DUBLIN, Aug. 20, 2018 /PRNewswire/ —

The “Minimally Invasive Surgical Instruments Market by Product, by Application, by End User, by Geography – Global Market Size, Share, Development, Growth, and Demand Forecast, 2016-2023” report has been added to ResearchAndMarkets.com’s offering.

Global minimally invasive surgical instruments market is forecasted to attain revenue of $53.1 billion by 2023.

The growth led by growing geriatric population, surge in prevalence of chronic diseases, increasing government healthcare expenditure, and growing demand for minimally invasive surgeries globally.

On the basis of product, the minimally invasive surgical instruments market has been categorized into handheld instruments, electrosurgical instruments, guiding devices, and inflation systems. Handheld instruments held a 36.4% share in 2016 in the global market, since these instruments lead to decreased strain on fingers during operative procedures, further increasing its adoption amongst surgeons globally.

The minimally invasive surgical instruments market is classified into neurosurgery, cosmetic surgery, urology, obstetrics and gynecology, ophthalmology, cardiovascular, orthopedic surgery, laparoscopy, and others, on the basis of application. Laparoscopy held the largest share in the market during the entire analysis period and the category is expected to occupy a 25.1% share by 2023, due to the rising prevalence of obesity and increasing use of laparoscopy for weight reduction (bariatric) surgeries.

On the basis of end user, the minimally invasive surgical instruments market is bifurcated into hospitals, ambulatory surgical clinics (ASCs), and research institutes. Hospitals held the largest share of more than 59.3% in 2016.

Asia-Pacific (APAC) is the fastest growing market for minimally invasive surgical instruments

APAC minimally invasive surgical instruments industry is predicted to witness the fastest growth in demand, registering 11.5% CAGR during the forecast period, owing to the increasing number of patients suffering from chronic diseases, rising geriatric population, increasing per capita income, and improving healthcare facilities in the region.

According to the United Nations Economic and Social Commission for Asia and the Pacific (UNESCAP), people aged 65 years and above constituted approximately 11.4% of the population in 2013, and the count is estimated to increase by approximately 20% by 2050. With rising population there are also chances for the population to get subjected to diseases. Thus, these rising figures, with respect to the geriatric population, are an important factor leading to the increasing demand for minimally invasive surgical instruments in the region.

The rising per capita income is likely to increase the affordability of people for expensive surgical procedures, involving minimally invasive surgical instruments. According to the World Bank, the GDP per capita of India increased from $1,345.8 in 2010 to $1,709.4 in 2016. A similar trend has been observed for other developing countries, such as Papua New Guinea, the Philippines, and Indonesia, which is contributing to the growth of the APAC market.

Mergers and acquisitions are taking place at a high rate among players for a larger share

Globally, key players in the minimally invasive surgical instruments industry are acquiring other firms to gain a larger market share. For instance, in June 2017, Johnson & Johnson acquired Actelion Pharmaceuticals Ltd. (Actelion). Actelion manufactures the surgical devices. Moreover, in January 2017, the company acquired Abbott Medical Optics (AMO), a subsidiary of Abbott Laboratories. The acquisition includes ophthalmic products in three areas of patient care: cataract surgery, laser refractive surgery, and consumer eye health. These product lines joined the world- leading ACUVUE Brand Contact Lenses business, and the combined organization will operate with the name Johnson & Johnson Vision.

Some of the other major players operating in the minimally invasive surgical instruments market Applied Medical Resources Corporation, B. Braun Melsungen AG, CONMED Corporation, HOYA Corporation, Medtronic plc, Smith & Nephew plc, Stryker Corporation, Zimmer Biomet Holdings Inc. 

Key Topics Covered 

Chapter 1. Research Background
1.1 Research Objectives
1.2 Market Definition
1.3 Research Scope
1.3.1 Market Segmentation By Product
1.3.2 Market Segmentation By Application
1.3.3 Market Segmentation By End User
1.3.4 Market Segmentation By Geography
1.3.5 Analysis Period
1.3.6 Market Data Reporting Unit
1.3.6.1 Value
1.4 Key Stakeholders

Chapter 2. Research Methodology
2.1 Secondary Research
2.2 Primary Research
2.2.1 Breakdown Of Primary Research Respondents
2.2.1.1 By Region
2.2.1.2 By Industry Participant
2.2.1.3 By Company Type
2.3 Market Size Estimation
2.4 Data Triangulation
2.5 Assumptions For The Study

Chapter 3. Executive Summary

Chapter 4. Introduction
4.1 Definition Of Market Segments
4.1.1 By Product
4.1.1.1 Handheld Instruments
4.1.1.1.1 Cutter Instruments
4.1.1.1.1.1 Trocars
4.1.1.1.1.2 Rasps
4.1.1.1.1.3 Others
4.1.1.1.2 Visualizing Scopes
4.1.1.1.3 Auxiliary Instruments
4.1.1.1.3.1 Staplers
4.1.1.1.3.2 Closure Devices
4.1.1.1.3.3 Cannulas
4.1.1.1.3.4 Clamps
4.1.1.1.4 Retractors
4.1.1.1.5 Dilators
4.1.1.1.6 Forceps And Spatulas
4.1.1.1.7 Graspers
4.1.1.1.8 Sutures
4.1.1.1.9 Others
4.1.1.2 Guiding Devices
4.1.1.2.1 Guiding Catheters
4.1.1.2.2 Guidewires
4.1.1.3 Inflation Systems
4.1.1.3.1 Balloons Dilators And Inflators
4.1.1.3.2 Insufflators And Insufflator Needles
4.1.1.4 Electrosurgical Instruments
4.1.1.4.1 Electrosurgical Instruments And Accessories
4.1.1.4.2 Electrosurgical Generators
4.1.1.4.3 Electrocautery Devices
4.1.2 By Application
4.1.2.1 Laparoscopy
4.1.2.2 Cardiovascular
4.1.2.3 Cosmetic Surgery
4.1.2.4 Orthopedic Surgery
4.1.2.5 Obstetrics And Gynaecology
4.1.2.6 Ophthalmology
4.1.2.7 Neurosurgery
4.1.2.8 Urology
4.1.2.9 Others
4.1.3 By End User
4.1.3.1 Hospitals
4.1.3.2 Ascs
4.1.3.3 Research Institutes
4.2 Market Dynamics
4.2.1 Drivers
4.2.1.1 Rise In Government Healthcare Expenditure
4.2.1.2 Increasing Geriatric Population And Surge In Prevalence/Incidence Of Chronic Diseases
4.2.1.3 Increasing Preference For Miss
4.2.1.4 Impact Analysis Of Drivers On Market Forecast
4.2.2 Restraints
4.2.2.1 Erratic Regulatory Environment
4.2.2.2 Improper Sterilization Procedures
4.2.2.3 Impact Analysis Of Restraints On Market Forecast
4.2.3 Opportunity
4.2.3.1 Lucrative Opportunities In Emerging Economies
4.3 Porter’S Five Forces Analysis
4.3.1 Bargaining Power Of Buyers
4.3.2 Bargaining Power Of Suppliers
4.3.3 Intensity Of Rivalry
4.3.4 Threat Of New Entrants
4.3.5 Threat Of Substitutes

Chapter 5. Global Market Size And Forecast
5.1 By Product
5.1.1 Handheld Instruments By Type
5.1.1.1 Cutter Instruments By Type
5.1.1.2 Auxiliary Instruments By Type
5.1.2 Guiding Devices By Type
5.1.3 Inflation Systems By Type
5.1.4 Electrosurgical Instruments By Type
5.2 By Application
5.3 By End User
5.4 By Region

