Monday, January 18, 2016

News: BioPoly® Patent Issues

January 08, 2016
Written by: BioPoly, LLC
FORT WAYNE, IN – BioPoly LLC announced that another US patent pertaining to the BioPoly®technology has issued. According to the Company, this patent protects the partial resurfacing implant designs and method of implantation. The patent is part of an extensive IP portfolio strategy that BioPoly LLC has employed to globally protect its unique orthopaedic material, manufacturing methods, and implant technology.
The proprietary BioPoly® material technology combines an orthopaedic polymer (i.e. ultra-high molecular weight polyethylene or UHMWPE) with an orthopaedic lubricating molecule, hyaluronic acid or HA. The combination of these materials results in a very unique and important orthopaedic material that is robust (due to the UHMWPE) enough to carry anatomical loads, yet self-lubricated (due to the HA) so that it is extremely biocompatible with cartilage tissues. BioPoly® orthopaedic implants, therefore, permit surgeons to replace only the damaged portion of joints (knee, patella, shoulder, etc…) as opposed to the entire joint. The BioPoly portfolio currently includes implants that partially resurface the joint, allowing patients to return to a pain-free lifestyle with normal activities very quickly.
BioPoly® products are CE marked and have been in use clinically since 2012. They are available in many countries throughout the world through our global distribution partner, OrthoD Group. BioPoly products have not yet been approved by the FDA for use in the US.

About BioPoly LLC
BioPoly LLC is an ISO 13485 certified orthopaedic implant manufacturer located in Fort Wayne, Indiana. The Company is developing, manufacturing and marketing products for use in sports medicine, orthopaedics, and spinal markets. Additional medical applications of the BioPoly®technology in cardiovascular and trauma markets are also being pursued.

BioPoly, LLC


BioPoly™

Hyaluronic acid (HA) is a naturally occuring substance found in joint synovial fluid.  Its primary role is to act as a lubricant enabling smooth pain free articulation.

Ultra High Molecular Weight Polyethelyne (UHMWPE) is a biocompatible polymer with a long history of use in orthopaedic implants, primarily as the bearing material in total joint arthroplasty.

Utilizing a patented process these two materials have been combined to create an advanced orthopaedic biomaterial with exceptional wear properties and sufficient strength to support anatomical loading.

Advanced Properties

Histological image of BioPoly
in an osteochondral defect
from a preclinical study
The BioPoly™ material with its interpenetrated HA molecules give BioPoly enhanced lubricity over traditional UHMWPE contributing to lower wear rates and a lower coefficient of friction.

With the now hydrophilic (water attracting) surface the BioPoly material can better interface with hydrophilic tissues like natural cartilage.

BioPoly has sufficient strength to support anatomical loading yet it has a stiffness an order of magnitude less than implantable metals.

Published at BioPoly News

News: K2M Group Holdings, Inc. Reports Preliminary Fourth Quarter and Full Year 2015 Financial Results With 17% Annual Growth

LEESBURG, Va., Jan. 11, 2016 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (Nasdaq:KTWO) (the "Company" or "K2M"), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine and minimally invasive technologies and techniques, today reported preliminary financial results for the fourth quarter and full year ended December 31, 2015.



Fiscal Year 2015 Financial Summary:
  • Full year 2015 revenue of $216.0 million to $216.3 million, up approximately 16% year-over-year, or 17% on a constant currency basis
  • The Company continues to expect full year 2015 Adjusted EBITDA will be within the range of its previously provided guidance

Fourth Quarter Revenue Summary:
  • Total Q4 revenue of $54.1 million to $54.4 million, up approximately 10% to 11% year-over-year
    -- Domestic Q4 revenue of $39.2 million to $39.4 million, up approximately 10% year-over-year, comprised of:
    • U.S. Complex Spine growth of approximately 12% year-over-year
    • U.S. Minimally Invasive Spine (MIS) growth of approximately 20% year-over-year
    • U.S. Degenerative growth of approximately 6% year-over-year
  • International Q4 revenue of $15.0 million to $15.1 million, up approximately 11% year-over-year, or 14% on a constant currency basis

