Blog Tag: Stryker
DePuy Synthes, a part of the Johnson & Johnson Medical Devices Companies, announced recently that it has signed a definitive agreement to acquire the assets of Medical Enterprises Distribution, LLC, which includes the automated ME1000™ Surgical Impactor tool used in hip replacement surgery. The two companies had previously formed an exclusive agreement to co-market the hip application of the ME1000™. The financial terms of the acquisition are not being disclosed. The transaction is expected to close in the second quarter of 2018.
According to Medical Enterprises, the ME1000™ delivers constant, stable energy that is designed to automate bone preparation, implant assembly and positioning in total hip arthroplasty (THA). DePuy Synthes said that the company plans to develop and broaden the surgical impactor technology for a range of orthopaedic surgery procedures.
“The acquisition of assets of Medical Enterprises Distribution is a key example of going beyond the implant to provide complete solutions to achieve better outcomes.” – Ciro Roemer, Company Group Chairman of DePuy Synthes
The hip replacement global market was $6.5 billion in 2015 and is predicted to reach $9.1 billion by 2025. The global market for all joint replacements is expected to reach $30 billion by 2025. Other companies in the joint replacement markets include Zimmer Biomet, Smith & Nephew, and Stryker.
In the recent press release, DePuy Synthes also announced an exclusive marketing agreement with JointPoint Inc. to co-market a hip navigation system for analysis of implant selection during THA. Earlier this year, DePuy Synthes announced the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery for total and partial knee replacement. In discussing the Orthotaxy acquisition, Ciro Roemer, Company Group Chairman of DePuy Synthes, said “Our goal is to bring to market a robotic-assisted surgery technology that is an integral part of a comprehensive orthopedics platform, delivering value to patients, physicians and healthcare providers across the episode of care.” Other companies in the joint replacement market are likely seeking to create comprehensive orthopedic platforms as well.
According to the press release, Ivy Sports Medicine’s portfolio includes: the only FDA-approved collagen meniscus implant on the market; an all-inside repair device; and an inside-out meniscal suturing platform.
Ivy Sports Medicine describes its Collagen Mensicus Implant (CMI) as a completely absorbable implant made from a porous structure that serves as a guide for the body’s own cells in order to make use of the body’s own healing ability.
Regarding the acquisition, Matt Moreau, Vice President and General Manager of Stryker’s Sports Medicine business, said:
The acquisition of Ivy Sports Medicine strengthens our capabilities and fits strategically with our current portfolio. Ivy’s complete meniscal platform, coupled with their clinical history, will allow us to provide our customers with multiple solutions to address meniscal repair. This is an area of sports medicine where there is continued opportunity to address unmet customer needs. The Ivy portfolio provides a unique platform for us to build upon as we seek to continue advancing the treatment of meniscal injuries.
Ivy Sports Medicine is only one of Stryker’s several acquisitions during 2016. Some of Stryker’s others notable acquisitions include Sage Products, Physio-Control, Synergetics, SafeWire, and Stanmore Implants.
Supreme Court Makes it Easier for Medical Device Companies to Recover Enhanced Damages for Patent Infringement
The Patent Act provides that, in a case of infringement, courts “may increase the damages up to three times the amount found or assessed.” Previously, in order to recover enhanced damages under the Patent Act, a patent owner had to show two things: (1) the infringer acted with objective recklessness and (2) the risk of infringement was either known or should have been known to the accused infringer. Both of these elements had to be shown by the relatively high standard of “clear and convincing” evidence.
The Supreme Court’s recent decision in Halo Electronics, Inc v. Pulse Electronics, Inc. drastically changed the standard for enhanced damages and made it easier for patent owners to obtain an enhanced damages award. The Court eliminated the objective recklessness prong and lowered the standard of proof from “clear and convincing evidence” to “preponderance of the evidence.” The Court also adopted an abuse of discretion standard for appellate courts reviewing a district court’s decision to grant enhanced damages.
Previously, patent owners struggled to obtain enhanced damages even when they could establish that the infringer acted with bad faith. Infringers were able to avoid enhanced damages by making a reasonable defense at trial. Thus, the ability of a patent owner to obtain enhanced damages sometimes depended more on the ingenuity of the defendant’s attorney than the defendant’s culpability at the time of the challenged conduct. By eliminating the objective recklessness prong, the Supreme Court refocused the analysis on the defendant’s knowledge at the time of the infringing conduct.
