Posted on | March 8, 2014 | No Comments
United Orthopedic Corporation Enters U.S. Market (press release)
Website http://www.uocusa.com/
Today, United Orthopedic Corporation (UOC) – a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments – announced its entrance into the American market, offering clinically proven, safe and cost-effective hip and knee devices through its U.S. subsidiary, UOC USA.
“United Orthopedic Corporation is the first Asian orthopedic company to receive FDA approval for joint reconstruction”
Posted on | March 7, 2014 | No Comments
Doctors testing silk screws and plates for bone fracture repair (DVice)
We’re all familiar with how people who have nasty bone fractures will often get steel plates and screws implanted to hold things together. But now researchers from Tufts University and Beth Israel Deaconess Medical Center in Boston, are experimenting with screws molded from material produced by silkworms to repair fractures in rats, and they have found that there are several advantages over traditional steel screws.
Posted on | March 5, 2014 | No Comments
Medtronic Sued by 1,000 Infuse Patients (MedPageToday)
Medtronic said about 1,000 people have sued the company over its bone morphogenetic protein-2 (BMP-2) product, Infuse, and that many more lawsuits may be coming.
In addition, several states now are looking into sales and marketing practices involving Infuse, which is used in spine surgery.
In a statement, company spokesperson Cindy Resman said the cases are in early procedural stages, and none have resulted in a finding of liability against Medtronic.
Some court rulings have led to dismissals and others have limited claims.
“Medtronic stands behind Infuse bone graft and will vigorously defend it in court,” she said.
Posted on | March 3, 2014 | No Comments
INFUSE LAWSUIT MAY GO TO A JURY (Orthopedics This Week)
far, U.S. Supreme Court “Preemption” decisions have kept Medtronic, Inc. from having to go to a jury to defend itself in several Infuse lawsuits.
But that may be about to change as a state judge in Minnesota has ruled that the company can be sued in state court on charges that it manipulated research and misled surgeons about the dangers of off-label uses of Infuse.
The judge had previously refused to let a case of a patient who claims he was injured by the product proceed because of the Supreme Court rulings that usually exclude people injured by federally approved medical devices from suing the manufacturer. But after additional analysis of more detailed allegations filed after the initial decision, Judge Laurie Miller is allowing the case to proceed for three allegations.
Posted on | February 28, 2014 | No Comments
Olympus Corporation Announces Plans To Discontinue Operations For Its Biotechnology Division In The U.S. (press release)
Read all stories regarding the OP-1 saga
Olympus Corporation announced today that it plans to discontinue operations for its U.S. biotechnology division, Olympus Biotech.
The company expects the entire closure process to take some time to complete and it will start with the Hopkinton, MA facility. Commercial operations and product availability will end May 30, 2014 in the United States and Canada.
Posted on | February 28, 2014 | No Comments
SINGLE USE, CORDLESS POWER TOOLS DEBUT IN SURGERY (Orthopedics This Week)
Thomas Ferro, orthopedic surgeon and Medical Director of the Bone & Joint Center at Arroyo Grande, California, has performed the first knee replacement procedure using FDA cleared single-use, cordless, handheld power tools in an orthopedic operation in the United States. According to a Business Wire report, specialty surgical power tools that are used to cut and shape bone are required in over 1.5 million orthopedic procedures annually in the United States.
Posted on | February 27, 2014 | 1 Comment
Artelon® Product Line Under New Ownership, Relocates Operations from Sweden to U.S. (press release)
International Life Sciences, LLC (dba, Artelon®) acquired the assets of Artimplant® AB in January 2014 and has relocated operations from Sweden to the United States. This international relocation allows Artelon® to more closely engage its largest customer base and provide additional opportunities for product development that were not previously available.
Adam Barese now serves as the Chief Executive Officer of the Organization. After garnering almost two decades of medical industry experience with Wyeth Pharmaceuticals, in sales, marketing, and sales management, and as a orthopedic/biologic sales director with Genzyme in the Biosurgical division, Barese most recently built a multistate medical distributorship which included the Artelon® products as part of his portfolio.
Posted on | February 26, 2014 | No Comments
BIOMET SEEKING $1 BILLION IN IPO? (Orthopedics This Week)
According to the Wall Street Journal, Biomet, Inc. is in talks with bankers about an initial public offering (IPO).