2016 Preliminary Outlook:
  • 2016 revenue guidance of $246 million to $250 million or 14% to 16% year-over-year, on an as reported basis

"Our preliminary financial results for the full year of 2015 reflect total revenue growth of approximately 17% year-over-year on a constant currency basis, fueled by our strong complex spine portfolio," said President and Chief Executive Officer, Eric Major. "2015 was a significant year of innovation in complex spine.  Over the past year, we released the MESA® 2 Deformity Spinal System, EVEREST® Deformity Spinal System, the NILE™ Alternative Fixation System, and the CAPRI™ Corpectomy Cage System.  We expect these spine products – as well as our recently launched CASCADIA™ Interbody Systems – to fuel the continued strong top-line growth expected for our Company in fiscal year 2016.”
The financial estimates presented above are preliminary and remain subject to management's final review as well as audit by the Company's independent registered accounting firm. The Company intends to report complete fourth quarter and full-year 2015 financial results in late February or early March. Details regarding the timing of the release of those results, as well as details of a conference call and publicly available webcast, will be announced in a subsequent press release.

About K2M Group Holdings, Inc.
K2M Group Holdings, Inc. is a global medical device company focused on designing, developing and commercializing innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most difficult and challenging spinal pathologies. K2M has leveraged these core competencies to bring to market an increasing number of products for patients suffering from degenerative spinal conditions. These technologies and techniques, in combination with a robust product pipeline, enable the Company to favorably compete in the global spinal surgery market. Additional information is available online at www.K2M.com.

Forward-Looking Statements
This press release contains forward-looking statements that reflect our current views with respect to, among other things, our operations and financial performance.  Forward-looking statements include all statements that are not historical facts.  In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability; our ability to successfully demonstrate the merits of our technologies; pricing pressure from our competitors, hospitals and changes in third-party coverage and reimbursement; competition and our ability to develop and commercialize new products; aggregation of hospital purchasing from collaboration and consolidation; hospitals and other healthcare providers may be unable to obtain adequate coverage and reimbursement for procedures performed using our products; the safety and efficacy of our products is not yet supported by long-term clinical data; our dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors; the proliferation of physician-owned distributorships; concentration of sales from a limited number of spinal systems or products that incorporate these technologies; loss of the services of key members of our senior management, consultants or personnel; ability to enhance our product offerings through our research and development efforts; failure to properly manage our anticipated growth; acquisitions of or investments in new or complementary businesses, products or technologies; ability to train surgeons on the safe and appropriate use of our products; requirements to maintain high levels of inventory; impairment of our goodwill or intangible assets; disruptions in our information technology systems; any disruption in operations at our headquarters facility or an ability to ship a sufficient number of our products to meet demand; ability to strengthen our brand; fluctuations in insurance cost and availability; extensive governmental regulation; failure to obtain or maintain regulatory approvals and clearances; requirements for new 510(k) clearances, premarket approvals or new or amended CE Certificates of Conformity; medical device reporting regulations, voluntary corrective actions or agency enforcement actions; a recall of our products or the discovery of serious safety issues with our products; possible enforcement action if we engage in improper marketing or promotion of our products; the misuse or off-label use of our products; delays or failures in any future clinical trials;  the results of clinical trials; procurement and use of allograft bone tissue; environmental laws and regulations; compliance by us or our sales representatives with fraud and abuse laws; U.S. legislative or regulatory healthcare reforms; medical device tax provisions in the healthcare reform laws; our need to generate significant sales to become profitable; potential fluctuations in sales volumes and our results of operations may fluctuate over the course of the year; uncertainty in our future capital needs; continuing worldwide economic instability; our inability to protect our intellectual property rights; our reliance on patent rights that we either license from others or have obtained through assignments; our patent litigation; the outcome of potential claims that we, our employees, our independent sales agencies or our distributors have wrongfully used or disclosed alleged trade secrets or are in breach of non-competition or non-solicitation agreements with our competitors; potential product liability lawsuits; operating risks relating to our international operations; our ability to comply with the Foreign Corrupt Practices Act and similar laws associated with our activities outside the United States; control by and possible conflicts of interest with our controlling shareholder; increased costs and additional regulations and requirements as a result of becoming a public company; our ability to implement and maintain effective internal control over financial reporting in the future; the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 18, 2015, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment.  New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release.  We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made.  We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.  We may not actually achieve the plans, intentions or expectations disclosed in our forward looking statements and you should not place undue reliance on our forward-looking statements.
 
Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA 443-213-0500
K2M@westwicke.com

Published at Nasdaq GlobeNewswire

Friday, January 15, 2016

News: CareFusion Receives Two 510(k) Clearances For Spine Products

FRANKLIN LAKES, N.J., Dec. 10, 2015 /PRNewswire/ -- CareFusion, a BD company (NYSE: BDX), today announced the U.S. Food and Drug Administration (FDA) has cleared two 510(k)s for its spine augmentation devices.

The new 13-gauge AVAmax® Vertebral Balloon system expands the company's offerings in devices to treat vertebral compression fractures. The balloon fits down a 13-gauge cannula, which has a cross-sectional area that is 37 percent smaller than the 11-gauge cannula and 50 percent smaller than the 10-gauge cannula. The smaller size creates a smaller access point, resulting in less trauma than larger cannulas. This will be the smallest straight-line vertebral balloon in the industry to date, enabling vertebral augmentation higher in the spine than with current offerings. The 13-gauge balloon will be offered in 10mm, 15mm and 20mm lengths.
The new 11-gauge AVAflex® Vertebral Balloon System will enable targeted balloon placement across the midline of the vertebral body through a unipedicular, lateral approach, but higher in the spine through a smaller cannula than current products. The AVAflex needle then allows targeted cement placement for an optimal fill. Once commercially available, the 11-gauge AVAflex balloon will be the smallest curved balloon in the industry and will also have the benefits of a smaller access point and less trauma to the patient. The 11-gauge AVAflex will be available in 15mm, 20mm and 30mm lengths.
"We are committed to investing in research and development to create new innovations that benefit patients and providers," said Jim Leitl, worldwide vice president and general manager of Infection Prevention, V. Mueller and Interventional Specialties for BD. "We are proud to offer a wide variety of minimally invasive vertebral augmentation devices for providers to choose the right treatment for their patients."
CareFusion expects a full commercial launch within a year. With this launch, CareFusion will maintain the most comprehensive portfolio of vertebral balloon products in the industry.
About CareFusion 
CareFusion, a BD company, serves the health care industry with products and services that help hospitals measurably improve the safety and quality of care. The company develops industry-leading technologies including Alaris® infusion pumps and IV sets, MaxPlus® and MaxZero IV connectors and sets, Pyxis® automated dispensing and patient identification systems, AVEA®, LTV®series and AirLife® ventilation and respiratory products, ChloraPrep® products, MedMined® services for data mining surveillance, V. Mueller® surgical instruments, and an extensive line of products that support interventional medicine. For more information please visit www.carefusion.com.

About BD
BD is a leading medical technology company that partners with customers and stakeholders to address many of the world's most pressing and evolving health needs. Our innovative solutions are focused on improving medication management and patient safety; supporting infection prevention practices; equipping surgical and interventional procedures; improving drug delivery; aiding anesthesiology and respiratory care; advancing cellular research and applications; enhancing the diagnosis of infectious diseases and cancers; and supporting the management of diabetes. We are more than 45,000 associates in 50 countries who strive to fulfill our purpose of "Helping all people live healthy lives" by advancing the quality, accessibility, safety and affordability of healthcare around the world. In 2015, BD welcomed CareFusion and its products into the BD family of solutions. For more information on BD, please visitwww.bd.com.

Published at PR NewsWire



News: MiMedx Group (MDXG) Announces Completion of Stability Acquisition

Image result for medimax group inc
MiMedx Group, Inc. (NASDAQ: MDXG) announced today the completion of the acquisition of Stability Inc., d/b/a Stability Biologics, a provider of human tissue products to surgeons, facilities and distributors serving the surgical, spine and orthopedics sectors of the healthcare industry. The transaction was originally announced on January 10, 2016.

