Park City, UT

3 days / 6 sessions
Current Issues in Spine

February 2-4, 2017

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December 6, 2018 OrthoSpineNews

LOGAN, UtahDec. 6, 2018 /PRNewswire/ — IntraFuse, a start-up medical device company operated by Surgical Frontiers, is focused on advanced surgical devices for improving outcomes for orthopedic extremity procedures, announced today that the United States Patent and Trademark Office has recently granted the company a key patent related to its FlexThread Intramedullary Fracture Fixation system.

US Patent 10,136,929 entitled “Flexible Bone Implant” is the first patent to issue from the intellectual property portfolio held by the company that includes additional pending US and international patent applications. The patent covers the novel combination of an intramedullary rod with cross fixation on end and a flexible bone screw on the other end. This platform technology enables percutaneous, secure fracture fixation of long bones of the extremities, especially for curved bones or where the surgical technique requires an off-axis approach to the intramedullary canal.

The simple and elegant design is easier to implant and lower cost than today’s standard-of-care fracture fixation hardware. Incorporating IntraFuse’s proprietary FlexThread technology, the distal end of the implant is a flexible, intramedullary screw and the proximal end is a rigid, high-strength intramedullary rod. Upon insertion of the implant into the bone, the rigid rod portion of the implant spans and supports the fracture and the flexible screw portion bends as needed to thread into the intramedullary canal. With internal screw fixation on one side of the fracture and cross screw fixation through the rod on the other side of the fracture, proper bone alignment and length can be maintained during the healing period.

The FlexThread System is currently FDA 510(k) cleared for fibula and clavicle indications, and the FlexThread™ technology is in further development for additional indications, include fractures of the fifth metatarsal bone, also known as a Jones fracture.

IntraFuse is a development stage medical device company incubated and operated by Surgical Frontiers.

About Surgical Frontiers
Surgical Frontiers develops advanced surgical technologies that are ready for clinical use.   Focused primarily on musculoskeletal injuries and pathologies, the company collaborates with surgeons, industry, universities, and investors to bring advanced surgical technologies to the market that improve healthcare.

Media Contact:
Mr. Wade Fallin 
CEO
205883@email4pr.com 
http://surgicalfrontiers.com/intrafuse/ 
800-230-3710

SOURCE Surgical Frontiers

Related Links

http://surgicalfrontiers.com


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December 5, 2018 OrthoSpineNews

Jupiter, Florida, Dec. 05, 2018 (GLOBE NEWSWIRE) — JUPITER, FLORIDA (December 5, 2018) — Jupiter Medical Center is the first hospital in the southeastern United States to use SpineJack®, an implantable system that relieves the pain of acute vertebral compression fractures (VCFs), the most common fracture in patients with osteoporosis. The innovative device stabilizes and restores damaged vertebra to their original shape and height in a minimally invasive procedure that takes about 30 minutes.

“We take pride in offering the most advanced treatment options available,” said Don McKenna, president and chief executive officer of Jupiter Medical Center. “With this new technology, we are establishing Jupiter Medical Center as a leader in spine care not just locally, but nationally.”

Approved by the U.S. Food and Drug Administration in September, SpineJack® has been commercially available in Europe since 2008, with more than 70,000 units implanted worldwide.  It is produced domestically by the Stryker medical technology company.

“This is a revolutionary advancement for treating many patients suffering from acute osteoporotic vertebral compression fractures,” said Dr. Jeffrey Miller, medical director of Neuroendovascular Surgery and co-medical director of the Stroke Program at Jupiter Medical Center. “We know from its success in Europe over the last decade that it significantly improves the patient’s quality of life almost immediately.”

“SpineJack® is part of the expanding array of treatment options available in Jupiter Medical Center’s Interventional Radiology Program,” said Dr. Lee A. Fox, medical director of Imaging at Jupiter Medical Center. “Our program offers a full scope of advanced diagnostic procedures and minimally invasive therapies, and we are delighted to bring this new treatment option to our patients.”

Dr. Miller performed Jupiter Medical Center’s first SpineJack® on Nov. 6. His patient, 75-year-old Robert Fischer of North Palm Beach, is pleased with the outcome.  “It’s only been three weeks and I feel close to perfect – I’d say 95 percent,” said Fischer, who was diagnosed with osteoporosis earlier this year after he began suffering debilitating back pain.

