Invibio's monopoly on implant-grade PEEK to be broken up by the FTC

Device Supplier Settles Monopoly Allegations With FTC (RAPS)
UK-based Invibio, the first company to sell implant-grade polyetheretherketone (known as PEEK) to the world’s largest medical device makers for spinal and other medical implants, has agreed to settle Federal Trade Commission (FTC) charges that it violated federal antitrust law by using long-term exclusive contracts to monopolize the PEEK market.
According to the FTC, two other companies, Solvay Specialty Polymers (the US Food and Drug Administration [FDA] cleared the first spinal implant device using Solvay PEEK in 2010) and Evonik Corp. (FDA approved the first spinal implant device using Evonik PEEK in 2013) tried to enter the implant-grade PEEK market, but Invibio’s anticompetitive tactics impeded them from effectively competing and Invibio retained about 90% of PEEK sales worldwide.
“This case affirms that the first company to enter a market cannot rely on anticompetitive contract terms to lock up customers and box out rivals,” said Debbie Feinstein, director of the FTC’s Bureau of Competition. “This settlement is designed to provide buyers a meaningful choice among suppliers, to open the door to price competition, and to enhance innovation.”
Invibio adopted an all-or-nothing negotiation strategy for its supply contracts that required medical device makers to agree to use only Invibio PEEK for all or nearly all of their PEEK-containing implantable devices, FTC contends. Industrial-grade PEEK was developed first in the late 1970s by Invibio’s corporate parent, Victrex, and in 1999 Invibio began to market a grade of PEEK suitable for implants.
These contracts enabled Invibio to maintain high prices for PEEK and also allegedly threatened to stifle incentives to develop new and improved forms of PEEK.
Settlement
Under the proposed consent order, Invibio, Inc. and Invibio Limited and Victrex are prohibited from entering into exclusive supply contracts and from preventing current customers from using an alternate source of PEEK in new products. In addition, Invibio must allow current customers meeting certain conditions to modify existing contracts to eliminate the requirement that the customer purchase PEEK for existing products exclusively from Invibio.
Invibio is also barred from using pricing terms in new contracts that could effectively result in an exclusive arrangement between Invibio and a device maker.
“These prohibited terms include setting minimum purchase requirements; conditioning discounts or important services on a device maker’s purchase from Invibio of a specified percentage of its PEEK requirements; and providing retroactive volume discounts,” FTC says.
Details about the case are set forth in the analysis to aid public comment for this matter. The FTC voted unanimously to issue the complaint and accept the proposed consent order for public comment.
The consent agreement will be subject to public comment for 30 days, continuing through 27 May 2016. Comments can be filed electronically.
FTC Complaint
Consent Order
Supplier of High-Performance Polymer for Medical Implants Settles FTC Charges that It Monopolized Sales to World’s Largest Medical Device Makers

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DePuy partners with Materialise for 3D printing of titanium skull & face implants

Johnson & Johnson gets in on 3D printing with Materialise deal for titanium skull & face implants (MassDevice)
see my interview with Materialize CEO
Johnson & Johnson (NYSE:JNJ) said this week that it inked a deal with 3D printing shop Materialise for titanium craniofacial implants customized to individual patients’ anatomies.
Leuven, Belgium-based Materialise will print the Trumatch line of implants for J&J’s DePuy Synthes business, for treating patients with disorders of the face and skull. The companies have worked together on craniofacial technology  for 6 years, Johnson & Johnson said.
“The Trumatch CMF solutions portfolio includes several advanced technologies for facial reconstruction, orthognathic surgery, distraction, and cranial reconstruction,” DePuy Synthes EMEA VP Elmar Zurbriggen said in prepared remarks. “The agreement with Materialise will enable us to continue to bring more personalized solutions to the marketplace furthering our ability to improve patient care.”
Materialise creates the implants using a computed tomography scan of the patient’s skull. The Trumatch line is slated to hit the market in Australia and Europe, J&J said.
“The launch of Trumatch orthognathic and titanium 3D-printed implants is currently being rolled out in the EMEA countries,” Zurbriggen said.
Financial terms of the deal were not disclosed.

