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SeaSpine Announces Preliminary Results for Second Quarter 2017

Posted On July 12, 2017 By OrthoSpineNews In Financial /  

CARLSBAD, Calif., July 11, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today preliminary financial results for the three-months ended June 30, 2017.

Preliminary revenue for second quarter 2017 is expected to be in the range of $34.0 to $34.2 million, an increase of approximately 3% compared to the prior year period.  Based on this preliminary estimate, spinal instrumentation revenue is expected to be approximately $16.6 million and orthobiologics revenue is expected to be approximately $17.6 million. U.S. revenue for the second quarter 2017 is expected to increase approximately 1%, to approximately $30.4 million, with US spinal instrumentation revenue expected to decrease approximately 5% and orthobiologics revenue expected to increase approximately 7.5% over the prior year period.

At June 30, 2017, cash and cash equivalents are expected to be approximately $12.3 million and outstanding borrowings under the Company’s credit facility are expected to be approximately $4.0 million. SeaSpine realized $4.6 million in net proceeds in the second quarter 2017 through the sale of approximately 477,000 shares of its common stock under its “at the market” equity offering program.

“We are executing on our strategy to deliver mid-single digit revenue growth in 2017 while simultaneously focusing on cash conservation,” said Keith Valentine, President and Chief Executive Officer. “We continue to focus on our strengthening distributor base and expanding product portfolio.”

About SeaSpine
SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal instrumentation solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal instrumentation portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal instrumentation product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: delivering mid-single digit revenue growth in 2017 while simultaneously conserving cash; and continuing to strengthen the Company’s distributor base and expand its product portfolio.  In addition, this release contains preliminary financial results for the second quarter 2017.  Preliminary results are provided prior to completion of all internal and external review procedures and therefore are subject to adjustment.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the clinical needs of surgeons and patients; the Company’s ability to attract new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; unexpected expense, including as a result of developing and supporting the launch of new products; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

Investor Relations Contact Lynn Pieper Lewis (415) 937-5402 ir@seaspine.com

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K2M Group Holdings, Inc. Announces Long-Term Exclusive Distribution Agreement with Mitsubishi Corporation Subsidiary Japan Medicalnext Co., Ltd.

Posted On July 12, 2017 By OrthoSpineNews In Spine, Top Stories /  

LEESBURG, Va., July 10, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced the signing of a new, long-term, exclusive agreement with Mitsubishi Corporation subsidiary Japan Medicalnext Co., Ltd., a wholly-owned entity of MC Healthcare, Inc. and a prominent supplier of medical devices in Japan, for the distribution of K2M’s innovative spinal technologies.

Pursuant to the agreement, Japan Medicalnext is the exclusive distributor of K2M’s spine products in Japan. The terms of the agreement include a long-term partnership of up to seven years. With more than 250 employees—including 50 orthopedic sales professionals—in seven offices located throughout the country, Japan Medicalnext has significant experience in medical device distribution, including the Japanese spinal surgery market.

“We are pleased to announce a new, long-term exclusive distribution agreement with Japan Medicalnext and look forward to this partnership enhancing our potential to increase our market share beyond our existing relationships in Japan’s estimated $300 million spine market,” said K2M President and CEO Eric Major. “We are excited that the management of Japan Medicalnext has a wealth of spine experience within Japan and are applying their market expertise with their established infrastructure to help grow our business in this region.”

In April, K2M secured registrations from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for several of its innovative products, including its MESA® and EVEREST® Spinal Systems, and will continue to seek additional product registrations over the next year.

For more information about K2M, visit www.K2M.com.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS™, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques, and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn, and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “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 in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; in adequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; 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 and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems;  our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations;  our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, 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. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA, 443-213-0500
K2M@westwicke.com
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Regenexx Announces Successful Merger with Harbor View Medical

Posted On July 12, 2017 By OrthoSpineNews In Biologics, Top Stories /  

July 11, 2017

BROOMFIELD, Colo.–(BUSINESS WIRE)–Regenexx, a Colorado-based stem-cell-treatment network and pioneer in the invention of interventional orthopedics, today announced that it successfully merged with Harbor View Medical, a leader in orthopedic stem cell therapy and part of the Regenexx network, which became effective in May 2017. As part of the transition, Jason Hellickson has assumed the CEO role. This merger positions Regenexx to further expand its National Network to better serve patients and our corporate partners.