Chapter 6. North America Market Size And Forecast
6.1 By Product
6.1.1 Handheld Instruments By Type
6.1.1.1 Cutter Instruments By Type
6.1.1.2 Auxiliary Instruments By Type
6.1.2 Guiding Devices By Type
6.1.3 Inflation Systems By Type
6.1.4 Electrosurgical Instruments By Type
6.2 By Application
6.3 By End User
6.4 By Country

Chapter 7. Europe Market Size And Forecast
7.1 By Product
7.1.1 Handheld Instruments By Type
7.1.1.1 Cutter Instruments By Type
7.1.1.2 Auxiliary Instruments By Type
7.1.2 Guiding Devices By Type
7.1.3 Inflation Systems By Type
7.1.4 Electrosurgical Instruments By Type
7.2 By Application
7.3 By End User
7.4 By Country

Chapter 8. APAC Market Size And Forecast
8.1 By Product
8.1.1 Handheld Instruments By Type
8.1.1.1 Cutter Instruments By Type
8.1.1.2 Auxiliary Instruments By Type
8.1.2 Guiding Devices By Type
8.1.3 Inflation Systems By Type
8.1.4 Electrosurgical Instruments By Type
8.2 By Application
8.3 By End User
8.4 By Country

Chapter 9. LAMEA Market Size And Forecast
9.1 By Product
9.1.1 Handheld Instruments By Type
9.1.1.1 Cutter Instruments By Type
9.1.1.2 Auxiliary Instruments By Type
9.1.2 Guiding Devices By Type
9.1.3 Inflation Systems By Type
9.1.4 Electrosurgical Instruments By Type
9.2 By Application
9.3 By End User
9.4 By Region

Chapter 10. Competitive Landscape
10.1 Market Share Analysis Of Key Players
10.2 Global Strategic Developments Of Key Players
10.2.1 Mergers And Acquisitions
10.2.2 Product Launch
10.2.3 Partnership And Collaboration
10.2.4 Facility Expansion

Chapter 11. Company Profiles
11.1 Abbott Laboratories
11.1.1 Business Overview
11.1.2 Product And Service Offerings
11.2 Applied Medical Resources Corporation
11.2.1 Business Overview
11.2.2 Product And Service Offerings
11.3 B. Braun Melsungen AG
11.3.1 Business Overview
11.3.2 Product And Service Offerings
11.4 Conmed Corporation
11.4.1 Business Overview
11.4.2 Product And Service Offerings
11.5 Hoya Corporation
11.5.1 Business Overview
11.5.2 Product And Service Offerings
11.6 Johnson & Johnson
11.6.1 Business Overview
11.6.2 Product And Service Offerings
11.7 Medtronic Plc
11.7.1 Business Overview
11.7.2 Product And Service Offerings
11.8 Smith & Nephew Plc
11.8.1 Business Overview
11.8.2 Product And Service Offerings
11.9 Stryker Corporation
11.9.1 Business Overview
11.9.2 Product And Service Offerings
11.1 Zimmer Biomet Holdings Inc.
11.10.1 Business Overview
11.10.2 Product And Service Offerings

For more information about this report visit https://www.researchandmarkets.com/research/w2x2r6/global_minimally?w=5

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New York, NY, Aug. 20, 2018 (GLOBE NEWSWIRE) — Zion Market Research has published a new report titled “Cartilage Repair/Regeneration Market by Treatment Modality (Cell-Based and Non-Cell Based), by Treatment (Cartilage Replacement and Cartilage Repair), by Type (Fibro Cartilage, Hyaline Cartilage, and Elastic Cartilage), and by End-Use (Ambulatory Surgical Centers, Hospitals & Clinics, Surgical Centers, and Others): Global Industry Perspective, Comprehensive Analysis & Forecast, 2017 – 2024”. According to the report, global cartilage repair/regeneration market was valued at approximately USD 4.3 billion in 2017 and is expected to generate revenue of around USD 6.5 billion by end of 2024, growing at a CAGR of around 5.8% between 2018 and 2024.

The primary factor driving the global cartilage repair/regeneration market is the growing prevalence of joints & bones disorders all across the globe. Increasing obese and geriatric population base all across the globe are the prominent factors driving the cartilage repair/regeneration market. According to the World Health Organization, by 2050 the number of people of age 60 or above will get doubled and is estimated to reach a value of 2.1 billion globally, from 962 million in 2017 globally.

Browse through 71 Tables & 29 Figures spread over 110 Pages and in-depth TOC on “Global Cartilage Repair/Regeneration Market Size, Share, Trends and Forecast, 2017 – 2024”.

Request Free Sample Report of Global Cartilage Repair/Regeneration Market Report @ https://www.zionmarketresearch.com/sample/cartilage-repair-cartilage-regeneration-market

According to the NIH (National Institute of Health), one-third of the adults in America aged above 45, generally suffer from cartilage damage issue. However, the high cost of treatment is acting as a hurdle for the cartilage repair/regeneration market and may affect its growth in the long term. Nonetheless, a significant investment by the government for the development of the process & therapies used for the treatment of cartilage damage along with the growing awareness are likely to disclose the new avenues for the market.

The cartilage repair/regeneration market is divided by treatment modality, type, treatment, and end-use.
Based on treatment modality, the cartilage repair/regeneration market has been segmented into cell-based and non-cell based. The cell-based segment is sub-segmented into growth factor technology, chondrocyte transplantation, and stem cells and the non-cell based segment is sub-segmented into cell-free composites, tissue scaffolds, and stem cells. By treatment modality, the cell-based treatment is estimated to hold the largest market value share attributed to the fact of long-term & effective results.

Download Free PDF Report Brochure: https://www.zionmarketresearch.com/requestbrochure/cartilage-repair-cartilage-regeneration-market

On the basis of treatment, cartilage repair/regeneration market has been segmented into cartilage replacement and cartilage repair. The cartilage replacement segment is sub-segmented into autologous chondrocyte implantation and osteochondral transplant and the cartilage repair segment is sub-segmented into cell-based cartilage resurfacing, microfracture, and non-surgical treatment.

By type segment, the cartilage repair/regeneration market is categorized into fibrocartilage, hyaline cartilage, and elastic cartilage.

Based on end use, the cartilage repair/regeneration market is classified into ambulatory surgical centers, surgical centers, hospital & clinics, and others. Hospital & clinics segment holds the maximum share and is expected to boost the market over the forecast period.

Browse the full “Cartilage Repair/Regeneration Market by Treatment Modality (Cell-Based and Non-Cell Based), by Treatment (Cartilage Replacement and Cartilage Repair), by Type (Fibro Cartilage, Hyaline Cartilage, and Elastic Cartilage), and by End-Use (Ambulatory Surgical Centers, Hospitals & Clinics, Surgical Centers, and Others): Global Industry Perspective, Comprehensive Analysis & Forecast, 2017 – 2024 “ report at https://www.zionmarketresearch.com/report/cartilage-repair-cartilage-regeneration-market

In the cartilage repair/regeneration market, North America is anticipated to cover the prominent market value share over the estimated time. The U.S. is by far the leading cartilage repair/regeneration market by country in North America. The U.S. market is anticipated to grow with significant CAGR over the near future. Increasing number of cases of cartilage damage due to the active involvement in sports along with the significant investments by the government for the in therapies & procedures adopted for the treatment is supporting the growth of cartilage repair/regeneration market in North America. According to research data by the American Orthopedic Society for Sports Medicine, over 3.5 million athletes receive medical treatment due to sports injuries each year.

