MINNEAPOLIS — Medical device maker Medtronic confirms it is eliminating 2,000 jobs worldwide, including 500 in Minnesota.About half of the jobs being eliminated are in the U.S.
A Medtronic spokeswoman said about 65 percent of the job cuts have already occurred. The rest will be eliminated in the current fiscal year that ends next April.Most of the job losses are in the Fridley-based company's Cardiovascular Group and in its spine business, with nearly half related to Medtronic's efforts to consolidate manufacturing.The total of 2,000 jobs to be cut includes 230 job cuts Medtronic announced earlier this month at the company's Memphis-based spine facility.
Thursday, May 23, 2013
Wednesday, May 22, 2013
Titan Spine Announces New Appointments
MEQUON, Wis. -- Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, announced today that it has named two spine surgeons to its Key Opinion Leader Advisory Team, Dr. Kade T. Huntsman of Salt Lake City, Utah and Dr. Axel Reinhardt of Potsdam, Germany. The new members bring broad experience in degenerative spine conditions and innovative interbody fusion techniques, and in their new roles will help guide the development of the Company’s Endoskeleton® Interbody Device portfolio.Paul Slosar, MD, Medical Director for Titan Spine, said, “We welcome Dr. Huntsman and Dr. Reinhardt to our Key Opinion Leader Advisory Team, where their thought leadership will be invaluable as we look to enhance our surface technology platform. Their clinical expertise and insights into fusion techniques will assist our efforts to build out our Endoskeleton implant portfolio for new applications in spine care, and help further our commitment to optimizing the outcomes of interbody fusion through the application of our surface technology expertise.”Dr. Huntsman is a board certified spine surgeon who specializes in degenerative spine conditions and spine trauma at St. Mark’s Hospital, LDS Hospital, and Salt Lake Orthopaedic Clinic in Salt Lake City, Utah. He has led research into the safety and efficacy of a variety of interbody fusion techniques, with a focus on the lateral approach. He is a member of numerous medical societies, including the American Academy of Orthopaedic Surgeons, the North American Spine Society, and the Scoliosis Research Society.Dr. Reinhardt is Head of the Department of Spinal Surgery at the Specialized Orthopaedic Hospital in Potsdam, Germany, and Medical Director of Oberlin Clinic, also in Potsdam. He is a founding member of the Spine Study Group, a multicenter initiative focused on investigating degenerative spine diseases and operative treatment results. Dr. Reinhardt is also a member of AO Spine and was the first in Europe to perform surgical cases using Titan Spine’s interbody fusion devices.
“Titan Spine’s surface technology has the potential to transform interbody fusion by enabling the device to actively contribute to bone formation at the implant site. I am excited to collaborate with the Company and fellow members of the Key Opinion Leader Team to further the development of this unique technology and its integration into spinal care,” said Dr. Huntsman.
Dr. Reinhardt commented, “The Endoskeleton devices provide an ideal environment for bone growth by promoting the body’s natural osteogenic response. They also offer advantages for efficient implantation and positioning in the disc space, with strong bone purchase, and in my experience, patients have achieved rapid and robust fusion. I look forward to helping guide the development of the technology and increasing awareness of its value among surgeons internationally.”
Titan Spine markets a full line of Endoskeleton interbody devices for use in the lumbar and cervical spine. The cages feature a proprietary acid-etched surface that is textured at the macro, micro and cellular levels to support bone purchase and new bone growth. Cellular research has demonstrated the surface promotes a superior bone-forming response as compared to smooth titanium and PEEK implants.
About Titan Spine
Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface.
“Titan Spine’s surface technology has the potential to transform interbody fusion by enabling the device to actively contribute to bone formation at the implant site. I am excited to collaborate with the Company and fellow members of the Key Opinion Leader Team to further the development of this unique technology and its integration into spinal care,” said Dr. Huntsman.
Dr. Reinhardt commented, “The Endoskeleton devices provide an ideal environment for bone growth by promoting the body’s natural osteogenic response. They also offer advantages for efficient implantation and positioning in the disc space, with strong bone purchase, and in my experience, patients have achieved rapid and robust fusion. I look forward to helping guide the development of the technology and increasing awareness of its value among surgeons internationally.”