Regenexx Corporate will be headquartered in Des Moines, IA, while Regenexx’s Affiliate Program and Research and Development will be lead out of the company’s Broomfield, CO location. Dr. Christopher Centeno, founder of orthopedic stem cell treatments and leader of interventional orthopedics in the United States and pioneer of the Regenexx patented procedures, will continue his role as Chief Medical Officer and remain in clinic operations in Broomfield, and continues the advancements of regenerative medicine through the largest research and data collection effort in orthopedic regenerative medicine.

“As the most advanced non-surgical orthopedic care available in the United States, I’m excited to continue our mission to producing the best possible patient outcomes through interventional orthopedics,” said Jason Hellickson, CEO, Regenexx. “In addition to individual personalized care, we will continue to provide both employers and their employees with cost savings results and successful interventions to orthopedic surgery.”

Since joining the Regenexx Network in late 2014, Hellickson has reengineered clinic operations which increased capacity by more than 300 percent while offering a streamlined approach beneficial to both patients and clinic staff. He is the innovator and leader of the Regenexx Corporate Program that enables large employers access to the Regenexx procedures. Since adding Regenexx procedures to their self-funded health and workers’ compensation plans, corporate partners have saved as much as 83 percent in their orthopedic surgical expenses, totaling in the many millions of dollars. In his new role, Hellickson will continue to architect the Regenexx national clinical operations to create more streamlined approaches to patient care and expand Regenexx clinics nationwide.

“We look forward to continuing the build-out of Regenexx clinics, streamlining affiliate networks of more than 50 clinics nationwide, and adding additional clinics in major metropolitan areas including Chicago, Atlanta, Dallas, Philadelphia, and Charlotte under Jason’s helm,” said Christopher Centeno, MD. “We’re excited about the experience and enthusiasm that Jason brings to Regenexx.”

Regenexx is the world leader in interventional orthopedics using orthobiologics and has been issued many patents for it’s evidence-based stem cell and blood platelet treatments used for back pain, joint pain, arthritis and acute orthopedic injuries. The benefits of interventional orthopedics are so revolutionary that seventy percent of orthopedic issues currently treated with surgery could instead be handled using regenerative methods. Mesenchymal stem cells are multipotent, adult stem cells that are therapeutic agents in the repair and regeneration of muscle, tissue, cartilage and bone. Regenexx procedures use a patient’s own bone marrow-derived stem cells, or blood platelets, through a blood draw, to customize needle-based, precisely-guided procedures to treat common orthopedic conditions. Its procedures have been proven to have the same or better outcomes compared to their surgical alternative.

For more information on the Regenexx Corporate Program call: 888-547-6667. For general information on Regenexx, please visit www.Regenexxcorporate.com. For a map of current Regenexx clinics and providers click here.

About Regenexx and the Regenexx Physician Network
The Regenexx® Procedures are the nation’s most advanced non-surgical stem cell and blood platelet treatments for common joint injuries and degenerative joint conditions, such as osteoarthritis and avascular necrosis. These stem cell procedures utilize a patient’s own stem cells or blood platelets to help heal damaged tissues, tendons, ligaments, cartilage, spinal disc, or bone.

For more information on Regenexx, please visit: http://www.regenexx.com

Contacts

For Regenexx
Kaitlyn Ethier
kethier@matternow.com

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VEXIM: Continued Growth and Adoption of the SpineJack® in Q2 2017

Posted On July 11, 2017 By OrthoSpineNews In Financial, Spine, Top Stories /  

July 11, 2017

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces its consolidated sales results for the second quarter, as of June 30th, 2017.

“VEXIM sales performance in the second quarter is in line with our expectations. VEXIM is growing substantially in all regions in Europe and around the world. We expect a strong growth of our business in the second half of the year, meeting our business objectives and aiming at financial break-even for the year 2017“, said Vincent Gardès, CEO of VEXIM.