North America is anticipated to be followed by Europe and is expected to show a significant growth in the near future. This growth of cartilage repair/regeneration market is mainly supported by high per capita income which allows the population base to afford costly treatments of cartilage damage in this region.

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NEW YORK and CANTON, Mass., Aug. 17, 2018 /PRNewswire/ — Avista Healthcare Public Acquisition Corp. (NASDAQ :AHPA ) (“AHPAC”), a publicly traded special purpose acquisition company, and Organogenesis Inc. (“Organogenesis” or the “Company”), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care, Surgical and Sports Medicine markets, today announced that they have entered into a definitive merger agreement, under which Organogenesis will become a wholly owned subsidiary of AHPAC.  Affiliates of Avista Capital Partners (“Avista”), a leading private equity firm, have agreed to invest $92 million in the combined company in conjunction with the transaction.  Following the closing of the transaction, Organogenesis will be listed on the Nasdaq Stock Exchange under the ticker symbol “ORGO.”  The combined company will have an anticipated initial enterprise value of approximately $673 million.

Organogenesis’ mission is to provide integrated healing solutions that substantially improve medical outcomes and the lives of patients, while lowering the overall cost of care.  Organogenesis’ versatile product portfolio is designed to treat a variety of patients with repair and regenerative needs across the continuum of care.  Today, Organogenesis has over 600 employees worldwide and is led by a management team of talented individuals with more than 75 years of collective regenerative medicine experience.

“We are delighted to be partnering with Organogenesis, as the Company is well-positioned to benefit from secular tailwinds driving growth in the Advanced Wound Care, Surgical and Sports Medicine sectors,” said Thompson Dean, Executive Chairman of AHPAC.  “Organogenesis represents an ideal partner for AHPAC given its leading position in the large and attractive regenerative medicine sector, numerous growth opportunities and demonstrated ability to execute on product development and commercialization capabilities.”

Gary S. Gillheeney, Sr., President and Chief Executive Officer of Organogenesis, said, “This is an important day in the history of Organogenesis.  We look forward to working with Tom Dean, AHPAC and Avista Capital Partners to continue building a successful enterprise.  This transaction will provide Organogenesis with capital that we will use to accelerate our growth plan for both our existing product portfolio and R&D pipeline.”

Additional Transaction Terms and Conditions

This transaction will be funded through a combination of cash, stock, and rollover debt financing.  Organogenesis’ key existing shareholders will remain committed long-term partners by rolling over their equity into the combined company.

The boards of directors of AHPAC and the Company have unanimously approved the proposed transaction and shareholders of the Company representing approximately 89% of the outstanding stock of the Company have agreed to support approval of the proposed transaction in any consent solicitation or shareholders’ meeting in connection with the transaction. Completion of the proposed transaction, which is expected before the end of the year, is subject to customary and other closing conditions, including regulatory approvals and receipt of approvals from AHPAC’s shareholders.

Credit Suisse Securities (USA) LLC is acting as financial advisor to AHPAC.  Weil, Gotshal & Manges LLP is acting as legal advisor to AHPAC.  Foley Hoag LLP is acting as legal advisor to Organogenesis.

Investor Presentation Information

AHPAC and Organogenesis are simultaneously releasing a slide presentation with information on the proposed transaction; this presentation will be filed with the Securities and Exchange Commission (SEC) as an exhibit to AHPAC’s Form 8-K, which will be filed to report its entry into the merger agreement, and can be viewed on the SEC website at www.sec.gov.  Investors are encouraged to review these materials.

About Organogenesis Inc.

Organogenesis Inc. is a leading regenerative medicine company offering a portfolio of bioactive and acellular biomaterials products in advanced wound care and surgical biologics, including orthopaedics and spine.  Organogenesis’s comprehensive portfolio is designed to treat a variety of patients with repair and regenerative needs.  For more information, visit www.organogenesis.com.

About Avista Healthcare Public Acquisition Corp.

AHPAC is a special purpose acquisition company that completed its initial public offering in October 2016.  AHPAC was formed for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or business combination with one or more businesses.  AHPAC is sponsored by Avista Acquisition Corp., which was formed for the express purpose of acting as the sponsor for AHPAC.  Avista Acquisition Corp. is an affiliate of Avista Capital Holdings, L.P.  For more information, visit www.avistapac.com/ahpac.

About Avista Capital Partners

Founded in 2005, Avista is a leading New York-based private equity firm with over $6 billion invested in more than 30 growth-oriented healthcare businesses.  Avista targets businesses with strong management teams, stable cash flows and robust growth prospects and utilizes a proactive, hands-on approach to create value in our portfolio companies.  Avista’s Operating Executives and Advisors are an integral part of the team, providing strategic insight, operational oversight and senior counsel, that help drive growth and performance to create long-term value and sustainable businesses.  For more information, visit www.avistacap.com.

Contacts:

Forward Looking Statements

This communication includes “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995.  Forward-looking statements may be identified by the use of words such as “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters.  Such forward looking statements include estimated financial information.  Such forward looking statements with respect to revenues, earnings, performance, strategies, prospects and other aspects of the businesses of Avista, Organogenesis or the combined company after completion of the business combination are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward looking statements.  These factors include, but are not limited to: (1) the occurrence of any event, change or other circumstances that could give rise to the termination of the Agreement and Plan of Merger between AHPAC and Organogenesis (the “Merger Agreement”) and the proposed business combination contemplated therein; (2) the inability to complete the transactions contemplated by the Merger Agreement due to the failure to obtain the approval of the shareholders of AHPAC or the failure to satisfy the other conditions to closing in the Merger Agreement; (3) the ability of AHPAC to continue to meet applicable Nasdaq listing standards; (4) the risk that the proposed business combination disrupts current plans and operations of Organogenesis as a result of the announcement and consummation of the transactions described herein; (5) the ability to recognize the anticipated benefits of the proposed business combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably, maintain relationships with customers and suppliers and retain its management and key employees; (6) costs related to the proposed business combination; (7) changes in applicable laws or regulations; (8) the possibility that Organogenesis may be adversely affected by other economic, business, and/or competitive factors; and (9) other risks and uncertainties indicated from time to time in the definitive registration statement of AHPAC filed in connection with the proposed business combination and the joint proxy/consent solicitation statement/prospectus contained therein, including those under “Risk Factors” therein, and other documents filed or to be filed with the Securities and Exchange Commission (“SEC”) by AHPAC.  Investors are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made.  AHPAC and Organogenesis undertake no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.  Anyone using the presentation does so at their own risk and no responsibility is accepted for any losses which may result from such use directly or indirectly.  Investors should carry out their own due diligence in connection with the assumptions contained herein.  The forward-looking statements in this communication speak as of the date of this communication.  Although AHPAC may from time to time voluntarily update its prior forward-looking statements, it disclaims any commitment to do so whether as a result of new information, future events, changes in assumptions or otherwise except as required by applicable securities laws.

Disclaimer

This communication shall neither constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.  This communication relates to a proposed business combination between AHPAC and Organogenesis.

Additional Information and Where to Find It

In connection with the proposed business combination between Organogenesis and AHPAC, AHPAC intends to file with the SEC a registration statement on Form S-4 and joint proxy/consent solicitation statement/prospectus forming a part thereof (the “Registration Statement”).  This communication does not contain all the information that should be considered concerning the proposed business combination.  This communication is not a substitute for the Registration Statement that AHPAC will file with the SEC or any other documents that AHPAC may file with the SEC or that AHPAC or Organogenesis may send to stockholders in connection with the proposed business combination.  It is not intended to form the basis of any investment decision or any other decision in respect to the proposed business combination.  AHPAC’s shareholders and other interested persons are advised to read, when available, the preliminary and definitive Registration Statement, and documents incorporated by reference therein, as these materials will contain important information about AHPAC, Organogenesis and the business combination.  The proxy statement and the prospectus contained in the Registration Statement will be mailed to AHPAC’s shareholders as of a record date to be established for voting on the proposed business combination.

