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Orthopedic and Dental Industry News

June 2006

Medicrea Completes Public Offering BY HUYEN NGUYEN, JUNE 30, 2006

This week, Medicrea announced it had completed its public offering by listing its shares on the Euronext Exchange. The Company issued 1,459,396 new shares at €7.94 per share or a total of €11.58 million. Proceeds from the offering will help... more

Smith & Nephew Receives DOJ Subpoena BY ARIELLA P. GOLOMB, MD, JUNE 30, 2006

Smith & Nephew announced today that it had received a subpoena from the U.S. Department of Justice, Antitrust Division, for documents relating to possible antitrust issues over the manufacture and sale of orthopedic implant devices, joining its peers Zimmer, Biomet,... more

Orthopedic News Roundup 29-Jun-06 BY HUYEN NGUYEN, JUNE 29, 2006

Appointment: Spine Wave announced that it has elected Ron Pickard to its Board of Directors. In addition to his role on the Board, Mr. Pickard will be actively involved in key projects including the development and commercialization of Spine Wave's... more

Biomet Reports In-line 4Q:06 BY JOHN CHOPACK, JUNE 29, 2006

BMET reported its 4Q:06 (May fiscal year) financials this week. Earnings totaled $0.46 per share excluding non-recurring items which was in-line with analyst estimates. Revenues increased 7%, as reported, and 10% on a constant currency basis to $540 million which... more

Smith & Nephew and Q-MED Form Hyaluronic Acid Treatment Alliance BY ARIELLA P. GOLOMB, MD, JUNE 28, 2006

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

NuVasive Gets IDE Approval for NeoDisc BY JOHN MCCORMICK, JUNE 28, 2006

This morning NuVasive announced that it has received conditional approval of an Investigational Device Exemption (IDE) from the FDA to begin clinical trial enrollment of its NeoDisc cervical disc replacement device. The NeoDisc outcomes will be compared to the traditional... more

Decline in FDA Enforcement Activity BY ARIELLA P. GOLOMB, MD, JUNE 27, 2006

Yesterday, Representative Henry Waxman (D-CA) released a report entitled, "Prescription for Harm: The Decline in FDA Enforcement Activity," which was prepared by the House Committee on Government Reform, Special Investigations Division. After 15 months of investigation and a review of... more

Stryker and DePuy added to DOJ Investigation BY JOHN MCCORMICK, JUNE 27, 2006

By mid-afternoon yesterday Stryker and DePuy made it clear that, like Biomet and Zimmer, they too were under investigation by the U.S. Department of Justice (DOJ) for potential antitrust violations. DePuy indicated in their press release that the DOJ has... more

Update on the Statistical Method for Clinical Trials BY NICK ADAM, JUNE 26, 2006

The CDRH recently published a "Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials - Draft Guidance for Industry and FDA Staff". The draft guidance describes the FDA's suggestions for the use of Bayesian statistics in the... more

Biomet Also Receives Subpoena BY JOHN MCCORMICK, JUNE 26, 2006

This morning, Biomet announced that it has a subpoena from the Department of Justice, Antitrust Division, requesting documents regarding possible violations of federal criminal law, including possible violations of the antitrust laws, relating to the manufacture and sale of orthopedic... more

Zimmer Gets Dept. of Justice Subpoena BY JOHN MCCORMICK, JUNE 26, 2006

Zimmer Holdings Inc. said Friday the Justice Department's antitrust division subpoenaed company documents pertaining to an investigation of possible violations of federal criminal law, including possible violations of antitrust laws, involving the manufacture and sale the Company's standad lines of... more

Orthopedic News Roundup 22-Jun-06 BY HUYEN NGUYEN, JUNE 22, 2006

Appointment: Smith & Nephew appointed Michael G. Frazzette as President of the Endoscopy division and a member of the Company's Group Executive Committee. Mr. Fazzette recently served as President & CEO of MicroGroup, Inc., a private, equity-owned contract manufacturer of... more

Who is Les Weinstein? BY LAUREN UZDIENSKI, JUNE 21, 2006

You may not know his name, but Les Weinstein plays a crucial role at the Center for Devices and Radiological Health (CDRH). Appointed in 2000 as the agency's first Ombudsman, he is an external voice of neutrality in disputes between... more

IND Approval Granted For Zimmer/ISTO Technologies' Neocartilage Graft BY ARIELLA P. GOLOMB, MD, JUNE 21, 2006

Each year, hundreds of millions of people injure the cartilage in their knees, shoulders and other joints. Today Zimmer Holdings and ISTO Technologies announced that the U.S. Food and Drug Administration (FDA) has approved ISTO's Investigational New Drug (IND) application... more

Poor Quality of US Health Care Despite High Spending BY HUYEN NGUYEN, JUNE 20, 2006

A patient survey funded by The Commonwealth Fund demonstrated that from a patient's perspective, the US had poor overall quality of health care, despite the highest levels of per-capita spending. We learned about this study when it was recently highlighted... more

When Will the US Catch Up with International Coding Standards? BY ARIELLA P. GOLOMB, MD, JUNE 19, 2006

