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Implanet Reports Full-Year 2018 Results

Implanet Reports Full-Year 2018 Results

  • Gross margin improvement (55.6% in 2018, up from 50.1% in 2017)
  • Operating loss reduction (loss of €5.4 million in 2018, down from €6.2 million in 2017)

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

Implanet (Euronext Growth: ALIMP, FR0010458729, eligible for PEA-PME equity savings plans) (Paris:ALIMP) (OTCQX:IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today announces its results for the financial year ended on December 31, 2018, and approved by the Board of Directors on April 18, 2019.

In 2018, we finalized the shutdown of our Arthroscopy business and reorganized our sales and marketing operations for the JAZZ® product range in the top European target markets (United Kingdom and Germany). Implanet converted to a direct sales model in these priority markets, reflecting the strategy previously introduced in the United States and France. In addition, the major partnerships we signed during 2018 with Kico Knee Innovation Company and SeaSpine, Inc., a wholly owned subsidiary of SeaSpine Holdings Corporation (NASDAQ: SPNE) should allow us to accelerate our revenue growth in the US and international markets”, commented Ludovic Lastennet, Implanet’s Chief Executive Officer.

N.B. The audit of the consolidated financial statements has been completed. The auditors’ report is currently being prepared.

JAZZ® revenue down 14% despite increases of 8% in France and 2% in the United States (at constant exchange rates) where Implanet operates a direct sales model

As disclosed in previous releases, Implanet made the decision to shut down its Arthroscopy business (€0.2 million in revenue in 2018 compared to €0.6 million in 2017) and to reorganize its sales and marketing operations for the JAZZ® product range in Europe in 2018. Accordingly, Implanet established a branch in the United Kingdom and a subsidiary in Germany, with first surgeries taking place in the fourth quarter of 2018.

This transition is the main factor accounting for the 14% decline in the Group’s FY 2018 revenue to €6.7 million. JAZZ® sales continued to grow in markets in which Implanet has a direct presence, rising 8% in France to €1.6 million and 2% (at constant exchange rates) to €1.9 million in the United States. In the rest of the world, Implanet recorded JAZZ® revenue of €0.6 million (down 54% compared to FY 2017, as a result of the reorganization in Europe).

Implanet sold 8,246 JAZZ® units in FY 2018 (compared to 9,117 units in 2017). Of this total, 4,347 units were sold in France (up 6% compared to 2017), 1,676 in the United States (up 9% compared to 2017) and 2,223 in the Rest of the world (down 36% compared to 2017 as a result of the reorganization in Europe).

The Implanet group’s strategic plan focuses on three priorities:

Improvement in gross margin ratio and tight control of operating expenses

The FY 2018 gross margin improved by more than 5 points to 55.6% (compared to 50.1% in FY 2017).

Implanet kept a tight control of its operating expenses through its strict cost management policy, resulting in a significant operating loss reduction (€5.4 million in 2018, down from €6.2 million in the previous financial year).

Implanet posted a FY 2018 net loss of €5.6 million, compared to a loss of €6.6 million in FY 2017.

In addition, Implanet continued to restructure its operations and it should allow the company to realize additional fixed cost savings of almost €1.0 million p.a..

Cash position

At December 31, 2018, Implanet held €0.7 million in cash and short-term investments (vs. €4.0 million at December 31, 2017). During FY 2018, it reduced its cash burn from €3.1 million in the first half to €1.9 million in the second half of 2018, owing principally to restructuring measures and the Group’s reorganization.

On November 9, 2018, the Company arranged a bond financing facility of up to €1.0 million with Nice & Green. Nice & Green subscribed for all the convertible bond tranches between December 2018 and March 2019.

Implanet believes that it has sufficient working capital for the next 12 months on the basis of its cash position, the new €3.0 million convertible bond financing line arranged with Nice & Green on April 15, 2019 and the agreement with the Nouvelle Aquitaine region concerning a €0.5 million loan. Furthermore, under the resolutions approved by shareholders at the Extraordinary General Meeting on March 25, 2019, Implanet continues to explore additional solutions to finance the acceleration in its business development.

Continued innovation

Over the past few years, Implanet has continued to invest heavily in innovation and the clinical assessment of its two product ranges.