AHPAC Shareholders will also be able to obtain a copy of the Registration Statement once it is available, and other documents containing important information about AHPAC and Organogenesis once such documents are filed with the SEC, without charge, at the SEC’s website at http://sec.gov or by directing a request to: Avista Healthcare Public Acquisition Corp., 65 East 55th Street, 18th Floor, New York, NY 10022.

Participants in the Solicitation

AHPAC and its directors, executive officers and other members of its management and employees and Organogenesis and its directors and management may be deemed to be participants in the solicitation of proxies from AHPAC’s shareholders in connection with the proposed business combination.  Shareholders are urged to carefully read the Registration Statement regarding the proposed business combination when it becomes available, because it will contain important information.  Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of AHPAC’s shareholders in connection with the proposed business combination will be set forth in the Registration Statement when it is filed with the SEC.  Information about AHPAC’s executive officers and directors and Organogenesis’s management and directors also will be set forth in the Registration Statement relating to the proposed business combination when it becomes available.

SOURCE Avista Capital Partners

SUWANEE, Ga., Aug. 14, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB: SNWV) reported financial results for the three months ended June 30, 2018 with the SEC on Tuesday, August 14, 2018 and will provide a business update on a conference call today, August 14, 2018 at 10:00 a.m. Eastern Time.

Highlights of the second quarter and recent weeks:

• Record revenue for the second quarter of 2018 was $453,210, up 308% from the second quarter of 2017.
• The Company named Shri Parikh President of SANUWAVE’s Global Healthcare division.
• The Company entered into an agreement with Johnfk Medical Inc. (“FKS”), pursuant to which the Company and FKS will enter into a joint venture for the manufacture, sale and distribution of the Company’s dermaPACE^® and orthoPACE^® devices covering 11 countries in Southeast Asia.  The initial payment per the agreement has been received, initial orders have been shipped in Q3 and this agreement is expected to drive significant growth in the near term.
• The Company signed a binding term sheet for a joint venture with Tarbaca Lightning covering 3 countries in Central America.
• The Company appointed Dr. Perry Mayer, Medical Director and principal at The Mayer Institute in Hamilton, Ontario, Canada, to its Clinical Advisory Board.
• The Company appointed AMBIENSYS SRL as its distributor for dermaPACE in Romania.  The initial orders have been shipped and training successfully occurred in Q2.
• Third quarter medical conference attendance activity for the Company is expected to be a record eight meetings.
• Perfusion case study kicked off in July with Rutgers, UCLA, and Northwestern University.  We anticipate full results from this clinical work to be released in early 2019.

Since the FDA clearance, we have begun to develop and implement a platform for rolling out the dermaPACE System for treating DFU’s in the US.  We are taking a methodical approach to the roll out to ensure we ultimately achieve our goal – the delivery of a dermaPACE System to any location in the US that will be treating DFU’s. As we have stated on prior calls, we have five goals for 2018 which will deliver accelerating growth throughout the year and establish the platform for continued growth in 2019 and beyond as we penetrate the US and global wound care market.  The goals for 2018 remain:

• Initial revenue in the U.S.
• Expand senior management team in U.S. wound market
• Enter 4 new international markets
• Begin supportive clinical work
• Expansion of Board of Directors and Science Advisory Board

We are well on track to achieve or exceed all the goals we established for 2018 and this translates to revenue increases throughout the year.  As we hire experienced senior managers in the areas of Reimbursement, Clinical, and Sales, we anticipate revenue expansion occurring in the US toward the end of 2018 building a strong foundation to deliver substantial domestic revenue in 2019.

Second Quarter Financial Results

Revenues for the three months June 30, 2018 were $453,210, compared to $111,045 for the same period in 2017, an increase of $342,165, or 308%.  Revenues resulted primarily from sales in the United States and Europe of our dermaPACE and orthoPACE devices and related applicators.  The increase in revenues for 2018 was due to the higher sale of devices and both new and refurbished applicators in the United States and Europe as compared to the same period in 2017.

Research and development expenses for the three months ended June 30, 2018 were $368,377, compared to $437,909 for the same period in 2017, a decrease of $69,572, or 16%.  The decrease in research and development expenses was due to lower stock-based compensation expense and to lower consultant costs related to the FDA submission and follow up which was partially offset by the hiring of a full-time software engineers and an accrual of bonus for 2018.

General and administrative expenses for the three months ended June 30, 2018 were $2,030,799, as compared to $951,908 for the same period in 2017, an increase of $1,078,891, or 113%.  The increase in general and administrative expenses was due to the hiring of a president and human resources director and the related stock-based compensation expense for stock options issued, higher travel costs, accrual of bonus, higher public company costs related to investor relations, higher costs related to leasing of product, and higher consultant fees related to the commercialization of the dermaPACE System.

Net loss for the three months ended June 30, 2018 was $2,888,259, or ($0.02) per basic and diluted share, compared to a net loss of $1,415,937, or ($0.01) per basic and diluted share, for the same period in 2017, an increase in the net loss of $1,472,322.  The increase in the net loss for 2018 was primarily due to higher general and administrative expenses as noted above as well as higher interest expense related to convertible promissory notes which was partially offset by gain on warrant valuation adjustment.

We anticipate that our operating losses will continue over the next few years as we incur expenses related to commercialization of our dermaPACE system for the treatment of diabetic foot ulcers in the United States. If we are able to successfully commercialize, market and distribute the dermaPACE system, we hope to partially or completely offset these losses in the future.

Six Months ended June 30, 2018 Financial Results

Revenues for the six months June 30, 2018 were $797,482, compared to $260,614 for the same period in 2017, an increase of $536,868, or 206%.  Revenues resulted primarily from sales in the United States and Europe of our dermaPACE and orthoPACE devices and related applicators.  The increase in revenues for 2018 was due to the higher sale of devices and both new and refurbished applicators in the United States and Europe as compared to the same period in 2017.

Research and development expenses for the six months ended June 30, 2018 were $717,781, compared to $698,247 for the same period in 2017, an increase of $19,534, or 3%.  The increase in research and development expenses was due to the hiring of two full-time software engineers, stock-based compensation expense for stock options issued, accrual of bonus, and consulting fees related to reimbursement strategy which was partially offset by lower consultant costs related to the FDA submission and follow up.

General and administrative expenses for the six months ended June 30, 2018 were $2,976,405, as compared to $1,400,514 for the same period in 2017, an increase of $1,575,891, or 113%.  The increase in general and administrative expenses was due to the hiring of a president and human resources director and the related stock-based compensation expense for stock options issued, higher travel costs, accrual of bonus, recruiting fees for open positions, higher legal and accounting fees related to SEC filings and higher consultant fees related to the commercialization of the dermaPACE System.

Net loss for the six months ended June 30, 2018 was $8,744,914, or ($0.06) per basic and diluted share, compared to a net loss of $1,909,469, or ($0.01) per basic and diluted share, for the same period in 2017, an increase in the net loss of $6,835,445.  The increase in the net loss for 2018 was primarily due to higher general and administrative expenses as noted above as well as higher interest expense related to convertible promissory notes and loss on warrant valuation adjustment.