Titan Spine markets a full line of Endoskeleton interbody devices for use in the lumbar and cervical spine. The cages feature a proprietary acid-etched surface that is textured at the macro, micro and cellular levels to support bone purchase and new bone growth. Cellular research has demonstrated the surface promotes a superior bone-forming response as compared to smooth titanium and PEEK implants.
About Titan Spine
Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface.
Medtronic Spine reports flat 4th quarter revenue
May 21--Medical device maker Medtronic Spine on Tuesday reported revenue of $811 million for its fourth quarter, a 1 percent drop from the same period last year.Memphis-based Medtronic Spine is the second-largest division of Medtronic Inc., based in Minneapolis, which reported fourth-quarter revenue of $4.5 billion, a 4 percent gain, or 5 percent adjusting for a negative foreign currency impact.For its fiscal year, which ended April 26, the parent company reported revenue of $16.6 billion, a 3 percent increase, or 5 percent adjusted for foreign currency impacts.Medtronic Spine, which employs about 1,300 people in Memphis and 5,600 worldwide, reported that its fourth quarter earnings were "flat" when adjusted for the impact of foreign currency.It's "core spine" revenue was flat globally and up 1 percent in the United States while market share grew by two percentage points year-over-year, the firm reported.Core spine "includes a wide range of therapies, implants, fusion systems and surgical instruments used to treat spinal disorders caused by degenerative conditions, trauma, tumors or deformities," according to a company statement.Medtronic Spine revenue for BMP, a biologic that stimulates bone regrowth, declined 1 percent and revenue from balloon kyphoplasty (BKP) continued to decline, the company reported.Earlier this month, Medtronic Spine officials said the firm will cut about 60 jobs in Memphis as part of a global restructuring of its operations."We delivered market share gains again in Core Spine and revenue continued to stabilize in our fourth quarter," Doug King, president of Medtronic Spine, said in a statement.
Tuesday, May 21, 2013
Cerapedics Appoints President and Chief Operating Officer
WESTMINSTER, Colo. --Cerapedics, Inc. announced today that its Board of Directors has appointed Glen A. Kashuba as the company’s new chief executive officer, effective June 1, 2013.Kashuba formerly served as worldwide president of Spine & Bone Healing Technologies, Inc., a Biomet company, while concurrently serving as senior vice president on Biomet’s worldwide operating board, encompassing Biomet’s orthopedics, spine, trauma, biologics and sports medicine businesses.
“Glen is a well-known and respected leader in the spine and orthopedics industries. He had many opportunities available to him and we are delighted that he has chosen to join Cerapedics to lead the company through several upcoming major value inflection points,” said Jonathan Silverstein, chairman of Cerapedics and general partner at OrbiMed.
“I am honored to join Cerapedics as CEO and work with the talented group of individuals who have built this company and brought its unique products to market,” Kashuba said. “Our goal is for Cerapedics to be a leader in the global bone biologics market by providing a powerful and safe orthobiologics solution to the clinicians and patients we serve. I look forward to leading the Cerapedics team to that goal.”
Kashuba’s tenure at Biomet also included the role of worldwide president for Biomet Spine and Trauma, where he had profit and loss responsibility for all functional areas, including sales force management and supply chain optimization. Kashuba’s commercial responsibilities included managing sales of greater than $400 million, driven by more than 500 direct and independent sales representatives. Kashuba was also responsible for launching more than 25 new products into the market during his tenure at Biomet.Prior to his leadership roles at Biomet, Kashuba held a number of division president roles at Johnson & Johnson where he served as worldwide president for Cordis Endovascular and Neurovascular and as worldwide president for Codman Neuro Sciences. Kashuba also served as U.S. president for DePuy Spine. Kashuba received his B.S. in industrial engineering from Rutgers University.Kashuba succeeds Paul Mraz, who earlier this year announced his intention to retire from the company. “The board would like to thank Paul for his years of service and leadership during which the company launched i-FACTOR™ bone graft in 25+ countries outside the U.S. and enrolled its U.S. IDE pivotal clinical trial,” Silverstein said.Cerapedics also announced today that it named Jeffrey G. Marx, Ph.D., as its president and chief operating officer. Marx formerly served as vice president of corporate development at Orthovita, Inc. Marx had numerous other responsibilities as part of the senior leadership team during his 13-year tenure. Orthovita was a leading orthobiologics and biosurgery company that was acquired by Stryker for $318 million in 2011.Following the acquisition, Marx led the integration of Orthovita into Stryker and served as vice president of corporate development at Stryker Orthobiologics. Marx received his B.S. in ceramic science and engineering from Penn State University and his Ph.D. in ceramic engineering from Missouri University of Science and Technology.
