08.05.15
$928 Million
KEY EMPLOYEES:
Peter J. Arduini, President, CEO & Director
Glenn G. Coleman, Corp. VP & Chief Financial Officer
Mark Augusti, Corp. VP & President, Orthopedics and Tissue Technologies
Kenneth Burhop, Corp. VP & Chief Scientific Officer
Robert T. Davis Jr., Corp. VP & President, Specialty Surgical Solutions
John Mooradian, Corp. VP, Global Operations and Supply Chain
Dan Reuvers, Corp. VP & President, International
Joseph Vinhais, Corp. VP, Global Quality Assurance
Judith E. O’Grady, Corp. VP, Global Regulatory Affairs
NO. of EMPLOYEES: 3,400
HEADQUARTERS: Plainsboro, N.J.
Integra LifeSciences Holdings Corp. certainly is no newcomer to the orthopedic business. It may not have as much “history” as some of the more venerable firms with which it competes (DePuy Synthes, Stryker Corp., Zimmer-Biomet Holdings Inc., Medtronic plc), but that hasn’t stopped the 26-year-old company from charting a successful growth course through this industry’s all-too-often complicated and competitive waters.
As was the case for so many firms in the medical device sector, 2014 was a year of transition for Integra. The company may have reported solid top- and bottom-line gains for its fiscal year (ended Dec. 31), but officials with the Plainsboro, N.J.-based firm chose a path for their company that they claimed would be more streamlined and profitable.
“During 2014, we made significant progress … and I believe we are at an exciting and pivotal point in our transformation,” said Peter Arduini, president and CEO.
What transformation you ask?
In November, the company announced plans to spin off its spine business and realign its portfolio. Specifically, in 2014, the company chose to consolidate its five business divisions into three. Following the spinoff, the company would have a simplified, two-division global structure. Neurosurgery and Instruments were combined worldwide to create a new division called Specialty Surgical Solutions. Orthopedics and Tissue Technologies were consolidated globally and include the extremities business, comprising small bone orthopedics and wound care. The portfolio realignment, according to company brass, is part of a larger transformation strategy that began in 2012 and centers on “optimizing the business and accelerating growth.”
The spinoff created a new publicly traded company (which went public on July 1 this year). SeaSpine—the name of a former Integra acquisition—focuses on spine hardware and orthobiologics. Integra acquired Vista, Calif.-based SeaSpine in 2011 for $89 million in cash. The company is still based in Vista.
“These strategic changes create a much stronger platform for organic growth and execution, and we believe both companies will grow faster separately than together,” said Arduini. “Moving forward, Integra will have a simpler, more focused structure from which to operate, which should improve our ability to achieve our longer-term growth and margin improvement objectives. Further, we believe these moves create exciting opportunities for our shareholders and both organizations.”
Integra officials said the separation would provide both companies with a faster top-line growth profile; allow the new SeaSpine to invest more in top-line growth initiatives such as sales, marketing and research and development (R&D), and to access the capital markets; accelerate Integra’s operating margin expansion plans; and unlock equity value for Integra’s shareholders.
SeaSpine’s portfolio consists of spinal hardware solutions, including unique interbody devices, minimally invasive surgery solutions, and deformity correction products, as well as IsoTis, a leading brand in orthobiologics, including a range of osteoconductive and osteoinductive solutions using demineralized bone and synthetic matrices.
Integra’s board of directors named Kirt Stephenson, former CEO and co-founder of SeaSpine, as board chairman of the new SeaSpine.
“I’m excited about the opportunity to create another company focused on growth through new product development, strategic acquisitions and partnerships,” said Stuart Essig, Integra’s board chairman. “As a public company, SeaSpine will have a host of options to accelerate its growth and effectively invest in new business opportunities. The board believes this will be achieved more fully as a standalone public company rather than through a strategic merger or divestiture of the business. Further, Rich Caruso, Integra’s founder, and I personally look forward to remaining shareholders of both companies.”
