09.11.12
Bioventus LLC is locating its new international headquarters in the Netherlands, about 12 miles outside Amsterdam in Hoofddorp. The company’s international operating company, Bioventus Coöperatief U.A., recently signed a letter of intent to lease about 7,200 square feet of office space on the 15th floor of the South Tower of a high-rise office building called Zuidtoren.
The new headquarters space is expected to open in November. The offices will house employees supporting finance, customer care, operations, marketing, sales and human resources.
With its U.S. headquarters in Durham, N.C., Bioventus was born out of Smith & Nephew plc’s former Biologics and Clinical Therapies division, which was formed in 2008 and now generates about $240 million in worldwide revenue. Bioventus is a standalone orthopedic technology company with nearly 500 employees in the United States, most of whom who worked at Smith & Nephew’s old Biologics division. It currently has several products in its portfolio designed to help accelerate bone healing and treat osteoarthritis pain.
Global Smith & Nephew Biologics employees still are operating under the Smith & Nephew name, but are migrating slowly over to Bioventus as legal and regulatory approvals are gained.
The company’s flagship product is Exogen, a system that uses ultrasound signals to accelerate bone healing. It is the only U.S. Food and Drug Administration-approved device on the market that uses a low intensity pulsed ultrasound signal for bone healing. It is used for non-union fractures, which are fractures that have not healed properly, and certain kinds of stress fractures. A number of clinical studies have shown that Exogen can accelerate the healing of fresh fractures by 38 percent, can heal cortical bone in tibia 58 days faster, and can heal cancellous bone in distal radius 37 days faster.
Exogen is available globally.
Smith & Nephew has offices in the Netherlands. Since Bioventus still has employees that were formerly with Smith & Nephew, locating its headquarters near Amsterdam will be easier on workers that already are situated in the area.
Tornier to Acquire OrthoHelix
Dutch orthopedic device company Tornier NV, which just appointed new Chief Financial Officer Shawn T. McCormick this past July, now has signed a definitive agreement to acquire OrthoHelix Surgical Designs Inc. The acquisition is valued at $135 million plus additional payments over two years, which will be based on achieving certain revenue growth milestones. Payment of the $135 million will consist of $100 million in cash and $35 million in Tornier stock. Tornier intends to use cash on hand and borrowings to pay for the acquisition.
Based in Medina, Ohio, OrthoHelix is a medical device company developing a line of implants and instruments for use in small bone reconstructive surgery, including specialty implantable screw and plate systems for the repair of small bone fractures and deformities predominantly in the foot and ankle. OrthoHelix’s sales for the calendar year 2012, which are based in the United States, are projected to reach approximately $29 million, an increase of more than 30 percent compared with 2011. OrthoHelix’s gross profit margin on 2012 sales is expected to exceed 80 percent and earnings before interest, taxes, depreciation and amortization is expected to be positive. The addition of OrthoHelix is expected to more than double Tornier’s lower extremity revenue and allow Tornier to increase its focus on foot and ankle surgeons.
“We are pleased to welcome the employees, surgeon advisors, and distribution partners of OrthoHelix to Tornier. OrthoHelix’s technology, products, and surgeon focused culture will help us take our ‘specialists serving specialists’ strategy to the next level,” said Douglas W. Kohrs, president and CEO of Tornier. “The transaction will enable us to substantially expand our sales coverage of foot and ankle surgeons, significantly enhance our addressable lower extremity market opportunity, and position us to achieve more consistent growth across our upper and lower extremity product categories.”
OrthoHelix’s flagship product line is the MaxLock Extreme small bone screw and plate systems featuring proprietary anatomic contouring, low profile, and multiplanar fixation. The hope is that the combination of the Maxlock line with Tornier’s ankle arthroplasty, biologics, and other foot and ankle implants will create one of the broadest offerings for lower extremity surgical specialists in the orthopedic industry. Tornier intends to channel OrthoHelix’s products through its own already-established international sales presence.
“We are very excited by the opportunities that the OrthoHelix and Tornier combination will present to our surgeon customers and our employees, said Dennis Stripe, president and CEO of OrthoHelix. “We believe Tornier’s resources will position us to drive significant organic growth in the lower extremity business through product innovation, access to novel arthroplasty and biologic products, and, over time, an international presence for OrthoHelix through Tornier’s distribution network. We are confident that our ‘surgeons speak—we deliver’ culture will only be enhanced as part of Tornier.”
Wright Launches Second-Generation Foot and Ankle Plating System
Orthopedic medical device company Wright Medical Group Inc. has launched the Ortholoc 3Di reconstruction plating system for foot and ankle surgery.
