Monday, August 31, 2015

News: ConforMIS Initiates Voluntary Recall of Specific Serial Numbers of Patient-Specific Instrumentation for the iUni, iDuo and iTotal Systems

BEDFORD, Mass., Aug. 31, 2015 (GLOBE NEWSWIRE) -- ConforMIS, Inc. (NASDAQ:CFMS) today announced that it has initiated a voluntary recall of specific serial numbers of patient-specific instrumentation for its iUni, iDuo, iTotal CR and iTotal PS knee replacement product systems. 

ConforMIS has initiated this action in response to three recent complaints of moisture on the patient-specific instrumentation. In all three cases, the knee replacement procedures were completed without apparent incident and the Company does not believe that the customized knee implants used in these procedures were themselves affected. While the number of complaints the Company has received is small, and the Company has not received any reports of adverse events related to these complaints to date, the Company initiated this recall voluntarily and is working to resolve the complaints quickly.

Based on an initial assessment, ConforMIS believes that the recalled instrumentation held excess water before undergoing the commonly used ethylene oxide sterilization process and, as a result, may contain small amounts of ethylene glycol residue. Ethylene glycol residue may form when ethylene oxide comes into contact with water. ConforMIS has temporarily suspended its use of the ethylene oxide sterilization process and is working expeditiously to investigate the root cause of the excess moisture and evaluate potential corrective and preventative actions.

A total of approximately 950 patient-specific instrumentation sets are affected by this recall, of which approximately 650 sets were used in knee-implant procedures and approximately 300 sets have been shipped but not yet used in scheduled surgeries.  The patient-specific instruments were manufactured and distributed from the Company's new manufacturing facility between July 18, 2015 and August 28, 2015.  ConforMIS is seeking the return of the approximately 300 knee replacement product systems, which include the patient-specific instrumentation sets. The Company does not believe that the customized knee implants included with the sets themselves were affected.  

ConforMIS is in the process of notifying the affected healthcare facilities of this recall and is arranging for replacement of the recalled products.  ConforMIS will be sending a Customer Notification letter to each affected healthcare facility detailing steps for return of affected products.

The Company expects manufacturing to be substantially reduced in September and possibly October as it completes its investigation and executes a plan of resolution.  The Company maintains a validated, alternative sterilization process that it already uses in the production of certain of the Company's implants and instruments and plans to increase its reliance on this alternative process until it has completed its investigation and taken all necessary corrective action.  This alternative sterilization process has significantly limited capacity as compared to the ethylene oxide sterilization process.  The Company expects that the combined impacts of the recalled products which were shipped but not used, the lower production capacity over the period of investigation and resolution and the potential commercial disruption will have a negative effect on its sales.  Assuming the effects of these factors, the Company is revising its guidance for the fiscal year 2015 as it now expects total revenue for the full year 2015 in a range of $64 million to $66 million, representing year-over-year growth of 33% to 37% on a reported basis and 39% to 43% on a constant currency basis. This revised revenue guidance is a reduction of $8 million as compared to the previous revenue guidance in a range of $72 million to $74 million.

About ConforMIS, Inc.
ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient's unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 470 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints. 

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com.

Constant Currency
The Company provides certain information regarding the Company's current or projected financial results on a "constant currency basis." This information estimates the impact of changes in foreign currency rates on the translation of the Company's current or projected future period financial results as compared to the applicable comparable period. This impact is derived by taking the adjusted current or projected local currency results and translating them into U.S. Dollars based upon the foreign currency exchange rates for the applicable comparable period. It does not include any other effect of changes in foreign currency rates on the Company's results or business.

Cautionary Statement Regarding Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about ConforMIS's analysis of recent product complaints and the source of the potential contamination of the sets , expectations regarding its manufacturing interruption, strategy, future operations, future financial position and results and expected market growth, including expectations regarding the potential impact and advantages of using customized implants, total revenue and revenue mix by product and geography, product gross margin and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," or "would" and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. ConforMIS may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on its forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements the Company makes as a result of a variety of risks and uncertainties, including risks related to its estimates regarding the expected scope of its recall, the duration of its manufacturing interruption, the impact of its manufacturing interruption on its financial results, potential market opportunity for its current and future products, its expectations regarding its sales, expenses, gross margins and other results of operations, and the other risks and uncertainties described in the "Risk Factors" sections of the Company's public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS's views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS's views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS's views as of any date subsequent to the date hereof.