Cash and cash equivalents decreased by $59,470 for the six months ended June 30, 2018 and decreased by $71,502 for the six months ended June 30, 2017.  For the six months ended June 30, 2018 and 2017, net cash used by operating activities was $1,598,202 and $572,492, respectively, primarily consisting of compensation costs, research and development activities and general corporate operations. The increase of $1,025,710 in the use of cash for operating activities for the six months ended June 30, 2018, as compared to the same period for 2017, was primarily due to the increased operating expenses and decreased payables in 2018.  Net cash used by investing activities for the six months ended June 30, 2018 consisted of purchase of property and equipment of $13,612.  Net cash provided by financing activities for the six months ended June 30, 2018 was $1,563,313, which consisted of $1,159,785 from the issuance of convertible promissory notes, $38,528 from the exercise of warrants, $136,000 net increase in line of credit, $85,000 from the issuance of short term notes payable and $144,000 from an advance from related party.  Net cash provided by financing activities for the six months ended June 30, 2017 was $514,757, which consisted of $421,690 from advances from related parties and $93,067 from exercise of warrants.

“During the second quarter we continued to meet our objectives for 2018 by signing 3 international deals, hiring Shri Parikh to lead the healthcare group, adding science advisor in Dr. Perry Mayer, and kicking off clinical work to support sales domestically,” stated Kevin A. Richardson II, Chairman of the Board of SANUWAVE.  “We expect continued growth over last year as we continue to market our products both domestically and abroad,” concluded Mr. Richardson.

Conference Call

The Company will host a conference call on Tuesday, August 14, 2018, beginning at 10AM Eastern Time to discuss the second quarter financial results, provide a business update and answer questions.

Shareholders and other interested parties can participate in the conference call by dialing 877-407-8033 (U.S.) or 201-689-8033 (international) or via webcast at http://www.investorcalendar.com/event/36506.

A replay of the conference call will be available beginning two hours after its completion through August 28, 2018, by dialing 877-481-4010 (U.S.) or 919-882-2331 and entering PIN 36506 and a replay of the webcast will be available at http://www.investorcalendar.com/event/36506 until November 14, 2018.

About SANUWAVE Health, Inc. 
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE^® technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE^®, received US FDA clearance in December 2017 for the treatment of Diabetic Foot Ulcers.  dermaPACE is the only Extracorporeal Shockwave Technology (ESWT) device cleared or approved in the US for the treatment of DFUs.  Internationally, dermaPACE is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand, and South Korea.  SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron^® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron^® and orthoPACE^® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

Contact:

Millennium Park Capital LLC
Christopher Wynne
312-724-7845
cwynne@mparkcm.com

SANUWAVE Health, Inc.
Kevin Richardson II
CEO & Chairman
978-922-2447
investorrelations@sanuwave.com

(FINANCIAL TABLES FOLLOW)

(EMAILWIRE.COM, August 11, 2018 ) Artificial Disc Market  to exceed USD 4.5 billion by 2024 as per a new research report. Steadily growing number of osteoarthritis and rheumatoid arthritis procedures around the world is a primary factor responsible for artificial disc market growth. Increasing incidences of degenerative disc diseases and adult patient’s willingness to opt for artificial disc are predominant factors boosting the global artificial disc market growth.

Moreover, promoting factors such as improving medical literacy, medical tourism and growing practice of advanced medical interventions are some of the high impact rendering forces.

From patient’s side, growing ability of patients to afford cost intensive artificial disc procedures also happens to be a major factor for market growth. Furthermore, low probability of re-operation with artificial disc also plays a key role in patient’s decision to undergo procedure. Rising per capita income in emerging economies should further add on to the market demand and therefore spur the market growth during the forecast period.

Request sample copy of this report @ https://www.gminsights.com/request-sample/detail/1183

However, risks associated during and after the procedure such as development of infections, dislocation of disc, stenosis etc. mind-blocks patient from undergoing the surgery, especially seen in young patient population. Moreover, inadequate insurance coverage on artificial disc procedures in many countries happens to be a major constraint in market growth.

Cervical artificial disc market commanded over 60% of total artificial disc market in 2016 in years to come, rising number of cervical artificial discs surgeries and accessibility of more number of products will add to growth of artificial cervical disc market. Recent approvals of distinctive types of cervical disc in U.S. should prove to be a growth promoter in near future. Metal on biopolymer material should continue to be the most commonly used during the forecast timeframe, because of its high biocompatibility, shock absorbing capability and ease of insertion these advantages have resulted to higher demand of metal on biopolymer than metal on metal in recent past. In coming years, improvements in metal on biopolymer material should drive its market growth.

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AMSTERDAM, The Netherlands, Aug. 08, 2018 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today reported financial results for its second quarter ended July 1, 2018 and increased its 2018 annual guidance.  Unless otherwise noted, all net sales growth rates in this release are stated on a constant currency basis.

Net sales totaled $205.4 million during the second quarter ended July 1, 2018, representing 14.3% as reported and 12.9% constant currency growth, an estimated 370 basis point improvement versus the first quarter of 2018.  Gross margins were 77.8% during the quarter ended July 1, 2018 and were 78.5% on a non-GAAP adjusted basis.  Reconciliations of all historical non-GAAP financial measures used in this release to the most comparable GAAP measures can be found in the attached financial tables.

Robert Palmisano, president and chief executive officer, commented, “We produced outstanding results across the board in the second quarter, including 13% constant currency net sales growth, an estimated 370 basis point increase versus the first quarter of 2018, and we exited the quarter on a strong, positive trajectory, which we expect to continue throughout the remainder of 2018.  These results represent another strong performance in our U.S. upper extremities business, which grew 22% in the second quarter, driven by 24% growth in our U.S. shoulder business.  We anticipate that continued penetration of our SIMPLICITI shoulder system, our ongoing PERFORM Reversed launch and accelerating adoption of our BLUEPRINT enabling technology will continue to drive market-leading shoulder sales growth in 2018.”

Palmisano further commented, “Our U.S. lower extremities growth rate accelerated to 9% in the second quarter, driven by approximately 15% growth in total ankle and improved growth in our core lower extremities business.  The lower extremities business returned to market rates of growth well ahead of schedule, driven primarily by increased contributions from our expanded sales organization.  We are on a good trajectory headed into the second half of the year when we expect the third quarter launch of our PROstep Minimally Invasive Surgery System to provide further momentum for this business.  We also received PMA approval for AUGMENT Injectable Bone Graft and initiated launch activities in the U.S.  We believe the superior handling characteristics and ease of use of AUGMENT Injectable, combined with the proven clinical benefits of AUGMENT, will accelerate the growth in our biologics business in the back half of this year.”

Net loss from continuing operations for the second quarter of 2018 totaled $90.6 million, or $(0.85) per diluted share.

The company’s net loss from continuing operations for the second quarter of 2018 included the after-tax impacts of a $39.9 million non-cash loss on extinguishment of debt to write-off unamortized debt discount and deferred financing fees associated with the partial settlement of its 2020 convertible notes, a loss of $32.9 million related to mark-to-market adjustments on derivatives, non-cash interest expense of $12.3 million related to its convertible notes, non-cash foreign currency translation charges of $1.9 million, and $1.3 million of transaction and transition costs associated with non-cash inventory provisions.  These charges were offset by an unrealized gain of $2.5 million related to mark-to-market adjustments on contingent value rights (CVRs) issued in connection with the BioMimetic acquisition and a $6.2 million U.S. tax benefit within continuing operations recorded as a result of the pre-tax gain recognized within discontinued operations due to the previously announced $30.75 million insurance settlement.