“I look forward to leading Cerapedics through the current FDA submission process and future product pipeline development. Rarely do you have the opportunity to introduce a whole new category within an established market like bone grafting, especially one with such potential to help doctors and patients achieve better outcomes with safety and reliability,” Marx said.
About Cerapedics, Inc.
Cerapedics, a 2012 Colorado Companies to Watch (COCTW) winner, is a medical device company focused on developing and commercializing novel osteobiologic products based upon its proprietary synthetic small peptide (P-15™) technology platform. i-FACTOR bone graft is the only biologic bone graft that utilizes a small peptide as an attachment factor intended to stimulate the natural bone healing process resulting in safe, predictable bone formation at a fraction of the cost of growth factors. i-FACTOR is currently available for sale in many countries outside the U.S.
“Glen is a well-known and respected leader in the spine and orthopedics industries. He had many opportunities available to him and we are delighted that he has chosen to join Cerapedics to lead the company through several upcoming major value inflection points,” said Jonathan Silverstein, chairman of Cerapedics and general partner at OrbiMed.
“I am honored to join Cerapedics as CEO and work with the talented group of individuals who have built this company and brought its unique products to market,” Kashuba said. “Our goal is for Cerapedics to be a leader in the global bone biologics market by providing a powerful and safe orthobiologics solution to the clinicians and patients we serve. I look forward to leading the Cerapedics team to that goal.”
Kashuba’s tenure at Biomet also included the role of worldwide president for Biomet Spine and Trauma, where he had profit and loss responsibility for all functional areas, including sales force management and supply chain optimization. Kashuba’s commercial responsibilities included managing sales of greater than $400 million, driven by more than 500 direct and independent sales representatives. Kashuba was also responsible for launching more than 25 new products into the market during his tenure at Biomet.Prior to his leadership roles at Biomet, Kashuba held a number of division president roles at Johnson & Johnson where he served as worldwide president for Cordis Endovascular and Neurovascular and as worldwide president for Codman Neuro Sciences. Kashuba also served as U.S. president for DePuy Spine. Kashuba received his B.S. in industrial engineering from Rutgers University.Kashuba succeeds Paul Mraz, who earlier this year announced his intention to retire from the company. “The board would like to thank Paul for his years of service and leadership during which the company launched i-FACTOR™ bone graft in 25+ countries outside the U.S. and enrolled its U.S. IDE pivotal clinical trial,” Silverstein said.Cerapedics also announced today that it named Jeffrey G. Marx, Ph.D., as its president and chief operating officer. Marx formerly served as vice president of corporate development at Orthovita, Inc. Marx had numerous other responsibilities as part of the senior leadership team during his 13-year tenure. Orthovita was a leading orthobiologics and biosurgery company that was acquired by Stryker for $318 million in 2011.Following the acquisition, Marx led the integration of Orthovita into Stryker and served as vice president of corporate development at Stryker Orthobiologics. Marx received his B.S. in ceramic science and engineering from Penn State University and his Ph.D. in ceramic engineering from Missouri University of Science and Technology.
“I look forward to leading Cerapedics through the current FDA submission process and future product pipeline development. Rarely do you have the opportunity to introduce a whole new category within an established market like bone grafting, especially one with such potential to help doctors and patients achieve better outcomes with safety and reliability,” Marx said.
About Cerapedics, Inc.