VCFs are the most common medical condition experienced by those with osteoporosis or low bone mass. VCFs occur when the vertebral body in the spine collapses, which can lead to severe pain, spinal deformity and loss of height. The fractures more commonly occur in the middle (thoracic) and lower (lumbar) portions of the spine. While osteoporosis is the most common cause, these fractures may also be caused by trauma or metastatic tumors. The lifetime risk of osteoporotic fracture for those older than 50 years of age is one in two for women and one in four for men.

“SpineJack® treats back pain by targeting the cause and, as a result, it reduces the need for long-term use of pain medication,” Dr. Miller said. “In addition to enhancing our patients’ quality of life, this procedure could have a significant impact in the effort to combat opioid addiction.”

For decades the only nonsurgical treatments for VCFs were bed rest, bracing (which limits mobility) and pain medication. Vertebroplasty has been used since the early 1990s and more recently kyphoplasty, which has become a mainstay in the treatment of VCFs. In vertebroplasty, bone cement is injected directly into the fractured vertebra, where it quickly hardens and acts like an internal cast. In kyphoplasty, a balloon is inserted into the fracture to expand the space before the cement is added. Neither procedure restores the vertebral body to its full height.

SpineJack® was invented by a French physician whose inspiration was a scissor jack, the diamond-shaped car jack that is commonly used to lift a vehicle when changing a flat tire. Instead of a kyphoplasty balloon, the procedure utilizes a titanium implant that resembles a tiny scissor jack, which is deployed into the fractured vertebral body. Once in place, the SpineJack® is expanded to lift the compressed vertebra and restore it to its normal height. Two implants are used in the procedure, one on each side of the vertebral body. They are locked into the desired expanded position and bone cement is then injected to stabilize the vertebra. The implant becomes encapsulated with bone cement resulting in pain relief for the patient.

Fischer proved to be the ideal patient to undergo the first SpineJack® at Jupiter Medical Center.  In August, while spending the summer in Rhode Island, he underwent a kyphoplasty procedure to treat a VCF in his upper back. While wintering in South Florida just a few months later, he suffered a second VCF during a round of golf—this time in his lower back. His primary care physician referred him to Dr. Miller, who thought he would be a good candidate for SpineJack®.

“My recovery was much quicker,” he said. “With (kyphoplasty), that recovery took about 10 weeks before I felt as good as SpineJack® feels now, just three weeks later. I would definitely recommend it.”

Performed on an outpatient basis, the procedure is appropriate for patients who have been diagnosed with a VCF within four to six months of treatment. For more information, visit https://www.jupitermed.com/spinejack or call 561-263-2200.

About Jupiter Medical Center

A not-for-profit 327-bed regional medical center consisting of 207 private acute-care hospital beds and 120 long-term care, sub-acute rehabilitation and Hospice beds, Jupiter Medical Center is reimagining how to restore the community’s health and wellness. Award-winning physicians, world-class partnerships and innovative techniques and technology enable Jupiter Medical Center to provide a broad range of services with specialty concentrations in cardiology, oncology, imaging, orthopedics & spine, digestive health, emergency and pediatric services, lung & thoracic, women’s health, weight management and men’s health.

Founded in 1979, Jupiter Medical Center has approximately 1,650 team members, 637 physicians and 640 volunteers. Jupiter Medical Center continues to perform in the top 10 percent of hospitals for patient quality and satisfaction. For more information on Jupiter Medical Center, please call (561) 263-2234 or visit www.jupitermed.com.

Attachments

Ernestine Williams
Jupiter Medical Center
5612633852
Ernestine.Williams@jupitermed.com

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December 5, 2018 OrthoSpineNews

DALLASDecember 5, 2018 /PRNewswire/ —

FX Shoulder USA, Inc. will begin in December 2018 the FDA approved Investigational Device Exemption (IDE) clinical study of the Easytech Reversed stemless, a shoulder prosthesis, with its first implantation scheduled for December.

Easytech Reversed Stemless is an innovative shoulder arthroplasty implant that will be under clinical study with (9) sites and (12) surgeons across the U.S. participating. Building on the current success in France (home of FX Shoulder USA’sparent company, FX Solutions), where over 800 Easytech Stemless Reversed prostheses have been successfully implanted, FX Shoulder USA is slated to enroll patients at two (2) investigational sites in December and continue enrollment with additional sites beginning in January 2019.