The system will be available in the United States through Wright’s specialized foot and ankle sales force, as well as in select countries outside the United States through Wright’s direct and distributor-based sales organization.
The Ortholoc 3Di Plating System includes a number of anatomical plates, screws and specialized surgical instrumentation used for fracture fixation, osteotomies, and fusions of the foot. This system is the next generation version of the original system that received 510(k) clearance from the U.S. Food and Drug Administration in 2010. The 3Di provides multiple screw options and adds Wright’s Ortholoc 3Di polyaxial locking technology, which is designed to enable the surgeon to adjust the screw trajectory to meet the anatomic requirements of the patient while providing a strong locking construct to promote bone fixation, according to the company.
“Along with other planned new product launches, the Ortholoc 3Di Plating System is a core foundational portion of our foot and ankle product portfolio, and will be key to exiting the year at well above market rates of growth for our foot and ankle business,” said Robert Palmisano, president and CEO of Wright Medical. “We expect to expand this system in the future to treat other areas of the foot, including complex mid-foot and hind-foot procedures.”
Based in Arlington, Tenn., Wright Medical manufactures artificial joints and biologics, including implants for the hip and knee, and extremity implants for the hand, elbow, shoulder, foot and ankle.
United States Military Hospitals Adopt HemaClear Tourniquet
Joint Task Force National Capital Region Medical (JTF CapMed) in Bethesda, Md., has adopted the HemaClear single-use, sterile tourniquet device for bloodless orthopedic procedures. JTF CapMed treats wounded, ill and injured, active duty, and retired service members and their families.
As a result, the Walter Reed National Military Medical Center and Fort Belvoir Community Hospital in Bethesda will begin using the HemaClear tourniquet device, and will have it readily available to treat military orthopedic patients. This is a significant milestone for HemaClear, as the company has been focusing on the goal of expanding the tourniquet device’s use in Military Army Surgical Hospital (commonly known as MASH) units within battle zones. The company asserts that military physicians can guarantee the device’s sterility without relying on an electronic box for a reliable occlusion.
“It is humbling to see that veterans are receiving top-notch care from physicians,” said Grant Castor, national sales manager of OHK Medical Devices, the company that manufactures HemaClear’s device. “HemaClear enables physicians to perform bloodless procedures more proximally, thus reducing the amount of blood loss, increasing the visibility for the physician, and contributing to a better outcome for the patient.”
Bloodless procedures have the advantage of reducing infection rates and increasing the surgical field. Bloodless surgical technology makes surgery easier to perform, cheaper to administer, and altogether safer for patients.
Founded in 1999 by an international team of medical specialists and engineers, HemaClear is a privately held company based in Haifa, Israel. OHK Medical is located in the same city, and is concerned with the development and manufacture of self-contained, sterile, and exsanguinating tourniquets for hospitals.
Globus Medical’s Recent IPO Posts a Modest Success
Globus Medical initial public offering (IPO) on Aug. 3 saw moderate success. Shares of the spinal device company ended their first day up 12 percent at $13.50 per share trading on NASDAQ under the symbol GMED. The initial goal of the company and its bankers was to set an offer price range of $16-$18 per share, but this was revised due to low demand.
At the beginning of September, the company’s stock was trading around $16.15.
Audubon, Pa.-based Globus Medical develops spinal implants and other products for the treatment of patients with a variety of spinal disorders. The company sold 2.94 million shares while shareholders sold 8.82 million shares, bringing the total to 11.76 million shares sold for $12 each. Globus raised $35.3 million in gross proceeds during the initial offering.
Globus’ banking partners that brought the company public were Goldman Sachs, Bank of America/Merrill Lynch, and Piper Jaffray Companies. The Aug. 3 closing price of $13.50 a share brought the company’s value to $1.23 billion.
Globus Medical’s annual revenue for 2011 was $331.5 million, up 8 percent from the previous year. The company reported a net income of $60.8 million, or $0.67 per diluted share, compared with a net profit of $54.5 million in 2010.
Although Globus’ IPO may not have resulted in the original value investors expected due in part to the lowering of the initial price, the orthopedic device sector has been enjoying growth and is expected to continue to grow considerably in the next several years. This is mainly due to an aging population that typically means an increase in the need for orthopedic devices and surgeries such as joint replacement. Also, as dictated by the Patient Protection and Affordable Care Act signed into law in 2010, Medicaid will be expanded to cover more people beginning January 2014, allowing greater access to medical products including those of the type that Globus Medical provides.