Investor contact
Oksana Bradley
(781) 374-5598
Published at Nasdaq GlobeNewswire

News: NovaBone Launches Breakthrough Minimally Invasive Bone Graft System

Image result for NovaBoneJACKSONVILLE, Fla.--()--NovaBone Products, a leading biologics medical device company, today announces the U.S. Food and Drug Administration’s (FDA) approval of the NovaBone MacroFORM MIS Delivery System™ designed for use in minimally invasive orthopedic procedures.
“We continue to reach milestones we have established”
For the first time, surgeons can directly deliver Bone Marrow Aspirate (BMA) to a graft which is housed in a closed, ready to use minimally invasive cannula. The system was developed for surgeons who require controlled and precise delivery of bone grafting material to surgical sites that are not readily accessible.
“The MacroFORM MIS Delivery System™ builds off the commercial success of the intuitively-designed collagen devices we have launched over the past several months,” said Dennis McBride, Vice President of Sales and Marketing. “Moreover, NovaBone’s MacroFORM™ technology, which offers more bioactivity than any other competitive product, is now available in multiple formulations, and delivery options.”
NovaBone Products has announced release of six new collagen products in the last twelve months; the devices are based on the company’s regenerative medicine technology and core competencies in designing innovative and cost-effective medical devices that meet the demands of surgeons. NovaBone now has the broadest offering of bone graft substitutes in the world.
“We continue to reach milestones we have established," said Art Wotiz, President of NovaBone Products. ”Our team has done an excellent job in terms of both design and manufacturing of collagen products and creating a robust pipeline of products that harness the natural healing process of the body.”
NovaBone Products, a privately held company based in Florida, USA since 2002 and a recognized industry leader in bioactive glass design and manufacturing, developed the first bioactive synthetic bone graft offered to the orthopaedic community.

Contacts

NovaBone Products
Dennis McBride, 908-881-0081
Vice President of Sales and Marketing

Published at Business Wire

News: Aurora Spine Corporation Files Condensed Consolidated Financial Statements for the Six Months Ended June 30, 2015

CARLSBAD, CALIFORNIA--(Marketwired - Aug. 28, 2015) -
NOT FOR DISTRIBUTION IN THE UNITED STATES OR OVER UNITED STATES WIRE SERVICES
Aurora Spine Corporation
Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSX VENTURE:ASG) announces financial results for the six months ended June 30, 2015. The financial statements together with the Management Discussion and Analysis can be found on SEDAR at www.sedar.com.

To our Shareholders:
Q2 2015 saw an increase in net sales over Q2 2014 of over 100%. During Q2 2015 we expanded the availability of our family of products in our Screwless Procedure™, a cutting-edge surgical approach to spine fusion. The Screwless Procedure features: our ZIP® MIS Fusion System, our TiNano® Interbody cages, and our new COMPASS 4D™ retractor system.
Highlights from Q2 2015
  • Achieved over $1.1M in gross sales for the quarter, despite incurring a return of product totaling $178K during the quarter due to delayed hospital approvals.
  • The TiNano® interbody portfolio continues to be our fastest growing product line, representing approximately 60% of our Q2 revenues.
  • TiNano Discover cervical interbody cage sales in Q2 continued to increase, posting over 183% increase over Q1 2015 sales.
During the quarter, we continued our efforts to add new hospitals, surgeons and distributors to our customer base. We added to our sales group in the central region of the US. Also, we completed development of our VOX LLIF system, and saw our first surgeries in June 2015.
The Screwless Procedure has been developed to increase the possibility of significant benefits to patients, hospitals, and surgeons, including reduced surgery time, less blood loss, shorter hospital stays, and significantly faster recovery time. These benefits will continue to be the driving force of Aurora Spine's competitive advantage and growth.
Sales outside of the United States represented approximately 7% of revenues in Q2 2015 and we anticipate an ongoing international presence.
For the balance of 2015, we will focus on:
  • Continuing our strategy of building a strong revenue base in the North American market. We will accomplish this by expanding product usages, and our product offering, with our current distribution network, developing new distribution channels and training new surgeons on the Aurora product advantages;
  • Adding a Vice President of U.S. Sales and additional sales representatives.
  • Growing our TiNano portfolio of products; and
  • Continuing to lower our operating costs.
None of this would be possible without the dedication and commitment of our hardworking colleagues at Aurora. I want to thank them for the great accomplishments they have made this year, for Aurora and ultimately, for patients. They have embraced change and risen to the numerous challenges before them, and I am grateful for their ongoing support of our company and our mission.
I would also like to thank you, our investors, for your continued support. Together, we have built a strong foundation, and I look forward to the opportunities ahead of us. I am truly grateful to be part of an organization that makes such a positive improvement in the lives of patients around the world.
Sincerely,
Trent J. Northcutt, President and Chief Executive Officer
About Aurora Spine
Aurora Spine is focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies.
Forward-Looking Statements
This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Information" in Aurora Spine's final prospectus (collectively, "forward-looking information"). Forward-looking information in this news release includes information concerning the growth potential of Aurora Spine's products and its operating results. Aurora Spine cautions investors of its securities about important factors that could cause Aurora Spine's actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