“The Easytech Reversed may be exactly what the U.S. market is in need of, and a reversed stemless prosthesis could potentially be the future of shoulder arthroplasty,” said Baptiste Martin, CEO of FX Shoulder USA. “We are excited to begin our clinical study and enthusiastic to see the results with each successive case throughout. There is a lot of excitement among the surgeon investigators for Easytech Reversed,” he continued. In Europe, as per the article in Med Device Online dated April 11, 2018, stemless implants are projected to surpass stemmed implants by 2025.

Founded in 2011, FX Solutions has developed a large, unique and innovative range of prosthetic shoulder products, which include the Easytech Reversed Stemless. FX Solutions is now the second largest player in the French market, with more than 3,000 prostheses sold in 2018.

FX Shoulder USA, based in Dallas, Texas, is the direct provider of FX Solutions shoulder replacement devices in the U.S. FX Shoulder USA was founded in January 2018 and focuses exclusively on shoulder arthroplasty with a growing distribution network.

Forward-Looking Statements

Statements in this press release, other than statements of historical fact, are forward-looking statements, are based on our current plans and expectations and are subject to risks and uncertainties that might cause actual results to differ materially from those such statements express or imply. The business and operations of the company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements. These risks and uncertainties include, but are not limited to, our ability to generate sufficient revenue to fund our commercial operations and development programs; and risks related to the development of Stemless Reversed shoulder prostheses, including regulatory approvals, mandates, oversight and other requirements. In this press release, forward looking statements include those concerning the development of the Stemless Reversed shoulder prosthesis, its safety and efficacy profile, its potential to benefit patients and our ability to make it available to those patients.  We disclaim any intention or duty to update forward-looking statements made in this press release.

http://www.fxshoulder.com

info@fxshoulder.com

SOURCE FX Shoulder USA

(Logo: https://mma.prnewswire.com/media/794130/FX_Shoulder_USA_Logo.jpg )

(Photo: https://mma.prnewswire.com/media/794131/FX_Shoulder.jpg )


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December 4, 2018 OrthoSpineNews

December 04, 2018

NOBLESVILLE, Ind.–(BUSINESS WIRE)–Nexxt Spine LLC, a medical device company focused on designing, manufacturing, and distributing innovative spinal solutions, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) and full commercial launch of its SAXXONY® Posterior Cervical Thoracic System—a system designed to stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments via posterior screw fixation in patients with degenerative disease, deformity, tumor, or trauma.

“The SAXXONY® System adds a robust posterior complement to our well received anterior cervical fixation offering as we continue to innovate and grow our fusion portfolio,” said Andy Elsbury, Nexxt Spine President.

The comprehensive offering includes standard and smooth shank screws available in a variety of diameter and length combinations, low profile cross connectors featuring multi-axis adjustability, and various configurations of offset, parallel, and axial connectors. The implant offering is complemented by streamlined instrumentation designed to ease rod placement and facilitate procedural efficiency.

In order to simplify longer complex constructs, the SAXXONY® Posterior Cervical Thoracic System has been designed to seamlessly link to the INERTIA® Pedicle Screw System with a variety of 3.5 to 5.5mm or 3.5 to 6.5mm rod-to-rod connectors and transition rods.

About Nexxt Spine

Nexxt Spine, LLC is a privately held medical device manufacturer dedicated to increasing procedural efficiency and patient outcomes through development of innovative products, manufactured on the most technologically advanced platforms, and utilizing irreproachable quality standards to treat painful and debilitating spinal pathologies. The company is growing rapidly and continues to recruit regional sales managers and independent distributors. For more information on Nexxt Spine and its products, please visit www.nexxtspine.com or email info@nexxtspine.com.

Contacts

Sarah Caito
scaito@nexxtspine.com


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December 4, 2018 OrthoSpineNews

December 04, 2018

MEMPHIS, Tenn.–(BUSINESS WIRE)–In2Bones Global, Inc. today announced the U.S. commercial market release of the CoLink Afx® Ankle Fracture System. The system is a collection of five plate families that address traumatic fractures and osteotomies (removal of bone) of the ankle.

Anatomy specific plate options consist of Lateral Fibula, Posterior-Lateral Fibula, One-Third Tubular, Medial Tibia, and Posterior Tibia. Associated 2.7 and 3.5mm cortical screws are offered with innovative CoLink® VAL- Variable Angle Locking Technology.

The low profile anatomically, designed titanium plates are type II anodized. They provide a stronger smoother surface compared to standard color anodization used in most plates on the market. The ultra-thin plates, along with minimal prominence at the plate and screw head interface, provide additional protection against patients experiencing soft tissue irritation, which can occur with conventional trauma hardware.

