Zimmer Biomet acquires an imaging company to diagnose hip impingement

Zimmer Biomet picks up imaging company Clinical Graphics (MassDevice)
Zimmer Biomet (NYSE:ZBH) said today that it picked up novel imaging company Clinical Graphics for an undisclosed amount.
Warsaw, Ind.-based Clinical Graphics produces 3D range-of-motion simulation technology designed to aid in making treatment decisions for hip conditions which require early interventions, including femoracetabular impingement and dysplasia.
“3D imaging represents the next generation of treating joint pain, and we’re excited to team up with Clinical Graphics and integrate our technologies to further enhance the clinical utility of our market leading hip portfolio,” Zimmer Biomet joint reconstruction president Dan Williamson saidin prepared remarks.
Zimmer Biomet said it plans to integrate the newly acquired imaging platform into its hip preservation portfolio.
“Zimmer Biomet is a well-respected leader in musculoskeletal healthcare, and an ideal parent company to usher our breakthrough technologies into mainstream clinical practice as the standard of care for managing joint disease. We’re thrilled to join the Zimmer Biomet family and look forward to working together to improve the care of patients living with joint pain,” Clinical Graphics managing director Peter Krekel said in prepared remarks.
Last month, Zimmer Biomet said it paid an unspecified amount to acquire CD Diagnostics and its line of immunoassay and biomarker products.
Four years ago, the duo inked a pact that led to the development and marketing of the Synovasure periprosthetic joint infection test, Warsaw, Ind.-based Zimmer Biomet said.

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A better personalized scoliosis brace by UNYQ with 3D with sensors and 3D printing technology

3D Printed Scoliosis Brace with Embedded Wearable Tech Showcased at White House Event (ODTMag)
UNYQ, the San Francisco- and Seville-based pioneer in personalized prosthetics and orthotics, today showcased their new scoliosis brace, UNYQ Align, and their personalized prosthetic cover, UNYQ Performance, at a White House event hosted by the White House Office of Public Engagement and Office of Science and Technology Policy. UNYQ Align combines 3D-printing and digital design, powered by the Intel Curie module, into a stylish, customized, and lightweight medical device that assists scoliosis sufferers.
For this special White House event, UNYQ teamed up with Studio Bitonti, led by famed designer, Francis Bitonti, to imagine a brand new type of UNYQ Align brace. The result is not only fashionable, but, through innovative topology optimization technology, Studio Bitonti and UNYQ were able to reduce the material significantly to create their most breathable and lightweight scoliosis brace yet.
“It was a privilege to collaborate with UNYQ on this solution. These are the kinds of projects designers need to be paying very close attention to,” said Francis Bitonti, CEO of Studio Bitonti. “UNYQ Align demonstrates how innovative technologies, designers, and technologists can combine to revolutionize treatment of medical conditions and dramatically improve the lives of the people who rely on assistive devices.”
 
To read the full feature, see it at ODTmag – 3D Printed Scoliosis Brace with Embedded Wearable Tech Showcased at White House Event
 
 

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Stryker acquires another extremities company

Stryker to acquire Instratek assets (MassDevice)
Stryker (NYSE:SYK) said that it agreed to acquire Instratek for an undisclosed amount at the end of the 4th quarter.
The medtech giant will take on the Houston-based company’s portfolio of staple and hammertoe implants, as well as its minimally invasive soft tissue recession instrumentation.
“This acquisition supports our commitment to growth in extremities with products that complement our existing portfolio, strengthen our leadership in the forefoot segment and provide immediate access into minimally invasive soft tissue recession procedures,” Stryker Orthopaedics president David Floyd said in prepared remarks.
The Kalamazoo, Mich.-based company went on a buying spree this year, spending a total of more than $4.5 billion on acquisitions, not including several deals that went for undisclosed amounts. Stryker acquired 4 companies, including Stanmore Implants and Sage Products. They also bought CareFusion’s vertebral compression fracture portfolio, SafeWire’s spine device line, and Synergetics neurostimulation assets.
The Instratek acquisition comes just days after an appeals court overturned enhanced damages awarded to Stryker in its patent infringement suit against Zimmer Biomet (NYSE:ZBH). The court upheld the willful infringement ruling against Zimmer, but sent it back to a Michigan federal judge to reconsider the enhanced damages and attorney fee awards.
Stryker’s stock was trading at $110.38 apiece during mid-morning activity, down 0.13%.

