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MiMedx Provides Additional Information and Context to Wall Street Journal Article

Wednesday August 15 th 2018

MARIETTA, Ga., Aug. 15, 2018 /PRNewswire/ – MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today provided additional background and context to certain points, including third party statements, in an article published by The Wall Street Journal (“WSJ”) on August 14, 2018:

MiMedx products are manufactured according to current Good Tissue Practices (cGTP) standards, pursuant to the Food and Drug Administration (“FDA”) regulations specified in 21 CFR 1271, which are the requirements and guidelines the Company must follow. MiMedx is also in compliance with the American Association of Tissue Banks’ 14th standard, of which the Company is a fully accredited member in good standing.

In addition, certain MiMedx products are marketed as cellular and tissue based products (“HCT/Ps”) under Section 361 of the Public Health Service Act until either a biologics license application (“BLA”) by the Company is approved or the FDA’s enforcement discretion under the November 2017 guidance document1 ends. Since the 2016 inspection report from the FDA referenced by the WSJ, MiMedx has continued its transition to cGMP compliance for certain products as it conducts clinical trials to seek approval for certain indications under a BLA filing for its micronized dehydrated Amnion/Chorion Membrane (“dHACM”) injection (AmnioFix® Injectable).

In terms of the clinical evidence supporting the Company’s products, MiMedx continues to build its compendium of clinical studies, including numerous randomized controlled studies, to support the use of EpiFix®. In addition, the Company has three ongoing investigational new drug programs with the FDA covering clinical studies intended to support an eventual BLA for micronized dHACM injection. As an example, interim results from a Phase 2B multicenter, randomized controlled trial evaluating the use of micronized dHACM injection as a treatment for Plantar Fasciitis were recently published in Foot and Ankle International. The interim results reflected statistically significant improvement in pain and foot function compared to the placebo control group. MiMedx also began enrolling patients into its Phase 3 Plantar Fasciitis trial in January 2018.

Selling micronized amniotic tissue-based products is a broad industry matter now covered by a finalized guidance document1 from the FDA on homologous use and minimal manipulation of HCT/Ps. The guidance stated that all micronized amniotic products would require a biologics license to be lawfully marketed in the United States, and that FDA would use its enforcement discretion to provide a 36-month transition period. MiMedx is committed to the transition process as described in the November 2017 guidance.  In the meantime, and until the end of the transition period, MiMedx continues to sell its micronized allograft products as HCT/Ps in the United States. 

MiMedx continues to make progress on its market expansion objectives and clinical trial programs while continuing to maintain positive operating cash flow with no outstanding long-term debt. The Board and management team remain focused on positioning MiMedx to capitalize on the full array of opportunities presented by the Company’s processing capabilities, clinical science, customer relationships and scale.

As previously disclosed, the MiMedx Audit Committee is conducting an independent internal investigation into current and prior-period matters concerning sales and distribution practices and other matters. The Audit Committee is working diligently with its advisors to complete the investigation, and the Company is also working to prepare its financial statements for audit and regain compliance with Securities and Exchange Commission reporting obligations as soon as practicable.

About MiMedx

MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the Company’s mission to provide physicians products and tissues to help the body heal itself.  The Company processes the human placental tissue utilizing its proprietary PURION® Process methodology, among other processes, to produce safe and effective allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements Additional forward-looking statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” 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. For more detailed information on the risks and uncertainties, please review the Risk Factors section of the Company’s most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and the Company assumes no obligation to update any forward-looking statement.

1.        See FDA, Guidance for Industry and Staff: Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use (Nov. 2017).

 

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SOURCE MiMedx Group, Inc.

The global IP Multimedia Subsystem (IMS) market size is estimated to grow from USD 1.79 billion in 2018 to USD 3.71 billion by 2023, at a Compound Annual Growth Rate (CAGR) of 15.7%

LONDON, August 15, 2018 /PRNewswire/ — The increasing need by telecom operators to reduce their CAPEX and OPEX is driving the growth of the IMS market.

Download the full report: https://www.reportbuyer.com/product/5484964

The global IP Multimedia Subsystem (IMS) market size is estimated to grow from USD 1.79 billion in 2018 to USD 3.71 billion by 2023, at a Compound Annual Growth Rate (CAGR) of 15.7% during the forecast period.

The IMS market is in the growing phase and expected to grow at a moderate pace across the globe.Low Capital Expenditure (CAPEX) and Operational Expenditure (OPEX), increasing number of Long-Term Evolution (LTE) mobile subscribers across the globe, and the growth of the network infrastructure are expected to drive the market growth.