The company’s second quarter 2018 non-GAAP net loss from continuing operations, as adjusted for the above items, was $9.6 million.  The company’s second quarter 2018 non-GAAP adjusted EBITDA from continuing operations, as defined in the non-GAAP to GAAP reconciliation provided later in this release, was $25.6 million. The attached financial tables include reconciliations of all historical non-GAAP measures to the most comparable GAAP measures.

Cash and cash equivalents totaled $313.2 million as of the end of the second quarter of 2018.

Palmisano concluded, “Overall, second quarter net sales growth improved significantly, with Upper Extremities, Lower Extremities, Biologics and International all accelerating their constant currency growth rates.  Based on the strength of the underlying business and the approval of AUGMENT Injectable, we are increasing our guidance, which now calls for annual constant currency net sales growth of 10% to 12%, excluding the impact of the four fewer selling days in the fourth quarter of 2018.  I believe we are set up well for the remainder of 2018.  Our end markets remain healthy and fast growing, our gross margins are outstanding, and our new product pipeline is full of innovative and commercially impactful products and surgical solutions across all parts of our business.”

Outlook

As a result of the approval of AUGMENT Injectable and the performance of the business, the company is increasing its net sales guidance for full-year 2018 to approximately $808 million to $820 million from its previous guidance of approximately $800 million to $812 million.  This guidance range has approximately 0.5% cushion from foreign currency exchange rates as compared to current rates.  In addition, this range implies full-year 2018 constant currency net sales growth of 10% to 12%, excluding the estimated $9 million impact of the four fewer selling days in fourth quarter of 2018.

The company is raising its full-year 2018 non-GAAP adjusted EBITDA from continuing operations, as described in the non-GAAP reconciliation provided later in this release, to a range of $106 million to $113 million.

The company expects its non-GAAP adjusted earnings per share from continuing operations, including share-based compensation, as described in the non-GAAP to GAAP reconciliation provided later in this release, for full-year 2018 to be a loss of $0.14 to $0.21 per diluted share.

The company estimates approximately 106.4 million diluted weighted average ordinary shares outstanding for fiscal year 2018.

The company’s non-GAAP adjusted EBITDA from continuing operations target is measured by adding back to net loss from continuing operations charges for interest, income taxes, depreciation and amortization expenses, non-cash share-based compensation expense and non-operating income and expense.  Additionally, the company’s adjusted EBITDA from continuing operations target excludes possible future acquisitions; other material future business developments; and due diligence, transaction and transition costs associated with acquisitions and divestitures.

The company’s non-GAAP adjusted earnings per share from continuing operations target is measured by adding back to net loss from continuing operations non-cash interest expense associated with the convertible notes; due diligence, transaction and transition costs associated with acquisitions and divestitures; mark-to-market adjustments to CVRs; non-cash mark-to-market derivative adjustments; non-cash gains and losses associated with foreign currency translation of balances denominated in foreign currencies; and charges for non-cash amortization expenses, net of taxes. Note that as a result of the company’s relatively low effective tax rate due to the valuation allowance impacting a substantial portion of the company’s income/loss, the company is currently estimating the tax effect on amortization expense at 0%. Further, this non-GAAP adjusted earnings per share from continuing operations target excludes possible future acquisitions and other material future business developments.

All the historical non-GAAP financial measures used in this release are reconciled to the most directly comparable GAAP measures. With respect to the company’s 2018 financial guidance regarding non-GAAP adjusted EBITDA from continuing operations and non-GAAP adjusted earnings per share from continuing operations, however, the company cannot provide a quantitative reconciliation to the most directly comparable GAAP measures without unreasonable effort due to its inability to make accurate projections and estimates related to certain information needed to calculate some of the adjustments as described above, including the foreign currency fluctuations and market driven fair value adjustments to CVRs and derivatives. The anticipated differences between these non-GAAP financial measures and the most directly comparable GAAP measure are described above qualitatively.

The company’s anticipated ranges for net sales from continuing operations, non-GAAP adjusted EBITDA from continuing operations, and non-GAAP adjusted earnings per share from continuing operations are forward-looking statements, as are any other statements that anticipate or aspire to future events or performance.  They are subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets.  The anticipated targets are not predictions of the company’s actual performance.  See the cautionary information about forward-looking statements in the “Cautionary Note Regarding Forward-Looking Statements” section of this release.

Supplemental Financial Information

To view the second quarter of 2018 supplemental financial information, visit ir.wright.com.  For historical information on Wright Medical Group N.V. segment reporting changes and non-GAAP combined pro forma financial information, please refer to the presentation posted on Wright’s website at ir.wright.com in the “Financial Information” section.

Internet Posting of Information

Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com.  The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.

Conference Call and Webcast

As previously announced, Wright will host a conference call starting at 3:30 p.m. Central Time today.  The live dial-in number for the call is (844) 295-9436 (U.S.) / (574) 990-1040 (Outside U.S.).  The participant passcode for the call is “Wright.”  A simultaneous webcast of the call will be available via Wright’s corporate website at www.wright.com.

A replay of the call will be available beginning at 5:30 p.m. Central Time on August 8, 2018 through August 15, 2018.  To hear this replay, dial (855) 859-2056 (U.S.) / (404) 537-3406 (Outside U.S.) and enter code 9379128.  A replay of the conference call will also be available via the internet starting today and continuing for at least 12 months.  To access a replay of the conference call via the internet, go to the “Investor Relations – Presentations/Calendar” section of the company’s corporate website located at www.wright.com.

The conference call may include a discussion of non-GAAP financial measures.  Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this release, the Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (SEC) today, or otherwise available in the “Investor Relations – Supplemental Financial Information” section of the company’s corporate website located at www.wright.com.

The conference call may include forward-looking statements.  See the cautionary information about forward-looking statements in the “Cautionary Note Regarding Forward-Looking Statements” section of this release.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide.  Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics.  For more information about Wright, visit www.wright.com.

™ and ® denote trademarks and registered trademarks of Wright Medical Group N.V. or its affiliates, registered as indicated in the United States, and in other countries.  All other trademarks and trade names referred to in this release are the property of their respective owners.