The International Classification of Diseases (ICD), which is overseen by the World Health Organization, is the international standard diagnostic classification for all general epidemiological and many health management purposes. ICD-10 was adopted in the US in 1999 for reporting mortality,... more

FDA Gives Orthovita The Go Ahead To Manufacture VITAGEL BY ARIELLA P. GOLOMB, MD, JUNE 16, 2006

Orthovita announced that it has obtained pre-market approval (PMA) from the FDA to market its VITAGEL(TM) surgical hemostat manufactured on-site at its Malvern, Pennsylvania facility. Orthovita has been distributing VITAGEL since the first quarter of 2005 through a distribution agreement... more

A Voice for Innovation: MDMA BY LAING RIKKERS, JUNE 16, 2006

On June 14th and 15th, we attended the Medical Device Manufacturers Association (MDMA) Annual Meeting. The organization provides medical device entrepreneurs an opportunity to have their voices heard on the hill. Innovation in our industry generally comes from the smaller... more

Orthopedic News Roundup 15-Jun-2006 BY HUYEN NGUYEN, JUNE 15, 2006

Appointment: Orthofix International N.V. named Michael M. Finegan as Vice President of Corporate Development. Mr. Finegan was formerly with Boston Scientific, where he was Vice President of Corporate Sales. Business Update: Clearant has hired four territory representatives who will be... more

Ascension Orthopedics Receives FDA Approval for Pyrocarbon Toe Implant BY JOHN CHOPACK, JUNE 15, 2006

Ascension Orthopedics announced that it received FDA approval for a pyrocarbon foot implant called PyroSphere. It is designed to treat patients suffering from arthritis of the fourth and fifth tarsometatarsal joints of the foot. This approval represents Ascension's initial entry... more

Who's Who of the Medical Device Lobby BY ARIELLA P. GOLOMB, MD, JUNE 14, 2006

The Hill, "The Newspaper for and about the U.S. Congress", posted on its website last week a list of 14 top medical device industry lobbyists. Leading this list is Stephen Ubl, who is seen as "a triple-A superweight." Newly appointed... more

Orthofix Appoints New Head of Corporate Development BY JOHN MCCORMICK, JUNE 13, 2006

This morning Orthofix announced the appointment of Michael M. Finegan as Vice President of Corporate Development and head of the Company's new Corporate Development Group. His duties will include identifying external opportunities for the company to increase its revenues and... more

Breakthrough For Rare Orthopedic Genetic Disorder; Broad Implications For Orthopedics BY ARIELLA P. GOLOMB, MD, JUNE 9, 2006

A Single Codon Mutation Causes A Debilitating Disease Fibrodysplasia Ossificans Progressiva (FOP) is a rare autosomal dominant genetic disorder that causes muscles and other connective tissue to turn into bone and is estimated to affect one in two million patients... more

Class III Continues for Bone Growth Stimulation BY LAING RIKKERS, JUNE 9, 2006

On Friday, June 2, the FDA's Orthopedic and Rehabilitation Devices Panel met to discuss the RS Medical petition to reclassify noninvasive bone growth stimulators from Class III to Class II. In a 4-2 vote, the panel recommended leaving the bone... more

Orthopedic News Roundup 8-Jun-06 BY HUYEN NGUYEN, JUNE 8, 2006

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

Sales Representatives' Accountability for Patient Safety BY ARIELLA P. GOLOMB, MD, JUNE 8, 2006

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

A Preliminary Abstract from SPORT Published BY DAVID KRESSEL, JUNE 7, 2006

Among the many interesting talks and posters at the International Society for the Study of the Lumbar Spine annual meeting, data from the Spine Patient Outcomes Research Trial (SPORT) will be presented. The overall study compares non-operative treatment to surgical... more

Wall Street Journal Writes About Consolidation in Orthopedics BY DAVID KRESSEL, JUNE 7, 2006

In this morning's Wall Street Journal, an article by Jon Kamp (subscription required) covers the topic of consolidation in the orthopedic industry. In October we suggested M&A activity would increase, and in April Biomet started the speculation that large-scale consolidation... more

Ariella P. Golomb, MD joins HealthpointCapital BY EDITOR, JUNE 2, 2006

Dr. Golomb's primary responsibility is the development of HealthpointCapital's research products, conferences and industry relationships. Prior to joining HealthpointCapital, Dr. Golomb was a Project Leader for the Health Care Practice of the Boston Consulting Group. more

Orthopedic News Roundup 1-Jun-06 BY HUYEN NGUYEN, JUNE 1, 2006

Appointment: A medical imaging company ONI Medical appointed Victor Ruiz to Vice President, of the Corporate Strategy and Marketing division. Mr. Ruiz's past experience include world-famous imaging companies: GE Medical Systems and Cardinal Health Inc. Clinical Update: LDR Spine announced... more

Has the Total Hip Market Slowed? What are the Drivers Looking Ahead? BY JOHN CHOPACK, JUNE 1, 2006

There has been a significant amount of discussion by Wall Street analysts regarding a slowdown in the total hip arthroplasty market. While we agree that there has been a slowdown, we believe it is more moderate than the rest of... more

Complete Archive