However, security concerns in virtualization, lack of availability of skilled workforce, and unwillingness of telecom operators to transit from the legacy infrastructures to a virtual environment may hamper the growth of the market, but for a specific period.

The mobile operator segment is expected to hold the larger market share during the forecast period.
Among telecom operators, the mobile operators segment is expected to hold the largest market share during forecast period.Mobile operators have been facing several challenges, such as updating the legacy systems to meet the current demands for end-customers, intense competition, high CAPEX and OPEX, and low Return on Investment (RoI).

Hence, they are in the process of seeking scalable and cost-effective solutions. All these factors are expected to be the key reason for the rapid adoption of IMS solutions and services by telecom operators.

Asia Pacific is expected to grow at the highest CAGR during the forecast period.
APAC is expected to grow at the highest growth rate during the forecast period.The majority of the mobile and fixed operators in the APAC region are still using traditional IMS solutions.

However, this trend is expected to change while operators would eventually shift toward virtualized and cloud-based solutions. Hence, the demand for IMS market would be huge in this region.

In-depth interviews were conducted with Chief Executive Officers (CEOs), marketing directors, innovation and technology directors, and executives from various key organizations operating in the IMS market.

The breakup of the profiles of primary participants is given below:
• By Company: Tier 1 – 25%, Tier 2 – 35%, and Tier 3 – 40%
• By Designation: C-Level – 45%, Director Level – 51%, and Others – 4%
• By Region: North America – 39%, Europe – 25%, APAC – 30%, and Rest of the World (RoW) – 6%

The key IMS vendors profiled in the report are as follows:
• Ericsson (Sweden)
• Huawei (China)
• NEC (Japan)
• Nokia (Finland)
• ZTE (China)
• Athonet (Italy)
• Cirpack (France)
• Cisco (US)
• CommVerge Solutions (China)
• Dialogic (US)
• Interop Technologies (US)
• Italtel (Italy)
• Metaswitch (UK)
• Mavenir (US)
• Oracle (US)
• Radisys (US)
• Ribbon Communications (US)
• Samsung (South Korea)
• WIT Software (Portugal)

Research Coverage
The IMS market has been segmented by component (product and service), telecom operator, and region. A detailed analysis of the key industry players has been done to provide insights into their business overview; services; key strategies; new service launches; partnerships, agreements, and collaborations; expansions; and competitive landscape associated with the global IMS market.

Reasons to Buy the Report

The report would help market leaders/new entrants in the following ways:
• The report segments the IMS market comprehensively and provides the closest approximations to the revenue numbers for the overall market and subsegments across different regions.
• The report is expected to help stakeholders understand the pulse of the market and provide information on the key market drivers, restraints, challenges, and opportunities.
• The report is expected to help stakeholders understand their competitors better and gain more insights to enhance their position in the market. The competitive landscape section includes competitor ecosystem, new services developments, partnerships, and acquisitions.

Download the full report: https://www.reportbuyer.com/product/5484964

About Reportbuyer
Reportbuyer is a leading industry intelligence solution that provides all market research reports from top publishers

For more information:
Sarah Smith
Research Advisor at Reportbuyer.com
Email: sarah@reportbuyer.com
Tel: +1 (718) 213 4904
Website: www.reportbuyer.com

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SOURCE ReportBuyer

Best Lawyers in America 2019 Recognizes 72 Waller Attorneys

NASHVILLE, Tenn., Aug. 15, 2018 /PRNewswire/ – 72 attorneys from Waller Lansden Dortch Davis, LLP were selected by their peers for inclusion in The Best Lawyers in America© 2019. Waller attorneys were recognized by Best Lawyers in 60 distinct practice areas with many attorneys recognized in multiple areas. Attorneys representing each of Waller’s five offices in Austin, Birmingham, Chattanooga, Memphis and Nashville were among those honored. In addition, ten Waller attorneys were named “Lawyer of the Year” for specific practice areas in their respective cities:

·         Larry B. Childs – Litigation – Banking and Finance (Birmingham)

·         George W. Bishop III – Litigation – Mergers and Acquisitions (Nashville)

·         Chase Cole – Corporate Law (Nashville)

·         James M. Doran, Jr. – Product Liability Litigation – Defendants (Nashville)

·         Stanley E. Graham – Labor Law – Management (Nashville)

·         Robb S. Harvey – Litigation – Intellectual Property (Nashville)

·         Richard A. Johnson – Trusts and Estates (Nashville)

·         E. Andrew Norwood – Technology Law (Nashville)

·         Patsy Powers – Health Care Law (Nashville)

·         I.C. “Jack” Waddey, Jr. – Patent Law (Nashville)

“Being recognized by our peers is always a great honor, said Waller chairman Matt Burnstein. “The 2019 edition of Best Lawyers highlights both Waller’s depth and our continuing commitment to client service.”