Follow the Leader
Early in the year, Integra LifeSciences hired Kenneth Burhop, Ph.D., as corporate vice president and chief scientific officer (CSO). Burhop is responsible for setting Integra’s strategic scientific vision and road map, leading the company’s portfolio prioritization and management, and evaluating corporate development and new product opportunities. Burhop holds several patents. He is a scientific expert in various research areas, including wound healing and wound dressing development. Burhop has extensive experience in biotechnology and medical device research and development, including the development of biocompatible materials, pharmaceuticals and biopharmaceuticals, and electromechanical devices. Prior to Integra, Burhop was chief scientific officer at Sangart Inc. Prior to joining Sangart, he spent more than 20 years with Baxter Healthcare Corp. in a series of leadership roles, including most recently vice president of R&D for Baxter Pharmaceutical Technologies. Before that, Burhop was vice president/global scientific lead for Baxter’s Medication Delivery Division. Burhop received his Ph.D. and M.S. in veterinary science as well as his B.A. in zoology from the University of Wisconsin-Madison.
In April, Integra hired Mark Augusti as a corporate vice president and president of the company’s Orthopedics and Tissue Technologies businesses. Prior to joining Integra, Augusti served as CEO of Durham, N.C.-based Bioventus—a biotechnology spinoff from Smith & Nephew.
“I am pleased that Mark has become a member of our team,” said Arduini. “With more than 25 years of experience in orthopedics, in particular, extremities and biologics, Mark brings a depth of general management experience and leadership that will be instrumental to our growth strategy.”
Prior to his time with Bioventus, Augusti spent nine years with Smith & Nephew in a series of leadership roles, most recently as president of Smith & Nephew’s Biologic Division, where he was appointed to lead Smith & Nephew’s new biologics initiative (which became Bioventus). He also served as president of Smith & Nephew’s Orthopedic Trauma and Clinical Therapies business and senior vice president and general manager of the Trauma business. Prior to that, he spent 13 years at GE Medical Systems, where he held various sales, marketing and strategic management roles. Augusti received his MBA from UCLA Anderson School of Management, and his B.S. in computer science and economics from Duke University.
Signed, Sealed, Delivered
Late in the fiscal year, the company closed on the acquisition of the product portfolio from Metasurg. The addition of the Metasurg product portfolio enhances Integra’s lower extremity product line. It also offers the opportunity to distribute a biologic allograft derived from human placental tissue as a possible complement to Integra’s wound care product offering, according to Integra’s leadership. Metasurg was founded in 2005 in Houston, Texas, and focused on the foot and ankle market. The acquired portfolio includes the DigiFuse Cannulated Intramedullary Fusion System, MemoFix Super Elastic Nitinol Staple System, Ti6 screw portfolio, BioMotion First MPJ Hemi System and TruArch Subtalar Implant System. In addition to the implants, the acquisition also gave Integra the opportunity to distribute an amniotic product line called BioFix Regenerative Biologics.
In September, Integra agreed to acquire Medtronic’s MicroFrance and Xomed Manual ENT and laparoscopy instrumentation lines for approximately $60 million in cash. The MicroFrance business, which includes Xomed’s Manual ENT instruments, designs, manufactures and sells reusable handheld instruments to ear, nose and throat (ENT) and laparoscopy surgeons. Under the terms of the agreement, Integra acquired a portfolio of approximately 4,000 MicroFrance and Xomed Manual ENT and laparoscopic surgical instruments, as well as a manufacturing facility in St. Aubin le Monial, France. The deal was wrapped up by October.
At the beginning of the fiscal year, the company completed the acquisition of the DuraSeal product lines from Covidien plc (now part of Medtronic). The deal, announced in October of 2013, called for Integra to purchase the Confluent Surgical product lines from Covidien plc. The brand includes surgical sealants, adhesion barriers, and—most notably—the DuraSeal, which is used in spinal surgery and applied over stitches to prevent cerebrospinal fluid from leaking out of the incision site. The technology was approved by the U.S. Food and Drug Administration (FDA) in 2009. Under the terms of the agreement, Covidien received an initial cash payment of $235 million from Integra at the close of the transaction.
Prolific Year for New Technology
Part of the company’s ongoing strategy for expansion has been a steady release of new technology across all its product categories. In this area, 2014 was no exception.
