Zimmer's LDR deal could force others to grow a "dealmaking" spine

Zimmer’s LDR Deal Could Force Others to Grow a Dealmaking Spine (The Street)
The $1 billion transaction could inspire other medical device companies and private equity firms to bend over backwards for spinal device assets.
Globus Medical (GMED) , K2M Group Holdings (KTWO) , NuVasive (NUVA) , Orthofix International (TK) , Xtant Medical Holdings (XTNT) and Alphatec (ATEC) are among spine companies that investors should keep tabs as prospective targets or buyers following Zimmer Biomet Holdings’ (ZBH) recent $1 billion deal for LDR Holding (LDRH) , according to health care industry sources.
The Zimmer-LDR transaction, announced earlier this month, reaffirms that there continues to be an appetite for innovation in the spinal devices market despite risks the space has seen over the past several years, including regulatory challenges when it comes to the approval of new devices, high procedural costs and pricing pressures.
“It means there’s clear interest in the space,” one source said, requesting anonymity. “Some of the guys similar to LDR from a size and scale perspective become almost easier acquisition targets.”
Kohlberg & Co.’s recent play in the sector may also be indicative of more private equity interest in the space. Kohlberg purchased a majority stake in Amendia, which makes medical devices used in spinal surgical procedures, in May. Financial terms of the deal weren’t disclosed, but as The Deal previously reported, the transaction was said to fetch a valuation of about $170 million.
“I think the PE guys, when they see some of the multiples being paid for these businesses, it may spur them into action,” the source said. “It affirms the view that the spine market is an enormous market opportunity.”
Even Zimmer’s seemingly hefty premium for LDR–64% more than the closing price of the target’s shares one day prior to the announced deal on June 7–hasn’t satisfied some investors.
LDR shares finished slightly above the $37 per share price over the past five consecutive trading days. Just Wednesday, 1.5%-shareholder Empirical Capital Management, in a letter to the board of the San Diego-based company, urged it to either solicit a superior transaction at no less than $42 a share or remain an independent company.
Despite analysts’ belief that the transaction followed a competitive process of some sort, Empirical managing partner Cristan Blackman complained in the letter that the agreement lacked any sign of such an auction, such as a go-shop provision or a no-solicitation covenant.
Representatives of Zimmer and LDR couldn’t be reached Tuesday. The Deal previously reported, however, that while a competitive bid for the spine disorder technology company is not anticipated, fear of Zimmer becoming an substantially greater competitive threat with LDR under its wing could motivate other buyers.
While the Zimmer-LDR deal in one sense opens the doors for further M&A among spinal device companies, it’s important to note that LDR was a particularly unique technology play, noted Brean Capital’s Jason Wittes.
“Its safe to say there’s going to be more of a consolidation period,” Wittes said. “LDR was the most obvious takeout.”
LDR is viewed as a highly attractive asset largely because of its Mobi-C CDR device, which is the first and only FDA-approved product that treats both one- and two-level damaged cervical discs.
With LDR no longer on the market–assuming successful completion of the pending deal–K2M, whose current market cap is approaching $640 million, would make a logical bolt-on acquisition for a large medical device company.
Globus, with a market cap sitting at about $2.2 billion, and NuVasive, with a market cap of about $2.9 billion, represent the next sizable players that could emerge as takeout candidates, according to Wittes, Leerink Partners’ Rich Newitter, and the anonymous source.
Both Globus and NuVasive could also participate in consolidation.
Other companies that operation in the spine fixation space and are among possible targets include Lewisville, Texas-based Orthofix, with a market cap approaching $800 million, as well as the much smaller Belgrade, Mont.-based Xtant Medical, with a market cap of just $25 million, and Carlsbad, Calif.-based Alphatec, with a market cap of about $27 million, Newitter added.
NuVasive, in particular, is viewed of as being in a separate category as it works to gain share in the new and growing non-fusion spine market, and is likely more of a buyer than a seller for now, sources said.
CEO Greg Lucier, having taken the reigns of NuVasive in May 2015, has been outspoken about his intentions to bulk up through M&A.
The San Diego-based company earlier this month announced its third deal of the year, agreeing to pay $98 million for patient monitoring company Biotronic NeuroNetwork. In an even larger move, NuVasive in January said it would pay up to $410 million for Ellipse Technologies, a maker of noninvasive magnetically adjustable implant systems.
Because NuVasive and the slightly smaller Globus are pretty sizable companies, they have larger sales force teams in place that make a buyout more complex to execute, said Brean’s Wittes.
Meanwhile, Xtant CEO Dan Goldberger said that the company hasn’t received any formal or informal interest at this time.
“We’re not specifically for sale, but as a small public company, things happen,” he said by phone Wednesday.
Xtant, created via Bacterin’s purchase of X-spine Systems for $60 million last July, will continue to look for ways both organically and via potential acquisition opportunities, he said.
At less than half the size of each, LDR is just in the process of building a sales force, which made a deal a more doable, he explained.
Welsh, Carson, Anderson & Stowe, which took K2M public in May 2014, controls an approximately 33% stake in the spinal device maker. Having first invested in K2M in July 2010, the firm could be growing closer to desiring an exit in full.
Its unlikely that two of the medium-sized players, Globus and K2, will combine, since the current competitive landscape would create immediate cannibalization, noted one industry banker.
Besides Zimmer, NuVasive and Globus, large medical device companies including Johnson & Johnson (JNJ) , Medtronic (MDT) , Stryker (SYK) and Smith & Nephew (SNN) can all be thrown in the mix as potential buyers of spine companies, sources said.
Orthofix officials declined comment. Representatives of K2M, Nuvasive, Globus and Alphatec did not return calls and emails on Wednesday seeking comment.