Following is a complete list of the Waller attorneys recognized in The Best Lawyers in America© 2019.

Austin, TX

  • Fletcher H. Brown

‒      Health Care Law

  • Kevin W. Brown

‒      Commercial Litigation

  • Richard W. Harrison

‒      Commercial Litigation

‒      Litigation – Construction

‒      Litigation – Intellectual Property

‒      Litigation – Patent

  • Eric J. Taube

‒      Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law

‒      Bet-the-Company Litigation

‒      Commercial Litigation

‒      Litigation – Banking and Finance

‒      Litigation – Bankruptcy

‒      Litigation – Real Estate

‒      Litigation – Securities

 

Birmingham, AL

  • William C. Athanas

‒      Criminal Defense: White Collar

  • Larry B. Childs 

‒      Banking and Finance Law

‒      Commercial Litigation

‒      Litigation – Banking and Finance

‒      Litigation – Construction

‒      Litigation – Securities

  • Colin H. Luke

‒      Health Care Law

‒      Mergers and Acquisitions Law

 

Chattanooga, TN

  • Pat Murphy

‒      Banking and Finance Law

‒      Corporate Law

  • Roddy Bailey

‒      Mergers and Acquisitions Law

Memphis, TN

  • Al Bright, Jr.

‒      Commercial Transactions / UCC Law

  • Denise D. Burke

‒      Health Care Law

  • G. Robert Morris

‒      Corporate Law

 

Nashville, TN

  • Stephen C. Baker

‒      Real Estate Law

  • George W. Bishop III

‒      Corporate Law

‒      Health Care Law

‒      Litigation – Mergers and Acquisitions

‒      Mergers and Acquisitions Law

  • Robert E. Boston

‒      Bet-the-Company Litigation

‒      Commercial Litigation

‒      Employment Law – Management

‒      Labor Law – Management

‒      Litigation – Labor and Employment

  • James B. Bristol

‒      Employee Benefits (ERISA) Law

‒      Employment Law – Management

‒      Litigation – ERISA

‒      Tax Law

  • Brian R. Browder

‒      Health Care Law

  • Alexander B. Buchanan

‒      Administrative / Regulatory Law

‒      Corporate Law

‒      Public Finance Law

  • Matthew R. Burnstein

‒      Corporate Law

‒      Mergers and Acquisitions Law

  • Jeffrey A. Calk

‒      Real Estate Law

  • Edward M. Callaway

‒      Environmental Law

  • Robert “Bo” R. Campbell, Jr.

‒      Banking and Finance Law

‒      Project Finance Law

‒      Real Estate Law

·         William T. Cheek III

‒      Food and Beverage Law

‒      Nonprofit/Charities Law

  • John D. Claybrook

‒      Real Estate Law

  • Ryan Cochran

‒      Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law

  • Chase Cole

‒      Corporate Law

‒      Mergers and Acquisitions Law

  • Lew Conner

‒      Arbitration

‒      Bet-the-Company Litigation

‒      Commercial Litigation

‒      Family Law

‒      Family Law Mediation

‒      Litigation – Construction

‒      Mediation

  • Marcus M. Crider

‒      Employment Law – Management

‒      Labor Law – Management

‒      Litigation – Labor and Employment

  • Walter H. Crouch

‒      Commercial Litigation

‒      Litigation – Intellectual Property

  • Paul S. Davidson

‒      Commercial Litigation

‒      Litigation – Antitrust

‒      Litigation – Intellectual Property

‒      Litigation – Mergers and Acquisitions

‒      Litigation – Securities

  • Ames Davis

‒      Commercial Litigation

  • James M. Doran, Jr.

‒      Bet-the-Company Litigation

‒      Commercial Litigation

‒      Mass Tort Litigation / Class Actions – Defendants

‒      Product Liability Litigation – Defendants

  • Christopher S. Dunn

‒      Construction Law

‒      Litigation – Construction

  • Derek W. Edwards

‒      Commercial Litigation

  • Robert P. Felber, Jr.