In November, the company rolled out a new orthobiologic implant. The Demineralized Bone Matrix (DBM) Strip implant is used primarily for posterior lumbar fusion, a surgical procedure intended to promote bone fusion along the posterior elements of the spine. Available in two forms, the Integra Shaped Strip and Integra Pocket Strip are 100 percent human allograft, providing a natural biologic scaffold with verified osteoinductive potential, the company claimed. The implant features a deep recess designed to accommodate placement of additional graft material. When hydrated, the graft is pliable, maintains integrity upon irrigation, and can be contoured to varying patient anatomy.
Also in November, Integra released its Expandable Interbody System in the United States. The system, which received 510(k) clearance from the FDA earlier in 2014, is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease. The device is intended for use with autogenous bone graft and supplemental fixation and can be used in either posterior or transforaminal lumbar interbody fusion procedures, which are performed to help alleviate pain and nerve compression by fusing and stabilizing adjacent vertebrae in the lower back. The Expandable Interbody System is designed to minimize the amount of implant insertion forces while achieving the patient-specific anatomical fit needed for proper treatment, according to the company. The system offers different implant footprints, a range of implant height expansions and instrumentation, as well as in-situ height expansion and, if necessary, the ability to reposition intraoperatively.
In September, the company introduced the Integra Freedom Wrist Arthroplasty System in the United States. The Freedom Wrist is an advanced implant design and includes enhanced instrumentation to aid in “efficient and potentially more reproducible surgical results,” officials said. The implant adds to the company’s upper extremity portfolio.
In July last year, the company completed its multicenter clinical trial evaluating the safety and effectiveness of the Integra Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers (DFU). The data collected formed the foundation for the premarket approval supplement application the company filed with the FDA in February this year. An FDA approval with published data will form the key to securing reimbursement. Assuming FDA approval and timely publication of a peer-reviewed journal article, the company plans to launch the resulting DFU product in the middle of 2016.
March saw the expansion of the company’s skin and wound product line with the introduction of the Integra Wound Matrix (Thin). Integra Wound Matrix (Thin) is a collagen-glycosaminoglycan wound matrix that maintains and supports a healing environment for wound management. Available in a variety of sizes, it may be used for second-degree burns, partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, skin tears) and draining wounds. Terminally sterilized, Integra Wound Matrix (Thin) can be stored at room temperature, has a 24-month shelf life, and is intended for one-time use.
Also in March, Integra rolled out its Laminoplasty System in the United States. The system, which is used to treat patients with ossification of the posterior longitudinal ligament, cervical myelopathy and degenerative spinal canal stenosis, is designed for use after open-door laminoplasty procedures in the cervical and thoracic spine (C3-T3). The system encompasses a variety of arched plate designs, self-drilling bone screws and multiple insertion options, offering surgeons choices when treating patients with central canal stenosis and myelopathy. The global laminoplasty market is estimated to reach approximately $70 million by 2015. With the addition of the Laminoplasty System, Integra is well positioned to gain a key foothold in this rapidly growing market.
Integra LifeSciences introduced its line of titanium bone wedges, designed for internal fixation for bone fractures or osteotomies in the foot and ankle, in February. The wedges may be used in corrective procedures, such as Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies. They are composed of commercially pure titanium formed into a cancellous-like structure that mimics the strength and porosity of human bone. The system is available in 15 different pre-shaped anatomical sizes, to accommodate various skeletal deformities in the foot. Osteotomies are procedures in which surgeons realign or remove a segment of bone located near a damaged joint to help correct deformities, typically in the foot. Bone wedges are designed to provide bone-grafting material for osteotomy corrections. They provide a scaffold for bone growth, as well as biologic stability and structural support for deformity corrections. Ancillary plates are used to hold bone graft material in place and prevent it from expulsion.
More of a manufacturing milestone than a product development one, Integra wrapped up an ongoing FDA issue at its facility in Añasco, Puerto Rico. Following FDA inspections in the fall of 2012, the agency issued a warning letter for the facility in February 2013. On Nov. 26, 2013, the FDA completed its second inspection of the Añasco facility and issued a new Form 483 with six additional observations. On Sept. 30, 2014, the FDA completed its third inspection of the facility, and concluded that the company had addressed the issues raised in the warning letter and previous inspectional observations, and it issued no other inspectional observations. The Añasco warning letter was closed out effective Jan. 14 this year.