The Court’s new contemporaneous focus will likely influence the prelitigation conduct of patent owners and accused infringers. Demand letters informing accused infringers of their infringement and relevant patents will likely become more common place. Opinion letters will also likely take on an increased significance for accused infringers. Not all instances will warrant a full-blown infringement and validity analysis but, under the new standard, accusations of patent infringement should be given prompt, thorough, and carefully documented consideration.
Stryker Corporation recently announced the purchase of United Kingdom-based Stanmore Implants from SIW Holdings Limited for £35.6 million (about $52 million USD) in an all-cash transaction. According to Stanmore’s website, it is a highly specialized organization, focusing on orthopaedic oncology and complex primary and revision cases in the upper limb, lower limb and pelvis. Stryker notes that Stanmore has a significant focus on serving the needs of the orthopaedic oncology market, including making custom implants for adults and juveniles suffering from cancer.
The acquisition of Stanmore Implants provides Stryker with differentiated technologies designed to provide the most effective solutions for orthopaedic oncology surgeons. This addition underscores Stryker’s commitment to our core joint replacement business and expands our presence in the global orthopaedic oncology market.
Stanmore’s online portfolio of products for adult patients includes modular implant solutions for the femur, tibia, knee, and humerus as well as oncology implants for the upper and lower limbs, and the pelvis. Stanmore’s portfolio also includes minimally-invasive prostheses for juvenile patients that can be adjusted, e.g., until the patient reaches full skeletal maturity, and what Stanmore calls its “non-invasive extendable implants” that are designed to be lengthened periodically by an external drive unit.
The purchase of Stanmore is the latest in a string of acquisitions for Stryker: in February, 2016, Stryker acquired Physio-Control International (in a $1.28 billion all-cash transaction); in February, 2016, Stryker agreed to acquire Synergetics’ neurology portfolio; in March, 2016 Stryker agreed to acquire Sage Products (in a $2.775 billion all-cash transaction); in April, 2016, Stryker acquired SafeWire’s minimally-invasive surgical portfolio; and in April, 2016, Stryker acquired CareFusion vertebral compression fracture (VCF) portfolio of products (in another all-cash transaction).
Medical device maker Stryker Corp. recently announced that it will buy Physio-Control, a manufacturer of emergency defibrillators and other emergency medical response products based in Redmond, Washington. According to Stryker’s press release, the deal is a $1.28 billion all-cash acquisition and is expected to close at the beginning of Q2 2016.
Physio-Control opened its doors in 1955. Since then, Physio-Control reports that it has become one of the Seattle area’s largest medical device manufacturers — it currently employs more than 1,400 people globally and posted $503 million in revenue in 2015. Stryker explains that the acquisition permits Stryker to expand its emergency medical services (EMS) business both domestically and abroad (specifically in Europe). Regarding the deal, Stryker Chairman and Chief Executive Officer Kevin Lobo states:
Physio-Control’s focused strategy and their culture will fit well within the EMS business of our medical division, further leveraging our existing call pattern. We look forward to welcoming the Physio-Control team to Stryker.
Stryker’s acquisition of Physio-Control follows on the heels of its recent agreement to purchase Sage Products LLC for $2.78 billion in cash and its recent agreement to purchase Synergetics USA, Inc.’s neuro portfolio in another all-cash transaction. Moreover, as reported by the Venture Capital Post, Stryker has said that more deals will be done by the company soon. Mr. Lobo has been quoted as saying that:
One of the reasons to postpone the share repurchase program was to make sure we still have the capacity, so this will not be the last deal that we do.
According to its recent press release, Stryker Corporation has reached an agreement to acquire Sage Products, LLC from Chicago private equity firm Madison Dearborn Partners in a $2.775 billion cash transaction. Stryker describes itself as medical technologies company based in Kalamazoo, Michigan, specializing in orthopedic implants for hip, knee, and other replacement surgeries, as well as various medical-surgical, neurosurgical, and spinal technologies. According to its website, Cary, Illinois-based Sage develops products for prevention of hospital-acquired injuries and infections in patients and clinicians. Sage’s products include solutions for oral care, skin preparation and protection, patient cleaning and hygiene, turning and positioning devices and heel care boots.