Continued growth in the second quarter 2017

Revenues in millions of euros (IFRS, as of June 30th)

Quarterly sales Half-year sales
Region Q2 2017 Q2 2016 Variation (%) H1 2017 H1 2016 Variation (%)
Europe 5.0 4.2 +20% 9.3 7.9 +18%

International1

 0.7 0.4 +50% 1.0 0.7 +60%
Total 5.7 4.6 +23% 10.3 8.6 +21%

€5.7 million in sales, VEXIM continues to expand in all geographies

In Europe, VEXIM’s business continues to grow substantially reaching €9.3 million in the first half of 2017, representing a 18% growth compared to the same period in 2016. Since 2016, sales have increased in all countries and are progressing according to plan.

Outside of Europe, where quarterly sales increased 50% over the same period last year, VEXIM continues to see growing interest in the SpineJack® technology. As previously announced, VEXIM is in the process of launching SpineJack® products in Brazil and anticipates a continued strong growth in sales in the second part of 2017.

Financial reporting schedule:
2017 half-year results: September 14th, 20172

About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital3, and from OSEO public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 67 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on Euronext Growth Paris since May 3rd 2012. For further information, please visit www.vexim.com

SpineJack®4, an innovative implant for treating Vertebral Compression Fractures
The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

1 Cf. segment reporting applied since VEXIM switched to IFRS consolidated financial statements.
2 Indicative date, subject to changes.
3 Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.
4 This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tel.: +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tel.: +33 1 44 54 36 66
Tel.: +33 6 48 82 18 94
vexim@alizerp.com

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Prosthetic knee type may determine cost of care for amputees

Posted On July 11, 2017 By OrthoSpineNews In Financial /  

By Elizabeth Zimmermann Young – July 11, 2017

ROCHESTER, Minn. — In a new study published in Prosthetics and Orthotics International, Mayo Clinic researchers describe the direct medical costs of falls in adults with a transfemoral amputation. In this type of amputation, the leg is amputated above the knee. This work “provides a comparison for policymakers when evaluating the value of more expensive … technologies,” say the authors.

Every week in the U.S., more than 3,500 people have a transfemoral amputation. However, of the 185,000 new amputee patients each year, only 25-30 percent receive a prosthetic leg and knee.

Of those who receive a prosthetic leg and knee, the policies that govern insurance payments grant basic mechanical knees for most. Despite growing data that newer technology reduces falls and improves physical capabilities, only high-functioning patients (based on mobility and activity levels) are deemed eligible for a knee with microprocessor technology.

A team of Mayo Clinic researchers would like to change that.

“We want to help provide the best quality of life and prosthesis for each individual,” says Benjamin Mundell, Ph.D., the study’s lead author. Dr. Mundell, a trained health economist who is currently a medical student at Mayo Clinic School of Medicine, says, “It is important to look beyond the initial cost differences of a microprocessor knee compared to a mechanical knee and understand what downstream costs might be avoided with a better prosthesis.”

“Microprocessor knees are designed to help improve balance and reduce falls,” he says. “The fear of falling for those with mechanical knees likely reduces their overall physical activity and if they do fall and require hospitalization, the cost of care is almost as expensive as a microprocessor knee.”

 

READ THE REST HERE

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MCRA Advises Orthopedic Industry To Adopt Integrated Value Creation Strategy

Posted On July 11, 2017 By OrthoSpineNews In Regulatory /  

NEW YORK, July 11, 2017 /PRNewswire-USNewswire/ — In an address given in Paris, France to delegates attending the 13th annual IMPLANTS conference on orthopedic innovation, U.S. executive David W. Lown advised that companies will be left behind in a crowded orthopedic market unless they adopt an integrated and compliant research,  development, and commercial access strategy.