“This comprehensive set allows me to fix any pattern of ankle fracture,” says Travis Hanson, MD of Houston Methodist Orthopedics and Sports Medicine.

“It has every type of plate and screw combination that I need,” he says. “The contoured design of the new CoLink® Afx System provides increased confidence that my patients will receive a plate that fits their specific anatomy. These are the most low profile plates that I have used around the ankle.”

“We’re very excited about the commercial market release of the CoLink® Afx System,” says Jon Simon, Sr. Vice President of Marketing at In2Bones. “Expanding our portfolio into the high-volume ankle fracture market with a truly best-in-class product provides tremendous growth opportunities for us heading into 2019.”

For more information about In2Bones Global, Inc. extremity products, please visit www.In2Bones.com.

About In2Bones

Headquartered in Memphis, Tennessee, In2Bones is a global designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the upper (hand, wrist, elbow) and lower (foot and ankle) extremities. For more information, visit www.in2bones.com.

Contacts

Jon Simon | Sr. Vice President of Marketing
In2Bones USA
M: 512.739.5793 • O: 901.260.7931 • F: 844-712-6637
Email: jsimon@i2b-usa.com
https://www.linkedin.com/company/22344175/

Bob Reed
Element-R Partners
630.579.1770
bob@rurelevant.com


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November 30, 2018 OrthoSpineNews

UDINE, ItalyNovember 30, 2018 /PRNewswire/ —

LimaCorporate is pleased to announce the launch of the SMR TT Hybrid Glenoid, the latest addition to the SMR Shoulder System.

The SMR Shoulder System is a total shoulder replacement designed to provide surgeons a wide range of options to address the different patients’ pathologies. There have been over 150,000 implants performed worldwide.

SMR TT Hybrid Glenoid is the first glenoid component with hybrid fixation convertible from anatomic to reverse. Being part of the SMR Shoulder System, SMR TT Hybrid Glenoid has been designed to provide an innovative solution for glenoid replacement allowing for proper soft tissues management thanks to an optimal range of sizes, mismatch options, and a reliable fixation supported by a combination of polyethylene and Trabecular Titanium, LimaCorporate’s proprietary 3D printed technology.

After a limited release phase, the SMR TT Hybrid Glenoid has been launched in the USA and New Zealand. SMR TT Hybrid Glenoid has also received the CE mark and will be officially launched next year in February during the Paris Shoulder Course.

This important accomplishment has been reached thanks to the contribution of a panel of experienced shoulder surgeons coming from all over the world.

This year, the SMR Shoulder System has been awarded by the Orthopaedic Data Evaluation Panel (ODEP) in the UK, two ratings (ODEP ratings can be found on odep.org.uk) a 10A rating for the SMR Reverse with Uncemented Fixation (Metal Glenosphere / Polyethylene Liner Combination), making it the only Reverse with a 10A rating available on the market and a 5A ODEP Rating – SMR Reverse HP with Uncemented Fixation (Polyethylene Glenosphere / Metal Liner Combination).

“We are very excited about the introduction of this innovative device on the market, which allows LimaCorporate to further complete the Shoulder portfolio, keeping its outstanding clinical heritage and approaching a new fixation philosophy,” said Luigi Ferrari, CEO of LimaCorporate.

About LimaCorporate

LimaCorporate is a global medical device company providing reconstructive and custom-made Orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients. Based in Italy, LimaCorporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient. LimaCorporate’s product range includes large joint revision and primary implants and complete extremities solutions including fixation.

For additional information on the Company, please visit: limacorporate.com

Limacorporate S.p.A.
Via Nazionale, 52
33038 Villanova di San Daniele del Friuli
Udine – Italy
T: +39-0432-945511
E: info@limacorporate.com

SOURCE Limacorporate S.p.A.

(Logo: https://mma.prnewswire.com/media/637371/Lima_Corporate_Logo.jpg )


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November 28, 2018 OrthoSpineNews

Memphis, Tenn., (November 27, 2018) – In2Bones Global, Inc. today announces the commercial launch of the CoLink® View Plating System.

CoLink® View Bone Plates, marketed under the CoLink® View brand name, incorporate a unique combination of titanium metal and a high-performance polymer called polyether ether ketone (PEEK).

The CoLink® View Plates offer transverse joint compression through an X-ray transparent PEEK hub. This allows the surgeon to watch the patient’s bone fusion site during the post-surgical healing process.

Traditional metal plates cannot do this because metal absorbs X-rays and blocks the image underneath. The “see-through” hub is unique to this new In2Bones plating system, and one of many device innovations designed by the company.