Stability Biologics, which will operate as a wholly owned subsidiary of MiMedx, has developed an innovative proprietary platform in bioactive bone graft products and tissue allografts including structural/particulate bone, tendons/ligaments, structural allografts, demineralized bone matrix (DBM) and skin products for burns and traumatic wound care. Most recently, Stability Biologics introduced Physio™, a unique bone grafting material comprised of 100% bone tissue with no added carrier, thus maximizing bone forming potential.
MiMedx affirmed its previously announced expectations for the transaction to be accretive to Full Year 2016 Adjusted EPS* and its conservative projection for the 2016 Stability Biologics revenues from its processed tissue and bone product sales and distribution to be at least $15 million. The Company also confirmed that the closing consideration for the transaction was $10 million paid at closing, comprised of 60% cash and 40% stock, plus assumed debt, with future contingent consideration to be paid through a two-year earn out arrangement based on the 2016 and 2017 performance of the Stability Biologics business. MiMedx affirmed that it still expects the earn out to be the larger portion of the overall consideration for the transaction.
Published at streetinsider.com

News: Kapstone Medical & Band-Lok Announce Issuance Of US Patent For Orthopedic Tether Clamp & Implantation System

United States Patent No. 9,173,685 was issued by the United States Patent and Trademark Office to North Carolina-based Band-Lok, LLC on November 3rd, 2015.
Tuesday, January 12th, 2016, 3:00 AM 

Waxhaw, North Carolina – Kapstone Medical, LLC, a product development and intellectual property service provider for medical device innovators, and , an orthopedic medical device innovation firm, are pleased to report receipt of the official United States Letters Patent for the Band-Lok Tether Clamp and Implantation System, U.S. Patent No. 9,173,685, which was issued by the United States Patent and Trademark Office (USPTO) on November 3rd, 2015.

Kapstone Medical Device Development“The issuance of the US patent for this one-of-a-kind system is a positive step in our quest for outstanding patient care,” said Randy Roof, Co-Founder and President of Band-Lok, LLC. “Painstakingly invented by our core team of engineers and orthopedic experts, and filed in 2012, we are eager to begin seeing the benefits that we are sure the Tether Clamp and Implantation system will have on patients across the country.”
The Tether Clamp and Implantation System, developed through a collaboration between Band-Lok and Kapstone Medical, is a clamp housing assembly and method for providing stabilization as a bone anchor during an orthopedic surgical procedure. The assembly includes a housing, a locking element, and a band.
“Our intent with Band-Lok is to continue to provide leading edge, quality, patient-focused innovations to as many surgeons, medical centers, and patients as we can,” said John Kapitan, Co-Founder of Band-Lok, LLC and Founder and President of Kapstone Medical, LLC. “The Tether Clamp and Implantation System patent issuance is a decisive step in that direction.”
About Band-Lok, LLC
Based in Waxhaw, NC, Band-Lok LLC is a team of surgeons, orthopedic medical device experts and engineers focused on providing quality medical device systems to hospitals, surgeons, and patients across the United States.
 About Kapstone Medical, LLC
Kapstone Medical has been helping innovators develop and safeguard their ideas since 2007. It is a privately held engineering firm headquartered in Charlotte, North Carolina. The company integrates a suite of in-house disciplines to give physician inventors, entrepreneurs and manufacturers of all sizes the opportunity to efficiently develop new ideas on time and on budget. Kapstone Medical’s range of services includes all aspects of product development, IP protection, regulatory, quality assurance, and supply chain management.

Contact Information

John Kapitan
Founder & President, Kapstone Medical LLC
100 E. South Main St – P.O. Box 1458 – Waxhaw, NC 28173 – USA
phone: 704 843-7852
 Randy Roof
Co-Founder and President, Band-Lok LLC
101 Waxhaw Professional Park Dr., Suite A – Waxhaw, NC 28173 – USA
phone: 704-243-0892