Mr. Lown, General Manager of Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), noted that the complexity of clinical, regulatory and reimbursement dynamics can present many unforeseen business challenges to even the most experienced industry veterans. “Every phase of the technology lifecycle is becoming more interwoven and multifaceted,” he said.  “Given the substantial size of the device industry and the increasing concerns of rising healthcare costs, the Centers for Medicare and Medicaid Services (CMS), the U.S. Food and Drug Administration (FDA), and numerous other governmental and private stakeholders all have a seat at the table in influencing whether industry has proved safety, efficacy, and cost effectiveness over existing treatments. Although governmental and private constituents act individually for the most part, industry must execute their business strategies in an integrated fashion so that marketing claims are consistent with regulatory claims which are consistent with reimbursement coding and coverage, in order to compliantly adhere to the multiple U.S. laws of these constituents. Lastly, clinical evidence requirements are increasing on most technologies, both new and existing, thereby increasing the investment required for successful commercialization, which is putting additional strain on both companies and private investors to further invest in advancements.”

MCRA was founded in 2004 and has partnered with nearly 500 clients globally to design and execute integrated product development strategies.  “Since the 1960’s, the orthopedic industry was focused on bringing innovation accessible to surgeons in a quick and cost efficient manner. Device companies must realize today that industry-wide evidence requirements are quickly becoming analogous to the pharmaceutical industry and for those who invest properly both value creation and risk mitigation will be the reward.” Mr. Lown advised.

Full details of the proceedings of IMPLANTS 2017 are available at www.implants-event.com. For more information about MCRA go to: www.mcra.com.

About MCRA

Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves nearly 500 clients globally.

Contact
David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com

 

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

Related Links

http://www.mcra.com

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CrossRoads® Extremity Systems, LLC Announces Launch of the DynaFORCE™ Dynamic Compression Fixation System

Posted On July 11, 2017 By OrthoSpineNews In Extremities, Top Stories /  

MEMPHIS, Tenn., July 11, 2017 /PRNewswire/ — CrossRoads® Extremity Systems LLC., a privately held medical device company offering innovative foot & ankle fixation implant systems, announced that it has recently launched the first hybrid fixation system, DynaFORCE™. It represents the pinnacle of plate and nitinol clip fixation, featuring optimized dynamic compression, top loading insertion, and intraoperative placement flexibility with its unique implant and delivery instrument design.

Terrence Philbin, DO, from Columbus, OH, and Stuart Miller, MD, from Baltimore, MD were some of the first surgeons to use the new DynaFORCE system. Per Dr. Miller, “The plate and staple combination is brilliant. The exciting and innovative engineering of the implants and instruments has direct application to foot and ankle fixation.”

“The DynaFORCE system is very intuitive in the O.R.,” Dr. Philbin said. “The ability to use the dynamic compression staple in conjunction with a plate provides strong compression and stability. Another key benefit of nitinol fixation is the continuous compression you get after implantation. I look forward to utilizing DynaFORCE in multiple applications down the road.”

Designed to meet the needs of multiple applications in foot and ankle fixation, the DynaFORCE portfolio consists of a wide variety of plate and clip options that incorporate continuous adaptive compression.

Vernon Hartdegen, Co-Founder of CrossRoads, comments, “DynaFORCE represents our commitment to establishing a positive experience for foot and ankle surgeons and their patients.  The early clinical results are exceptional, and the product adoption is rapidly accelerating.  Early indications are that DynaFORCE will become the leading technology in foot and ankle fixation.”

DynaFORCE is currently wrapping up an alpha launch. Full US market availability is expected in August 2017.

About CrossRoads Extremity Systems

CrossRoads was founded in 2014 and is headquartered in Memphis, TN. CrossRoads has experienced rapid growth through creative product development and a strong distributorship network. CrossRoads’ goal is to provide a steady rhythm of novel and clinically relevant new products that distinguish us from other companies.

In addition to providing novel products, CrossRoads strives to find ways to help hospitals save money and improve efficiency. CrossRoads believes that as customers experience the EcoSMART™ model of using high quality, surgical grade instruments in sterile kits, and then realize the savings from instrument rebates; our EcoSMART Service will become the preferred model of surgeons, O.R. staff, and materials management.

For more information, please visit www.crextremity.com

©2017 CrossRoads Extremity Systems, LLC.  All Rights Reserved

Contact:
Vernon Hartdegen
SVP of Operations for CrossRoads Extremity Systems, LLC
pr@crextremity.com

 

SOURCE CrossRoads Extremity Systems, LLC.