In addition to X-ray transparency, PEEK has a benefit of being less stiff than metal and more similar to the elasticity of bone. Bones need mechanical stress (elasticity) during the healing process. Stiffer, all metal implants may eliminate the positive elasticity and slow healing.

The CoLink® View is the sixth In2Bones PEEK-related implant system to reach commercialization. It demonstrates In2Bones’ commitment to expanding the extremities market by launching innovative technological advancements to improve surgical outcomes and patient care.

For more information about In2Bones Global, Inc. extremity products, please visit www.In2Bones.com.

About In2Bones
Headquartered in Memphis, Tennessee, In2Bones is a global designer, manufacturer and distributor of medical devices for the treatment of disorders and injuries of the upper (hand, wrist, elbow) and lower (foot and ankle) extremities. For more information, visit www.i2b-usa.com.

Safe-Harbor Statement:
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements made in this press release, other than statements of historical fact, are forward-looking statements. Forward-looking statements reflect management’s current view of future performance, results, and trends and may be identified by their use of terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “will,” and other similar terms. The company wishes to caution readers that actual results might differ materially from those described in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties impacting the business, including increased competition, technical obsolescence, regulatory issues, general economic conditions and other risks.

Media Contacts:
Jon Simon | Sr. Vice President of Marketing
In2Bones USA
6000 Poplar Ave, Suite 115 Memphis, TN 38119
M: 512.739.5793 • O: 901.260.7931 • F: 844-712-6637
Email: jsimon@i2b-usa.com
https://www.linkedin.com/company/22344175/

Bob Reed
Element-R Partners
630.579.1770
bob@rurelevant.com

 


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November 27, 2018 OrthoSpineNews

November 27, 2018

MINNEAPOLIS–(BUSINESS WIRE)–Regentis Biomaterials today announced that Twin Cities-based TRIA Orthopedics is the first in Minnesota to perform a procedure using the GelrinC™ implant to treat damaged articular cartilage causing knee pain. GelrinC (pronounced “gel-rin-cee”) is an investigational device being evaluated as a treatment to help the body regrow cartilage in the knee. TRIA is the only site in Minnesota – and just one of 17 sites nationwide – enrolling patients with knee pain caused by damaged knee cartilage in the SAGE clinical trial.

Articular cartilage is the smooth, white tissue covering the ends of bones where they come together to form joints. Damage to the cartilage layer can be extremely painful for patients and is generally associated with sudden trauma. Surgical intervention is often required because of the limited capacity for cartilage to repair itself. The current standard of care is a procedure called microfracture, which involves making tiny holes in the bone underneath the damaged cartilage to stimulate the growth of new cartilage. However, the cartilage is more like scar tissue than the original hyaline cartilage; as a result, microfracture often provides only short-term relief and may require repeat surgeries.

“There are limited options for patients who continue to experience knee pain caused by damage to their articular cartilage,” said Dr. Brad Nelson, orthopedic surgeon. “The hope is that GelrinC, which requires only a single minimally invasive procedure, will promote repair of the cartilage and alleviate pain.”

People 18-50 years old with pain in one knee caused by damaged articular cartilage can inquire about the study by visiting www.MyKneeStudy.com or by calling (833) 430-8686.

About GelrinC™

In the U.S., GelrinC™ from Regentis Biomaterials is an investigational device for patients with articular cartilage damage in their knee. GelrinC’s unique mode of action allows it to be implanted as a liquid so that it completely fills the cartilage defect in the knee, and then be cured into a gel that enables the body’s own stem cells to settle on its surface. Six to 12 months after surgery, the GelrinC is gradually resorbed by the body and replaced by new cartilage tissue. Preliminary clinical trials in Europe have indicated that this regenerated tissue provides excellent improvement in pain and function. To learn more about GelrinC, please visit www.GelrinC.com.

About the SAGE Clinical Trial

The SAGE study is a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study comparing GelrinC to microfracture, the current standard of care treatment for damaged knee cartilage. The multi-center Phase III pivotal study will enroll 120 patients. All patients who meet study requirements and agree to enter the trial are provided GelrinC as treatment.