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Appeals court overturns triple damages in Zimmer Biomet’s $280M patent loss to Stryker

Appeals court overturns triple damages in Zimmer Biomet’s $280m patent loss to Stryker (MassDevice)
A federal appeals court today overturned the enhanced damages and attorney fees awarded in Stryker‘s (NYSE:SYK) $70 million patent infringement win over Zimmer Biomet (NYSE:ZBH), but upheld its prior ruling that patents were valid and infringed.
The case was sent back to the U.S. Court of Appeals for the Federal Circuit in June, when the Supreme Court held that the standard for enhanced damages awards in patent infringement cases should be relaxed. The case dates back to December 2010, when Stryker sued orthopedics rival Zimmer, alleging infringement of 3 patents covering wound debridement technology by Zimmer’s Pulsavac Plus device.
In February 2013 a jury in the U.S. District Court for Western Michigan awarded $70 million to Stryker in damages plus royalties, ruling that Zimmer infringed all 3 patents claimed in the suit. Judge Robert Jonker trebled the damages in August of that year, ruling that the infringement was willful, ordering a permanent injunction and granting Stryker’s bid for lost profit damages for another nearly $2.4 million. The judge also granted Stryker’s motion for prejudgment interest, awarding nearly $11.2 million, plus reasonable attorney’s fees and additional prejudgment interest on those fees at a rate of 3.83%.
The Federal Circuit court in 2014 rolled back that $228 million ruling, finding that Stryker failed to prove willful infringement. Stryker appealed to the Supreme Court, which vacated the appeals court’s ruling and ordered it to reconsider the case. The Supremes found that the Federal Circuit’s test was too rigid and allowed egregious infringers to evade liability.
In addition to upholding the validity and infringement rulings, today the appeals court upheld the willful infringement judgment against Zimmer, but sent the case back to Jonker for reconsideration of the enhanced damages and attorney fee awards.
“On the record in this case, willful misconduct is sufficiently established by the jury’s finding. The jury made its determination under the clear and convincing evidence standard, which is a higher standard than is now necessary. We therefore affirm the jury’s finding of willful infringement,” Chief Judge Sharon Prost wrote, according to court documents. “In doing so, we think the best course is to vacate the award of enhanced damages and remand to the district court for consideration of this issue. Thus, it is for the district court to determine whether, in its discretion, enhancement is appropriate here.
“The district court’s award of attorneys’ fees was based solely on its determination that Zimmer was liable of willful infringement. Though we uphold the district court’s willfulness determination, it does not necessarily follow that the case is exceptional,” Prost wrote. “Because there exist further allegations of litigation misconduct in this case and because the standard for finding an exceptional case has changed since the district court issued its ruling regarding attorneys’ fees, we also remand this issue for further consideration by the district court.”

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Naples startup to develop a resurfacing shoulder replacement