Wednesday, January 6, 2016

News: Agent Medical, LLC Launches Two New Lower Extremity Products

January 5, 2016 8:02 AM EST 

RICHMOND, Va., Jan. 05, 2016 (GLOBE NEWSWIRE) -- Agent Medical, LLC (“Agent Medical”), an orthopaedic medical device company pioneering solutions for patients suffering lower extremity maladies, today announced the launch of two new products that have already received positive reviews from surgeons.
Innovative Surgical SolutionsAgent Medical, headquartered in Richmond, VA, has brought to the market creative solutions to surgical challenges for orthopaedic and podiatric surgeons. The company has recently developed two products manufactured in the USA: the patent pending ArthroBridge™, a surgical implant for the treatment of hammertoes, and the patent pending ArthroMate™, an anatomically designed rasp system designed for rear foot fusion procedures.
According to J. Scott Munday, founder and president of Agent Medical and a 30-year veteran in the lower extremity medical market, the ArthroBridge™ and ArthroMate™ devices have been carefully designed and manufactured to overcome deficiencies in current products, assist physicians in minimizing operating room time and most importantly improving long-term results for patients. These devices have the ability to be game changers within the industry.
ArthroBridge
ArthroBridge™ is a titanium cannulated compression screw paired with a module inserted in the proximal side of the toe to create a lag structure that enhances compression of the joint and promotes better fusion. Designed with screw lengths from 15mm to 50mm and module sizes from 4.0mm to 5.0mm, the device provides for an array of sizing options to accommodate procedures on all toes including the IP joint. Its hex head design allows for simple insertion and removal of screws without stripping. The ArthroBridge™ device also comes complete with a sterile single-use instrument kit with multi-purpose instruments to streamline the surgical procedure for operating room staff. The device has been cleared by the FDA and can be used for primary and revision hammertoe surgeries, in addition to applications for fracture fixation in the hands and feet.
According to Munday, the ArthroBridge™ device eliminates many of the current problems that surgeons see today. He notes that some competitive designs are required to be coupled together at the same time that bone surfaces compress together. Additionally, others rely on an impaction of bones onto a design that does not provide for a dynamic compressive environment.
“These issues are just not practical for the surgeon or the patient,” Munday added. “We took these issues into account and our simple dual diameter design allows for stable, true internal lag compression that involves bones with differing medullary canal diameters. Our instrumentation and implant designs assure that dynamic compression is applied to the joints after the bone surfaces are prepared and compression applied. It’s a win-win for the surgeon and the patient.”
ArthroMate™
The ArthroMate™ Rear Foot Rasp System reduces the time, effort and expense in preparing joint surfaces for lower extremity fusions. It also eliminates the need for multiple instrument sets on the back table during fusion procedures. It comes in an array of sizes and shapes – starter, angled, paddled, and curved – for effective use on any joint in the foot during surgical fusion procedures.  The instrument also has applications in the hand, hip, knee and shoulder.
“When I founded Agent Medical, I not only wanted to improve patient outcomes, but also work with physicians to develop innovative products that will reduce the time and effort necessary to perform surgical procedures.” Munday said. “It’s exciting to see the impact our rasping system can have on the time it takes to prepare rear foot joints for fusion. This leads to reduced operating room times, lower costs and shorter patient sedation periods.”
About Agent MedicalHeadquartered in Richmond, VA, Agent Medical is a national medical device provider within the orthopaedic and podiatric market whose focus is solving challenges faced by the foot and ankle reconstructive surgeon, overcoming anatomical and biomechanical problems using solid principles of design and improving patient outcomes. The company includes an investment and management team well experienced in strategy development and business execution, finance, operations, customer service, marketing, product development and regulatory and risk management. The products will be sold by our growing network of distributors and by contacting Agent Medical directly at www.agentmedicalsolutions.com.
CONTACT
Investors & Media:
Brian Chandler 804-221-9177
Source: Agent Medical, LLC