Related Links

http://www.crextremity.com

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Zimmer Biomet Reports Certain Preliminary Second Quarter 2017 Results

Posted On July 11, 2017 By OrthoSpineNews In Financial /  

WARSAW, Ind., July 11, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that it expects second quarter revenues to be approximately $1.954 billion, which would be an increase of 1.1% over the prior year period, and an increase of 2.1% on a constant currency basis. The Company had previously anticipated second quarter revenues in the range of $1.940 billion to $1.960 billion, with constant currency growth to be in the range of 2.4% to 3.4%. The Company estimates that foreign exchange rates had a favorable impact of 120 basis points relative to what was assumed in second quarter guidance.

Excluding approximately 240 basis points of contribution from the LDR Holding Corporation acquisition, second quarter 2017 revenues are expected to decrease by 1.3%, or a decrease of 0.3% on a constant currency basis, from the second quarter of 2016. This expected constant currency revenue decrease is below the Company’s previously stated guidance range of growth of 0.0% to 1.0% on a similar basis.

“While production output increased at our legacy Biomet manufacturing site in Warsaw, Indiana during the second quarter, certain brands did not achieve targeted production levels as quickly as anticipated. We also experienced slower than expected sales recapture from previously affected customers in the United States,” said Dan Florin, Interim Chief Executive Officer, Senior Vice President and Chief Financial Officer. “As we look toward the second half of 2017, we are focused on restoring full product supply and improving customer engagement, while continuing to progress on our quality enhancement efforts.”

The Company also expects adjusted diluted earnings per share for the second quarter to be at or near the bottom of its previously issued guidance range of $2.08 to $2.13. The Company is unable to provide estimated GAAP (reported) diluted earnings per share results for the second quarter 2017, without unreasonable efforts, as the Company is finalizing the tax accounting related to recently acquired businesses and other certain items that are excluded from the computation of adjusted diluted earnings per share.

Zimmer Biomet will provide further details regarding its second quarter performance and will update its 2017 sales and earnings guidance during the Company’s second quarter earnings call scheduled on Thursday, July 27, 2017. All of the information in this press release is preliminary and subject to completion of quarter-end financial reporting processes and reviews.

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, 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 www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Website Information

We routinely post important information for investors on our website, www.zimmerbiomet.com, in the “Investor Relations” section.  We use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD.  Accordingly, investors should monitor the Investor Relations section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts.  The information contained on, or that may be accessed through, our website is not incorporated by reference into, and is not a part of, this press release.

Note on Non-GAAP Financial Measures

This press release includes non-GAAP financial measures that differ from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”).  These non-GAAP financial measures may not be comparable to similar measures reported by other companies and should be considered in addition to, and not as a substitute for, or superior to, other measures prepared in accordance with GAAP.

Preliminary sales change information for the three-month period ended June 30, 2017 is presented on a GAAP (reported) basis and on a constant currency basis, as well as on a basis that excludes the contribution from the Company’s acquisition of LDR Holding Corporation in July 2016.  Constant currency rates exclude the effects of foreign currency exchange rates.  They are calculated by translating current and prior-period sales at the same predetermined exchange rate.  The translated results are then used to determine year-over-year percentage increases or decreases.  Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures are included in this press release.

Projected diluted earnings per share for the three-month period ended June 30, 2017 is presented on an adjusted basis.  Projected adjusted diluted earnings per share excludes the effects of inventory step-up; certain inventory and manufacturing-related charges connected to discontinuing certain product lines, quality enhancement and remediation efforts; special items; intangible asset amortization; any related effects on our income tax provision associated with these items; and other certain tax adjustments.  Special items include expenses resulting directly from our business combinations and/or global restructuring, quality and operational excellence initiatives, including employee termination benefits, certain contract terminations, consulting and professional fees, dedicated project personnel, asset impairment or loss on disposal charges and other items.  Other certain tax adjustments include internal restructuring transactions that lower the tax rate on deferred tax liabilities recorded on intangible assets recognized as part of acquisition-related accounting or provide the Company access to offshore funds in a tax efficient manner.  As noted above, the Company is unable to provide projected diluted earnings per share for the three-month period ended June 30, 2017 on a GAAP (reported) basis, or a reconciliation of such GAAP amount to projected adjusted diluted earnings per share, without unreasonable efforts, as it is finalizing the tax accounting related to recently acquired businesses and other certain items that are excluded from the computation of adjusted diluted earnings per share.