Magic No. 11
The company grew revenue 11 percent to $928 million. Domestic revenues increased 11 percent to $714.0 million and were 77 percent of total revenues for the year. International revenues also increased 11 percent to $214.3 million. Foreign exchange fluctuations had a negative impact of $2.3 million on annual sales. Net income was $34 million, up from a loss of $21 million for FY13. U.S. Neurosurgery revenue was $244.6 million, an increase of 42 percent, largely the result of DuraSeal product sales arising out of the Confluent Surgical acquisition, which added $54.1 million in the period. Revenue for the U.S. Instruments division was $157.8 million, a decrease of 4 percent from the prior year. According to the company, lower sales were the result of sluggish sales in the acute-care and alternate-site businesses and product discontinuations. A partial-year contribution from Integra’s purchase of Medtronic’s MicroFrance in October partially offset the decline. Sales for U.S. Extremities were $143.4 million, an increase of 12 percent—mostly due to strong sales of dermal and wound-care products, including the company’s “thin” version of its Integra Wound Matrix, and from its shoulder product line, which increased as a result of the launch of a new reverse shoulder and increases in the number of distributors selling the technology. The remainder of the company’s lower and upper extremity franchise increased slightly during the period partially as a consequence of sales force turnover in the second quarter of 2014 as well as the transition to a new total foot system, officials reported. U.S. Spine division revenue, which includes spine hardware, orthobiologics and private-label products, were $171.4 million, a decrease of 6 percent. Sales of spine hardware softened due to ongoing pricing pressure, delays in expected product launches, and slower than anticipated addition of new distributors, according to the company’s leadership. The sales slump partially was offset by growth in orthobiologics, especially demineralized bone matrix and cancellous bone products, due to ongoing market demand. Sales of private-label products decreased from the prior-year period because some business was lost as a result of recall issues in 2013.
KEY EMPLOYEES:
Peter J. Arduini, President, CEO & Director
Glenn G. Coleman, Corp. VP & Chief Financial Officer
Mark Augusti, Corp. VP & President, Orthopedics and Tissue Technologies
Kenneth Burhop, Corp. VP & Chief Scientific Officer
Robert T. Davis Jr., Corp. VP & President, Specialty Surgical Solutions
John Mooradian, Corp. VP, Global Operations and Supply Chain
Dan Reuvers, Corp. VP & President, International
Joseph Vinhais, Corp. VP, Global Quality Assurance
Judith E. O’Grady, Corp. VP, Global Regulatory Affairs
NO. of EMPLOYEES: 3,400
HEADQUARTERS: Plainsboro, N.J.
Integra LifeSciences Holdings Corp. certainly is no newcomer to the orthopedic business. It may not have as much “history” as some of the more venerable firms with which it competes (DePuy Synthes, Stryker Corp., Zimmer-Biomet Holdings Inc., Medtronic plc), but that hasn’t stopped the 26-year-old company from charting a successful growth course through this industry’s all-too-often complicated and competitive waters.
As was the case for so many firms in the medical device sector, 2014 was a year of transition for Integra. The company may have reported solid top- and bottom-line gains for its fiscal year (ended Dec. 31), but officials with the Plainsboro, N.J.-based firm chose a path for their company that they claimed would be more streamlined and profitable.
“During 2014, we made significant progress … and I believe we are at an exciting and pivotal point in our transformation,” said Peter Arduini, president and CEO.
What transformation you ask?
In November, the company announced plans to spin off its spine business and realign its portfolio. Specifically, in 2014, the company chose to consolidate its five business divisions into three. Following the spinoff, the company would have a simplified, two-division global structure. Neurosurgery and Instruments were combined worldwide to create a new division called Specialty Surgical Solutions. Orthopedics and Tissue Technologies were consolidated globally and include the extremities business, comprising small bone orthopedics and wound care. The portfolio realignment, according to company brass, is part of a larger transformation strategy that began in 2012 and centers on “optimizing the business and accelerating growth.”