NSF International Acquires Becker & Associates Consulting
NSF International, an independent global public health and safety organization that develops standards as well as tests and certifies products for the food, water, health and consumer products industries, has acquired Becker & Associates Consulting, Inc., a clinical, regulatory and scientific consulting firm that specializes in U.S. Food and Drug Administration (FDA)-regulated industries, specifically medical devices, pharmaceuticals and biologics.
The terms of the deal were not disclosed.
Becker will become part of NSF’s Health Sciences Division, which offers training and education, consulting, good manufacturing practice (GMP) and good laboratory practice testing, certification, research and development and auditing services for the pharmaceutical, dietary supplement and medical device industries throughout the entire product life cycle.
“The partnership between NSF International and Becker comes at a time when the U.S. FDA is actively warning manufacturers and patients about the need for enhanced systems to ensure the safety of medical devices and pharmaceuticals,” said Ron Ginor, M.D., CEO of Becker & Associates Consulting. “With NSF’s role at the forefront of public health for 68 years and its global capabilities, we will be able to enhance and expand the scope and range of services we can offer to our customers.”
Ginor will remain CEO following the acquisition. President of Becker Consulting and former Director of Compliance at FDA’s Center for Devices and Radiological Health Ron Johnson also will continue his leadership of quality systems and compliance activities for the firm, directing the company’s expanding activities in North America, India, China and South America.
“The medical device and pharmaceutical sectors are in a period of flux following a number of significant regulatory changes,” Johnson said. “As part of NSF’s Health Sciences Division, we are able to help our clients not only meet FDA compliance but to educate their professionals to stay in compliance by leveraging the vast experience and resources of NSF International.”
Headquartered in Washington, D.C., Becker Consulting provides services to help client companies meet FDA requirements for developing, testing and marketing healthcare products. The company specializes in resolving clinical, regulatory and scientific challenges in the life sciences sector. The company also helps assure the safety and efficacy of drugs and medical devices, re-establishes manufacturing facilities after natural disasters, designs manufacturing processes for complex biologics, building systems for protecting blood banks, and develops testing protocols and clinical programs for the evaluation of novel drugs and devices.
The acquisition will complement Ann Arbor, Mich.-based NSF’s services, which include training and education for the pharmaceutical, biotech and medical device industries; consulting in quality systems, GMP and compliance/enforcement actions; clinical and regulatory consulting; analytical testing; bioanalytical testing for clinical trials; and product testing and certification.
“This is a singular opportunity for both NSF International and Becker to expand our global biotech, medical device and life science services,” said Kevan P. Lawlor, president and CEO of NSF International.
The new headquarters space is expected to open in November. The offices will house employees supporting finance, customer care, operations, marketing, sales and human resources.
With its U.S. headquarters in Durham, N.C., Bioventus was born out of Smith & Nephew plc’s former Biologics and Clinical Therapies division, which was formed in 2008 and now generates about $240 million in worldwide revenue. Bioventus is a standalone orthopedic technology company with nearly 500 employees in the United States, most of whom who worked at Smith & Nephew’s old Biologics division. It currently has several products in its portfolio designed to help accelerate bone healing and treat osteoarthritis pain.
Global Smith & Nephew Biologics employees still are operating under the Smith & Nephew name, but are migrating slowly over to Bioventus as legal and regulatory approvals are gained.
The company’s flagship product is Exogen, a system that uses ultrasound signals to accelerate bone healing. It is the only U.S. Food and Drug Administration-approved device on the market that uses a low intensity pulsed ultrasound signal for bone healing. It is used for non-union fractures, which are fractures that have not healed properly, and certain kinds of stress fractures. A number of clinical studies have shown that Exogen can accelerate the healing of fresh fractures by 38 percent, can heal cortical bone in tibia 58 days faster, and can heal cancellous bone in distal radius 37 days faster.
Exogen is available globally.
Smith & Nephew has offices in the Netherlands. Since Bioventus still has employees that were formerly with Smith & Nephew, locating its headquarters near Amsterdam will be easier on workers that already are situated in the area.
Tornier to Acquire OrthoHelix
Dutch orthopedic device company Tornier NV, which just appointed new Chief Financial Officer Shawn T. McCormick this past July, now has signed a definitive agreement to acquire OrthoHelix Surgical Designs Inc. The acquisition is valued at $135 million plus additional payments over two years, which will be based on achieving certain revenue growth milestones. Payment of the $135 million will consist of $100 million in cash and $35 million in Tornier stock. Tornier intends to use cash on hand and borrowings to pay for the acquisition.