Cerapedics, a 2012 Colorado Companies to Watch (COCTW) winner, is a medical device company focused on developing and commercializing novel osteobiologic products based upon its proprietary synthetic small peptide (P-15™) technology platform. i-FACTOR bone graft is the only biologic bone graft that utilizes a small peptide as an attachment factor intended to stimulate the natural bone healing process resulting in safe, predictable bone formation at a fraction of the cost of growth factors. i-FACTOR is currently available for sale in many countries outside the U.S.
Sunday, May 19, 2013
J&J Units Sued Over Spinal Implant Patent
Law360, New York (May 16, 2013, 1:30 PM ET) -- Two of Johnson & Johnson's DePuy Synthes units were hit Wednesday in Delaware federal court with allegations that they infringed Globus Medical Inc.'s patent covering a spinal implant.Globus sued DePuy Synthes Products LLC and DePuy Synthes Sales Inc., alleging their Zero-P VA intervertebral fusion implant product infringes U.S. Patent Number 8,328,872, which was issued to Globus in December. The suit alleges further that Synthes' infringement was willful.
"Synthes' continued manufacture, use, offers to sell, and/or selling of its Zero-P VA intervertebral fusion implants, despite its knowledge of the '872 patent, constitutes at least reckless disregard of the '872 patent," the complaint said. "Globus has suffered and will continue to suffer damages and irreparable injuries unless Synthes' infringement of the '872 patent is enjoined."
Intervertebral fusion implants generally relate to products that are surgically implanted to stabilize the spine. The Synthes Zero-P VA product targeted in Globus' suit is indicated for treating patients with degenerative spinal discs, according to Synthes.The Globus suit lodged Wednesday is not the first time the companies have fought it out over patent infringement allegations related to spinal implants.
In July 2011, Synthes lodged a suit in Delaware federal court, alleging that Globus infringed three patents related to intervertebral implants. That suit — which is pending and scheduled for a jury trial in June — alleged that Globus' Independence ALIF system, Coalition ACDF system and InterContinental Plate-Spacer products infringed the three Synthes patents.Another DePuy Synthes company — DePuy Inc. — was sued in September by an orthopedic surgeon's patent-holding company. In that suit, which is pending, Bonutti Skeletal Innovations LLC and Dr. Peter M. Bonutti alleged that DePuy had infringed some of its patents related to medical sutures and knee surgery methods.DePuy has also recently been fending off allegations that it sold a defective hip implant.On April 16, a jury in Illinois sided with DePuy in the second case alleging defects in its ASR XL metal hip to go to trial. Previously, however, a Los Angeles jury entered an $8.3 million verdict against DePuy in a similar suit over the allegedly defective hip implant.
Source:Scott Flaherty.http://www.law360.com
"Synthes' continued manufacture, use, offers to sell, and/or selling of its Zero-P VA intervertebral fusion implants, despite its knowledge of the '872 patent, constitutes at least reckless disregard of the '872 patent," the complaint said. "Globus has suffered and will continue to suffer damages and irreparable injuries unless Synthes' infringement of the '872 patent is enjoined."
Intervertebral fusion implants generally relate to products that are surgically implanted to stabilize the spine. The Synthes Zero-P VA product targeted in Globus' suit is indicated for treating patients with degenerative spinal discs, according to Synthes.The Globus suit lodged Wednesday is not the first time the companies have fought it out over patent infringement allegations related to spinal implants.
In July 2011, Synthes lodged a suit in Delaware federal court, alleging that Globus infringed three patents related to intervertebral implants. That suit — which is pending and scheduled for a jury trial in June — alleged that Globus' Independence ALIF system, Coalition ACDF system and InterContinental Plate-Spacer products infringed the three Synthes patents.Another DePuy Synthes company — DePuy Inc. — was sued in September by an orthopedic surgeon's patent-holding company. In that suit, which is pending, Bonutti Skeletal Innovations LLC and Dr. Peter M. Bonutti alleged that DePuy had infringed some of its patents related to medical sutures and knee surgery methods.DePuy has also recently been fending off allegations that it sold a defective hip implant.On April 16, a jury in Illinois sided with DePuy in the second case alleging defects in its ASR XL metal hip to go to trial. Previously, however, a Los Angeles jury entered an $8.3 million verdict against DePuy in a similar suit over the allegedly defective hip implant.