Published at streetinsider.com

News: NuVasive to Acquire Ellipse Technologies


SAN DIEGO, CA and ALISO VIEJO, CA -- (Marketwired) -- 01/05/16 -- 

Image result for nuvasiveReflects NuVasive's Focus on Transformative Spine Solutions, Reinforces Leadership Position With the Addition of Fast-Growing Complex Deformity Franchise; Expected to Accelerate the Company's Revenue Growth and Be Accretive to Non-GAAP Diluted Earnings per Share Within First 12 Months; Investor Conference Call to Be Held at 5:00 p.m. ET Today
NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, andEllipse Technologies, Inc. ("Ellipse"), a privately held medical technology company focused on revolutionizing procedural solutions for complex skeletal deformity, today announced that the Boards of Directors of both companies have unanimously approved a definitive agreement under which NuVasive will acquire Ellipse for a $380 million upfront cash payment and a potential $30 million milestone payable in 2017 related to the achievement of specific revenue targets. NuVasive expects the acquisition to accelerate its revenue growth toward the high-single digit range and to be slightly accretive to the Company's non-GAAP diluted earnings per share within the first 12 months and significantly accretive thereafter. NuVasive also expects the transaction to support its five-year, double-digit return on invested capital goal, consistent with the Company's previously stated acquisition criteria. 
The acquisition builds on NuVasive's reputation as the leading technology provider for spine procedure solutions by adding a highly regarded, disruptive technology platform. Ellipse's magnetic growing rod technology is currently receiving rapid adoption in the pediatric deformity and orthopedic markets, providing for new growth opportunities beyond NuVasive's current portfolio of winning solutions that address adult degenerative and deformity spinal conditions.
magecfilmEllipse is the developer and marketer of a novel platform of magnetically adjustable implant systems based on its MAGnetic External Control, or MAGEC®, technology. Ellipse's novel and proprietary implants are adjustable at the time of implantation and are distracted non-invasively over the course of treatment to accommodate the changing clinical needs of patients as they heal, grow or age. Ellipse's MAGEC technology enables physicians to customize therapy for patients in a non-invasive manner, reducing the need for further repeat surgical procedures, and providing meaningful improvements in patient clinical outcomes and quality of life while generating cost savings to the healthcare system.
"Ellipse's revolutionary technology, which has been enthusiastically received by surgeons, has the potential to become the standard of care for spine and orthopedic patients. It is in NuVasive's sweet-spot of game-changing innovation, bolstering our leadership in spine and providing new growth opportunities in the U.S. and around the world," saidGregory T. LucierNuVasive's Chairman and Chief Executive Officer. "NuVasive remains committed to adult deformity through our Integrated Global Alignment (iGA™) platform, and the acquisition of Ellipse will aggressively insert NuVasiveinto early onset and idiopathic scoliosis, an important and attractive part of the spinal deformity market for NuVasivewhere we have tremendous opportunities for accelerated growth. Additionally, this investment expands NuVasive'sfootprint into new niche markets with highly differentiated technology that -- when coupled with our market-making expertise -- will be strategically applied in other spine and orthopedic applications, including degenerative spine disease, trauma and knee osteoarthritis. Ellipse's robust product pipeline also enhances internal development and licensing opportunities for NuVasive, including areas where we look to assemble with our iGA™ and neuromonitoring expertise. We are very excited to welcome Ellipse's talented team to NuVasive and look forward to realizing the many operational and financial benefits this transaction creates."
Edmund J. Roschak, President and Chief Executive Officer of Ellipse Technologies, said, "Ellipse has made enormous strides since our founding ten years ago. Joining forces with NuVasive not only validates the promise of our technology, but provides us with the scale and resources necessary to realize our full potential, to the benefit of our surgeon customers and their patients, faster than we could achieve on our own. Additionally, NuVasive's longstanding commitment to developing market-leading, less invasive technological solutions represents a tremendous cultural fit. Innovation, a passion for excellence and improved clinical outcomes have all been hallmarks of Ellipse, and ones that I know will continue as part of NuVasive. We look forward to joining with NuVasive to continue to help improve patient lives."