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J&J CEO talks about M&A and ongoing restructuring in med device businesses

J&J CEO: On Track With Restructuring, Very Disciplined In M&A (MedDeviceOnline)

Johnson & Johnson CEO Alex Gorsky says that J&J is on track and reaping gains from the restructuring of its medical device business, six months after it announced accelerated innovation to keep up with market changes. Senior leadership also will continue to be very disciplined in evaluating M&A deals, in spite of the company’s deep pockets.
In January, J&J announced that it will streamline its workforce and certain offerings in the orthopedics, surgery, and cardiovascular segments in order to increase investments in innovation and to drive growth. Device sales had fallen 2.9 percent overall at the time of the announcement.
Fast forward six months, and the restructuring activities are beginning to help revive J&J’s device business. Worldwide device sales grew 0.8 percent in the second quarter to $6.4 billion, according to a press release. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales rose 3.9 percent, domestic sales increased 1.9 percent, and international sales grew 5.8 percent. Overall sales increased 3.9 percent to $18.5 billion during the second quarter.
J&J says growth was driven by endocutters, energy and biosurgical products in the Advanced Surgery business; electrophysiology products in the Cardiovascular business; joint reconstruction and U.S. trauma products in the Orthopaedics business; and ACUVUE contact lenses in the Vision Care business.
“We’re gaining momentum and accelerating growth through our unique and broad-based approach to innovation. Our performance this quarter was roughly in-line with market growth, and we’re pleased with the progress here, but far from satisfied,” J&J CEO Alex Gorsky said during a conference call. He said he is confident about achieving above-market growth globally, which the company projects to be 3 percent to 5 percent annually over the next five years.
Gorsky added, “If we look at the restructuring, I think overall that team is on track. They’re doing actions to strengthen their go-to-market model to accelerate their pace of innovation. They’re prioritizing some additional platforms and geographies and all while streamlining some operations but really keeping very high quality standards. We think they’re on track with a plan that they articulated earlier in the year and we’re confident that as they move through this, they will be not only a stronger but a more innovative and a more efficient business.”
He said that the company also is on schedule to net approximately $800 million to $1 billion in annual savings related to restructuring efforts by the end of 2018, with some savings reinvested into the device business to speed product innovation. This will be complemented by “innovation in terms of our commercial offerings and contracting,” such as growing more profitable multi-product line agreements for the U.S. orthopedic and surgery business from the current 25 percent to 40 percent, said Gorksy, who mentioned that hospital admissions were up 3 percent, and surgical procedures grew 3.5 percent overall.
Also by 2018, the company plans to launch over 20 new products in both the clinical and consumer product segments with total sales potential of $8 billion, which will drive overall growth between 4 and 6 percent per year by 2020, according to an MDO article.
Gorksy said in the call that industry consolidation will continue, but believes that J&J is “well-positioned,” particularly with regard its surgical and orthopedic offerings. He touted solid growth in both knees and hips, which grew 4.5 percent and 5.5 percent, respectively. He was pleased with the performance of J&J’s cardiovascular business, particularly the electrophysiology business, Biosense Webster, which grew 18.5 percent in the second quarter. But he acknowledges that “other areas in cardiovascular ranging from valves to structural heart to others could definitely be opportunities,” and the company will observe how the technology and market evolve.
J&J will continue an interested-yet-cautious approach in evaluating M&A opportunities.
Gorsky in January highlighted J&J’s acquisition of atrial fibrillation device-maker Coherex Medical and its surgical robotics joint venture with Verily as the type of deals that J&J will likely make. Gorksy in the recent conference call mentioned the acquisition of BioMedical Enterprises, which filled a key portfolio gap in elective foot and ankle surgery.
“And as we said for some time, whenever we’re looking at inorganic growth opportunities, we look at tuck-ins, we look at mid-size deals,” Gorsky told analysts. “But we’re going to be very disciplined. We’re going to be very decisive about how we do it, and ultimately try to better serve patients and consumers.”
J&J has $39 billion in cash and marketable securities on hand for M&A, but the company can afford to be patient, according to Bloomberg.
“Although we’re actively involved in considering them, valuations come into play, and willingness of the other party to do an acquisition at certain valuations come into play,” said J&J CFO Dominic J. Caruso during the call. “So that’s regardless of how much money we have available to spend. So we don’t really look at that as the main driver of how we’re going to do acquisitions. We look at what value we’re going to create for shareholders by doing the acquisition at the right value, so we can improve returns for our shareholders.”