CONTACT INFORMATION

  • Aurora Spine Corporation
    Trent Northcutt
    President and Chief Executive Officer
    (760) 424-2004

    Aurora Spine Corporation
    Eric Fronk
    Chief Financial Officer
    (760) 424-2004
  • Published at Market Wired

Friday, August 28, 2015

News: Study Demonstrates Dramatic Reduction in Progression of Osteoarthritis with the Arthrosurface "Inlay" Patellofemoral Implant Design Compared to Traditional "Onlay" Implant

Arthrosurface Incorporated logo.FRANKLIN, Mass.Aug. 27, 2015 /PRNewswire/ -- A recent study by Feucht et al, published in the KSSTA Knee Journal, compared the Arthrosurface HemiCAP® Wave implant, which is based on an "inlay" Arthroplasty design, versus an "onlay" design implant for isolated patellofemoral disease. While both implant groups showed similar improvements in function and pain scores, none of the patients in the "inlay" group showed progression of osteoarthritis (OA). However, 53% of the patients in the "onlay" group, showed progression of OA in other parts of the knee, namely the femoral-tibial compartments. Progression of OA is the number one reason for revising a patellofemoral implant to a Total Knee.
Steven Ek, President and CEO of Arthrosurface® commented, "Over 20 years ago, the orthopedic community largely abandoned patellofemoral joint arthroplasty. A relatively high number of these first generation implants, which were simply mounted on top of the existing arthritic joint surfaces, were revised early to total knees due to the progression of OA. In 2006, after reviewing the clinical history of PF arthroplasty, Arthrosurface® took a completely different approach in the design of its PF implants.  They were specifically created to be recessed and set into the arthritic joint surface, preserving the native biomechanics of the knee and replicating the patient's existing joint surface. This novel concept became known as an "inlay" implant. I believe our patient's remarkable success stories and their unmatched return to high-demand activities reignited interest in treating isolated PFJ disease within the orthopedic community.  Many of the large orthopedic companies have since re-introduced an updated version of their PF devices, but they are all still "onlay" designs. I truly believe that they have missed the point. This publication identifies the profound clinical outcome differences in tibiofemoral OA progression between "onlay" and "inlay" devices. We are very happy that this study has validated our design team's insight. Our hope is that younger surgeons who have begun treating patients using PF implants will fully appreciate the clinical history of PF arthroplasty devices in the context of this study."
While it is not known why over half of the patients with the "onlay" devices developed progressive OA in the other knee compartments, the authors of the study stated that, "one hypothesis is that the more anatomic approach of the inlay design better reproduces the complex kinematics of the patella-femoral joint. Soft tissue irritation due to over-stuffing of the patella-femoral joint with an "onlay" component may cause persistent synovitis, which is a well-known risk factor for the development and progression of OA due to secretion of pro-inflammatory cytokines."
Matthias Schurhoff MD, VP of Clinical Affairs at Arthrosurface, commented, "Historically, problems related to poor implant design are seen early on, usually within the first few years after implantation. This study highlights a concern that 'onlay' implants for isolated PF disease may disturb normal knee kinematics leading to overloading and disease progression in other parts of the joint. 'Inlay' arthroplasty may offer younger patients a better long term option, especially if they want to continue to stay active."
About Arthrosurface
Arthrosurface, Inc. is a leader in the design and distribution of orthopedic devices for joint preservation, restoration and resurfacing. The HemiCAP® system is a unique, less invasive technology that can be used to treat a wide variety of joint conditions caused by trauma, injury and disease. Founded in 2002, Arthrosurface markets and distributes its products in the US and around the world.