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5.2 Million Total Knees implanted from 2000 to 2010

5.2 MILLION TOTAL KNEE REPLACEMENTS (Orthopedics This Week)
Doctors implanted an estimated 5.2 million total knees from 2000 to 2010, according to The Centers for Disease Control and Prevention’s National Center for Health Statistics. The rate of knee replacement went up, in that time period, by 86% for men and 99% for women.
The mean age of patients having a knee replacement was 66.1 years in 2014 according to a report by the American Joint Replacement Registry, as reported by Arkansas Online. For nearly 95% of the cases, osteoarthritis was the underlying diagnosis.
Medicare reports that, in 2014, it paid for more than 400,000 knee and hip replacements at a cost to the taxpayers of about $7 billion. The study by Blue Cross and Blue Shield, conducted in 2015, also mapped out the very wide range of costs for knee and hip replacements in 64 markets around the country. The study found the average typical cost for a total knee replacement was lowest at $11,317 in Montgomery, Alabama, and highest at $69,654 in New York. The highest variation in a single market was in Dallas, Texas, where the cost of a knee replacement ranged from $16,772 to $61,585.

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Study: Metal-on-metal hips impede osteoblast formation

Study: Metal-on-metal hips impede osteoblast formation (MassDevice)
A study of metal-on-metal hip implants found that the metal ions released when the parts of the cobalt-chromium-molybdenum devices rub against each other were able to penetrate into bone marrow, where they impeded the formation of bone-growing cells.
Metal-on-metal hip implants came under intense scrutiny following the high-profile August 2010 recall of DePuy Orthopaedics’ ASR XL acetabular and ASR hip resurfacing systems. Johnson & Johnson pulled the devices off the market after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants. The devices, many of which have been recalled or otherwise pulled from the market, have been found to deliver failure rates as high as 43% after 9 years.
Some reports warned that hundreds of thousands of patients may have also been exposed to toxic compounds from metal-on-metal implants, putting them at risk of developing cancer, cardiomyopathy, muscle and bone destruction and changes to their DNA. Since 2010 the controversy has ensnared other device makers, with personal injury lawsuits piling up even against metal-on-metal implants that haven’t undergone a recall.
The new study, published in the August issue of the journal Biomaterials, found that cobalt and chromium release contributes to bone loss. A Berlin-based team of researchers tested adjacent tissues, joint fluids and bone marrow to discover that both metal particles and dissolved metals play a role.
Dissolved metal ions in bone marrow interfere with mesenchymal stromal cells, the precursor to the osteoblasts that mineralize bone. Analysis of marrow with high metal concentrations showed that the MSCs had lost the ability to form osteoblasts; the team of physicians and researchers from Charité – Universitätsmedizin Berlin and DRK Klinikum Westend then duplicated the effect by exposing cell cultures to equivalent levels of chromium and cobalt.
“Considering the adverse effects of wear products from CoCrMo on MSCs, our data imply that the use of this alloy for mechanically loaded articulating surfaces and taper connections should be carefully reconsidered,” the study’s authors wrote.
“In order to ensure long-term success and an implant lifespan of more than 15 years, we need to further improve our understanding of the biological effects of the materials used, in particular those of the implanted metals,” Dr. Carsten Perka, Medical Director of the Center for Musculoskeletal Surgery, said in prepared remarks. “This is why we will further encourage and promote interdisciplinary collaborations between physicians, toxicologists and biologists at the Berlin-Brandenburg Center for Regenerative Therapies.”
