Sunday, June 28, 2015
Thursday, June 25, 2015
This cost effective off the shelf system was built around the popular 3 blade style retractor body. Working with lateral access KOL's to determine the right set configuration, the Tyber Medical basic retractor system is meant to contain everything a surgeon needs for successful lateral surgery at a competitive price. Recognizing the growing need for this type of system as well as the high cost barrier to entry, Tyber Medical intends to level the playing field with this strategic move in the lateral lumbar market segment.
89 Headquarters Plaza North, #1464
News: Exactech Receives FDA 510(K) Clearance for Its Optetrak Logic® Constrained Condylar Prosthesis | Clearance Welcome News for Knee Surgeons with Complex Revision Knee Arthroplasty Cases
GAINESVILLE, Fla.--(BUSINESS WIRE)--Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder, spine and biologic materials, announced today it has received clearance from the U.S. Food and Drug Administration to market the Optetrak Logic® Constrained Condylar (CC) Prosthesis for revision knee arthroplasty cases.
“The FDA clearance of Optetrak Logic CC further expands the Exactech Knee system offerings for surgeons who desire predictable and reproducible outcomes. Our new revision system will give knee surgeons additional options to treat their patients with revision total knee surgery including difficult challenges like significant bone loss.”
Exactech CEO David Petty said, “The FDA clearance of Optetrak Logic CC further expands the Exactech Knee system offerings for surgeons who desire predictable and reproducible outcomes. Our new revision system will give knee surgeons additional options to treat their patients with revision total knee surgery including difficult challenges like significant bone loss.”
A surgeon-focused, patient-driven innovation, Optetrak Logic CC offers a modern solution for reproducibility in the most complex and challenging knee arthroplasty cases. The new addition to Exactech’s clinically recognized knee system introduces an advanced implant system and precision tools to consistently achieve optimized implant placement and bone coverage.
The Optetrak Logic CC Prosthesis is indicated for use in patients undergoing surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems; this device is also indicated for when previous devices have failed.
Surgeons around the world have documented excellent Optetrak® results.1 Offering advanced approaches to knee replacement, the Exactech Knee system combines a clinically-recognized system of proven implant system with personalized surgical workflows for reproducible outcomes, case after case.
The Optetrak Logic CC system will have limited availability in 2015, ramping up to a full market launch in 2016.
For more information about the Exactech Knee system, visit www.exac.com.
1 Data on file at Exactech, Inc.
Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech, Inc. can be found at http://www.exac.com. Copies of Exactech’s press releases, SEC filings, current price quotes and other valuable information for investors may be found at http://www.exac.com andhttp://www.hawkassociates.com.
An investment profile on Exactech may be found at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.
This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.
Wednesday, June 24, 2015
News: Zimmer Completes Combination with Biomet | Zimmer Biomet to be a Leading Musculoskeletal Innovator
"The coming together of Zimmer and
Biomet is a momentous achievement. We are excited to move forward as one company and to pursue new opportunities that benefit patients, healthcare professionals and employees around the globe," said David Dvorak, President and CEO of Zimmer Biomet. "Over the past several months, our integration planning teams have been working to ensure that we capture the best of both companies and create a seamless and efficient transition. I look forward to continuing to work closely with our employees for the benefit of all of our stakeholders."
Biomet will be a leading innovator in the $45 billion musculoskeletal healthcare market, committed to creating innovative solutions for the evolving global healthcare industry. The Company will offer a comprehensive and diversified portfolio of musculoskeletal solutions. The scale of Zimmer Biomet will provide for increased competitiveness in core franchises and a stronger presence in emerging markets. Zimmer Biomet also expects to create operational synergies that will enhance value for stockholders.
Biomet: New Branding
The Company today unveiled its new logo, which was designed to utilize the visual components of both the legacy Zimmer and Biomet brands.
Additionally, the Company unveiled its new tagline -- "Your progress. Our promise." -- which underscores the Company's longstanding commitment to helping people live better lives.
Healthcare Professionals to Enjoy Innovative Solutions
With substantial investments in research and development, a deep commitment to medical training and education, a highly experienced and knowledgeable global team and a collaborative, personalized approach to working with healthcare professionals, the Company will develop and introduce cutting edge musculoskeletal products and services designed to achieve exceptional patient outcomes. Zimmer Biomet's expanded sales force will also be increasingly effective in all geographies by having access to a broader portfolio.
Delivering Value for Stockholders
The transaction is expected to be double-digit accretive to the Company's adjusted earnings per share in the first year following today's closing. Zimmer Biomet also expects to achieve net annual synergies of approximately
$350 million by the third year following closing, with approximately $135 million anticipated in the first 12 months. The Company anticipates leveraging its scalable platforms and achieving cross-selling opportunities.
Updated Financial Guidance
Biomet estimates second quarter 2015 constant currency revenue growth, excluding Biomet acquired revenue, to be in a range of 1.0% to 1.5%, or 1.5% to 2.0% on a billing day, constant currency basis. Full-year 2015 constant currency revenue compared to pro forma 2014 revenues is now expected to increase between 1.5% and 2.0%. Previously, the Company had estimated full-year constant currency revenue would increase between 1.5% and 2.5% over 2014 pro forma revenues. The pro forma adjustments to the prior year reflect the inclusion of Biomet revenue for the comparable post-merger closing period in the prior year and the impact of the previously announced divestiture remedies.