‒      Franchise Law

‒      Trade Secrets Law

‒      Trademark Law

  • Carla F. Fenswick

‒      Health Care Law

  • Stanley E. Graham

‒      Employment Law – Management

‒      Labor Law – Management

‒      Litigation – Labor and Employment

  • J. Leigh Griffith

‒      Government Relations Practice

‒      Litigation and Controversy – Tax

‒      Tax Law

  • Robert L. Harris

‒      Banking and Finance Law

‒      Commercial Finance Law

  • Robb S. Harvey

‒      Advertising Law

‒      Commercial Litigation

‒      Copyright Law

‒      Entertainment Law – Music

‒      Entertainment Law – Theater

‒      First Amendment Law

‒      Franchise Law

‒      Litigation – First Amendment

‒      Litigation – Intellectual Property

‒      Litigation – Patent

‒      Media Law

‒      Privacy and Data Security Law

‒      Trade Secrets Law

‒      Trademark Law

  • Philip F. Head

‒      Real Estate Law

  • E. Brent Hill

‒      Corporate Law

‒      Health Care Law

  • Richard A. Johnson

‒      Tax Law

‒      Trusts and Estates

  • J. Steven Kirkham

‒      Real Estate Law

  • David E. Lemke

‒      Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law

  • Theodore W. Lenz

‒      Commercial Finance Law

‒      Commercial Transactions / UCC Law

  • Nora L. Liggett

‒      Health Care Law

  • Kim Harvey Looney

‒      Administrative / Regulatory Law

‒      Corporate Law

‒      Health Care Law

‒      Litigation – Health Care

  • Gerald F. Mace

‒      Banking and Finance Law

  • W. Kenneth Marlow

‒      Health Care Law

  • E. Marlee Mitchell

‒      Corporate Law

‒      Mergers and Acquisitions Law

‒      Securities / Capital Markets Law

  • Donald R. Moody

‒      Corporate Law

‒      Mergers and Acquisitions Law

  • Andrew S. Naylor

‒      Employment Law – Management

‒      Labor Law – Management

‒      Litigation – Labor and Employment

  • James H. Nixon III

‒      Commercial Transactions / UCC Law

  • E. Andrew Norwood

‒      Copyright Law

‒      Information Technology Law

‒      Litigation – Intellectual Property

‒      Litigation – Patent

‒      Patent Law

‒      Technology Law

‒      Trade Secrets Law

‒      Trademark Law

  • W. Travis Parham

‒      Commercial Litigation

‒      Litigation – Banking and Finance

‒      Litigation – Real Estate

‒      Litigation – Securities

  • John Park

‒      Litigation – Labor and Employment

  • Michael R. Paslay

‒      Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law

‒      Litigation – Bankruptcy

  • Thomas H. Peebles IV

‒      Eminent Domain and Condemnation Law

  • MaryEllen S. Pickrell

‒      Corporate Law

  • Patsy Powers

‒      Health Care Law

  • G. Scott Rayson

‒      Corporate Law

‒      Health Care Law

‒      Mergers and Acquisitions Law

  • Colbey B. Reagan

‒      Health Care Law

  • L. Hunter Rost, Jr.

‒      Mergers and Acquisitions Law

  • Michael K. Stagg

‒      Environmental Law

  • J.D. Thomas

‒      Health Care Law

  • John C. Tishler

‒      Bankruptcy and Creditor Debtor Rights / Insolvency and Reorganization Law

‒      Litigation – Bankruptcy

  • Charles A. Trost

‒      Tax Law

‒      Trust and Estates

  • Beth E. Vessel

‒      Mergers and Acquisitions Law

  • I.C. “Jack” Waddey, Jr.

‒      Patent Law

‒      Trademark Law

  • James M. Weaver

‒      Environmental Law

‒      Gaming Law

‒      Government Relations Practice

  • G. Michael Yopp

‒      Litigation and Controversy – Tax

‒      Tax Law

‒      Trusts and Estates

Media Contact: 
Sarah Brawner
Phone: 615-610-0323
sarah.brawner@finnpartners.com

Related Links

Waller

Waller Law Blogs

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SOURCE Waller Lansden Dortch Davis

Automotive Sunroof Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2018

Tuesday August 14 th 2018

LONDON, August 14, 2018 /PRNewswire/ — Automotive Sunroof Market – Overview

This report analyzes and forecasts the market for automotive sunroof at the global and regional level.The market has been forecasted based on revenue (US$ Mn) and volume (Thousand Units) from 2018 to 2026.

Download the full report: https://www.reportbuyer.com/product/4951675

The study includes drivers and restraints of the global automotive sunroof market.It also covers the impact of these drivers and restraints on the demand for sunroof during the forecast period.

The report also highlights opportunities and future scope in the automotive sunroof market at the global and regional level.