In February, the FDA said it would require the manufacturers of metal-on-metal hip implants to put the devices through its stringent pre-market approval process. The federal safety watchdog said its final order affects 2 types of MoM hips: Hip joint metal/metal semi-constrained with a cemented acetabular component, and hip joint metal/metal semi-constrained with an uncemented acetabular component.

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Shame on the FDA

FORMER FDA DEPUTY DIRECTOR CHARGED WITH INSIDER TRADING (Orthopedics This Week)
FDA INSIDER TRADING SUSPECT COMMITS SUICIDE (Orthopedics This Week)
The FDA regulates billions of dollars of the U.S. economy. The agency’s pending decisions about approvals and clearances are closely guarded. If leaked, investors and competitors can gain or lose huge advantages, or worse, public health is impacted.
Most of the time the secrecy works. But a recent prosecution of a former deputy director of the FDA for providing tips on approvals to three hedge fund managers who then made tens of millions off the nonpublic information, reminds us of the importance of a corrupt-free agency.
On June 15, 2016, the Securities and Exchange Commission (SEC) charged two hedge fund managers and the former FDA employee, Gordon Johnston, with insider trading. Johnston worked at the FDA for a dozen years and, allegedly, remained in close contact with the former colleagues while working as vice president of regulatory sciences at the Generic Pharmaceutical Association (GPhA), from which he resigned in 2011 and worked as the group’s representative to FDA.
According to the SEC complaint, “Johnston concealed his separate role as a hedge fund consultant and obtained confidential information about anticipated FDA approvals for companies to produce enoxaparin, a generic drug that helps prevent the formation of blood clots.” The Regulatory Affairs Profession Society (RAPS) reported that Johnston allegedly funneled to one of the hedge fund managers the details of his conversations with FDA personnel, including a close friend he mentored during his time at the agency and who still currently works with the agency.
“Between late 2009 and early 2010, Johnston learned from an Office of Generic Drugs (OGD) Division Director, who was a friend and former mentee to Johnston and with whom Johnston had a decades-long close and personal relationship, that an enoxaparin ANDA [abbreviated new drug application] was ‘moving’ toward approval, meaning that OGD’s approval was becoming more imminent,” according to the complaint. “Johnston was immediately aware, upon learning this information, that he had received valuable nonpublic information. In particular, Johnston knew that the approval of an enoxaparin ANDA was valuable news because it would be the first time a generic counterpart to the brand-name drug Lovenox was approved.”
Johnston has pleaded guilty, according to prosecutors cited by Bloomberg.
Previous FDA Insider Trading
FDA deals with nonpublic information, and, reported RAPS, as many FDA employees formerly worked in industry and vice versa, this isn’t the first time an FDA official has been charged with insider trading. In 2012, Cheng Yi Liang, a former FDA chemist was sentenced to five years in prison for engaging in insider trading on multiple occasions based on material, nonpublic information he obtained in his capacity as an FDA scientist.
In 2014, FDA Deputy Commissioner for Operations and COO Walter Harris testified before the House Committee on Oversight and Government Reform about monitoring FDA personnel’s use of the agency’s IT systems, saying, “FDA personnel are permitted access to information provided to the Agency by medical product sponsors and others and are required to maintain the strict confidentiality of that information.”
According to federal prosecutors, the hedge fund managers, Sanjay Valvani and Christopher Plaford executed stock trades based on the insider information while employed as Visium Asset Management hedge fund managers. Plaford has also reportedly pled guilty.
What is unknown at this time is the identity of the FDA employee who shared the confidential information with Johnston. An FDA spokesperson reportedly declined to comment for news stories of the scheme, which allegedly lasted from about 2005 through 2011.
The agency must investigate this leak and offer a transparent explanation to assure the public that its secrets are safe.