Non-GAAP Financial Measures  

To supplement the company’s consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles, the company uses certain non-GAAP financial measures in this release. Reconciliations of the historical non-GAAP financial measures used in this release to the most comparable GAAP measures for the respective periods can be found in tables later in this release. Wright’s non-GAAP financial measures include net sales, excluding the impact of foreign currency; net income, as adjusted; EBITDA, as adjusted; gross margin, as adjusted; earnings, as adjusted; and earnings, as adjusted, per diluted share, in each case, from continuing operations. The company’s management believes that the presentation of these measures provides useful information to investors.  These measures may assist investors in evaluating the company’s operations, period over period. Wright’s non-GAAP financial measures exclude such items as non-cash interest expense related to the company’s convertible notes, non-cash loss on extinguishment of debt, transaction and transition costs, net gains and losses on mark-to-market adjustments on CVRs and derivative assets and liabilities, net non-cash gains and losses on foreign currency translation all of which may be highly variable, difficult to predict and of a size that could have substantial impact on the company’s reported results of operations for a period.  It is for this reason that the company cannot provide without unreasonable effort a quantitative reconciliation to the most directly comparable GAAP measures for its 2018 financial guidance regarding non-GAAP adjusted EBITDA from continuing operations and non-GAAP adjusted earnings per share from continuing operations. Management uses the non-GAAP measures in this release internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets.  Investors should consider non-GAAP financial measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “could,” “may,” “will,” “believe,” “estimate,” “continue,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the company’s anticipated financial results for 2018, including net sales from continuing operations, adjusted EBITDA from continuing operations and adjusted earnings per share from continuing operations, anticipated continued strong shoulder sales growth, at or above market growth for our U.S. lower extremities business, accelerated growth in our biologics business in the second half of 2018, and the success of our new products, including our PROstep Minimally Invasive Surgery System. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the failure of the company’s 2017 U.S. sales force additions to achieve expected results, delay or failure to drive U.S. lower extremities or biologics sales to anticipated levels; continued supply constraints; failure to integrate the legacy Wright and Tornier businesses and realize net sales synergies and cost savings from the merger with Tornier or delay in realization thereof; operating costs and business disruption as a result of the merger, including adverse effects on employee retention and sales force productivity and on business relationships with third parties; integration costs; actual or contingent liabilities; adverse effects of diverting resources and attention to providing transition services to the purchaser of the large joints business; the adequacy of the company’s capital resources and need for additional financing; the timing of regulatory approvals and introduction of new products; physician acceptance, endorsement, and use of new products; failure to achieve the anticipated commercial sales of our AUGMENT^® Bone Graft and other new products; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims and product recalls; pending and threatened litigation; risks associated with the metal-on-metal master settlement agreement and the settlement agreement with the three settling insurers; risks associated with the subsequent metal-on-metal settlement agreements and ability to obtain the additional new insurance proceeds contingent thereon; risks associated with international operations and expansion; fluctuations in foreign currency exchange rates; other business effects, including the effects of industry, economic or political conditions outside of the company’s control; reliance on independent distributors and sales agencies; competitor activities; changes in tax and other legislation; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 31, 2017 filed by Wright with the SEC on February 27, 2018 and subsequent SEC filings by Wright, including without limitation its Quarterly Reports on Form 10-Q for the quarters ended April 1, 2018 and July 1, 2018. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investors & Media:

Julie D. Dewey
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817
julie.dewey@wright.com

–Tables Follow–

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WALTHAM, Mass., Aug. 09, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, announced its financial and operating results for the quarter ended June 30, 2018.

“Our focus in the second quarter of 2018 was on the NeoCart Biologics License Application submission and we remain on track to announce top-line data in the third quarter of 2018.  In preparation for this exciting milestone, we enhanced our management team with the addition of Lynne Kelley as Chief Medical Officer.  Lynne’s experience and capabilities in medical and regulatory affairs and product development will be instrumental as we advance the preparation of the upcoming BLA for NeoCart,” said Adam Gridley, President and Chief Executive Officer of Histogenics.  “We also made important progress on the international expansion of the NeoCart platform alongside MEDINET, our NeoCart development and commercialization partner in Japan, as they prepare for the initiation of the Phase 3 trial in Japan in the second half of the year.”

Second Quarter 2018 and Recent Highlights

• NeoCart top-line Phase 3 Data Release on Track for Third Quarter of 2018:  Histogenics expects to report top-line data from its 249-patient Phase 3 randomized, controlled clinical trial of NeoCart in the third quarter of 2018.  The trial is designed to show superiority of NeoCart at one year after treatment as compared to microfracture, the current standard of care, and will follow patients for three years.
• Expansion and Enhancement of Executive Team:  In July 2018, Histogenics appointed Lynne Kelley as its Chief Medical Officer.  In this role, Dr. Kelley will leverage her 20 plus years of executive management and surgical experience in medical affairs, clinical operations, regulatory affairs and product development to establish Histogenics’ medical affairs strategy and build a medical affairs team to support the potential launch of NeoCart.  Dr. Kelley will also work with the executive team on the preparation of the upcoming Biologics License Application (BLA) for NeoCart and any related discussions with the United States Food and Drug Administration (FDA).
• Held Inaugural Investor Day:  In June 2018, Histogenics hosted its first investor day in New York City.  Members of Histogenics’ management team discussed the commercialization plan for NeoCart and provided an overview of its Restorative Cell Technology platform.  The team was joined by leading orthopedic surgeons who shared their overall experiences with and provided their clinical perspectives on NeoCart, as well as a NeoCart patient from the Phase 3 clinical trial who provided his thoughts on his recovery, specifically the impact NeoCart has had on his ability to return to work and sports activities.  The event also included a discussion on the NeoCart mechanism of action based on work conducted as part of Histogenics’ collaboration with Cornell University.  A full replay of the webcast is available via the “Investor Relations” page of Histogenics’ website, www.histogenics.com, or by clicking here.

Financial Results for the Second Quarter of 2018

Loss from operations was $(7.3) million in the second quarter of 2018, compared to $(6.4) million in the second quarter of 2017.  The increase in operating expenses was due to an increase in both research and development expenses and general and administrative expenses.

Research and development expenses were $4.5 million in the second quarter of 2018, compared to $4.2 million in the second quarter of 2017.  The increase was primarily due to increases in consulting, salaries and materials in connection with the potential submission of a BLA for NeoCart with the FDA and was partially offset by a reduction in patient costs related to the NeoCart Phase 3 clinical trial, for which enrollment was completed in June 2017.  General and administrative expenses were $2.8 million in the second quarter of 2018, compared to $2.2 million in the second quarter of 2017.  The increase was primarily due to higher salaries and consulting expenses related to increased activities to support the potential commercialization of NeoCart.

Net loss attributable to common stockholders was $(3.7) million in the second quarter of 2018, or $(0.13) per share, compared to $(5.5) million, or $(0.25) per share, in the second quarter of 2017.  The decrease in net loss attributable to common stockholders is primarily due to the conversion of convertible preferred stock issued in connection with the 2016 private placement into common stock and a change in the fair value of the warrant liability which generated a gain in the second quarter of 2018, both of which were partially offset by an increase in operating expenses.

As of June 30, 2018, Histogenics had cash, cash equivalents and marketable securities of $8.8 million, compared to $8.0 million at December 31, 2017.  Histogenics believes its current cash position will be sufficient to fund its operations into the fourth quarter of 2018.

Conference Call and Webcast Information

Histogenics management will host a conference call on Thursday, August 9, 2018 at 8:30 a.m. EDT.  A question-and-answer session will follow Histogenics’ remarks.  To participate on the live call, please dial (877) 930-8064 (domestic) or (253) 336-8040 (international) and provide the conference ID “6679509” five to ten minutes before the start of the call.

To access a live audio webcast of the presentation on the “Investor Relations” page of the Histogenics website, please click here. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the presentation.

About Histogenics Corporation

Histogenics (Nasdaq:  HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  Histogenics completed enrollment of its NeoCart Phase 3 clinical trial in June 2017 and expects to report top-line, one-year superiority data in the third quarter of 2018.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws.  Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; MEDINET’s ability to initiate NeoCart clinical development in Japan in a timely manner; NeoCart’s regulation as a Regenerative Medical Product in Japan; the market size and potential patient population in Japan; the scope, progress, timing, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov.  Additional factors may be set forth in those sections of Histogenics Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, to be filed with the SEC in the third quarter of 2018.  In addition to the risks described above and in Histogenics’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
 (Unaudited)
(in thousands, except share and per share data)

HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS 
(Unaudited)
(in thousands)

SOURCE: Histogenics Corporation

WARSAW, Ind., Aug. 08, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today its financial results for the second quarter ended June 30, 2018.