Management uses these non-GAAP financial measures internally to evaluate the performance of the business and believes they are useful measures that provide meaningful supplemental information to investors to consider when evaluating the performance of the Company.  Management believes these measures offer the ability to make period-to-period comparisons that are not impacted by certain items that can cause dramatic changes in reported operating results, to perform trend analysis, to better identify operating trends that may otherwise be masked or distorted by these types of items and to provide additional transparency of certain items.  In addition, certain of these non-GAAP financial measures are used as performance metrics in the Company’s incentive compensation programs.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  All statements that address expectations, plans or projections about the future, including statements about Zimmer Biomet’s expected financial results, growth prospects and business strategy, are forward-looking statements.  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.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Zimmer Biomet disclaims 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 its periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release 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 news release.

ZIMMER BIOMET HOLDINGS, INC.

PRELIMINARY RECONCILIATION OF REPORTED NET SALES % CHANGE TO

CONSTANT CURRENCY % CHANGE AND

% CHANGE EXCLUDING LDR HOLDING CORPORATION

(unaudited)

For the Three Months Ended
June 30, 2017

Foreign

Constant

Exchange

Currency

% Change

Impact

% Change

Net Sales % Change

1.1 %

(1.0)%

2.1%

Impact of LDR Holding
Corporation

(2.4)

–

(2.4)

% Change excluding
LDR Holding Corporation

(1.3) %

(1.0)%

(0.3)%

ZBH-Fin

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmer.com

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Surgeons’ Perspectives on Premium Implants in Total Joint Arthroplasty

Posted On July 11, 2017 By OrthoSpineNews In Recon /  

Posted June 30, 2017 – Amy S. Wasterlain, MD; Ricardo J. Bello, MD, MPH; Jonathan Vigdorchik, MD; Ran Schwarzkopf, MD, MSc; William J. Long, MD, FRCSC

Abstract

Declining total joint arthroplasty reimbursement and rising implant prices have led many hospitals to restrict access to newer, more expensive total joint arthroplasty implants. The authors sought to understand arthroplasty surgeons’ perspectives on implants regarding innovation, product launch, costs, and cost-containment strategies including surgeon gain-sharing and patient cost-sharing. Members of the International Congress for Joint Reconstruction were surveyed regarding attitudes about implant technology and costs. Descriptive and univariate analyses were performed. A total of 126 surgeons responded from all 5 regions of the United States. Although 76.9% believed new products advance technology in orthopedics, most (66.7%) supported informing patients that new implants lack long-term clinical data and restricting new implants to a small number of investigators prior to widespread market launch. The survey revealed that 66.7% would forgo gain-sharing incentives in exchange for more freedom to choose implants. Further, 76.9% believed that patients should be allowed to pay incremental costs for “premium” implants. Surgeons who believed that premium products advance orthopedic technology were more willing to forgo gain-sharing (P=.040). Surgeons with higher surgical volume (P=.007), those who believed implant companies should be allowed to charge more for new technology (P<.001), and those who supported discussing costs with patients (P=.004) were more supportive of patient cost-sharing. Most arthroplasty surgeons believe technological innovation advances the field but support discussing the “unproven” nature of new implants with patients. Many surgeons support alternative payment models permitting surgeons and patients to retain implant selection autonomy. Most respondents prioritized patient beneficence and surgeon autonomy above personal financial gain. [Orthopedics. 201x; xx(x):xx–xx.]

During the past 20 years, increasing costs for total hip arthroplasty and total knee arthroplasty have outpaced increases in reimbursement.1 Implant costs can comprise up to 50% of Medicare’s reimbursement for the entire procedure and hospitalization.2,3 This rise in costs without a commensurate rise in reimbursement threatens hospitals’ financial stability and may therefore reduce patient access to care. In response, numerous cost-containment strategies have been proposed and implemented to reign in these costs. Value-based alternative payment models such as the Medicare bundled payment provide a fixed fee for all costs associated with a total joint arthroplasty, incentivizing all players to collaborate to provide better quality care at lower cost.4 Many hospitals have subsequently developed guidelines for implant use, restricting access to more expensive or newer implants.