In 2018, it launched JAZZ Evo®, a new version of the JAZZ® implant developed to meet the constraints of vertebral fusion indications in adults, for which it obtained the CE mark and 510(K) authorization from the FDA. Implanet also introduced JAZZ Cap®, a dedicated screw-based solution for vertebral fusion, which obtained the CE mark in 2018 and FDA clearance in the first quarter of 2019.

In just a few years, JAZZ® has gone from being a niche/specialty product used solely for deformity indications in adolescents to one used on a daily basis in a far larger market—the treatment of degenerative conditions in adults—by providing surgeons with solutions to unmet needs. The JAZZ Cap® solution complements the screw fixings and enables the Company to target a vertebral fusion market estimated at $2.5 billion1.

Partnerships established to access new markets more rapidly, including the United States

In November 2018, Implanet announced it had entered into a distribution partnership with Kico Knee Innovation Company Pty Ltd (“KICO”) covering its Madison knee implant business in the United States and other markets in the future, such as Australia.

In February 2019, Implanet also established a strategic partnership with SeaSpine covering the distribution in the United States of its JAZZ® spinal product range and future technologies, which will dramatically increase its presence in the United States, the world’s largest market for spinal surgery products worth over $6 billion2 every year.

In addition to opening up new markets with substantial potential, these recent partnerships are a ringing endorsement of the clinical value of Implanet’s unique platform of orthopedic products and its ability to develop technologies meeting the highest market standards, which can be sold either directly or through international partnerships.

Next financial press release:

First-quarter 2019 revenues on April 24, 2019 after market close

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About Implanet

Founded in 2007, Implanet is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the Jazz® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Implanet’s tried-and-tested orthopedic platform, which is based on perfect control over the traceability of its products, provides it with a proven ability to promote this innovation. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. Implanet employs 38 staff and recorded 2018 sales of €6.7 million. For further information, please visit www.Implanet.com.
Based near Bordeaux in France, Implanet established a US subsidiary in Boston in 2013. Implanet is listed on Euronext™ Growth market in Paris.

This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 16, 2018 under number D.18-0337 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

1 Sources: i-Data 2010; D. K. Chin et al. Osteoporos Int (2007) 18:1219–1224; Company; 2015 Health Advances study
2 Source: GBI Research


Ludovic Lastennet, CEO
David Dieumegard, CFO
Tel.: +33(0)5 57 99 55 55

Investor Relations
Sandrine Boussard-Gallien
Tel.: +33 (0)1 44 71 94 94

Media Relations
Nicolas Merigeau
Tel.: +33 (0)1 44 71 94 94

SOURCE: BusinessWire April 18th 2019 – https://www.businesswire.com/news/home/20190418005521/en/Implanet-Reports-Full-Year-2018-Results

Osiris Therapeutics, Inc. Announces Closing of Acquisition by Smith & Nephew plc

Osiris Therapeutics, Inc. Announces Closing of Acquisition by Smith & Nephew plc

COLUMBIA, Md., April 17, 2019 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, announced today that it has completed the previously announced sale of Osiris to Smith & Nephew plc (“Smith & Nephew”) through the consummation of a merger of Osiris with and into an indirect wholly-owned subsidiary of Smith & Nephew (the “Subsidiary”) without a vote of the Osiris stockholders in accordance with Section 3-106.1 of the Maryland General Corporation Law.  A majority of the outstanding shares of Osiris common stock were tendered in the tender offer.  In the second-step merger, each share of Osiris common stock that was not purchased by Smith & Nephew in the tender offer (other than shares directly owned by the Subsidiary or by any subsidiary of Osiris) has been converted into the right to receive $19.00 per share in cash, without interest, subject to any required withholding of taxes, which is the same cash price per share as was paid in the tender offer.  As a result of the merger, Osiris became an indirect wholly-owned subsidiary of Smith & Nephew and Osiris’ shares will cease to be traded on the NASDAQ Global Select Market.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, researches, develops, manufactures and commercializes regenerative medicine products intended to improve the health and lives of patients and lower overall healthcare costs. We have achieved commercial success with products in orthopedics, sports medicine and wound care, including the Grafix product line, Stravix®, BIO and Cartiform®. We continue to advance our research and development by focusing on innovation in regenerative medicine, including the development of bioengineered stem cell and tissue‑based products. Osiris®, Grafix®, GrafixPL®, GrafixPL PRIME, Cartiform®, and Prestige Lyotechnologysm are our trademarks. BIO is a trademark of Howmedica Osteonics Corp., a subsidiary of Stryker Corporation. More information can be found on the Company’s website, www.osiris.com. (OSIR-G)