Published at PR Newswire

News: CMS Targets Hip and Knee Reimbursement


The U.S. Centers for Medicare & Medicaid Services (CMS) proposed a mandatory bundled payment model that, once passed, could impact hip and knee implant pricing.   



Earlier in 2015, CMS announced long-term goals to move the majority of reimbursement to value-based purchasing models, allowing hospitals to voluntarily implement models like bundled payments. The proposed Comprehensive Care for Joint Replacement (CCJR) Payment Model would take the decision-making power out of hospitals’ hands, making bundled payments mandatory in 75 cities. 

CMS chose to focus on lower extremity joint replacement because hip and knee reconstruction is the most common inpatient surgery that Medicare beneficiaries receive, and the average expenditure for surgery, hospitalization and recovery ranges from $16,500 to $33,000. (To ward off confusion, please note that CMS includes hip and knee in its definition of lower extremities.)  

CMS estimates that by incentivizing all stakeholders—hospitals, physicians, home health agencies, nursing facilities, etc.—to work together to reduce complications and readmissions, this specific program will yield Medicare savings of $153 million over its five-year period.  

How would it affect hospitals? Under the test model, CMS will set prices that include the cost of surgery and post-90-day care. Hospitals that spend below the target price will receive the difference from CMS, while those that spend above the target price must return the difference to CMS. A two percent cut in the target price is expected to be applied each year.  

How would it affect device companies? This would most likely enhance hip and knee implant price pressure, especially as hospitals face decreasing target rates throughout the program, and it may lead to continual vendor consolidation.  

Comparable to current bundled payment programs, CCJR promotes surgeon gainsharing. Hospitals have driven down implant costs by consolidating the manufacturers from which they purchase. A mandatory program would give hospitals greater leverage to incentivize surgeons to switch implant brands and receive a share of savings.  

“Our payment structure is changing,” Wael Barsoum, President of Cleveland Clinic Florida and Vice Chairman of the hospital system’s Orthopaedic Department, said to orthopaedic professionals at OMTEC 2015. “Why is that important to everyone in this room? Because you are one of the providers of the services that we give to patients. As we see our reimbursement going down, eventually you’re going to feel the pinch as well. As you decide every year coming into budget season, next year how you’re going to create your budget, you need to know what hospitals, what your consumers, are looking for from you.”  

CMS is accepting public comments through September 8 with an expectation of finalizing the rule by end of year. The proposal calls for launching the program in January 2016, but industry experts have said that hospital pushback might lead to a date change.

Published at Bonezone

News: Greatbatch Signs Definitive Agreement to Acquire Lake Region Medical for $1.73 Billion

  • Transformative Deal will create one of the World's Largest Medical Device OEM Suppliers and will be led by current Greatbatch President and CEO, Thomas J. Hook
  • Newly Combined Company to offer substantially more Comprehensive Portfolio for Customers
  • Double-Digit Cash EPS Accretion to Greatbatch in 2016 and meaningfully more accretive thereafter
FRISCO, Texas, Aug. 27, 2015 (GLOBE NEWSWIRE) -- Greatbatch, Inc. (NYSE:GB) today announced that it has entered into a definitive agreement to acquire Lake Region Medical for approximately $1.73 billion in cash and stock, a transformative deal that will create one of the largest medical device OEM suppliers in the world serving the cardiac, neuromodulation, vascular, orthopaedics and advanced surgical markets.

Greatbatch develops and manufactures critical medical device technologies for the cardiac, neuromodulation, vascular and orthopaedic markets; and batteries for high-end niche applications in the portable medical, energy, military, and environmental markets. Lake Region Medical helps bring life changing products from concept to point-of-care in the cardio & vascular and advanced surgical markets. These include offerings in electrophysiology, vascular access, cardiovascular, urology, oncology, orthopaedics, laparoscopy, biopsy/drug delivery, and arthroscopy.

Once the transaction has closed, the combined company will employ over 9,000 individuals globally with revenues of approximately $1.5 billion.