Founded in 2005, Ellipse has commercialized two highly differentiated and rapidly adopted product families: the MAGEC−EOS spinal bracing and distraction system for treatment of early onset scoliosis and the PRECICE® limb lengthening system, or PRECICE LLD, for treatment of limb length discrepancy. These products have been used to treat more than 5,000 patients worldwide. The global addressable market opportunity for Ellipse's currently commercialized products was approximately $1.2 billion as of the end of 2014 based on data from Life Science Intelligence, Inc. In addition, Ellipse's product candidates that leverage the MAGEC® technology platform addressed a significant global opportunity of more than 690,000 annual procedures based on this data. For 2015, Ellipse had revenues of approximately $40 millioncompared to approximately $26 million in 2014, representing 54% year-over-year growth. Ellipse's products are marketed and sold in the U.S. and 29 other countries. Revenues outside of the U.S. represented approximately 45% of Ellipse's revenues in 2014 and approximately 37% of revenues for 2015. For 2016, Ellipse's revenues are expected to be approximately $60 million on a pro forma basis as the company continues its exceptional growth trajectory.
The transaction is expected to close by the end of February 2016, subject to customary closing conditions and regulatory approvals. NuVasive expects to fund the acquisition with existing cash on hand.
After the closing of the transaction, NuVasive plans to maintain a Design Center of Excellence in Aliso Viejo, California, where Ellipse is headquartered. Mr. Roschak will join NuVasive as a member of the NuVasive executive leadership team reporting directly to Mr. Lucier.
Advisors
Goldman, Sachs & Co. is serving as exclusive financial advisor to NuVasive and DLA Piper is serving as its legal counsel.Piper Jaffray is serving as exclusive financial advisor to Ellipse and Latham & Watkins is serving as its legal counsel.
Investor Conference Call
NuVasive will hold a conference call today at 5:00 p.m. ET / 2:00 p.m. PT to discuss the details of transaction. The dial-in numbers are 1-877-407-9039 for domestic callers and 1-201-689-8470 for international callers. A live webcast of the conference call will be available online from the Investor Relations page of the Company's website at www.nuvasive.com.
After the live webcast, the call will remain available on NuVasive's website through February 5, 2016. In addition, a telephone replay of the call will be available until January 12, 2016. The replay dial-in numbers are 1-877-870-5176 for domestic callers and 1-858-384-5517 for international callers, using pin number: 13627758.
About NuVasive
NuVasive is an innovative global medical device company that is transforming spine surgery with minimally disruptive surgical products and procedurally-integrated solutions for the spine. NuVasive has emerged from a small startup to become the #3 player in the $9 billion global spine market and remains focused on market share-taking strategies as the Company continues on its path to become the industry's leading spine company. NuVasive offers a comprehensive spine portfolio of more than 90 unique products developed to improve spine surgery and patient outcomes. The Company's principal procedural solution is its Maximum Access Surgery, or MAS®, platform for lateral spine fusion. MAS was designed to provide safe, reproducible, and clinically proven outcomes, and is a highly differentiated solution with fully integrated neuromonitoring, customizable exposure, and a broad offering of application-specific implants and fixation devices designed to address a variety of pathologies.
About Ellipse Technologies
Ellipse Technologies, Inc. is a privately held medical device company located in Aliso Viejo, California. The company is dedicated to the design, development, and commercialization of its evolving proprietary MAGEC® technology platform for spinal and orthopedic applications. The MAGEC® technology platform enables precisely controlled, non-invasive postoperative adjustment of spinal and orthopedic implants allowing surgeons to better address a range of clinical needs. Ellipse develops products to significantly improve clinical outcomes in a variety of orthopedic applications through its collaboration with surgeon thought leaders. For more information, visit www.ellipse-tech.com.
Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive's results to differ materially from historical results or those expressed or implied by such forward-looking statements.
Forward-looking statements include, but are not limited to, statements about the timing of the anticipated acquisition, the funding of the anticipated acquisition, the potential benefits, synergies and cost savings of the anticipated acquisition, including the expected impact on future financial and operating results, and post-acquisition plans and intentions. The forward-looking statements contained herein are based on the current expectations and assumptions ofNuVasive and not on historical facts. The following important factors, among others, could cause actual results to differ materially from those set forth in the forward-looking statements: the satisfaction of conditions to closing the agreement, including the risk that the required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the acquisition; the loss of key employees; the risk that the businesses will not be integrated successfully; unexpected variations in market growth and demand for the combined company's products and technologies; and the risk that benefits and synergies from the acquisition may not be fully realized or may take longer to realize than expected. Additional risks and uncertainties that may affect future results are described in NuVasive's news releases and periodic filings with the Securities and Exchange Commission. NuVasive's public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.
Investor/Media Contact:

Stacy Roughan
NuVasive, Inc.
1-858-909-1812

Source: NuVasive, Inc.