For additional information, please contact:
Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834

Source: GlobeNewswire

MiMedx Announces Board Approval of Long-Range Strategic Plan

MiMedx Announces Board Approval of Long-Range Strategic Plan

Organization Focused on Execution of 2019 Priorities

Provides Update on Investigation and Other Matters

MARIETTA, Ga., April 11, 2019 /PRNewswire/ — MiMedx Group, Inc. (OTC PINK: MDXG) (“MiMedx” or “the Company”), an industry leader in advanced wound care and an emerging therapeutic biologics company, today reinforced its priorities for 2019 as part of its long-range strategic plan to enhance value for all MiMedx stakeholders. These priorities include sharpening our focus on the advanced wound care segment, developing and expanding our portfolio pipeline, and driving continued operational excellence to support future growth and sustained productivity.  

David Coles, Interim Chief Executive Officer, said, “Our long-range strategic plan positions MiMedx to capitalize on market expansion opportunities, and broaden the access customers and patients have to our leading technology portfolio throughout the continuum of care. We believe that the strategic priorities outlined will enable us to achieve the full potential of our product portfolio and further distinguish MiMedx as a leader in advanced wound care.”

Long-Range Strategic Plan 

In the second half of 2018, MiMedx initiated a process to further define its business priorities and develop a long-range strategic plan. Following management’s initial review, the Company retained a leading strategic advisory firm to validate market dynamics including its pipeline products, assess product adjacencies for acquisition or investment, and provide a framework for MiMedx to determine its capital allocation strategy to support its current and future business opportunities. 

MiMedx is a leader in the advanced wound care category. This category is expected to continue growing due to certain demographic trends, including an aging population, increasing incidence of obesity and diabetes, and the associated higher susceptibility to non-healing chronic wounds. Furthermore, the increasing number of patients requiring advanced treatment represents a significant cost burden on the healthcare system. After evaluating the potential impact of this data on the Company’s wound care franchise, MiMedx’s long-range strategic plan incorporates a strategy to not only participate in this market growth but to also increase the Company’s market share by demonstrating the positive health economics of our products and addressing patient needs earlier in the spectrum of care. 

MiMedx intends to seek capital to implement its long-range strategic plan, which includes expanding its product offerings for earlier patient access and product adoption throughout the care continuum and accelerating the Company’s timeline to achieve its long-term growth objectives, including the Biologics License Application (BLA) pipeline. The capital raise is also intended to provide liquidity to fund the costs associated with the ongoing Audit Committee investigation, the restatement of the Company’s financial statements and the near-term efforts by the Company to address certain contingent liabilities relating to pending and threatened lawsuits, pending governmental investigations and other legal proceedings. The Company is authorized by the Board of Directors to pursue a capital raise and has received unsolicited interest from a number of third parties.

Priorities for 2019

The long-range strategic plan serves as the foundation for the Company’s 2019 priorities. These priorities include sharpening our focus on the advanced wound care segment, developing and expanding our portfolio pipeline, and driving continued operational excellence to support future growth and sustained productivity. 

  • Focus on effective and efficient execution in core advanced wound care business, maximizing clinical adoption and health economics value.We are identifying and aligning sales territories to focus our salesforce and drive efficiencies, enabling the MiMedx field personnel and sales infrastructure to enhance productivity and better serve our customers and patients. The Company is building additional health economics outcomes data to support use of EpiFix® earlier in the care continuum and has expanded efforts to best position EpiCord® synergistically within the treatment paradigm, capitalizing on expanded product coverage throughout its leading technology portfolio. 
  • Enhance business development efforts, driving growth throughout the Company’s existing product portfolio pipeline and strategic adjacencies to create a long-term competitive advantage. MiMedx’s long-range strategic planning identified opportunities for innovative pipeline growth, strategic product adjacencies, and international regulatory and coverage expansion within targeted high growth markets. Additionally, an ongoing assessment of the Company’s development programs has highlighted the need for greater cross-functional collaboration and increased investment. The Company remains focused on advancing its BLA programs and is therefore aligning Voice-of-Customer input, industry expertise and sufficient resourcing toward U.S. Food and Drug Administration (FDA) approval for micronized dehydrated human amnion/chorion membrane (dHACM) to treat musculoskeletal degeneration across multiple indications. 
  • Enable operational and organizational excellence to support future growth and sustained productivity.The organizational realignment, cost reduction and efficiency program announced in December 2018 has positioned the Company to improve business efficiencies supportive of sustained, achievable and independent growth. The Company is on track to realize the realignment program’s intended cost savings, and management continues to position the business for long-term success. As part of a continuing assessment of salesforce effectiveness, the Company recently commenced an initiative to better stratify and support its existing customers and identify new account prospects where our reimbursement coverage and Group Purchasing Organization (GPO) and Integrated Delivery Network contracts best align with patient and provider opportunities. Furthermore, MiMedx recently conducted an independent and anonymous third-party employee engagement survey, in which over 75% of our employees participated. The results identified a number of areas for improvement, including promoting an improved company culture, additional investment in employee development and retention, and supporting better decision-making through process and infrastructure resulting in a better customer experience. The Company is developing a comprehensive plan to improve engagement through initiatives designed to realize improvement in each of these areas. 