"The combination of Greatbatch and Lake Region Medical brings together two highly complementary organizations that can provide a new level of industry leading capabilities and services to OEM customers while building value for shareholders," said Thomas J. Hook, president and chief executive officer, Greatbatch.

"Through this transformative deal, we are going to be at the forefront of innovating technologies and products that help change the face of healthcare, providing our customers with a distinct advantage as they bring complete systems and solutions to market. In turn, our customers will be able to accelerate patient access to life enhancing therapies."
The transaction is consistent with Greatbatch's strategy of achieving profitable growth and continuous improvement to drive margin expansion.

"I am very proud of the Lake Region Medical team and what they have accomplished over many years," said Donald J. Spence, chairman and chief executive officer, Lake Region Medical. "Today marks the start of an important new chapter for the Company and I am confident the combination of Lake Region Medical and Greatbatch will form an even stronger entity with unmatched technology and manufacturing capabilities to better serve our customers into the future."

"We expect considerable operating synergies resulting in sustained profitable growth, as well as double-digit adjusted cash EPS growth," said Michael Dinkins, executive vice president and chief financial officer of Greatbatch.

Strategic and Financial Benefits of the Transaction
Greatbatch and Lake Region Medical believe the combination positions the company for enhanced product development and manufacturing services to customers across multiple medical device segments, as well as the energy and portable medical markets. The combination adds diversification and scale across product lines, customers, industries and geographies. The transaction is double-digit accretive to Greatbatch adjusted cash EPS in 2016 and meaningfully more accretive thereafter.
  • More comprehensive portfolio of solutions and services to OEM customers: Both companies have highly-regarded positions with OEM customers in different sub-segments of the cardiac rhythm management, neuromodulation, vascular, orthopaedics and advanced surgical market segments. As a result, the newly combined company will be able to offer a substantially more comprehensive portfolio for customers utilizing the best technologies, providing a single point of support, and driving optimal outcomes.
  • Added scale and diversification: The combination creates a company with operations in the United States, Latin America, Europe and Asia-Pacific. The combination also broadens proprietary technologies and high volume, world-class manufacturing capabilities. In addition, it diversifies Greatbatch into the advanced surgical, vascular and interventional cardiology segments of medical technology.
  • Enhanced customer access and experience: Both Greatbatch and Lake Region Medical bring decades of innovation, R&D design excellence, operating excellence and committed partnerships with customers. Greatbatch expects to leverage the expanded R&D resources, manufacturing capabilities and reputation for innovation, quality and reliability to increase partnership opportunities with legacy customers. The combined company in partnership through OEM customers is ultimately expected to help hospitals, physicians and the healthcare systems improve patient outcomes in a cost-effective manner.
  • Stronger financial profile and solid earnings accretion: 2014 combined revenues of Greatbatch and Lake Region Medical were approximately $1.5 billion. The transaction is expected to be double-digit accretive to cash EPS in 2016, the first full fiscal year post closing and meaningfully more accretive thereafter. The combined company expects to achieve net annual synergies at the operating profit level of $25 million in 2016 which is expected to increase to at least $60 million in 2018.
  • Strong balance sheet and cash flow generation: The combined company is expected to generate strong cash flow from operations resulting from the continued operating profitability, operating synergies and approximately $360 million of net operating loss carryforwards (NOL's) at Lake Region Medical acquired in the transaction. The NOL's will be subject to traditional Section 382 limitations. The company expects the strong cash flow to enhance future financial flexibility.
In the transaction, Greatbatch will pay approximately $478 million in cash, issue an aggregate of 5.1 million shares of common stock and options to Lake Region Medical's equity holders and assume approximately $1 billion of Lake Region Medical net debt.
The agreement has been unanimously approved by the Boards of Directors of both companies. The cash portion of the transaction will be financed with existing cash on hand as well as proceeds from a fully committed financing loan package led by M&T Bank, Credit Suisse and KeyBanc Capital Markets. At closing, current Greatbatch stockholders are expected to own approximately 83.4% of the combined company and current Lake Region Medical shareholders are expected to own approximately 16.6%. The transaction is expected to close in the fourth quarter of 2015 subject to customary closing conditions and pending completion of all necessary regulatory reviews.

Piper Jaffray is acting as exclusive financial advisor and Hodgson Russ LLP is acting as legal advisor to Greatbatch. Simpson Thacher & Bartlett LLP is acting as legal advisor to Lake Region Medical.