Source:Scott Flaherty.http://www.law360.com
Saturday, May 18, 2013
VESTAKEEP® PEEK-Based Spinal Implant Receives FDA 510(k) Approval
PARSIPPANY, N.J. -- Xiphos™ ALIF, a VESTAKEEP® PEEK-based (polyetheretherketone) spinal implant developed by DiFusion Technologies, has received the U.S. Food and Drug Administration’s (FDA) 510(k) approval for use in Interbody Fusion Devices (IBF) devices.
“DiFusion Technologies is very excited about the FDA 510(k) approval of the VESTAKEEP® PEEK-based Xiphos™ ALIF spinal implant,” said Derrick Johns, managing director of DiFusion Technologies. “This milestone helps pave the way for more innovative medical devices developed from bioactive polymers. Evonik’s VESTAKEEP® PEEK’s strength and ductility proved to be critical for the FDA approval and the excellent test results Xiphos™ ALIF received.”
“We are pleased with the approval DiFusion received using VESTAKEEP®,” said Sanjeev Taneja, vice president of Evonik’s High Temperature Polymers Business. “Evonik always strives to meet the needs of its customers and helping DiFusion Technologies achieve FDA 510(k) approval for Xiphos™ ALIF is an example of our efforts. This marks the second product line DiFusion is using VESTAKEEP® PEEK for and demonstrates the strong relationships necessary for success in this space.”VESTAKEEP® PEEK is characterized by its superior biocompatibility and biostability making it suitable as a raw material used in the development of medical devices. Its excellent sterilization resistance and good combination of stiffness and ductility make it excellent for use in spinal implants that must meet extremely high mechanical, thermal, and chemical requirements.
For additional product information, please visit: www.vestakeep.com
Company information
Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals. Profitable growth and a sustained increase in the value of the company form the heart of Evonik’s corporate strategy. Its activities focus on the key megatrends health, nutrition, resource efficiency and globalization. Evonik benefits specifically from its innovative prowess and integrated technology platforms.Evonik is active in over 100 countries around the world. In fiscal 2012 more than 33,000 employees generated sales of around €13.6 billion and an operating profit (adjusted EBITDA) of about €2.6 billion.
“DiFusion Technologies is very excited about the FDA 510(k) approval of the VESTAKEEP® PEEK-based Xiphos™ ALIF spinal implant,” said Derrick Johns, managing director of DiFusion Technologies. “This milestone helps pave the way for more innovative medical devices developed from bioactive polymers. Evonik’s VESTAKEEP® PEEK’s strength and ductility proved to be critical for the FDA approval and the excellent test results Xiphos™ ALIF received.”
“We are pleased with the approval DiFusion received using VESTAKEEP®,” said Sanjeev Taneja, vice president of Evonik’s High Temperature Polymers Business. “Evonik always strives to meet the needs of its customers and helping DiFusion Technologies achieve FDA 510(k) approval for Xiphos™ ALIF is an example of our efforts. This marks the second product line DiFusion is using VESTAKEEP® PEEK for and demonstrates the strong relationships necessary for success in this space.”VESTAKEEP® PEEK is characterized by its superior biocompatibility and biostability making it suitable as a raw material used in the development of medical devices. Its excellent sterilization resistance and good combination of stiffness and ductility make it excellent for use in spinal implants that must meet extremely high mechanical, thermal, and chemical requirements.
For additional product information, please visit: www.vestakeep.com
Company information
Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals. Profitable growth and a sustained increase in the value of the company form the heart of Evonik’s corporate strategy. Its activities focus on the key megatrends health, nutrition, resource efficiency and globalization. Evonik benefits specifically from its innovative prowess and integrated technology platforms.Evonik is active in over 100 countries around the world. In fiscal 2012 more than 33,000 employees generated sales of around €13.6 billion and an operating profit (adjusted EBITDA) of about €2.6 billion.
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