Additionally, Zimmer Biomet estimates second quarter 2015 adjusted, fully diluted earnings per share to be in a range of
$1.55 to $1.58 and reaffirms its adjusted full year, fully diluted earnings per share range estimate of $6.60 to $6.80. The Company will provide further financial information on the transaction and expectations for the balance of fiscal 2015 when it hosts its second quarter earnings conference call scheduled for July 30, 2015.
Expanded Board of Directors
As of today's merger closing, the size of the Company's Board of Directors has been increased to 12 members. Effective immediately,
Michael W. Michelson, Member, Private Equity, KKR, and Jeffrey K. Rhodes, Partner, TPG, have been appointed to the Board. Messrs. Michelson and Rhodes previously served as members of the board of directors of Biomet. Mr. Michelson joined KKR in 1981 and has played a significant role investing in and developing the firms' portfolio companies. Mr. Rhodes joined TPG in 2005 and is a leader of the firm's investment activities in the healthcare services, pharmaceutical and medical device sectors. " Mike Michelson and Jeff Rhodes bring a wealth of healthcare industry experience to Zimmer Biomet's Board of Directors," said Larry Glasscock, Chairman of the Board. "We welcome them to the Board and look forward to their contributions."
About Zimmer Biomet
Founded in 1927 and headquartered in
Warsaw, Indiana, USA, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; spine, bone healing, craniomaxillofacial and thoracic products; dental implants; and related surgical products.
We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.
We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit zimmerbiomet.com or follow Zimmer Biomet on Twitter at twitter.com/zimmerbiomet.
Cautionary Statement Regarding Forward-Looking Statements
This communication contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forward-looking terms such as "may," "will," "expects," "believes," "anticipates," "plans," "estimates," "projects," "assumes," "guides," "targets," "forecasts," and "seeks" or the negative of such terms or other variations on such terms or comparable terminology. Such forward-looking statements include, but are not limited to, statements about the benefits of the merger between
Zimmer and LVB Acquisition, Inc. ("LVB"), the parent company of Biomet, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of 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 merger will not be realized, or will not be realized within the expected time periods; the risks and uncertainties related to our ability to successfully integrate the operations, products and employees of the legacy companies; the effect of the potential disruption of management's attention from ongoing business operations due to integration matters related to the merger; the effect of the merger on our relationships with our customers, vendors and lenders and on our operating results and business generally; the risks and uncertainties normally incidental to the orthopaedic industry, including price and product competition; the success of our quality and operational excellence initiatives; changes in customer demand for our products and services caused by demographic changes or other factors; the impact of healthcare reform measures, including the impact of the U.S. excise tax on medical devices; reductions in reimbursement levels by third-party payors and cost containment efforts of healthcare purchasing organizations; dependence on new product development, technological advances and innovation; shifts in the product category or regional sales mix of our products and services; supply and prices of raw materials and products; control of costs and expenses; the ability to obtain and maintain adequate intellectual property protection; the ability to form and implement alliances; challenges relating to changes in and compliance with governmental laws and regulations, including regulations of the U.S. Food and Drug Administration (the " FDA") and foreign government regulators, such as more stringent requirements for regulatory clearance of products; the ability to remediate matters identified in any inspectional observations or warning letters issued by the FDA; changes in tax obligations arising from tax reform measures or examinations by tax authorities; product liability and intellectual property litigation losses; the ability to retain the independent agents and distributors who market our products; dependence on a limited number of suppliers for key raw materials and outsourced activities; changes in general industry and market conditions, including domestic and international growth rates and general domestic and international economic conditions, including interest rate and currency exchange rate fluctuations; and the impact of the ongoing economic uncertainty affecting countries in the Euro zone on the ability to collect accounts receivable in affected countries. For a further list and description of such risks and uncertainties, see our periodic reports filed with the U.S. Securities and Exchange Commission (the " SEC"). Copies of these filings, as well as subsequent filings, are available online atwww.sec.gov, www.zimmerbiomet.com or on request from us. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Readers of this communication are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this communication.
Published at Zimmer Biomet Investor Relation
About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 14,000 employees and a presence in more than 100 countries. Annual sales in 2013 were more than. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew's expectations.
BELGRADE, Mont., June 24, 2015 (GLOBE NEWSWIRE) -- Bacterin International Holdings, Inc. (OTCQX:BONE) has been awarded a new group purchasing agreement for the Bone Tissue Synthetic Implantable Products Category with Premier, Inc. Effective July 1st, 2015, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for its members. Bacterin's contracted product portfolio includes OsteoSponge®, OsteoSelect® DBM Putty, OsteoWrap®, BacFast®, hMatrix® ADM, sports medicine allografts, and traditional allografts.