About Regentis Biomaterials

With offices in Princeton, New Jersey, and Or Akiva, Israel, Regentis Biomaterials is a privately held company focused on developing and commercializing proprietary hydrogels for tissue regeneration. The technology was originally developed at the Technion-Israel Institute of Technology by Dr. Dror Seliktar. For more information, please visit www.regentis.co.il.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

For media inquiries, please contact:
Joni Ramirez
Merryman Communications
323.532.0746
joni@merrymancommunications.com

Annelise Heitkamp
TRIA Orthopedics
952.977.3540
annelise.m.heitkamp@healthpartners.com


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November 21, 2018 OrthoSpineNews

November 20, 2018

WILTON, Conn.–(BUSINESS WIRE)–Altus Capital Partners, Inc. (“Altus”), an investment firm focused on the North American manufacturing sector, today announced it has acquired ChoiceSpine, LP, a leading designer, manufacturer, and marketer of specialized spinal implants, instrumentation and biologics for the surgical treatment of complex spine disorders. Financial terms of the transaction were not disclosed.

Based in Knoxville, TN and founded in 2006, ChoiceSpine, LP and Knox Spine, LLC (collectively, the Company) collaborates with physicians to develop new products which incorporate current medical technology with customized patient solutions. ChoiceSpine products include minimally invasive, cervical, thoracolumbar, interbody, lateral, and biologics kits and implants that increase procedural efficiency and efficacy.

“We recognize the need in the medical technology space for proven spinal products that can enhance the quality of life for spinal patients,” said Altus Co-Founder and Senior Partner Gregory L. Greenberg. “ChoiceSpine, a global medical device corporation specializing in innovative solutions for both spinal fusion hardware and biologics, demonstrates a track record of proven innovation, strong sales growth, increased distribution and the necessity of their products in the marketplace.”

Management will continue to invest in the expansion of the business. Altus Capital Partner Heidi Goldstein added, “We look forward to working with Founders Rick Henson and Marty Altshuler, who continue to invest alongside us in the Company, in further capitalizing on the depth of their design and engineering capabilities, sales growth and momentum.”

“We have built a deep bench of talent that has led the company with an increased focus on product design and engineering which benefit so many patients experiencing spinal injuries,” said Rick Henson. “We look forward to working with Altus in further developing our offerings as well as expanding into new product verticals to continue to grow the company and provide patient solutions for the treatment of spinal disorders,” added Marty Altshuler.

This is Altus’ third acquisition in less than two years and its second in the medical technology space. The firm successfully completed the tender offer for all of the outstanding shares of common stock of MGC Diagnostics Corporation (“MGC”), a global medical technology company dedicated to cardiorespiratory health solutions in December 2017, and the acquisition of Max Environmental Technologies, Inc., an integrated environmental solutions company, in February, 2017.

About ChoiceSpine

ChoiceSpine is a privately-held spinal device company located in Knoxville, TN. The company prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon-focused systems that are designed to be safe, efficient, and easy-to-use. By working closely with physicians and maintaining a service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to market.

About Altus Capital Partners

Altus Capital Partners is a private equity firm that makes control investments in middle market manufacturing businesses. We believe that our exclusive focus on manufacturing provides us with a unique understanding of the opportunities and challenges faced by companies in the sector. We utilize a patient, thoughtful investment approach and seek to partner with the management teams of our operating companies to achieve growth. With offices in Wilton, CT and Lincolnshire, IL, Altus Capital Partners has completed 18 platform investments and numerous add on acquisitions since 2003. For more information, please visit www.altuscapitalpartners.com/.

Contacts

Laura Brophy
Marketcom PR
203-331-7618
lbrophy@marketcompr.com


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November 19, 2018 OrthoSpineNews

ANNAPOLIS JUNCTION, MD, Nov. 19, 2018 (GLOBE NEWSWIRE) — Colfax Corporation (NYSE: CFX), a leading diversified technology company, today announced it has entered into a definitive agreement to acquire DJO Global Inc. (“DJO”) from private equity funds managed by Blackstone for $3.15 billion in cash. DJO is a global leader in orthopedic solutions, providing orthopedic devices, software and services spanning the full continuum of patient care, from injury prevention to rehabilitation.

“The acquisition of DJO is a compelling next step in the strategic evolution of Colfax that creates a new growth platform in the high-margin orthopedic solutions market,” said Matt Trerotola, President and Chief Executive Officer of Colfax. “As a clear market leader in bracing and rehabilitation systems – with a track record of innovative new products, globally recognized brands, and a diverse product portfolio – DJO is well-positioned to benefit from secular trends driven by changing demographics and increased preventive healthcare. This transaction reflects our strategic intent to diversify our portfolio and end-market exposure, reduce cyclicality, and increase profitability. We see significant opportunities to apply our proven Colfax Business System across DJO to create a continuous improvement culture, further improve productivity and margins, and accelerate innovation and new product development.”

