Spinal implants are tested according to several ASTM standards. ASTM F1717 is intended to provide a basis for the mechanical comparison among past, present and future spinal implant assemblies. Three static and one fatigue mechanical test of a spinal construct are governed by ASTM F1717. The three static tests are compression bending, tension bending and torsion. The fatigue test is a compression bending test. The mechanical tests are conducted in vitro using simplified loading schemes and do not attempt to mimic the complex loads of the spine.
Contract Manufacturing
Breeden’s Robert Fields quietly steps down from Steris board
By Mary Vanac
Robert Fields, a partner and managing director at Breeden Capital Management and Breeden Partners, quietly resigned from the Steris Corp. (NYSE:STE) board for personal reasons March 5.
Normally, the resignation of a director causes few questions. However, Fields and Richard Breeden, the former Securities and Exchange Commission chief who has since become an investment manager and shareholder activist, are a special case.
FDA warns endoscope makers on Steris System 1
The Food & Drug Administration is once again making noises about Steris Corp.’s (NYSE:STE) System 1 processor, warning endoscope manufacturers that they must change any labeling indicating that their devices can be reprocessed using the popular sterilizing device.
The Steris System 1 processor is typically used in surgical and endoscope suites for sterilizing and disinfecting medical devices.
In a letter dated Feb. 22, the FDA warned all endoscope makers that they must change the labeling on any devices that state they can be reprocessed using the Steris system and even suggested they add language indicating that “The STERIS System 1 (SS1) is not a legally marketed device.”
Third-quarter sales slip, losses narrow for AdvanSource Biomaterials
AdvanSource Biomaterials Corp. (AMEX:ASB) managed to pare its net losses during the third quarter, despite a decline in royalties from its medical device customers.
The Wilmington, Mass.-based polymer maker reported sales of $668,000 for the three months ended Dec. 31, 2009, down 2.9 percent compared with $688,000 during the third quarter of fiscal 2009. Net losses narrowed 45.8 percent to $542,000, compared with net losses of $1 million during Q3 2009.
Brooks Automation’s Q1 sales rise, net losses narrow
Brooks Automation Inc. (NSDQ:BRKS) boosted its top line and slashed losses during the first quarter.
Revenues for the Chelmsford, Mass.-based semiconductor imaging components maker neared $106.2 million for the three months ended Dec. 31, 2009, compared to revenues of $73.4 million during the same period last year. Compared with the fourth quarter last year, sales rose 65.7 percent from $64.1 million.
Brooks pared its Q1 net losses to $2.8 million, or 4 cents per diluted share, from $35.1 million, or 56 cents per diluted share, during Q1 2009. Net losses were also down sequentially from $14.5 million during Q4 2009.
Steris Corp.’s Q3 sales and earnings rise despite FDA uncertainty
By Mary Vanac
MENTOR, Ohio — Steris Corp. (NYSE:STE) reported higher operating profits and a modest increase in revenue for its fiscal third quarter over the year-ago quarter.
Bottom line dips for ICU Medical despite Q4 sales boost
ICU Medical Inc. (NSDQ:ICUI) posted fourth-quarter sales of $69.8 million for the three months ended Dec. 31, 2009, up 23 percent compared with $56.7 million during the same period last year. Net income fell 18 percent to $7.4 million, compared with $9 million during Q4 2008:
Bridgehead Solutions eyes Ohio
DUBLIN, Ohio — Startup Bridgehead Solutions LLC, which aims to help foreign device firms enter the U.S. market, could be headed to Ohio, but it’s going to take $2 million to $3 million to ensure the company finds its way to the Buckeye state.
Q2 less than perfect for Parexel
Restructuring costs cut deeply into second-quarter profits at Parexel International Corp. (NSDQ:PRXL) during the three months ended Dec. 31, with severance and related expenses costing the clinical research organization $14.3 million during the quarter.
The Waltham, Mass.-based clinical research organization recorded net income of $3.5 million, or 6 cents per share, on $284.7 million in revenues during its fiscal second period. That compares with a $5.2 million profit, or 9 cents per share, and $275.8 million in revenues during the year-ago quarter. In addition to severance payments, the bottom line was affected negatively by a client default, lease penalties associated with facility closings and a $6.1 investment impairment charge.
Riverside partners Tegra with Mississippi contract manufacturer
Riverside Partners is wasting little time putting its latest private equity fund to work, announcing the acquisition of a majority stake in a contract manufacturing company in Mississippi and partnering the new acquisition with Franklin, Mass.-based Tegra Medical.
The new pact is intended to extend both companies’ reach with OEMs in the orthopedic market. In particular, South Hernando, Miss.-based CTW Inc. has a strong position producing components for spine and trauma devices as well as knee, hip and dental applications. The company was founded in 1976, but has focused solely on precision medical device manufacturing since 2000.
Parexel International boosts Q2 earnings forecast
Contract research lab Parexel International Corp. (NASQ:PRXL) boosted its forecast for the three months ended Dec. 31, 2009, and for calendar 2010, reversing downbeat predictions made in October.
The Boston-based contract research organization is now saying it expects to report net earnings of between $3.5 million and $4.6 million on revenues of up to $285 million during the second quarter. It also issued its initial forecast for calendar 2010, predicting profits of between $35 million and about $40.5 million on between $1.115 billion and $1.145 billion in revenues for the 12-month period.