Recent Operational Accomplishments

MiMedx also announced the following recent operational accomplishments, which it expects will provide patients and health care providers across the country greater access to the Company’s products:   

  • renewed three-year contract with a large GPO, resulting in MiMedx having contracts with three of the four largest GPOs; 
  • addition of a well-known payer covering EpiFix, which expands the total covered lives to more than 315 million for MiMedx products across the U.S.; and 
  • world-renowned, multi-facility healthcare system’s selection of MiMedx as its preferred amniotic tissue product provider. 

Mr. Coles added, “We are focused on building on key successes like these, which are made possible by the teamwork and collaboration demonstrated at all levels of our organization, coupled with the strength of our evidence-based products.”

BLA Timeline Update

Management is assessing the Company’s readiness to file and commercialize its BLAs with the FDA. It is now evident that, in addition to protocol enhancements, further resources, capabilities and expertise will be required for commercial launch. The previously communicated timeline will be extended and updates will be provided as we complete our review. 

Additional Company Matters, including Financial Restatement, Audit Committee Investigation and Ongoing Legal Proceedings

MiMedx has made substantial progress in assessing the overall state of the Company and its business culture and is implementing corrective processes to define, remediate, and enhance internal procedures for business health and sustainability. The new management team has effected the implementation of procedures for enhanced and improved business and selling controls. These include a restructured and bolstered pricing committee; tightened policies, procedures and governance of credit; the establishment of an independent compliance department reporting to the Board of Directors; the assessment and initial implementation of remediation of Sarbanes Oxley-related controls; hiring a Vice President of Internal Audit to develop an internal audit function for the Company; and executing on the realignment program announced in December 2018.  

The Company continues to work diligently to complete the financial restatement. Due to the depth, breadth and complexity of issues identified through the Audit Committee’s investigation, the scope of work in connection with the preparation of the Company’s restated financial statements was expanded.  Investigative efforts initially focused on the accounting practices around specific distributors between 2012 and 2017. Additional concerns related to other customer accounts resulted in the need to analyze the Company’s revenue recognition practices for all years from 2012 to 2018; the Company is nearing the end of that review. At the same time, the Company has implemented improved processes and controls to monitor sales practices, authorize credits and returns, recognize revenue, and is advancing the Company’s financial restatements in an expedited manner in order to regain compliance with Securities and Exchange Commission (SEC) reporting obligations. Lastly, the investigation is nearing completion; until such time as the Audit Committee’s investigation is concluded, there may be other actions taken based, at least in part, on information from the investigation. Under the guidance of the Audit Committee, the Company is in the process of selecting a new auditor, and believes it will be able to begin the audit within a reasonable timeframe after the new auditor is engaged.

MiMedx previously disclosed investigations by the SEC and the U.S. Department of Justice (DOJ) related to, among other things, the Company’s financial reporting. These remain ongoing. In addition, the Department of Veterans Affairs (VA) Office of Inspector General (VA-OIG) has issued subpoenas to the Company, and the VA-OIG, in conjunction with the Civil Division of the DOJ, has requested, among other things, information related to the Company’s financial relationships with VA-affiliated providers. The Company continues to cooperate with these agencies.