Mr. Trerotola continued, “We are committed to reducing leverage and restoring balance sheet flexibility near-term and will explore strategic options for our Air and Gas Handling business. Longer term, we see tremendous opportunities to build our new medical technology platform with additional investment. We are excited to welcome DJO’s strong management team and talented associates to the Colfax family.”

“Joining Colfax is a win for our customers, and all DJO stakeholders,” said Brady Shirley, DJO President and CEO. “Colfax has the financial strength, experience, and proven business system to support our operational performance and growth.  Importantly, they are committed to our mission to get and keep people moving, and we are confident that the Colfax team’s operating expertise across a broad array of businesses makes them the ideal partner to help us build on our momentum, drive new levels of innovation, and continue to deliver outstanding service to our customers.”

Upon closing of the transaction, DJO Global will operate as a new segment within Colfax and be led by Mr. Shirley, who will report directly to Mr. Trerotola.

With leadership positions in most product categories, DJO provides a broad range of orthopedic care solutions including bracing, reconstructive implants, rehabilitation devices, software and services. Known for its innovative products, DJO’s portfolio of iconic brands are trusted by patients, athletes, and healthcare professionals globally. Headquartered in Vista, California, DJO has approximately 5,000 employees across 18 locations around the world. DJO’s revenue was $1.2 billion and adjusted EBITDA was $269 million for the twelve-month period ending September 2018.

Financing & Transaction Details
The transaction, which is expected to close in the first quarter of 2019, is expected to deliver adjusted EPS accretion in the first full year after closing. In addition, Colfax expects to realize future tax benefits from DJO’s approximately $800 million of net operating loss carryforwards.

Colfax expects to finance the transaction with approximately $100 million of cash from its balance sheet, proceeds from credit facilities and a contemplated debt offering, and $500 to $700 million from a contemplated offering of equity or equity-linked securities. J.P. Morgan and Credit Suisse have committed to provide bridge financing for the transaction. Colfax expects to maintain its existing debt ratings and will prioritize deleveraging to reduce its net leverage ratio to the mid-3x range by the end of calendar 2019. In connection with its deleveraging plans, Colfax is evaluating strategic options for its Air and Gas Handling business. Colfax does not intend to undertake any material acquisitions or share repurchases until its leverage metrics return to targeted levels.

The acquisition is subject to customary closing conditions, including receipt of applicable regulatory approvals.

Advisors
J.P Morgan is serving as financial advisor and Kirkland & Ellis is serving as legal advisor to Colfax.  Goldman, Sachs & Co. LLC, Credit Suisse, and Wells Fargo Securities, LLC are serving as financial advisors and Simpson Thacher & Bartlett LLP is serving as legal advisor to DJO.

Conference Call and Webcast
Colfax will host a conference call to discuss the transaction today at 8:30 a.m. Eastern. The call will be open to the public through 877-303-7908 (U.S. callers) or +1-678-373-0875 (international callers) and referencing the conference ID number 6068397 or through webcast via Colfax’s website at www.colfaxcorp.com under the “Investors” section. Access to a supplemental slide presentation can also be found at the Colfax website under the same heading. Both the audio of this call and the slide presentation will be archived on the website later today and will be available until the next quarterly call.

About Colfax Corporation
Colfax Corporation is a leading diversified technology company that provides air & gas handling and fabrication technology products and services to customers around the world principally under the Howden and ESAB brands. Colfax believes that its brands are among the most highly recognized in each of the markets that it serves. The Company uses its Colfax Business System (CBS), a comprehensive set of tools, processes and values, to create superior value for customers, shareholders and associates. Colfax is traded on the NYSE under the ticker “CFX.” Additional information about Colfax is available at www.colfaxcorp.com.

About DJO Global
DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation, enabling people to regain or maintain their natural motion. Its products are used by orthopedic surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and Exos™.
Additional information about DJO Global is available at www.DJOglobal.com.