The report comprises a detailed value chain analysis, which provides a comprehensive view of the global automotive sunroof market.The Porter’s Five Forces analysis model for the automotive sunroof market has also been included to help understand the competitive landscape in the market.

The study encompasses market attractiveness analysis, wherein the product is benchmarked based on market size, growth rate, and general market share.

The study provides a decisive view of the global automotive sunroof market by segmenting it in terms of type, material, operation, sales channel, vehicle type, and geography.These segments have been analyzed based on present and future trends.

Regional segmentation includes the current and forecast demand for sunroof in North America, Europe, Asia Pacific, Latin America, and Middle East Africa. The report also covers demand for individual segments in all major countries across all regions.

The study includes profiles of major companies operating in the global automotive sunroof market. Market players have been profiled in terms of attributes such as company overview, financial overview, business strategies, recent developments, key executive bios, and manufacturing footprint.

The market for sunroof is primarily driven by raised concern about enriching vehicle appearance and comfort while travelling.Global key players are primarily focusing on enhancing sunroof safety in order to avoid shattering, and investing in RD activities in order to reduce the heat from entering the vehicle without compromising visibility through the sunroof.

Hyundai Mobis has recently developed a panorama sunroof airbag system, which is likely to enhance in-vehicle safety during sunroof shattering and accidents. The new development is focused on preventing the vehicle occupants from falling out of the sunroof in case of an accident.

The report provides the estimated market size of sunroof for 2017 and forecast for the next nine years.The global market size of sunroof has been provided in terms of revenue and volume.

Market numbers have been estimated based on type, material, operation, sales channel, vehicle type, and regional segments of the automotive sunroof market. Market size and forecast for each type, material, operation, sales channel, and vehicle type have been provided in terms of global and regional/country markets.

In order to compile the research report, we have performed model mapping for vehicles having sunroof and conducted in-depth interviews and discussions with a number of key industry participants and opinion leaders.Primary research represents the bulk of research efforts, supplemented by extensive secondary research.

We reviewed key players’ product literature, annual reports, press releases, and relevant documents for competitive analysis and market understanding.Secondary research also includes a search of recent trade, technical writing, internet sources, and statistical data from government websites, trade associations, and agencies.

This has proven to be the most reliable, effective, and successful approach for obtaining precise market data, capturing industry participants’ insights, and recognizing business opportunities.

Secondary research sources that are typically referred to include, but are not limited to company websites, annual reports, financial reports, broker reports, investor presentations, and SEC filings, internal and external proprietary databases, and relevant patent and regulatory databases, national government documents, statistical databases, and market reports, news articles, press releases, and webcasts specific to companies operating in the market, National government documents, statistical databases, and market reports, American Automobile Association, European Automobile Manufacturers Association, Automotive Research Association of India, Organisation Internationale des Constructeurs d’Automobile (OICA), Factiva, etc.

Primary research involves e-mail interactions, telephonic interviews, Linked interviews, and face-to-face interviews for each market, category, segment, and sub-segment across geographies.We conduct primary interviews on an ongoing basis with industry participants and commentators in order to validate the data and analysis.

Primary interviews provide firsthand information on market size, market trends, growth trends, competitive landscape, and outlook, etc.These help validate and strengthen secondary research findings.

These also help develop the analysis team’s expertise and market understanding.

The global automotive sunroof market has been segmented as follows:

Global Automotive Sunroof Market: by Type
Pop-up Type
Spoiler Type
Panoramic Sunroof
Inbuilt Sunroof
Foldable Sunroof

Global Automotive Sunroof Market: by Material
Glass
Fabric

Global Automotive Sunroof Market: by Operation
Manually Operated
Electronically Operated

Global Automotive Sunroof Market: by Sales Channel
OEM
Aftermarket

Global Automotive Sunroof Market: by Vehicle Type
Passenger Vehicle
Commercial Vehicle

Global Automotive Sunroof Market: by Region/Country/Sub-region
North America
U.S.
Canada
Europe
Germany
U.K.
France
Italy
Spain
Rest of Europe
Asia Pacific
China
India
Japan
ASEAN
Rest of Asia Pacific
Middle East Africa
GCC
South Africa
Rest of Middle East Africa
Latin America
Brazil
Mexico
Rest of Latin America

Download the full report: https://www.reportbuyer.com/product/4951675

About Reportbuyer
Reportbuyer is a leading industry intelligence solution that provides all market research reports from top publishers

For more information:
Sarah Smith
Research Advisor at Reportbuyer.com
Email: sarah@reportbuyer.com
Tel: +1 (718) 213 4904
Website: www.reportbuyer.com

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SOURCE ReportBuyer