BioMimetic plans to launch Augment in the U.S. with a mix of 100 independent and direct sales reps, whom they say will cover about 75% of all U.S. foot and ankle procedures. The company intends to increase their sales force to 150 to 200 reps within two to three years of Augment's launch. Internationally, the company will set up independent distributors or partners in Europe and Australia and has a partnership in place in Canada. more
NADX's go-shop period ends . . . Smile Brands cancels its IPO . . . Sirona launches new products . . . Straumann receives award for Roxolid . . . Regenerating teeth from stem cells more
The FDA has announced plans to hold a two-day public hearing this November to gain feedback on the use of the internet and social media tools to promote drugs and devices. These platforms include YouTube, Wikipedia, Facebook, Twitter and any... more
According to a report by FDA News, Charles Grassley (R-Iowa) plans to reintroduce the Physician Payment Sunshine Act in the 111th Congress. The bill, first introduced in 2007, will require device makers to publicly disclose any payments or gifts given... more
Earnings Wright Medical reiterated 4Q:08 revenue and earnings guidance on a call this week and lowered 2009 guidance based on less favorable foreign exchange rates. The company is now calling for 2009 revenues in the range of $510 million to... more
Earnings Stryker announced a 2008 dividend of $0.40 per share, an increase of 21% over the 2007 dividend, which is payable January 30, 2009. President and CEO Stephen MacMillan said the increased dividend reflects the company's continued growth and strong... more
Last week's In3 Medical Device Industry Summit featured a talk on opportunities for device manufacturers in China, and we came away with a sense for the country's efforts to step up regulatory and legal practices to better reflect U.S. and... more
Seven months after the company announced the signing of its Deferred Prosecution Agreement, Zimmer has introduced a revised corporate compliance model designed to "aggressively reduce" conflicts of interest. The updated model includes a number of new safeguards against potential ethical... more
Earnings Artimplant reported 4Q:07 revenues of SEK 5.0 million ($0.8 million), up from SEK 1.6 million ($0.25 million) in the year-ago period. The net loss for 4Q:07 was SEK 2.1 million ($0.34 million), improved from a loss of SEK 9.5... more
Earnings Hanger Orthopedic Group reported 4Q:07 net sales of $170.8 million, beating estimates by $7.5 million and representing an 11% over the year-ago period. Revenue growth was attributed to an increase in same-center sales from Hanger's patient care business, an... more
Consumers Union, the publisher of Consumer Reports, recently petitioned the FDA for warnings about possible infection and device failure to accompany the rosy claims of DTC medical device marketing. However, some suggest the warnings could hinder a patient's care, and... more
M&A With certain conditions, the FTC will allow Kyphon to proceed with its planned acquisition of Disc-O-Tech Medical Technologies and Discotech Orthopedic Technologies Inc. Kyphon was directed to sell Disc-O-Tech's Confidence product lines to address antitrust concerns. When Kyphon announced... more
Last week's Medical Device Manufacturers Association Annual Meeting in Washington, D.C. gave us an opportunity to applaud the passion and dedication that defined MDMA's past accomplishments and will carry future negotiations on regulatory, reimbusement and marketplace issues for smaller device... more
More than 40% of investigators presenting data at the 2001 and 2002 Annual Meetings of AAOS reported conflicts of interest, and a new study in this month's JBJS shows that those conflicts were associated with positive study findings. Though investigators... more
Earnings Update: CryoLife provided an update on its 3Q:06 projected revenues, which are estimated at ~$20 million, a 22% increase over the comparable quarter of 2005. In 3Q:06, its tissue processing revenues were ~$10.3 million, an increase of 41%, and... more
HealthpointCapital's Interview with Jack Fleischer While conducting informational interviews for our latest research report on GPOs, we were fortunate enough to have the opportunity to speak with Jack Fleischer, VP of Strategic Sourcing at New York-Presbyterian Hospital, The University Hospital... more
Today's New York Times reported that Stanford University has followed the University of Pennsylvania and Yale by putting in place a new policy that would prohibit its physicians from accepting small gifts (like pens and mugs) and free drug samples... more
February 2010 update: This report is no longer available for purchase. Learn more here. Fact: GPO-negotiated contacts drive more than $100 billion in device purchases by hospitals. News Item: The DOJ, the Connecticut Attorney General, three U.S. Senators, and the... more
Appointment: SpineVision® SA has hired Julian Mackenzie as its new Chairman and CEO. Previously, Mr. Mackenzie was with Wright Medical serving as Director General and CFO. Business Update: Donor Referral Services of North Carolina is at the center of a... more
Appointment: Biomet, Inc. appointed Charles E. Niemier as President of EBI's operations following the resignation of its former president, Bart J. Doedens, M.D. Mr. Niemier has been a member of the senior management team and Board of Directors for more... more
Late last month, AdvaMed created a logo licensing program for the AdvaMed Code of Ethics. For $300 per year, companies can license this logo which shows they have signed and comply with the Code. In particular, the logo can be... more