The Journal reported on February 12, 2014 that the company is in discussion with banks about returning to public ownership after being taken private for $11.3 billion in 2007 by four Wall Street buyout firms. The buyout came after company founder, Dane Miller, Ph.D. was removed as the company CEO. He returned with the bankers to retake the public company by buying out the public shareholders. According to securities filings, $5.9 billion of debt still remains on the company’s balance sheet.
Posted on | February 24, 2014 | No Comments
STRYKER BUYS TWO COMPANIES IN FEBRUARY (Orthopedics This Week)
Download our 4-page analysis of Stryker HERE
Over the course of two days in February, Stryker Corporation announced agreements to acquire Berchtold Holding, AG, and Pivot Medical, Inc. for the company’s MedSurg and Neurotechnology division.
Berchtold, a privately held business in Germany and the U.S., sells surgical infrastructure equipment. The purchase price is $172 million. Pivot, is a Sunnyvale, California, privately held company that sells products for hip arthroscopy. No purchase price was provided for the Pivot acquisition in the press announcement.
Posted on | February 24, 2014 | No Comments
Will Stryker’s Acquisition Spree Strike It Rich? (Daily Finance)
Download our 4-page analysis of Stryker HERE
Orthopedics giant Stryker‘s impressed Wall Street in the early part of 2014, but this company is looking ahead to more than just the good feelings from its latest earnings report. Stryker is interested in growth — and it is looking to buy its way to better results by snapping up small and innovative firms that can give it a leg up on its competition.
Stryker made waves last year when it acquired robotic surgery maker MAKO Surgical, and 2014′s only brought more of a buying bonanza from this medical device giant. This past week, Stryker hit the headlines again by picking up German surgical tools firm Berchtold Holdings, a move it expects to boost its fast-growing endoscopy division. It’s a much smaller deal than the MAKO buy, especially for a company of Stryker’s size, with a market cap of more than $30 billion. But the acquisition of Berchtold gives a big boost to one of Stryker’s under-the-radar growth drivers in endoscopy and highlights the company’s M&A focus, something that’s likely to dominate this company’s news in the coming year.
Will Stryker’s acquisitions drive reward investors, though? Motley Fool contributor Dan Carroll tells you what to expect from this company’s latest buy — and how Stryker’s future could help the leading medical device stock surge.
Watch interview on YouTube here.. http://www.youtube.com/watch?v=xvLAN26otZc
Posted on | February 23, 2014 | No Comments
Medical Device Outsourced R&D – A Disruptive Innovation (for OrthoStreams, by David Skinlo, Marker Medical www.markermedical.com)
Clayton Christensen coined the term Disruptive Innovation to describe a process by which a product or service takes root initially in simple applications at the bottom of a market and then relentlessly moves up market, eventually displacing established competitors.
As we look at the medical device industry; it is clear that the pace of new technology has slowed. One major factor is, in part, due to the way new products are brought to market – in years past, surgeons and inventors who had ideas for new medical products simply reached out to large medical device companies to develop their product ideas. This business arrangement was often in the form of licensing deals or outright technology purchases. These deals were a well-spring of many of today’s medical technologies. However, in today’s environment with increased regulatory oversight, scrutiny of surgeon and manufacturer relationships, increased competition and a need to introduce new products to market quickly, a new approach – no, a disruptive innovation – is required. One trend that is quickly gaining popularity to meet the challenges of today’s market is to “outsource” medical device development to third parties – or what is simply referred to as “Outsourced R&D”. There are several companies in the market today that specialize in these services, one example is Marker Medical.
Posted on | February 20, 2014 | 1 Comment
ONE-BILL JOINT SURGERY GROWING (Orthopedics This Week)
Is the practice of charging one inclusive payment for surgical services, sometimes called “bundled payments,” the future of joint replacement surgery? Executives at Blue Cross Blue Shield of North Carolina (BCBSNC) and the surgeons at Triangle Orthopaedic Associates (TOA) believe that it is.
Instead of billing separately for the surgeon, hospital, physical therapist, anesthesiologist and others, the two organizations, since 2012, have cooperated to provide for one-bill replacement surgery for knees. And on November 1, 2013, they began offering the same flat fee bundled terms for hip replacements. The surgeries are performed at North Carolina Specialty Hospital in Durham.