MiMedx has also undertaken a comprehensive review of its historical VA sales and has recorded an obligation of $8 million in connection with a potential issue that it self-disclosed to the VA concerning the eligibility of one of its products for inclusion in the Company’s Federal Supply Schedule (FSS) contract. The matter is ongoing and no final determination has been made at this time.

Edward Borkowski, Executive Vice President and Interim Chief Financial Officer said, “We continue to work diligently to complete the financial restatement as soon as practicable, and we are making progress on the selection of a new auditor. Importantly, while these processes continue, the entire MiMedx team is committed to delivering on our 2019 priorities in support of the Company’s long-range strategic plan.”  

Mr. Coles added, “We remain focused on moving forward. The work we do is critical to patients and their families, and the compassion and steadfastness evidenced by employees at all levels of the organization demonstrates the Company’s commitment to advancing the treatment paradigm for evidence-based advanced wound care. We are confident that our current priorities will best position the Company to realize its long-term strategic growth objectives.”

About MiMedx

MiMedx® is an industry leader in advanced wound care and an emerging therapeutic biologics company developing and distributing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. The Company processes the human placental tissue utilizing its proprietary PURION® process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.5 million allografts to date. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements including statements regarding the Company’s plans to seek capital; its expectations that it will expand product offerings; its expectation that it will accelerate long term growth objectives, including its BLA pipeline; its expectations regarding the use of any capital raised funds; and its expectations regarding the timing of the selection of a new auditor, the completion of the Audit Committee’s investigation, and the completion of the restatement. Additional forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “would” and similar expressions and are based on management’s current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ materially from those set forth in the forward-looking statements as a result of various factors, including the reduction in workforce and non-employee-related expenses; the Company’s strategy, future operations, future financial position, future revenues or projected costs, including its ability to manage its operating expenses; whether the Company will be successful in obtaining capital on terms that it finds acceptable; whether opportunities to expand the strategic pipeline exist or may be acquired or accomplished at reasonable cost; future actions that may be taken in connection with the Audit Committee’s independent investigation and the financial restatement process; the total costs that have been and will be incurred to address the contingent liabilities relating to pending and threatened lawsuits, pending government investigations and other legal proceeding, and the timing associated with incurring such costs; the complexity of completing the restatement and the timeline for a new auditor being selected and completing the audit work necessary for the Company to regain compliance with its SEC reporting obligations; and the factors discussed in the Risk Factors section of the Company’s most recent annual report filed with the SEC. Any forward-looking statements speak only as of the date of this press release, and except as required by law, the Company assumes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Hilary Dixon
Corporate & Investor Communications

SOURCE MiMedx Group, Inc., PRNewswire, April 11, 2019

Mark Foster Appointed to CEO of Trice Medical

Mark Foster Appointed to CEO of Trice Medical

MALVERN, Pa.–(BUSINESS WIRE)–Trice Medical announced today the appointment of Mark Foster, President of Trice Medical, to President and Chief Executive Officer, effective June 30, 2019. Foster joined Trice in 2016, serving as V.P. of Global Sales and CCO and was promoted to President in March 2018. Prior to coming to Trice, Mark served as V.P. of U.S. Business for Smith and Nephew and in several leadership roles at Boston Scientific. Current CEO, Jeffrey F. O’Donnell Sr., will be retiring but will remain active with Trice as a Strategic Advisor.

“I am thrilled to make this announcement,” said O’Donnell, “I am very proud of the whole team at Trice Medical and what we have achieved in the past six years. Mark joined Trice with a strong set of ‘big company skills’ – quickly adding value while also learning how different ‘start-ups’ are. I look forward to assisting him in his transition to his new role as the CEO of an emerging growth company.”

“I’ve had the opportunity to work closely with both Jeff and Mark for several years,” added Gary Kurtzman, chairman of the board at Trice. “Jeff’s passion and drive have gotten us to this point. We will continue to leverage his skills and expertise as we enter the next stage of expansion and growth under Mark’s leadership.”

Trice recently announced the launch of the mi-ultra® and the acquisition of S.E.G-WAY™ Orthopedics (SegWAY). “Our mission is to build a great company that enhances quality of life,” commented Foster. “An in-office mi-eye® or mi-ultra® procedure allows the patient and surgeon to get instant, accurate information and by adding SegWAY, we now have a more diversified portfolio to treat patients with many different soft-tissue injuries, including the rapidly growing Endoscopic Carpal Tunnel Market. I am looking forward to leading our team to bring even more innovative technology that brings value to patients, physicians and payers,” Foster said.