Kevin Lobo, Chairman and CEO of Stryker, praised Sage’s “established leadership team and innovative products,” which “have driven consistent double-digit sales growth.” According to Lobo, the two companies share a “focus on offering products and services that support a mindset of prevention, specifically in the area of ‘never events’ such as hospital acquired infections.” The acquisition will “provide a consistent disposable revenue stream that will complement [Stryker’s] capital equipment offerings.”
Scott Brown, President and CEO of Sage Products, stated:
Sage is well-positioned for continued achievement and long-term success with Stryker, a company that understands our business, supports our goals and embraces our values.”
The transaction is expected to bring Stryker future tax benefits of over $500 million, as well as approximately 15 years of increased cash flows. According to Bloomberg, Madison Dearborn Partners will gain nearly 320% in the sale, having invested $350 million in Sage Products 3 years ago. The transaction is expected to close in the second quarter of 2016.
The U.S. Federal Trade Commission (FTC) recently issued a final order that conditionally approves the merger between Amsterdam, Netherlands-based Tornier N.V. and Memphis, Tennessee-based Wright Medical Group, Inc. Reuters reports that the all-stock transaction is valued at about $3.3 billion. Plans for the merger were first announced in October 2014, and approved by the shareholders of both companies in June 2015, subject to receipt of clearance by the FTC. Progress on the transaction was suspended when the FTC expressed concerns that the merger would reduce competition for total ankle replacements and total silicone rubber (silastic) toe replacements in the U.S. market.
The FTC’s Bureau of Competition enforces U.S. antitrust laws and works with the Bureau of Economics to investigate alleged anticompetitive business practices. On occasion, the Bureau urges the Commission to take law enforcement action. In this case, the FTC’s concerns were the final obstacle to the proposed merger. The recent final order, which follows a mandatory public comment period, settles the FTC’s allegations of anticompetitive behavior.
The order calls for Tornier to sell a portion of its U.S. assets and IP rights to Integra Lifesciences Corporation (NASDAQ: IART), a competitor in the U.S. orthopedics space, which is based in Plainsboro, New Jersey. The newly combined company will be required to provide Integra with ankle and toe replacement products for up to three years. Through this arrangement, the FTC seeks to foster competition in the affected market.
In addition to its upper and lower extremity portfolio, the merged companies will maintain a presence in the growing biologics market. Wright Medical recently obtained FDA approval on the Augment bone graft material (left), which is as an alternative to autograft in a variety of arthrodesis procedures. Tornier has developed a line of biologics that includes its BioFiber line of absorbable scaffolds and its Conexa reconstructive tissue matrix, both of which are used for soft tissue repair.
The U.S. market for cell-based therapies for musculoskeletal injuries (orthobiologics) is valued at over $1.5 billion and is expected to grow significantly in 2016. Other market participants in the orthobiologics space include Dublin, Ireland-based Medtronic (NYSE: MDT), San Diego, California-based NuVasive (NASDAQ: NUVA), Kalamazoo, Michigan-based Stryker (NYSE: SYK), and Johnson and Johnson’s West Chester, Pennsylvania-based DePuy Synthes (NYSE: JNJ). Orthobiologics are part of the growing field of regenerative medicine, which includes bioprinting and stem-cell based therapies, and is projected to be worth $6.5 billion in the U.S. by 2019. Bioprinting, itself, has received recent investment and growth.
Following the merger, the resulting company will be renamed Wright Medical Group, N.V. and will be incorporated and headquartered in the Netherlands.
Since its passage as part of the Affordable Care Act in 2010, the medical device tax has been hotly debated. The 2.3% excise levied on total revenues may effectively preclude new entrants while hindering the growth of established companies. While industries have turned to outsourcing for a number of years as a way to cut costs, the medical device industry may increasingly consider outsourcing in the coming years as a means to offset the effects of this tax. While outsourcing may help U.S. medical device companies, it may adversely affect Americans currently working in this sector.