The spinoff created a new publicly traded company (which went public on July 1 this year). SeaSpine—the name of a former Integra acquisition—focuses on spine hardware and orthobiologics. Integra acquired Vista, Calif.-based SeaSpine in 2011 for $89 million in cash. The company is still based in Vista.
“These strategic changes create a much stronger platform for organic growth and execution, and we believe both companies will grow faster separately than together,” said Arduini. “Moving forward, Integra will have a simpler, more focused structure from which to operate, which should improve our ability to achieve our longer-term growth and margin improvement objectives. Further, we believe these moves create exciting opportunities for our shareholders and both organizations.”
Integra officials said the separation would provide both companies with a faster top-line growth profile; allow the new SeaSpine to invest more in top-line growth initiatives such as sales, marketing and research and development (R&D), and to access the capital markets; accelerate Integra’s operating margin expansion plans; and unlock equity value for Integra’s shareholders.
SeaSpine’s portfolio consists of spinal hardware solutions, including unique interbody devices, minimally invasive surgery solutions, and deformity correction products, as well as IsoTis, a leading brand in orthobiologics, including a range of osteoconductive and osteoinductive solutions using demineralized bone and synthetic matrices.
Integra’s board of directors named Kirt Stephenson, former CEO and co-founder of SeaSpine, as board chairman of the new SeaSpine.
“I’m excited about the opportunity to create another company focused on growth through new product development, strategic acquisitions and partnerships,” said Stuart Essig, Integra’s board chairman. “As a public company, SeaSpine will have a host of options to accelerate its growth and effectively invest in new business opportunities. The board believes this will be achieved more fully as a standalone public company rather than through a strategic merger or divestiture of the business. Further, Rich Caruso, Integra’s founder, and I personally look forward to remaining shareholders of both companies.”
Follow the Leader
Early in the year, Integra LifeSciences hired Kenneth Burhop, Ph.D., as corporate vice president and chief scientific officer (CSO). Burhop is responsible for setting Integra’s strategic scientific vision and road map, leading the company’s portfolio prioritization and management, and evaluating corporate development and new product opportunities. Burhop holds several patents. He is a scientific expert in various research areas, including wound healing and wound dressing development. Burhop has extensive experience in biotechnology and medical device research and development, including the development of biocompatible materials, pharmaceuticals and biopharmaceuticals, and electromechanical devices. Prior to Integra, Burhop was chief scientific officer at Sangart Inc. Prior to joining Sangart, he spent more than 20 years with Baxter Healthcare Corp. in a series of leadership roles, including most recently vice president of R&D for Baxter Pharmaceutical Technologies. Before that, Burhop was vice president/global scientific lead for Baxter’s Medication Delivery Division. Burhop received his Ph.D. and M.S. in veterinary science as well as his B.A. in zoology from the University of Wisconsin-Madison.
In April, Integra hired Mark Augusti as a corporate vice president and president of the company’s Orthopedics and Tissue Technologies businesses. Prior to joining Integra, Augusti served as CEO of Durham, N.C.-based Bioventus—a biotechnology spinoff from Smith & Nephew.
“I am pleased that Mark has become a member of our team,” said Arduini. “With more than 25 years of experience in orthopedics, in particular, extremities and biologics, Mark brings a depth of general management experience and leadership that will be instrumental to our growth strategy.”
Prior to his time with Bioventus, Augusti spent nine years with Smith & Nephew in a series of leadership roles, most recently as president of Smith & Nephew’s Biologic Division, where he was appointed to lead Smith & Nephew’s new biologics initiative (which became Bioventus). He also served as president of Smith & Nephew’s Orthopedic Trauma and Clinical Therapies business and senior vice president and general manager of the Trauma business. Prior to that, he spent 13 years at GE Medical Systems, where he held various sales, marketing and strategic management roles. Augusti received his MBA from UCLA Anderson School of Management, and his B.S. in computer science and economics from Duke University.