Second Quarter & Recent Highlights

• Increased total revenue to $15.1 million for second quarter 2018, up 27.7% from $11.8 million in second quarter 2017
• Deployed $2.8 million of consignment sets during the second quarter 2018
• Added four incremental U.S. sales representatives in the second quarter 2018 for a total of 88 reps
• Launched 25^th surgical system, Pediatric Nailing Platform | FEMUR
• Increased revenue guidance to a range of 23% to 24% year-over-year growth and investment in consignment sets to $11.0 million for full year 2018

Mark Throdahl, Chief Executive Officer of OrthoPediatrics, commented, “We are extremely pleased to report record quarterly revenues of $15.1 million, which demonstrates strong and consistent execution across the business. As we continue to invest in consignment sets, R&D, and the expansion of our sales reps, we are strengthening our competitive position for sustainable future growth. We have supplemented our domestic sales force with 13 reps year-to-date to help support the $8.3 million of consigned sets deployed in the first half of the year, enabling us to broaden utilization of our pediatric systems. Furthermore, our investments in R&D drove recent FDA clearance of our 25^th surgical system and keep us on track to launch four additional systems by year end. We look forward to continued strong momentum as we continue to advance these initiatives. Our confidence grows due to greater than anticipated performance in the first half of the year, and so we anticipate our full year 2018 revenue growth will increase to a range of 23% to 24% with consigned set investments increasing to $11.0 million.”

Second Quarter 2018 Financial Results
Total revenue for the second quarter of 2018 was $15.1 million, a 27.7% increase compared to $11.8 million for the same period last year. U.S. revenue for the second quarter of 2018 was $11.5 million, a 24.6% increase compared to $9.2 million for the same period last year, representing 76% of total revenue. International revenue was $3.6 million, a 38.7% increase compared to $2.6 million for the same period last year, representing 24% of total revenue.

Trauma and Deformity revenue for the second quarter of 2018 was $9.9 million, a 25.3% increase compared to $7.9 million for the same period last year. Scoliosis revenue was $4.9 million, a 42.7% increase compared to $3.4 million for the second quarter 2017. Sports Medicine/Other revenue for the second quarter of 2018 was $0.3 million, a 36.3% decrease compared to $0.5 million for the same period last year.

Gross profit for the second quarter of 2018 was $11.3 million, a 29.4% increase compared to $8.7 million for the same period last year. Gross profit margin for the second quarter of 2018 was 74.7%, compared to 73.8% for the same period last year, reflecting the benefit of our four direct country conversions and partially offset by continued international set sales.

Total operating expenses for the second quarter of 2018 were $13.4 million, a 42.6% increase compared to $9.4 million for the same period last year. The increase in operating expenses was driven by a 66.9% increase in R&D, a 27.9% increase in sales and marketing, including higher commissions, and unusually higher, non-recurring professional fees associated with legal expense. Operating loss for the quarter increased to ($2.1) million from ($0.7) million for the same period last year.

Net interest expense for the second quarter of 2018 was $0.6 million, a 13.5% decrease compared to $0.7 million for the same period last year.

Net loss for the second quarter of 2018 was ($2.7) million, compared to ($1.3) million for the same period last year. Net loss per share attributable to common stockholders for the second quarter of 2018 was ($0.21) per basic and diluted share, compared to ($1.56) per basic and diluted share for the same period last year.

Adjusted EBITDA for the second quarter of 2018 was $0.7 million as compared to $0.3 million for the second quarter of 2017. The change was primarily driven by the significant increase in revenue and associated gross margin. See below for additional information and a reconciliation of non-GAAP financial information.

The weighted average number of diluted shares outstanding as of June 30, 2018 was 12,549,226 shares.

As of the second quarter of 2018 our independent sales agencies in the United States employed 88 full-time equivalent sales representatives specifically focused on pediatrics, up four from the 84 employed in the first quarter of 2018. This increase keeps us on track for 18 additional reps for the full year 2018.

Purchases of property and equipment during the second quarter of 2018 were $1.4 million, a 7.7% decrease compared to $1.5 million for the same period last year. This investment reflects the deployment of consigned sets, which includes product specific instruments and cases and trays. Including the implants, $2.8 million of consigned sets were deployed during the second quarter of 2018 compared to $3.0 million during the second quarter of 2017. Set deployment during the second quarter of 2017 was higher than normal because of the conversion of the U.K. and Ireland stocking distributor to an agency model.

As of June 30, 2018, cash and cash equivalents were $26.5 million, compared to $34.6 million as of March 31, 2018, and the Company had approximately $25.4 million in total outstanding indebtedness, including $3.9 million outstanding under the revolving credit facility.

Full Year 2018 Financial Guidance
OrthoPediatrics is providing financial guidance for the full year 2018, as follows:

• Revenue growth in a range of 23% to 24% year-over-year, up from prior guidance of 22%.
• Consigned set investments of approximately $11.0 million, up from prior guidance of $10.0 million.

Conference Call
OrthoPediatrics will host a conference call on Thursday, August 9, 2018 at 8:00 a.m. ET to discuss its financial results. The dial-in numbers are (855) 289-4603 for domestic callers and (614) 999-9389 for international callers. The conference ID number is 4835859. A live webcast of the conference call will be available online at OrthoPediatrics’ investor relations website, ir.orthopediatrics.com.

A replay of the webcast will remain available online at OrthoPediatrics’ investor relations website, ir.orthopediatrics.com, until OrthoPediatrics releases its third quarter 2018 financial results. In addition, a telephonic replay of the conference call will be available until August 16, 2018. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. The replay conference ID number is 4835859.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “goals,” “potential,” “objective,” “would” and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ Annual Report on Form 10-K filed with the SEC on March 15, 2018. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

Use of Non-GAAP Financial Measures
This press release includes the non-GAAP financial measure of Adjusted EBITDA, which differs from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). Adjusted EBITDA in this release represents net loss, plus interest expense (income), net plus other expense (income), depreciation and amortization, stock-based compensation expense, accelerated vesting of restricted stock upon our IPO, public company costs and initial public offering costs. Adjusted EBITDA is presented because the Company believes it is a useful indicator of its operating performance. Management uses the metric as a measure of the Company’s operating performance and for planning purposes, including financial projections. The Company believes this measure is useful to investors as supplemental information because it is frequently used by analysts, investors and other interested parties to evaluate companies in its industry. The Company believes Adjusted EBITDA is useful to its management and investors as a measure of comparative operating performance from period to period. Adjusted EBITDA is a non-GAAP financial measure and should not be considered as an alternative to, or superior to, net income or loss as a measure of financial performance or cash flows from operations as a measure of liquidity, or any other performance measure derived in accordance with GAAP, and it should not be construed to imply that the Company’s future results will be unaffected by unusual or non-recurring items. In addition, the measure is not intended to be a measure of free cash flow for management’s discretionary use, as it does not reflect certain cash requirements such as debt service requirements, capital expenditures and other cash costs that may recur in the future. Adjusted EBITDA contains certain other limitations, including the failure to reflect our cash expenditures, cash requirements for working capital needs and other potential cash requirements. In evaluating Adjusted EBITDA, you should be aware that in the future the Company may incur expenses that are the same or similar to some of the adjustments in this presentation. The Company’s presentation of Adjusted EBITDA should not be construed to imply that its future results will be unaffected by any such adjustments. Management compensates for these limitations by primarily relying on the Company’s GAAP results in addition to using Adjusted EBITDA on a supplemental basis. The Company’s definition of this measure is not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation. The schedules below contain a reconciliation of Net Income to non-GAAP Adjusted EBITDA.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

Company Contact

Xtant MedicalMolly Masonmmason@xtantmedical.comXtant Medical Holdings, Inc.

This article appears in: News Headlines

Referenced Stocks: XTNT

August 07, 2018