"We are excited to continue our successful relationship with Premier, which operates one of the nation's largest GPOs," said Bob Di Silvio, President of Bacterin. "Bacterin and Premier are focused on delivering quality products that are safe and clinically effective. This partnership and the ensuing collaboration with Premier Members allows both companies to continue to develop longer term programs that improve the way patient care is delivered nationwide."
Bacterin recently formed a national accounts team with a focus on driving revenues through contract utilization. In addition to Bacterin's GPO initiative, this team creates and executes strategies with Integrated Delivery Networks (IDNs) and various health systems, regionally and nationally. Bacterin entered into its first contract with Premier in July, 2012.
About Premier, Inc.
Premier, Inc. is a leading healthcare improvement company, uniting an alliance of approximately 3,400 U.S. hospitals and 110,000 other providers to transform healthcare. With integrated data and analytics, collaboratives, supply chain solutions, and advisory and other services, Premier enables better care and outcomes at a lower cost. Premier, a Malcolm Baldrige National Quality Award recipient, plays a critical role in the rapidly evolving healthcare industry, collaborating with members to co-develop long-term innovations that reinvent and improve the way care is delivered to patients nationwide. Headquartered in Charlotte, N.C., Premier is passionate about transforming American healthcare. Please visit Premier's news and investor sites on www.premierinc.com.
Bacterin International Holdings, Inc. (OTCQX:BONE) develops, manufactures and markets biologics products to domestic and international markets. Bacterin's proprietary methods optimize the growth factors in human allografts to promote bone growth, subchondral repair and dermal growth. These products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain, promotion of bone growth in foot and ankle surgery, promotion of cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries. For further information, please visit www.bacterin.com.
Important Cautions Regarding Forward-looking Statements
This news release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as "continue," "efforts," "expects," "anticipates," "intends," "plans," "believes," "estimates," "projects," "forecasts," "strategy," "will," "goal," "target," "prospects," "potential," "optimistic," "confident," "likely," "probable" or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability of the Company's sales force to achieve expected results, the Company's ability to meet its existing and anticipated contractual obligations, including financial covenant and other obligations contained in the Company's secured lending facility; the Company's ability to manage cash flow; the Company's ability to obtain shareholder approval of financing transactions; the Company's ability to develop, market, sell and distribute desirable applications, products and services and to protect its intellectual property; the ability of the Company's customers to pay and the timeliness of such payments; the Company's ability to obtain financing as and when needed; changes in consumer demands and preferences; the Company's ability to attract and retain management and employees with appropriate skills and expertise; the Company's ability to successfully conclude government investigations; the impact of changes in market, legal and regulatory conditions and in the applicable business environment, including actions of competitors; and other factors. Additional risk factors are listed in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading "Risk Factors." The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.
Investor Contact:COCKRELL GROUP877-889-1972Rich CockrellPublished at Nasdaq Globenewswire
News: Ellipse Technologies’ PRECICE® Limb Length Discrepancy Technology Used to Treat 2000th Patient
ALISO VIEJO, Calif.--(BUSINESS WIRE)--Ellipse Technologies, Inc., a global medical device company, announced today that its PRECICE limb length discrepancy technology has now been used to treat 2000 patients since its debut on the market three years ago.
“It’s particularly gratifying that this acceptance has been for a technology designed to provide substantial quality of life improvements for patients – which is our core mission at Ellipse. With the PRECICE system, we firmly believe that we are establishing a new standard of care to treat limb length discrepancy.”
The FDA-cleared and CE-Marked technology offers a quality of life enhancing option that helps patients of all ages who have limb length discrepancies. The PRECICE system includes an intramedullary nail that can be post-operatively and non-invasively adjusted, with precision, via an External Remote Controller. This advancement enables distraction osteogenesis with improved precision and bi-directional control during the lengthening phase, as reported in multiple peer-reviewed medical journals.
Prior to the introduction of the PRECICE system, the most common method of treatment included an extended, painful process involving adjustable external fixation systems, which are attached to the bone through skin incisions. Postoperative pain with external fixation devices can be significant and affect the quality of life and functional mobility often requiring prolonged medication use. Surgeons have long sought alternative, less invasive ways with reduced complications to treat patients with limb length discrepancies.
“In light of this landmark 2000th patient announcement, we’re very proud that our PRECICE technology has been so well received by the clinician and patient communities,” said Ellipse’s President and CEO, Ed Roschak. “It’s particularly gratifying that this acceptance has been for a technology designed to provide substantial quality of life improvements for patients – which is our core mission at Ellipse. With the PRECICE system, we firmly believe that we are establishing a new standard of care to treat limb length discrepancy.”
Roschak added that in the last year alone, more than 100 new surgeons started utilizing the PRECICE technology.
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 technology platform for orthopedic and spinal applications. This technology enables precisely controlled, non-invasive post-operative adjustment of implants allowing surgeons to better address a range of clinical needs. In addition to the PRECICE® technology, Ellipse also markets the MAGEC® system for children with spinal deformities. Ellipse is developing additional products to significantly improve clinical outcomes in a variety of applications through its collaboration with surgeon thought leaders. For more information, visit www.ellipse-tech.com.