Signed, Sealed, Delivered
Late in the fiscal year, the company closed on the acquisition of the product portfolio from Metasurg. The addition of the Metasurg product portfolio enhances Integra’s lower extremity product line. It also offers the opportunity to distribute a biologic allograft derived from human placental tissue as a possible complement to Integra’s wound care product offering, according to Integra’s leadership. Metasurg was founded in 2005 in Houston, Texas, and focused on the foot and ankle market. The acquired portfolio includes the DigiFuse Cannulated Intramedullary Fusion System, MemoFix Super Elastic Nitinol Staple System, Ti6 screw portfolio, BioMotion First MPJ Hemi System and TruArch Subtalar Implant System. In addition to the implants, the acquisition also gave Integra the opportunity to distribute an amniotic product line called BioFix Regenerative Biologics.
In September, Integra agreed to acquire Medtronic’s MicroFrance and Xomed Manual ENT and laparoscopy instrumentation lines for approximately $60 million in cash. The MicroFrance business, which includes Xomed’s Manual ENT instruments, designs, manufactures and sells reusable handheld instruments to ear, nose and throat (ENT) and laparoscopy surgeons. Under the terms of the agreement, Integra acquired a portfolio of approximately 4,000 MicroFrance and Xomed Manual ENT and laparoscopic surgical instruments, as well as a manufacturing facility in St. Aubin le Monial, France. The deal was wrapped up by October.
At the beginning of the fiscal year, the company completed the acquisition of the DuraSeal product lines from Covidien plc (now part of Medtronic). The deal, announced in October of 2013, called for Integra to purchase the Confluent Surgical product lines from Covidien plc. The brand includes surgical sealants, adhesion barriers, and—most notably—the DuraSeal, which is used in spinal surgery and applied over stitches to prevent cerebrospinal fluid from leaking out of the incision site. The technology was approved by the U.S. Food and Drug Administration (FDA) in 2009. Under the terms of the agreement, Covidien received an initial cash payment of $235 million from Integra at the close of the transaction.
Prolific Year for New Technology
Part of the company’s ongoing strategy for expansion has been a steady release of new technology across all its product categories. In this area, 2014 was no exception.
In November, the company rolled out a new orthobiologic implant. The Demineralized Bone Matrix (DBM) Strip implant is used primarily for posterior lumbar fusion, a surgical procedure intended to promote bone fusion along the posterior elements of the spine. Available in two forms, the Integra Shaped Strip and Integra Pocket Strip are 100 percent human allograft, providing a natural biologic scaffold with verified osteoinductive potential, the company claimed. The implant features a deep recess designed to accommodate placement of additional graft material. When hydrated, the graft is pliable, maintains integrity upon irrigation, and can be contoured to varying patient anatomy.
Also in November, Integra released its Expandable Interbody System in the United States. The system, which received 510(k) clearance from the FDA earlier in 2014, is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease. The device is intended for use with autogenous bone graft and supplemental fixation and can be used in either posterior or transforaminal lumbar interbody fusion procedures, which are performed to help alleviate pain and nerve compression by fusing and stabilizing adjacent vertebrae in the lower back. The Expandable Interbody System is designed to minimize the amount of implant insertion forces while achieving the patient-specific anatomical fit needed for proper treatment, according to the company. The system offers different implant footprints, a range of implant height expansions and instrumentation, as well as in-situ height expansion and, if necessary, the ability to reposition intraoperatively.
In September, the company introduced the Integra Freedom Wrist Arthroplasty System in the United States. The Freedom Wrist is an advanced implant design and includes enhanced instrumentation to aid in “efficient and potentially more reproducible surgical results,” officials said. The implant adds to the company’s upper extremity portfolio.
In July last year, the company completed its multicenter clinical trial evaluating the safety and effectiveness of the Integra Dermal Regeneration Template for the Treatment of Diabetic Foot Ulcers (DFU). The data collected formed the foundation for the premarket approval supplement application the company filed with the FDA in February this year. An FDA approval with published data will form the key to securing reimbursement. Assuming FDA approval and timely publication of a peer-reviewed journal article, the company plans to launch the resulting DFU product in the middle of 2016.