Viscosupplementation to treat osteoarthritis has traditionally been performed with a course of three or five injections. Today Smith & Nephew Inc. and Q-MED AB announced an alliance which paves the way for the US marketing of DUROLANE, the first and... more
Business Update: NuVasive announced that 90% of its sales force is now exclusively distributing its spine surgery products. This exclusive 175 person sales force includes both direct and independent sales representatives. Development & Distribution Agreement: Ars Arthro Biotechnologie GmbH, a... more
In contrast to the prevailing trend of limiting the access of pharmaceutical representatives to physician offices, medical device representatives are often a welcome addition in the operating room. Many surgeons have come to rely on the service they provide during... more
Yesterday morning, dj Orthopedics Inc. announced that it changed its name to DJO Inc. following its recent acquisition of Aircast Inc. The company acquired Aircast, famous to soccer moms for its ankle braces and casts, for $290 million at the... more
One of the most informative sessions at AAOS was a section of the Health Policy Update Symposium delivered by William L. Healy, M.D. of the Lahey Clinic. Healy gave real-life examples of the complicated and delicate balance of hospital economics,... more
Our current forecast for the orthopedic industry projects continued long term growth of 15%. For 2006, we expect growth to be slightly below this trend, at 12%. Despite continued strength in other segments of the industry, hip and knee reconstruction... more
Doctors pushed back against marketing and commercial pressures from the pharmaceutical and medical device industries last week. On January 25, the American Medical Association (JAMA) published "Health Industry Practices That Create Conflicts of Interest: A Policy Proposal for Academic Medical... more
The Company reported 4Q:05 revenues of $75 million which was a 10% increase over 4Q:04 revenues. dj Orthopedics also reported a 12% increase in 2005 revenues which totaled $286 million. Analysts were anticipating revenues of $71 million for the 4Q:05... more
Although we are focused on the orthopedics industry, we recently came across the announcement of an alliance in the cardiovascular industry that interested us. Although the technology and deal size were noteworthy, we also noticed the company cited a webcasted... more
Medtronic, Guidant and St. Jude Medical said they each received subpoenas from the U.S. Attorney in Massachusetts related to their heart devices. Medtronic also stated that the subpoenas sought documents related to people in a position to recommend purchase of... more
Regeneration Technologies, Inc. (RTI) (Nasdaq: RTIX), the highly reputable allograft industry leader, said this morning that it issued a voluntary recall of allograft implants that have been processed from donor tissue received from Biomedical Tissue Services. RTIX attributed this to... more
Scott Wiese named Vice President of Business Development & Marketing CARLSBAD, California, September 28, 2005 /PRNewswire/-- Alphatec Spine, Inc., ("Alphatec") today appointed Scott Wiese as Vice President of Business Development and Marketing. The hiring underscored the firm's recently completed transition... more
This week, we decided to post the Orthopedic News Roundup for Thursday, instead of Friday due to the upcoming holiday. Clearly the biggest headline this week is the announcement of a take-over bid by Musculoskeletal Transplant Foundation ("MTF") for Osteotech... more
The allograft industry is a curious phenomenon. Companies in this segment of the orthopedic industry are stand alone processors of human cadaveric musculoskeletal tissue for surgical implantation. Companies are stand alone because it seems that the metal benders in Warsaw,... more
For the five public allograft companies, sales for the first nine months of 2004 are running at around $234 million ($323 million annualized). Sales growth is slightly up - about 6%. Which is good news. Last year, public company allograft... more
You can always tell what managers are really thinking by the order of their comments on conference calls. For the quarter just ended (September 30/2004) Kyphon reported a 59% jump in net sales $55.8 million. Earnings soared to $6.1 million,... more
Last week, ArthroCare Corp (Nasdaq: ARTC) announced that for the third quarter ending September 30, revenues rose 30% on year-over-year (YOY) basis. Total revenues, which include product revenues, license fees and royalties, for 3Q:04 were $38.2 million versus the $29.4... more
While it is widely accepted that the baby boomer population will have a significant impact on the overall orthopedic industry, we believe that the Corin Group, located in the UK, has developed a unique product offering to address this younger,... more
Integra Life Sciences (IART), which reported a 58% jump in revenues to $185 million for the year ended December 31st, 2003, was downgraded by W.R. Hambrecht this past week. We have known IART CEO Stu Essig for quite a while... more
Charlie Federico liked his Physio-Stim distributor so much, that he decided to buy the company – for $150 million or 2.6x sales. This will be, by far, the largest transaction in Orthofix's history – and, we think, qualifies and that... more
KYPH, as it has each quarter since coming public, significantly outperformed both sales and earnings expectations last quarter. The numbers tell the story: $35.1 million in sales vs. $33.6 estimate and $20.7 million for the same period the year before.... more
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