Website – http://catalystortho.com/
Angels invest in local medical device startup (Naples News)
A Naples-based investment fund has bet its money on the success of a local orthopedic medical device startup.
The fund, Tamiami Angel Fund II, or T2 for short, has invested nearly $1 million in Catalyst OrthoScience to help the company ramp up the production of what it describes as a “breakthrough product” for shoulder-replacement surgery.
“The product we feel is revolutionary, not evolutionary. And we liked the progress that the management team had made,” said Tim Cartwright, chairman of Tamiami Angel Funds.
Steven Goldberg, chief of orthopedic surgery at Physicians Regional Healthcare System in Naples, founded Catalyst OrthoScience in December 2014. He started developing his product, called the Catalyst CSR Shoulder System, about four years ago. He has several patents for the device and others pending.
The device, which can fit in the palm of a hand, is made of two materials: a metal alloy, cobalt-chromium-molybdenum, and ultra-high molecular-weight polyethylene. It’s in the shape of a shoulder. Used with a new surgical approach, the implant requires less bone removal than other procedures for arthroplasty, or joint replacement.
T2 invested $930,000 in Catalyst OrthoScience. The fund was the lead investor in a $3.3 million Series A capital raise. Series A refers to the first significant round of capital raised from outside investors, and it’s the largest such raise in Southwest Florida this year, according to the MoneyTree Report from PricewaterhouseCoopers LLP.

Timothy J. Cartwright. (Photo: Submitted Photo)

Other investors in the new company include IrishAngels, a Chicago-based group whose members have ties to the University of Notre Dame.
Catalyst OrthoScience is one of two Naples-based companies T2 has invested in, and it’s one of the fund’s largest investments in a first round.
Investor dollars will go toward building inventory, beefing up sales and marketing, and completing the management team, Cartwright said.
“I think it’s an example of the types of companies that are the future for Naples and Southwest Florida in knowledge-based industries,” he said. “Of course, Arthrex, from this industry’s perspective, is a perfect example of that — and a huge example.”
Florida ranks second in the nation for medical device manufacturing locations registered with the FDA, with more than 660, which have nearly 21,000 employees, according to the Florida Medical Manufacturers Consortium.
The state’s life sciences industry is made up of nearly 6,000 companies, which support 83,000 jobs, according to BioFlorida, an industry trade group.
The U.S. Food and Drug Administration recently approved the use of Catalyst OrthoScience’s device in live patients. Since the approval last month, Goldberg has implanted the device in more than half a dozen patients. Soon other doctors will be trained on the product and how to do the surgery.
Bob Kaufman, a member of T2 and head of health care investing for Tamiami Angel Funds, also invested individually in the new company. He’s now the company’s chairman.
Asked why he liked the business so much, Kaufman said: “It’s a very rapidly growing space. Shoulder surgery is growing very quickly. So there is a lot of opportunity for a new device.”
Shoulder surgery is a $700 million a year market in the U.S., and it’s rapidly growing, he said.
“It’s projected to be a billion dollars in just a few years,” Kaufman said. “So it’s a very good market, and that is in the U.S. alone. There is much more than that if you include the whole world.”
Before Goldberg pitched his company to T2 for funding, he’d already hired Stephen Herrington, a 27-year veteran of the medical device industry, as his CEO. Herrington is a former senior executive with Biomet, which became part of the medical device giant Zimmer Holdings last year.
Catalyst OrthoScience has struck an agreement with a global partner that will manufacture its device, Herrington said. There may come a time when the company will own its own manufacturing plant and make its own product here, he said, but for a startup, the costs of doing that are too tremendous.
The new product will be beneficial to many patients because there is less stretching of muscles and ligaments involved in the surgical approach to implant it, Herrington said.
“The thing that differentiates this is it is very streamlined,” he said. “What we’ve seen so far with our interactions with customers is they can get up to speed very quickly. It’s a very intuitive system, very streamlined and very straightforward.”
Down the road, Herrington sees the possibility for the company to add more products and procedures to its offerings.
“We are actually going to work with a group of surgeons,” he said. “We’ve already got a group of surgeons lined up, so we are actually getting new ideas coming in every day that we are considering. We could very well expand into other markets.”
Catalyst OrthoScience is the 15th company Tamiami Angel Funds has invested in. The first two funds have invested nearly $9.5 million in early stage companies over the past five years including add-on dollars from its individual members. This will be the last company T2 invests in, with most of that fund’s money gone.
There are plans for a third angel fund, with a first meeting about it scheduled for October. The size of that fund has yet to be determined.
 

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