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First-Ever FDA clearance for cement-augmented pedicle screws

First-Ever FDA Clearance for Cement-Augmented Pedicle Screws (ODTMag)
Medtronic plc has announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the CD Horizon Fenestrated Screw Set, which can be used for patients diagnosed with advanced stage tumors involving the thoracic and lumbar spine. This marks the first U.S. clearance for cement-augmented pedicle screws. The CD Horizon Fenestrated Screws are used with Medtronic’s HV-R Fenestrated Screw Cement, a polymethylmethacrylate (PMMA) cement, and are intended for use at spinal levels where the structural integrity of the spine is not severely compromised.
Metastatic bone disease has been reported to occur in 60-80% of cancer patients, most frequently among those with primary malignancies of the breast, prostate, liver, and lung.1 The spine is the most common site of bone metastasis and can be impaired by metastatic bone tumors.2 Cement-augmented screws are designed to restore spinal stability in patients whose life expectancy is insufficient to allow for fusion to occur.
To read the full feature, see it at ODTmag – First-Ever FDA Clearance for Cement-Augmented Pedicle Screws
 

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Wow! an instant MRI in the office. Trice Medical is disrupting the joint diagnostics space.

New Device Gives Real-Time Answers for Joint Injuries (press release)
Sicklerville resident Amanda Butler had always been active. A runner and softball player growing up, she likes hiking through the mountains with her husband and two-year-old. But a nagging knee injury was making those hikes more and more difficult.
Despite surgery to treat a torn anterior cruciate ligament (ACL) and meniscus, Butler’s knee pain only worsened. “My knee would lock up. Any movement, or even sitting too long, would cause it to happen. It started happening more often too. I just wanted an answer to what was causing the pain, and to find out how to get better.”
The desire for a fast answer convinced Butler to try a new device used by Sean McMillan, DO, FAOAO, Chief of Orthopedics at Lourdes Medical Center of Burlington County, called Mi-eyeTM. Mi-eye uses a needle with an integrated camera and light source to perform a diagnostic arthroscopy in the doctor’s office—enabling patients to learn the cause of their orthopedic pain immediately rather than having to wait for the results of an MRI.
Lourdes is first in New Jersey to offer the device.

Results Right Away
“Mi-eye can eliminate the need to make an appointment for an MRI at another site, have the test done and then wait for the MRI results to be read and sent back to the orthopedic surgeon,” said Dr. McMillan. “By using Mi-eye in the office, we get real-time results. Because of this, we can diagnose injuries immediately and set up a treatment plan, and/or a surgery date, sooner. This gets patients back to their regular, everyday lives faster.”
Mi-eye is also helpful in cases when an MRI cannot be performed, such as when a person has a metal implant in the body or a pacemaker, said Dr. McMillan.
Here’s how Mi-eye works: A data cable attaches a portable LCD tablet to a disposable, single-use needle. The needle connects to a 2.1-millimeter arthroscope with an integrated camera and light source. The camera allows physicians to capture still images of the affected area.
Before the procedure, the injured area is numbed with a local anesthetic. The needle is inserted and the physician evaluates the condition of the injured area. The test takes about 10 minutes. After the needle is withdrawn, a bandage is put on the injection site. No recovery is needed from the diagnostic test.
“There was a tear all the way around my knee,” explained Butler, 36. “It was so bad that Dr. McMillan commented that he didn’t know how I was walking.”
Butler successfully underwent surgery on February 16. She no longer needs a cane or an ACE bandage for support. She goes to physical therapy to build up the strength in her knee, which is standard after meniscus surgery.
“The nice thing about having the Mi-eye exam was that I knew I needed surgery and that my surgery was scheduled right away,” said Butler. “Everything, including the follow-up appointment, was done within a month. I’m glad not to be in pain anymore and to have my quality of life back-and that couldn’t come soon enough. Dr. McMillian’s hands-on care provided me with the best options for my knee.”
Dr. McMillan said he’s excited to offer this new technology to patients and feels he’ll have a lot of use for it in his practice.
“Mi-eye allows physicians to provide patients with the answers to what is causing their pain on the first patient visit,” he said. “Not only does it save time, but it also gives patients peace of mind knowing what their injury is right away. And the sooner we can start treatment, the sooner the patient can heal and have a better all-around experience.”
 
Source: Lourdes Health System

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