Based in Medina, Ohio, OrthoHelix is a medical device company developing a line of implants and instruments for use in small bone reconstructive surgery, including specialty implantable screw and plate systems for the repair of small bone fractures and deformities predominantly in the foot and ankle. OrthoHelix’s sales for the calendar year 2012, which are based in the United States, are projected to reach approximately $29 million, an increase of more than 30 percent compared with 2011. OrthoHelix’s gross profit margin on 2012 sales is expected to exceed 80 percent and earnings before interest, taxes, depreciation and amortization is expected to be positive. The addition of OrthoHelix is expected to more than double Tornier’s lower extremity revenue and allow Tornier to increase its focus on foot and ankle surgeons.
“We are pleased to welcome the employees, surgeon advisors, and distribution partners of OrthoHelix to Tornier. OrthoHelix’s technology, products, and surgeon focused culture will help us take our ‘specialists serving specialists’ strategy to the next level,” said Douglas W. Kohrs, president and CEO of Tornier. “The transaction will enable us to substantially expand our sales coverage of foot and ankle surgeons, significantly enhance our addressable lower extremity market opportunity, and position us to achieve more consistent growth across our upper and lower extremity product categories.”
OrthoHelix’s flagship product line is the MaxLock Extreme small bone screw and plate systems featuring proprietary anatomic contouring, low profile, and multiplanar fixation. The hope is that the combination of the Maxlock line with Tornier’s ankle arthroplasty, biologics, and other foot and ankle implants will create one of the broadest offerings for lower extremity surgical specialists in the orthopedic industry. Tornier intends to channel OrthoHelix’s products through its own already-established international sales presence.
“We are very excited by the opportunities that the OrthoHelix and Tornier combination will present to our surgeon customers and our employees, said Dennis Stripe, president and CEO of OrthoHelix. “We believe Tornier’s resources will position us to drive significant organic growth in the lower extremity business through product innovation, access to novel arthroplasty and biologic products, and, over time, an international presence for OrthoHelix through Tornier’s distribution network. We are confident that our ‘surgeons speak—we deliver’ culture will only be enhanced as part of Tornier.”
Wright Launches Second-Generation Foot and Ankle Plating System
Orthopedic medical device company Wright Medical Group Inc. has launched the Ortholoc 3Di reconstruction plating system for foot and ankle surgery.
The system will be available in the United States through Wright’s specialized foot and ankle sales force, as well as in select countries outside the United States through Wright’s direct and distributor-based sales organization.
Ortholoc 3Di Foot Reconstruction System MTP Fusion Plate. Photo courtesy of Wright Medical Group Inc. |
The Ortholoc 3Di Plating System includes a number of anatomical plates, screws and specialized surgical instrumentation used for fracture fixation, osteotomies, and fusions of the foot. This system is the next generation version of the original system that received 510(k) clearance from the U.S. Food and Drug Administration in 2010. The 3Di provides multiple screw options and adds Wright’s Ortholoc 3Di polyaxial locking technology, which is designed to enable the surgeon to adjust the screw trajectory to meet the anatomic requirements of the patient while providing a strong locking construct to promote bone fixation, according to the company.
“Along with other planned new product launches, the Ortholoc 3Di Plating System is a core foundational portion of our foot and ankle product portfolio, and will be key to exiting the year at well above market rates of growth for our foot and ankle business,” said Robert Palmisano, president and CEO of Wright Medical. “We expect to expand this system in the future to treat other areas of the foot, including complex mid-foot and hind-foot procedures.”
Based in Arlington, Tenn., Wright Medical manufactures artificial joints and biologics, including implants for the hip and knee, and extremity implants for the hand, elbow, shoulder, foot and ankle.
United States Military Hospitals Adopt HemaClear Tourniquet
Joint Task Force National Capital Region Medical (JTF CapMed) in Bethesda, Md., has adopted the HemaClear single-use, sterile tourniquet device for bloodless orthopedic procedures. JTF CapMed treats wounded, ill and injured, active duty, and retired service members and their families.
As a result, the Walter Reed National Military Medical Center and Fort Belvoir Community Hospital in Bethesda will begin using the HemaClear tourniquet device, and will have it readily available to treat military orthopedic patients. This is a significant milestone for HemaClear, as the company has been focusing on the goal of expanding the tourniquet device’s use in Military Army Surgical Hospital (commonly known as MASH) units within battle zones. The company asserts that military physicians can guarantee the device’s sterility without relying on an electronic box for a reliable occlusion.
“It is humbling to see that veterans are receiving top-notch care from physicians,” said Grant Castor, national sales manager of OHK Medical Devices, the company that manufactures HemaClear’s device. “HemaClear enables physicians to perform bloodless procedures more proximally, thus reducing the amount of blood loss, increasing the visibility for the physician, and contributing to a better outcome for the patient.”
