spine business as critical to the company’s overall plans.
“Abbott made the assessment that overall, there’s less value (as a whole) than in the different parts. It makes sense from their perspective,” he told the news service. “We as well have to look at our portfolio in that way at all times.”
According to Ishrak, the company’s management has looked at whether different Medtronic businesses can perform better on their own. Medtronic’s spine business benefits from other units of Medtronic, such as its business that makes surgical tools and navigation systems.
“It’s something we always examine and now we’ve done that assessment for Medtronic ... that’s something we should do on a periodic basis and our assessment is that the different pieces of Medtronic actually add value,” he said.
Ishrak, previously CEO of GE Healthcare Systems, said the company’s board “fully supports” a strategy of increasing penetration of its devices in U.S. markets, as well as increasing its presence in emerging markets.
“If you just look at our existing products ... if they were the standard of care around the world, we’d have a $150 billion opportunity,” he said. “We’ve got about 10 percent of that. There are clear opportunities to increase penetration.”
He expects the spine business to eventually recover from troubles such as a U.S. Senate investigation into whether doctors who were paid by Medtronic failed to report significant side effects of Infuse spinal fusion product. The growth should return as an aging population demands treatment for common back ailments. Ishrak told Reuters he will do whatever it takes to maintain integrity and patient safety, and that hiding adverse side effects would not be tolerated.
Ishrak expects U.S. demand for medical devices to remain sluggish as long as the economy is weak and unemployment high. He said the company still is looking for acquisitions, especially in the cardiology space. Ishrak said he is not looking to cut Medtronic’s research budget, but he wants research and development to show more direct results. He said the company’s R&D spending is “appropriate” but that the return is “inadequate.” He said the company launched 60 products last year and only grew by 2 percent.
Medtronic had total sales of $16 billion in its fiscal year ended April 2010.
Medtronic and NuVasive Continue Their Slugfest
Minneapolis, Minn.-based Medtronic Inc. has moved for an injunction to bar rivalNuVasive Inc. from making or selling its CoRoent XL spinal implant. The move follows a recent jury decision that found NuVasive’s device infringes Medtronic patents. In September, a jury awarded Medtronic $102 million in damages and nearly $700,000 to NuVasive.
The next punch thrown by Medtronic was to ask the U.S. District Court for Southern California to “permanently enjoin Defendant NuVasive Inc. from making, using, offering to sell, selling, or importing the CoRoent XL implants,” according to court documents. The company also is seeking supplemental damages for a period not considered by the jury. It also wants the court to overturn the jury’s finding that it infringed portions of a NuVasive patent. NuVasive wants the judge in the case to overturn the verdict or grant a new trial.
The fracas began in 2008, when a group of Medtronic subsidiaries sued San Diego, Calif.-based NuVasive for infringing nine patents relating to spinal implants. In turn, NuVasive
accused Medtronic of infringing three of its patents.
Medtronic’s spinal division is located in Memphis, Tenn.
K2M on a New Product Roll
One new product release during a trade show is a job well done. Two new device introductions make quite an impression. Three? Wow, the company has been pretty busy. What about five? Someone’s been busy.
Leesburg, Va.-based K2M Inc. was on a new-product-release roll at this year’s annual meeting of the North American Spine Society (NASS) in Chicago, Ill., in early November. The company doesn’t seem to be able to help itself. In addition to the five new products introduced at NASS, K2M has made five additional product releases in the past month.
The meeting in Chicago was a little like a coming-home party. Seven years ago, the company introduced its first device at the annual NASS confab, which also happened to be in the Windy City at that time as well.
Company executives have been relentless in pursuing their growth strategy, particularly since the group’s acquisition by private equity firm Welsh, Carson, Anderson & Stowe late last year, Lane Major, senior vice president of Global Marketing andProduct Development, told Orthopedic Design & Technology.
K2M’s management team has been aggressive in its plans to become a player in the competitive spine market, going head to head with the “big boys” in the competitive $7 billion spinal implant market.
“We have been incredibly excited about this year’s NASS,” Major said. “Until you reach a certain size, a lot of folks don’t realize what’s going on, but we’ve had this kind of product development pace for quite some time. This year, in particular, was a new milestone. The transaction with Welsh Carson has allowed that growth to continue. Welsh Carson isn’t a company that comes in and tries to spin it out in a couple of years. It’s a long-term play. They’re looking for acompany with a good infrastructure and platform.”
Major said it’s the company’s “entrepreneurial spirit” that made it an attractive buy and has fueled its product development efforts.
“If we lose that spirit, you become like so many others,” he said. “We have to maintain that enthusiasm and growth.”
Though the company doesn’t report its sales figures because it is privately held, Major said the company has had 30 percent year over year growth. Moving forward, he said the company will continue to expand internally and through strategic partnerships and acquisitions.
“There’s a huge opportunity for organic growth and there are voids that we will fill in other ways. We’ve been looking at a number of alternatives and solutions,” Major said. Among those opportunities is the field of biologics, which he said the company has plans to enter.