Greatbatch President & Chief Executive officer, Thomas J. Hook, and Executive Vice President and Chief Financial Officer, Michael Dinkins, will host a conference call today at 8:30 a.m. EDT to discuss the definitive agreement. The conference call can be accessed from the Greatbatch website at www.greatbatch.com. The conference line is (866) 562-8327and the conference ID is 22878619.

About Lake Region Medical
Lake Region MedicalLake Region Medical collaborates with the world's leading medical device companies to deliver life-changing innovations that enhance the lives of patients. Backed by decades of experience and clinical expertise, the company helps customers bring products from concept to point-of-care in the cardio & vascular and advanced surgical markets. Lake Region Medical offers fully integrated outsourced manufacturing and engineering services, contract manufacturing, finished device assembly, original device development and supply chain management services. For more information, please visit  LakeRegion Medical.

About Greatbatch, Inc.
GreatbatchGreatbatch, Inc. (NYSE: GB) provides top-quality technologies to industries that depend on reliable, long-lasting performance through its brands Greatbatch Medical, Electrochem and QiG Group. The company develops and manufactures critical medical device technologies for the cardiac, neuromodulation, vascular and orthopaedic markets; and batteries for high-end niche applications in the portable medical, energy, military, and environmental markets. Additional information is available at www.greatbatch.com.

Forward-Looking Statements
Some of the statements contained in this press release are "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.

You can identify forward-looking statements by terminology such as "may," "will," "should," "could," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "potential" or "continue" or "variations" or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about the benefits of the proposed merger between Greatbatch and Lake Region, including future financial and operating results, the combined company's plans, objectives, expectations and intentions, the expected timing of completion of the transaction and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Greatbatch's management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties include, but are not limited to: the possibility that the anticipated synergies and other benefits from the proposed merger of Greatbatch and Lake Region will not be realized, or will not be realized within the anticipated time periods; the inability to obtain regulatory approvals of the merger (including the approval of antitrust authorities necessary to complete the transaction) on the terms desired or anticipated; the timing of such approvals and the risk that such approvals may result in the imposition of conditions that could adversely affect the combined company or the expected benefits of the transaction; the risk that a condition to closing the transaction may not be satisfied on a timely basis or at all; the risk that the proposed transaction fails to close for any other reason; the risks and uncertainties related to Greatbatch's ability to successfully integrate the operations, products and employees of Greatbatch and Lake Region; the effect of the potential disruption of management's attention from ongoing business operations due to the pending merger; the effect of the announcement of the proposed merger on Greatbatch's and Lake Region's relationships with their respective customers, vendors and lenders and on their respective operating results and businesses generally; risks relating to the value of the Greatbatch shares to be issued in the transaction; access to available financing (including financing for the acquisition or refinancing of Greatbatch's or Lake Region's debt) on a timely basis and on reasonable terms; and the following factors that may impact Greatbatch's and the combined company's business: dependence upon a limited number of customers; customer ordering patterns; product obsolescence; inability to market current or future products; pricing pressure from customers; inability to timely and successfully implement cost reduction and plant consolidation initiatives; reliance on third party suppliers for raw materials, products and subcomponents; fluctuating operating results; inability to maintain high quality standards for products; challenges to intellectual property rights; product liability claims; product field actions or recalls; inability to successfully consummate and integrate acquisitions and to realize synergies and to operate these acquired businesses in accordance with expectations; our unsuccessful expansion into new markets; failure to develop new products including system and device products; the timing, progress and ultimate success of pending regulatory actions and approvals, inability to obtain licenses to key technology; regulatory changes, including health care reform, or consolidation in the healthcare industry; global economic factors including currency exchange rates and interest rates; the resolution of various legal actions; and other risks and uncertainties that arise from time to time and are described in Greatbatch's periodic filings with the Securities and Exchange Commission. Greatbatch assumes no obligation to update forward-looking statements in this press release whether to reflect changed assumptions, the occurrence of unanticipated events or changes in future operating results, financial conditions or prospects, or otherwise.

Investor Relations Contact:
Elizabeth Cowell
Media Contact:
tel 214-618-4982
tel 716-759-5727
Christopher Knospe

Published at Nasdaq GlobeNewswire