March saw the expansion of the company’s skin and wound product line with the introduction of the Integra Wound Matrix (Thin). Integra Wound Matrix (Thin) is a collagen-glycosaminoglycan wound matrix that maintains and supports a healing environment for wound management. Available in a variety of sizes, it may be used for second-degree burns, partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, skin tears) and draining wounds. Terminally sterilized, Integra Wound Matrix (Thin) can be stored at room temperature, has a 24-month shelf life, and is intended for one-time use.
Also in March, Integra rolled out its Laminoplasty System in the United States. The system, which is used to treat patients with ossification of the posterior longitudinal ligament, cervical myelopathy and degenerative spinal canal stenosis, is designed for use after open-door laminoplasty procedures in the cervical and thoracic spine (C3-T3). The system encompasses a variety of arched plate designs, self-drilling bone screws and multiple insertion options, offering surgeons choices when treating patients with central canal stenosis and myelopathy. The global laminoplasty market is estimated to reach approximately $70 million by 2015. With the addition of the Laminoplasty System, Integra is well positioned to gain a key foothold in this rapidly growing market.
Integra LifeSciences introduced its line of titanium bone wedges, designed for internal fixation for bone fractures or osteotomies in the foot and ankle, in February. The wedges may be used in corrective procedures, such as Cotton (opening wedge) osteotomies of the medial cuneiform and Evans lengthening osteotomies. They are composed of commercially pure titanium formed into a cancellous-like structure that mimics the strength and porosity of human bone. The system is available in 15 different pre-shaped anatomical sizes, to accommodate various skeletal deformities in the foot. Osteotomies are procedures in which surgeons realign or remove a segment of bone located near a damaged joint to help correct deformities, typically in the foot. Bone wedges are designed to provide bone-grafting material for osteotomy corrections. They provide a scaffold for bone growth, as well as biologic stability and structural support for deformity corrections. Ancillary plates are used to hold bone graft material in place and prevent it from expulsion.
More of a manufacturing milestone than a product development one, Integra wrapped up an ongoing FDA issue at its facility in Añasco, Puerto Rico. Following FDA inspections in the fall of 2012, the agency issued a warning letter for the facility in February 2013. On Nov. 26, 2013, the FDA completed its second inspection of the Añasco facility and issued a new Form 483 with six additional observations. On Sept. 30, 2014, the FDA completed its third inspection of the facility, and concluded that the company had addressed the issues raised in the warning letter and previous inspectional observations, and it issued no other inspectional observations. The Añasco warning letter was closed out effective Jan. 14 this year.
Magic No. 11
The company grew revenue 11 percent to $928 million. Domestic revenues increased 11 percent to $714.0 million and were 77 percent of total revenues for the year. International revenues also increased 11 percent to $214.3 million. Foreign exchange fluctuations had a negative impact of $2.3 million on annual sales. Net income was $34 million, up from a loss of $21 million for FY13. U.S. Neurosurgery revenue was $244.6 million, an increase of 42 percent, largely the result of DuraSeal product sales arising out of the Confluent Surgical acquisition, which added $54.1 million in the period. Revenue for the U.S. Instruments division was $157.8 million, a decrease of 4 percent from the prior year. According to the company, lower sales were the result of sluggish sales in the acute-care and alternate-site businesses and product discontinuations. A partial-year contribution from Integra’s purchase of Medtronic’s MicroFrance in October partially offset the decline. Sales for U.S. Extremities were $143.4 million, an increase of 12 percent—mostly due to strong sales of dermal and wound-care products, including the company’s “thin” version of its Integra Wound Matrix, and from its shoulder product line, which increased as a result of the launch of a new reverse shoulder and increases in the number of distributors selling the technology. The remainder of the company’s lower and upper extremity franchise increased slightly during the period partially as a consequence of sales force turnover in the second quarter of 2014 as well as the transition to a new total foot system, officials reported. U.S. Spine division revenue, which includes spine hardware, orthobiologics and private-label products, were $171.4 million, a decrease of 6 percent. Sales of spine hardware softened due to ongoing pricing pressure, delays in expected product launches, and slower than anticipated addition of new distributors, according to the company’s leadership. The sales slump partially was offset by growth in orthobiologics, especially demineralized bone matrix and cancellous bone products, due to ongoing market demand. Sales of private-label products decreased from the prior-year period because some business was lost as a result of recall issues in 2013.