CAUTIONARY NOTE CONCERNING FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, including forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements concerning Colfax’s plans, objectives, expectations and intentions and other statements that are not historical or current fact. Forward-looking statements are based on Colfax’s current expectations and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such forward-looking statements. Factors that could cause Colfax’s results to differ materially from current expectations include, but are not limited to risks and uncertainties regarding Colfax and DJO’s respective businesses and the proposed acquisition, and actual results may differ materially. These risks and uncertainties include, but are not limited to, (i) the ability of the parties to successfully complete the proposed acquisition on anticipated terms and timing, including obtaining required regulatory approvals and other conditions to the completion of the acquisition, (ii)  access to available financing on a timely basis and reasonable terms, (iii) the effects of the transaction on Colfax and DJO operations, including on the combined company’s future financial condition and performance, operating results, strategy and plans, including anticipated tax treatment, unforeseen liabilities, future capital expenditures, revenues, expenses, earnings, synergies, economic performance, indebtedness, losses, future prospects, business and management strategies for the management, expansion and growth of the new combined company’s operations, and (iv) other factors detailed in Colfax’s and DJO’s respective reports filed with the U.S. Securities and Exchange Commission on Form 10-K and Form 10-Q.  In addition, these statements are based on a number of assumptions that are subject to change. This press release speaks only as of the date hereof. Colfax disclaims any duty to update the information herein.

The term “Colfax” in reference to the activities described in this press release may mean one or more of Colfax’s global operating subsidiaries and/or their internal business divisions and does not necessarily indicate activities engaged in by Colfax Corporation.

Non-GAAP Financial Measures and Other Adjustments  
Colfax has provided in this press release financial measures for DJO Global that have not been prepared in accordance with GAAP, including Adjusted EBITDA and Leverageable Adjusted EBITDA.  DJO Global provided Colfax with this information, which was derived from DJO Global’s historical unaudited financial statements for the twelve months ended September 29, 2018 and has not been audited or reviewed by Colfax’s or DJO Global’s independent public accountants.  DJO Global defines Adjusted EBITDA as net income (loss) attributable to DJO Global plus interest expense, net, income tax provision (benefit), and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items as permitted in calculating covenant compliance and other ratios under the agreements governing the outstanding debt of DJO Global’s subsidiary DJO Finance, LLC (DJO Finance).  DJO Global defines Leverageable Adjusted EBITDA as Adjusted EBITDA, as further adjusted to reflect certain additional non-cash items, non-recurring items and other adjustment items permitted in calculating covenant compliance and other ratios under the agreements governing the outstanding debt of DJO Finance. Adjusted EBITDA and Leverageable Adjusted EBITDA should not be considered as an alternative to net income (loss) attributable to DJO Global or other performance measures presented in accordance with GAAP, or as an alternative to cash flow from operations as a measure of liquidity.

Colfax believes this presentation of DJO Global’s Adjusted EBITDA and Leverageable Adjusted EBITDA is useful and helps management, investors and rating agencies enhance their understanding of the impact of the DJO Global acquisition on Colfax’s financial performance.  However, Adjusted EBITDA and Leverageable Adjusted EBITDA do not have a standardized meaning, and different companies may use different Adjusted EBITDA definitions.  Therefore, DJO Global’s definition of Adjusted EBITDA and Leverageable Adjusted EBITDA may not be comparable to the definitions used by other companies.

Non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information calculated in accordance with GAAP. Investors are encouraged to review the reconciliation of Adjusted EBITDA and Leverageable Adjusted EBITDA to the most directly comparable GAAP financial measure. A reconciliation of Adjusted EBITDA and Leverageable Adjusted EBITDA to GAAP net income has been provided below.

DJO Global, Inc.
Adjusted EBITDA Reconciliation of GAAP
Dollars in thousands
(Unaudited)

Twelve 
Months 
Ended September 29, 2018
Adjusted EBITDA
Net income attributable to DJO Global $ 397
Discontinued operations (567 )
Interest expense, net 181,091
Income tax provision (benefit) (55,196 )
Depreciation and amortization 107,646
Loss on disposal of assets, net 295
Restructuring and reorganization (1) 41,121
Acquisition integration 2,096
Blackstone monitoring fee 975
Financial reporting alignment (9,071 )
Adjusted EBITDA $ 268,787
Future cost savings 20,533
Stock compensation expense 4,522
Leverageable Adjusted EBITDA $ 293,842

(1) Consists of costs related to the company’s business transformation projects to improve the company’s operational profitability and liquidity.

NO OFFER OR SOLICITATION
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended or via an exemption from the requirements of the Securities Act.

Investors:                                                                    
Kevin Johnson, Vice President                                   
Colfax Corporation                                                      
+1-301-323-9090                                                        
investorrelations@colfaxcorp.com

Media:
Jim Barron or Jenny Gore
Sard Verbinnen & Co.
+1-212-687-8080