Gain-sharing attempts to realign hospital and physician incentives by compensating surgeons for making cost effective decisions that yield savings for the hospital.4 Compensation may be in the form of bonus payments, additional personnel resources such as physician assistants, research funds, or another item of value to the physician or the department.5 Although surgeons may reap small rewards from gain-sharing, they may have less autonomy to choose the implants they believe are best for their patients.

 

READ THE REST HERE

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Zimmer Biomet Announces Leadership Transition

Posted On July 11, 2017 By OrthoSpineNews In Recon, Top Stories /  

WARSAW, Ind., July 11, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, announced that David C. Dvorak has stepped down as President and Chief Executive Officer and a member of the Board of Directors, effective today. To assist with the transition, Mr. Dvorak will serve in an advisory capacity to the Company for a period of time. The Board has appointed Daniel P. Florin, Senior Vice President and Chief Financial Officer, to serve in the additional role of Interim CEO and a member of the Board of Directors until a permanent successor has been named.

The Zimmer Biomet Board is retaining a leading executive search firm to identify and evaluate candidates for the permanent CEO role.

Mr. Dvorak said, “Serving alongside Zimmer Biomet’s dedicated employees over the past 16 years and leading the Company as CEO for ten of those years has been a privilege and a highlight of my professional career. Our collective efforts grew employment from approximately 3,000 in 2001 to 18,000 today and built a Fortune 500 company. I am particularly proud of what we have accomplished working together with surgeons and clinicians to help millions of patients globally improve their quality of life.”

Larry C. Glasscock, Chairman of the Board of Zimmer Biomet, commented, “During David’s ten-year tenure as CEO, Zimmer Biomet has transformed into a truly global leader in musculoskeletal healthcare. Through a combination of organic growth and strategic acquisitions, Zimmer Biomet’s revenue has doubled and the Company has established a leading portfolio of technologies, solutions and personalized services. With this strong platform in place, there is tremendous opportunity for Zimmer Biomet. On behalf of the Board, I thank David for his many important contributions to our Company and industry over the years and wish him much success in the future.”

Mr. Glasscock continued, “We are fortunate to have a leader of Dan’s caliber and experience to step into the CEO role on an interim basis while the Board conducts its search process. Dan’s knowledge of Zimmer Biomet and his achievements here and at other medical device companies make him an excellent choice to support the Company through this interim period. We appreciate his willingness to take on this expanded role.”

Mr. Florin said, “Zimmer Biomet has a talented and dedicated team and an unmatched portfolio. I am honored to assume the Interim CEO role and I look forward to working closely with the Board, senior leadership team and our sales force as we strive to support our customers and enhance stockholder value.”

About Dan Florin

Dan Florin was appointed Senior Vice President and Chief Financial Officer of Zimmer Biomet in June 2015 and has over 16 years of executive experience in the medical device industry. He previously served as Senior Vice President and Chief Financial Officer of Biomet from June 2007 to June 2015. Prior to joining Biomet, Mr. Florin served as Vice President and Corporate Controller of Boston Scientific Corporation from 2001 until 2007. Before being appointed Corporate Controller in 2001, Mr. Florin served in financial leadership positions within Boston Scientific Corporation and its various business units. Mr. Florin previously worked for C.R. Bard from October 1990 through June 1995, and Deloitte from September 1986 to October 1990. Mr. Florin holds a Bachelor’s degree in Business Administration with a concentration in Accounting from the University of Notre Dame and an Executive MBA from Boston University.

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, 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 www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  All statements that address expectations, plans or projections about the future, including statements about Zimmer Biomet’s management transition plans, growth prospects and business strategy, are forward-looking statements.  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.  For a list and description of some of such risks and uncertainties, see Zimmer Biomet’s periodic reports filed with the U.S. Securities and Exchange Commission (SEC).  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  Zimmer Biomet disclaims 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 its periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release 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 news release.

ZBH-Corp

 

SOURCE Zimmer Biomet Holdings, Inc.

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