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Flower Orthopedics reduces surgical steps in Foot & Ankle surgery

Flower Orthopedics Launches The Flower E-Kit™ And IndicationCube™ (press release)

HORSHAM, Pa., June 7, 2016 /PRNewswire/ — Following the footsteps of the single-use and sterile FlowerCube™ concept, Flower Orthopedics announces the full market launch of the next generation in Ready-for-Surgery™ bone fixation solutions, the Flower E-Kit™. First of its kind, the innovative E-Kit™ contains all of the requisite cannulated and plating instruments in one multifunctional single-use instrument kit. Combined with the new IndicationCube™, it is an all-in-one solution tailored to address specific surgical indications.

Designed to reduce surgical steps, the E-Kit™ allows the surgeon to quickly and efficiently position all implants of midfoot, forefoot and ankle constructs. Compared to the current market standard, the Flower E-Kit™ effectively replaces two complete orthopedic instrument trays, reducing the waste associated with costly sterilization cycles in the operative facility.
The Flower IndicationCube™ utilizes the E-Kit™ as its nucleus to combine all of the implants required for a particular surgical indication in one easily portable Ready-for-Surgery™ set. The IndicationCube™ significantly reduces the number of extraneous components in the surgical field, allowing surgical teams to streamline the entire implantation process of the surgery.
“The E-Kit™ represents the next generation of single-use instrument kits. Using the E-Kit™ a physician is able, with only the four instruments in the kit, to complete complex foot reconstruction or even a comminuted ankle fracture procedure in significantly less time,” says Oliver Burckhardt, President & CEO of Flower Orthopedics. “The IndicationCube™, a new exciting addition to the FlowerCube portfolio, is specifically intended for foot ankle and ankle indications where plates are often used in combination with cannulated screws. It houses all of the implants that can be applied using the E-Kit™. As both the E-Kit™ and IndicationCube™ prove, Flower Orthopedics is all about driving Surgical Efficiency.”
Like all Flower bone fixation products, the Flower E-Kit™ and all implant components contained in the IndicationCube™ are sterile packaged and delivered Ready-for-Surgery™.
Flower Orthopedics: Surgical Efficiency Drives Healthcare Costs Savings
Whether it is addressing infection potential, eliminating set reprocessing expenses or preventing untimely delays in the OR, the Flower Orthopedics Ready-for-Surgery™ portfolio is a proven method that surgeons and healthcare facilities can use to reduce the overall cost of providing patient care. The Flower development team works tirelessly with leading surgeons to decrease the number of surgical steps of a given procedure and to design instruments that make surgeries faster and more reproducible. Combining the surgical efficiency with the inherent efficiencies of the Ready-for-Surgery™ model, Flower Orthopedics is reducing the cost of care for a wide range of extremity applications. (www.flowerortho.com)
SOURCE Flower Orthopedics
Related Links
http://www.flowerortho.com

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