Bloodless procedures have the advantage of reducing infection rates and increasing the surgical field. Bloodless surgical technology makes surgery easier to perform, cheaper to administer, and altogether safer for patients.
Founded in 1999 by an international team of medical specialists and engineers, HemaClear is a privately held company based in Haifa, Israel. OHK Medical is located in the same city, and is concerned with the development and manufacture of self-contained, sterile, and exsanguinating tourniquets for hospitals.
Globus Medical’s Recent IPO Posts a Modest Success
Globus Medical initial public offering (IPO) on Aug. 3 saw moderate success. Shares of the spinal device company ended their first day up 12 percent at $13.50 per share trading on NASDAQ under the symbol GMED. The initial goal of the company and its bankers was to set an offer price range of $16-$18 per share, but this was revised due to low demand.
At the beginning of September, the company’s stock was trading around $16.15.
Audubon, Pa.-based Globus Medical develops spinal implants and other products for the treatment of patients with a variety of spinal disorders. The company sold 2.94 million shares while shareholders sold 8.82 million shares, bringing the total to 11.76 million shares sold for $12 each. Globus raised $35.3 million in gross proceeds during the initial offering.
Globus’ banking partners that brought the company public were Goldman Sachs, Bank of America/Merrill Lynch, and Piper Jaffray Companies. The Aug. 3 closing price of $13.50 a share brought the company’s value to $1.23 billion.
Globus Medical’s annual revenue for 2011 was $331.5 million, up 8 percent from the previous year. The company reported a net income of $60.8 million, or $0.67 per diluted share, compared with a net profit of $54.5 million in 2010.
Although Globus’ IPO may not have resulted in the original value investors expected due in part to the lowering of the initial price, the orthopedic device sector has been enjoying growth and is expected to continue to grow considerably in the next several years. This is mainly due to an aging population that typically means an increase in the need for orthopedic devices and surgeries such as joint replacement. Also, as dictated by the Patient Protection and Affordable Care Act signed into law in 2010, Medicaid will be expanded to cover more people beginning January 2014, allowing greater access to medical products including those of the type that Globus Medical provides.
NSF International Acquires Becker & Associates Consulting
NSF International, an independent global public health and safety organization that develops standards as well as tests and certifies products for the food, water, health and consumer products industries, has acquired Becker & Associates Consulting, Inc., a clinical, regulatory and scientific consulting firm that specializes in U.S. Food and Drug Administration (FDA)-regulated industries, specifically medical devices, pharmaceuticals and biologics.
The terms of the deal were not disclosed.
Becker will become part of NSF’s Health Sciences Division, which offers training and education, consulting, good manufacturing practice (GMP) and good laboratory practice testing, certification, research and development and auditing services for the pharmaceutical, dietary supplement and medical device industries throughout the entire product life cycle.
“The partnership between NSF International and Becker comes at a time when the U.S. FDA is actively warning manufacturers and patients about the need for enhanced systems to ensure the safety of medical devices and pharmaceuticals,” said Ron Ginor, M.D., CEO of Becker & Associates Consulting. “With NSF’s role at the forefront of public health for 68 years and its global capabilities, we will be able to enhance and expand the scope and range of services we can offer to our customers.”
Ginor will remain CEO following the acquisition. President of Becker Consulting and former Director of Compliance at FDA’s Center for Devices and Radiological Health Ron Johnson also will continue his leadership of quality systems and compliance activities for the firm, directing the company’s expanding activities in North America, India, China and South America.
“The medical device and pharmaceutical sectors are in a period of flux following a number of significant regulatory changes,” Johnson said. “As part of NSF’s Health Sciences Division, we are able to help our clients not only meet FDA compliance but to educate their professionals to stay in compliance by leveraging the vast experience and resources of NSF International.”
Headquartered in Washington, D.C., Becker Consulting provides services to help client companies meet FDA requirements for developing, testing and marketing healthcare products. The company specializes in resolving clinical, regulatory and scientific challenges in the life sciences sector. The company also helps assure the safety and efficacy of drugs and medical devices, re-establishes manufacturing facilities after natural disasters, designs manufacturing processes for complex biologics, building systems for protecting blood banks, and develops testing protocols and clinical programs for the evaluation of novel drugs and devices.
The acquisition will complement Ann Arbor, Mich.-based NSF’s services, which include training and education for the pharmaceutical, biotech and medical device industries; consulting in quality systems, GMP and compliance/enforcement actions; clinical and regulatory consulting; analytical testing; bioanalytical testing for clinical trials; and product testing and certification.
“This is a singular opportunity for both NSF International and Becker to expand our global biotech, medical device and life science services,” said Kevan P. Lawlor, president and CEO of NSF International.