About Trice Medical:

Trice Medical was founded to fundamentally improve minimally invasive orthopedic diagnostics for the patient and physician providing instant answers. Trice Medical has pioneered fully integrated camera-enabled technology with the mi-eye 2™ and launched the world’s first Dynamic Imaging Platform combining a 15 MHz handheld ultrasound transducer with the mi-eye™ technology on one simple, portable platform. Trice Medical’s goal is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reducing the overall cost to the healthcare system. To learn more visit www.tricemedical.com.


Craig Carra, CFO

SOURCE: BusinessWire – https://www.businesswire.com/news/home/20190411005435/en/

Stryker’s Chairman and CEO Kevin Lobo Named Chairman of AdvaMed Board of Directors

Stryker’s Chairman and CEO Kevin Lobo Named Chairman of AdvaMed Board of Directors

WASHINGTON, D.C. – The Advanced Medical Technology Association (AdvaMed) today announced that Stryker’s Chairman and CEO Kevin Lobo has been named chairman of the AdvaMed Board of Directors for a two-year term. 

Since 2017, Lobo has served as chair of AdvaMed’s Membership and Business Development Committee, helping drive membership growth nearly 10 percent and increasing member retention of the association’s largest members to 96 percent over the course of his tenure. From 2015 to 2017, he chaired the association’s International Committee and currently chairs AdvaMed’s Industry Communications Committee. Lobo has been a member of the AdvaMed Board of Directors since 2012 and a member of the AdvaMed Board of Directors Executive Committee since 2014.  

“I’m proud to be a part of the medical technology community, and I’m honored to chair this great trade association, which helps advance our work on behalf of patients and health care progress around the world,” said Lobo. “The medtech ecosystem has never been more vibrant than it is today, with innovators delivering new treatments and cures at a rapid pace. AdvaMed plays a critical role in nurturing that ecosystem, and I’m excited to spearhead those efforts as chair.”  

During his chairmanship, Lobo plans to focus on increasing engagement with patient advocacy organizations; reinforcing the positive impact of the medical technology industry to patients and other relevant stakeholders; developing a more consistent, transparent and predictable pathway to approval and reimbursement for emerging medical technologies; and promoting diversity and inclusion within the medical technology industry.  

“Kevin is a proven leader in the medtech industry and within our association,” said Scott Whitaker, president and CEO of AdvaMed. “During his time on the AdvaMed Board of Directors, he’s translated his passion for this industry into tangible results for our companies, their customers and the patients they serve.  His leadership skills will benefit AdvaMed and this industry tremendously, and I look forward to working with him more closely in the coming years.”  

Lobo succeeds CVRx President and CEO Nadim Yared.  

“Nadim’s leadership has served AdvaMed incredibly well over the past two years,” said Whitaker. “As our first chair from a smaller medtech company, he has brought a unique perspective on the challenges facing start-ups and emerging growth companies. His vision of the association as the convener for all stakeholders in our innovation ecosystem has helped expand AdvaMed’s engagement into new areas and his impact will continue to be felt for years to come. On behalf of the entire association, I thank Nadim for his hard work, and I applaud his impressive record of accomplishments.”  

Among AdvaMed’s accomplishments under Yared’s leadership were:  

  • Securing another two-year suspension of the medical device tax, saving the industry nearly $2 billion annually; 
  • Successfully negotiating a fourth user fee agreement, ensuring continued improvements in the efficiency, transparency and predictability of the FDA review process; 
  • The launch of AdvaMed’s Value Frameworks to help members make the case for the value of medical devices and diagnostics; 
  • Continued progress on key Medicare coverage and payment reform proposals; 
  • Achieving significant regulatory reform in China and improved registration times in Brazil; 
  • A comprehensive refresh of the AdvaMed Code of Ethics; and  
  • Acquisition of The MedTech Conference operation and staging the association’s largest and most successful event ever in Philadelphia in 2018. 

AdvaMed also announced new committee and Board chairs for 2019-2021. A complete list is available here

SOURCE: AdvaMed March 27, 2019 – https://www.advamed.org/newsroom/press-releases/stryker%E2%80%99s-chairman-and-ceo-kevin-lobo-named-chairman-advamed-board-directors