While most of K2M’s manufacturing is outsourced, the company does do most of its own instrument manufacturing at a facility acquired a few years ago in Malvern, Pa.
“Our model has been very clear from day one and has never changed. For our product development—we have product managers and project engineers. Product managers are the CEOs of projects and project engineers are the CTOs (chief technology officers),” Major explained. “Those two roles, working with surgeons from around the world, fuel our innovation. You have to have the end-user involved from the beginning.”
He also noted that the company has brought in compliance and regulatory experts to ensure that the product development process and input from physicians is “done the right way.”
Products introduced during NASS included the Everest degenerative spinal system. It is a top-loading pedicle screw system that can accommodate titanium and cobalt chrome rods of two different diameters and a screw thread pitch designed to maximize both osteoporotic and dense bone fixation, according to the firm. Everest received 510(k) clearance from the U.S. Food and Drug Administration in April.
The company also expanded itsChesapeake line with the launch of an anterior-lumbar stabilization system, which is designed for the stabilization of the spine through an anterior approach. Manufactured from both biocompatible PEEK polymer and titanium, the system allows for anterior stabilization and fixation with a zero-profile design and using K2M’s Tifix locking technology.
K2M rolled out two new additions to its Aleutian line—the transforaminal-lumbar (TLIF) II interbody system and the anatomically narrow oblique interbody system. TLIF II includes an adjustable inserter, which allows for variable angulation of the implant from 0 to 55 degrees in-situ. The Anatomically Narrow system provides a range of anatomically designed PEEK Interbodies for oblique implant placement through a transforaminal-lumbar approach. The system also comes with unique instrumentation to facilitate more efficient intraoperative use of the system, officials noted.
In addition, the company introduced the Serengeti complex spine minimally invasive system, which executives said would bring K2M’s focus on complex spine and minimally invasive technology together into one system by providing surgeons the ability to address deformity, trauma and tumors while promoting tissue preservation. The system features next-generation instrumentation to perform controlled reduction, manipulation, and above skin compression and distraction using the Serengeti retractor.
Also featured at NASS was technology that K2M recently acquired. The Blue Ridge hybrid cervical plate system uses one-step locking technology developed by Amendia, a custom medical device developer and distributor in Marietta, Ga. The system features a nitinol locking mechanism that engages during screw insertion and requires no additional locking steps, K2M officials said.
Rochester Medical Relocatesin Indiana, Changes Name
Rochester Medical Implants is moving. The contract manufacturer of orthopedic implants and precision products has relocated its corporate offices and manufacturing operations from Rochester, Ind., to a new facility in Noblesville. As a result of its new location, the company will change its name to RMI. The company’s website and email addresses will be unaffected, according to a press release. The new facility is a 33,000-square-foot building, which company leadership said will provide increased capacity and opportunity for enhanced capabilities and services. All computer numerical control (CNC) equipment has been relocated and additional capital purchases are planned.
“We’re pleased with the growth we’ve seen in recent years. RMI has made improvements in its capabilities and services and our customers are beginning to take notice,” said Jim Evans, RMI president. “Noblesville offers an attractive business climate with access to the talent we need to support our growth.”
RMI is ISO 13485:2003 certified with core competencies in CAD/CAM engineering, 5-axis CNC milling, turning and wire electrical discharge machining, process development, material sourcing, laser marking, assembly and packaging.
Hip Startup SecuresSeries C Funding
Pivot Medical, a startup orthopedic company focused on devices for minimally invasive hip restoration, has completed a Series C funding round worth $32 million.
Led by new investor Chicago, Ill.-based Adams Street Partners, the funding round also included participation from new investor Delphi Ventures in Menlo Park, Calif.; founding investor Montreux Equity Partners, also in Menlo Park; and existing investor Ivy Capital Partners in Montvale, N.J.
The company will use the capital to support the commercial rollout of its Pivot Hip Arthroscopy System in the United States and Europe, and to expand its clinical research programs. The system, which was developed from the ground up, is designed make hip arthroscopy “safer, more efficient and easier for physicians to perform,” according to the company.
“Pivot Medical was founded to deliver new technologies that dramatically advance the field of minimally invasive hip restoration, and we are meeting this commitment with a comprehensive line of innovative, highly differentiated products that will enable physicians to successfully treat their hip pain patients while preserving the delicate and complex hip anatomy,” said Jack Giroux, president and CEO of Pivot Medical.
As part of the funding round, Dr. Michael Lynn of Adams Street Partners and John Maroney of Delphi Ventures will join Sunnyvale, Calif.-based Pivot Medical’s board of directors, which also includes Guy Mayer, CEO of Ascension Orthopedics Inc.; Dr. John Savarese of Montreux Equity Partners; Julian Nikolchev, Pivot Medical co-founder; and Giroux.
“With its total dedication to hip preservation, Pivot Medical has developed a unique, high-value and comprehensive technology platform that we believe has the potential to make significant inroads into the fast-growing market for hip restoration procedures,” said Lynn. “We look forward to joining Pivot’s top-notch management team as it rolls out this important technology to physicians and patients worldwide.”