Posted on | February 17, 2014 | No Comments
NEW YORK STEM CELL SUMMIT: 2014 PREVIEW (Orthopedics This Week)
Sales of stem cell products in 2013 skyrocketed, we estimate, 42% from 2012 to reach $236 million. With several new players entering the market, notably DePuy Synthes (the largest orthopedic company in the world), stem cell sales will accelerate, we estimate, by 61% to reach an eventual sales amount of $380 million. The principal driver of these sales will be improved versions of the cancellous bone with endogenous mesenchymal stem cells (MSCs), new allograft liquid forms with endogenous MSCs for orthopedic use and sharply rising visibility of cell-based companies and recent clinical study results.
Posted on | February 17, 2014 | No Comments
MAJOR AND SWEEPING CHANGES PLANNED FOR FDA (Orthopedics This Week)
Like the British navy sailing to the Falkland Islands, the Food and Drug Administration (FDA) has been signaling that big changes are afoot in 2014 in how the agency will be reorganized.
In late 2013, the agency announced it would need to “realign” its programs to keep up with “unparalleled challenges” posed by advances in science, globalization and product complexity.
Posted on | February 15, 2014 | No Comments
4-PAGE OVERVIEW INCLUDES THESE SECTIONS:
Posted on | February 14, 2014 | No Comments
Amedica lowers IPO price range, boosts shares on offer (Mass Device)
Amedica lowers the price range for its impending initial public offering, but boosts the number of shares it plans to offer.
Medical device company Amedica lowered the price range for its impending initial public offering, but said it would put more shares on offer.
Salt Lake City-based Amedica, which makes silicon nitride-based biomaterials for medical devices, said it plans to trade under the AMDA symbol on the NASDAQ exchange. The IPO, initially slated at nearly 3.2 million shares at $10 to $12 apiece, is now expected to run between $8 and $10 per share, with 3.5 million shares on offer.
Posted on | February 14, 2014 | No Comments
COURT CHILLS RELIANCE POD ALERT CHALLENGE (Orthopedics This Week)
Chill out, dude, and don’t bleed until you’re shot!
That’s in essence what a federal court in California told Reliance Medical Systems, LLC, on February 5, 2014, as it dismissed the company’s constitutional challenge to the U.S. Department of Health and Human Services’ Office of Inspector General’s (OIG) March 26, 2013 Special Fraud Alert (Alert) on physician-owned distributors (PODs).
Reliance, which used to be involved in PODs, argued that the Alert “chilled” their right to speak to physicians about ownership in PODs. Reliance filed suit against the OIG on October 8, 2013, alleging that the Alert violated the First Amendment right of speech, due process rights under the Fifth and Fourteenth Amendments, and the Administrative Procedures Act.
Posted on | February 14, 2014 | No Comments
Court Dismisses POD Lawsuit Against OIG (press release)
On February 5, 2014, a federal court dismissed a challenge to the U.S. Department of Health and Human Services’ Office of Inspector General’s (“OIG”) March 26, 2013 Special Fraud Alert (“2013 SFA”) on physician-owned distributors (“PODs”). The lawsuit was filed in the U.S. District Court in the Central District of California by Reliance Medical Systems, LLC (“Reliance”), which had historically included physician owners, and was considering a return to the POD business model. Reliance filed suit against the OIG on October 8, 2013, alleging that the 2013 SFA violated (i) the First Amendment right of speech, (ii) due process rights under the Fifth and Fourteenth Amendments, and (iii) the Administrative Procedures Act.
Posted on | February 11, 2014 | No Comments
Hip implant payout tops $50 million (Journal Gazette)
800 part of Biomet settlement
Biomet Inc. has agreed to pay a base rate of $200,000 each to patients who received a specific hip model and had to have it replaced, according to court documents.
Company officials estimated in a Securities and Exchange Commission document that the total payout could exceed $50 million.
The settlement was reached 16 months after about 1,000 lawsuits were combined in multidistrict litigation against the Warsaw-based orthopedic device-maker.
Posted on | February 9, 2014 | No Comments
Researchers blend orthopedics, engineering to better repair torn rotator cuffs (ECNMag)
Rotator cuff tears are among the most common orthopedic injuries among adults in the United States, due to wear and tear or the effects of age. With a 94 percent failure rate for surgical repairs of large tears in older patients, it’s no surprise that the injury is a major cause of pain and disability.
With a five-year, $3.1 million grant from the National Institutes of Health, orthopedic researchers and engineers at Washington University in St. Louis are working to discover a better way to improve the outcome of surgical repairs by studying the natural attachment of tendon to bone. This understanding could lead to the engineering of new tissues that could enhance cuff repair.
Orthopedics This Week MedPageToday
March 9, 2014
