Amedica Announces Successful Completion of First Valeo® C+CSC with Lumen Interbody Fusion Surgery

SALT LAKE CITY, Aug. 21, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA), an innovative biomaterial company that develops and commercializes silicon nitride for biomedical applications, is pleased to announce the successful completion of the first spine fusion surgery using the Valeo C+CSC with Lumen Interbody Fusion Device.

The first surgery was performed by Dr. Tarek Elalayli of Nashville, TN. “The implant, consisting of a novel combination of solid and porous silicon nitride, is well-designed, and the surgical implantation was straight forward. The benefits of this new device include the potential for bone in-growth as well as on-growth, while a central lumen gives the surgeon flexibility to add bone graft, if needed. The device and underlying technology are a step toward spine fusion without the need for bone graft additives; with the advantages of good radiographic visualization, and inherent antibacterial properties of silicon nitride. No other spinal fusion implant combines all these properties.” said Dr. Elalayli.

The Valeo C+CsC with Lumen is Amedica’s newest spinal implant that received FDA clearance earlier this year. The device is a composite silicon nitride implant that combines different densities of Amedica’s proprietary medical grade silicon nitride ceramic. A solid, outer shell of nanostructured silicon nitride is manufactured around an inner porous layer, called CsC (“cancellous structured ceramic). CsC is approved for clinical use in Europe, and published clinical data from the CASCADE clinical trial have shown that it achieves spinal fusion without added bone grafts or fillers, at rates similar to those achieved by bone autograft.

“Several of our published reports have challenged the existing dogma that the surface texture of a biomaterial alone affects bone healing. Instead, we have shown that surface microchemistry also plays a critically important role in promoting bone healing. In the case of silicon nitride, we can precisely engineer both the surface nanostructure, as well as the surface microchemistry of an implant in order to stimulate bone-forming cells, speed up bone fusion, and discourage bacterial adhesion. The Valeo C+CsC with Lumen device captures these advantages by manufacturing different material densities into one smart, bioactive implant that is already optimized for spinal fusion. In contrast, competing implants made of inert metal and plastic usually require enhancement with cost-added bone fillers, surface texturing, or related gimmicks” said Dr. Sonny Bal, Chairman of Amedica. “Unlike any other biomaterial available for spinal fusion today, silicon nitride is in a class by itself,” added Dr. Bal.

The Valeo C+CsC with Lumen Interbody Fusion Device is indicated for intervertebral body fusion of the cervical spine in skeletally mature patients. Additional information about Amedica’s complete line of products can be found at www.amedica.com.

About Amedica Corporation

Amedica is focused on the development and application of medical-grade silicon nitride ceramic. Amedica markets spinal fusion products and is developing implants for other biomedical applications, such as wear- and corrosion-resistant hip and knee bearings, and dental implants. The Company’s manufactures its products in its ISO 13485 certified manufacturing facility. Amedica’s FDA-cleared and CE-marked spine products are currently marketed in the U.S. and select markets in Europe and South America through its distributor network, and OEM partnerships.

For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.

Forward-Looking Statements
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated within this press release. A discussion of those risks and uncertainties can be found in Amedica’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 29, 2018, and in Amedica’s other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.

Contacts:
Amedica IR 
801-839-3502
IR@amedica.com

Global Minimally Invasive Surgical Instruments Market Outlook to 2023: A $53.1 Billion Opportunity

DUBLINAug. 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 Guineathe 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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Vericel Announces Appointment of Jonathan Hopper as Chief Medical Officer

CAMBRIDGE, Mass., Aug. 20, 2018 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, today announced the appointment of Jonathan Hopper as Chief Medical Officer.

Dr. Hopper formerly served as Senior Medical Director, Orthopedic Clinical Development for Ferring Pharmaceuticals, where he was responsible for establishing and executing the company’s strategy for Orthopedic clinical development.  Prior to joining Ferring Pharmaceuticals, he served in a number of senior medical roles including Vice President, Global Medical Director for Stryker Corporation.  Dr. Hopper also has significant medical device regulatory experience having served as a Senior Medical Officer for the UK Medicines and Healthcare products Regulatory Agency.  Dr. Hopper graduated with a M.B. Ch.B. from Birmingham University Medical School UK, is a Fellow of the Royal College of Surgeons, Edinburgh, and attained an M.B.A. at Keele University UK.

“Jon’s experience and expertise in orthopedics, wound care, and combination biologic device products are an ideal fit with Vericel’s current business and strategic focus,” said Nick Colangelo, president and chief executive officer of Vericel.  “Jon will play a key role in the execution of our life cycle management initiatives as well as our efforts to expand our product portfolio by accessing assets complementary to our existing business.”

About Vericel Corporation
Vericel is a leader in advanced cell therapies for the sports medicine and severe burn care markets.  The company markets two cell therapy products in the United States.  MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.  For more information, please visit the company’s website at www.vcel.com.

Epicel® and MACI® are registered trademarks of Vericel Corporation. © 2018 Vericel Corporation. All rights reserved.

This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding our efforts to expand our portfolio, the commercial potential of our products and growth in revenues, intended product development, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with business development activities, competitive developments, estimating the commercial growth potential of our products and product candidates and growth in revenues and improvement in costs, market demand for our products, and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission (“SEC”) on March 5, 2018, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management’s current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

(vcel-corp)

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Russo Partners LLC
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Russo Partners LLC
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+1 917-547-0434 (mobile)

Investor Contacts:
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Solebury Trout
crubin@troutgroup.com
+1 (646) 378-2947

Lee Stern
Solebury Trout
lstern@troutgroup.com
+1 (646) 378-2922

Global Cartilage Repair/Regeneration Market Will Reach USD 6.5 Billion By 2024: Zion Market Research

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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Xtant Medical Announces Appointment of Chief Financial Officer

BELGRADE, MT, Aug. 20, 2018 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American: XTNT), a leader in the development and commercialization of regenerative medicine products and medical devices, today announced the appointment of Kathie Lenzen as chief financial officer, effective August 20, 2018. Ms. Lenzen will report to Carl O’Connell, Xtant’s chief executive officer.

“Ms. Lenzen is an accomplished healthcare executive with significant financial expertise and we are pleased that she is joining our executive management team,” said Carl O’Connell. “In addition to the financial leadership she will provide to the organization, she is a strong strategic, cross-functional leader. Her appointment continues our commitment to building a highly skilled management team.”

Kathie Lenzen brings over 36 years of financial experience to Xtant. Most recently, Ms. Lenzen served as the senior vice president and general manager of Astora Women’s Health division. Prior to being in this position, she was the vice president of finance for American Medical Systems and drove financial performance to ensure EBITDA growth consistently outpaced revenue growth. She is versed in cross-departmental collaboration from a financial perspective, knowledgeable about information systems, restructuring for profitability, and merger and acquisition activities.

“I am excited to join the Xtant team and contribute to the Company’s growth strategy,” said Kathie Lenzen. “Xtant has made considerable progress over the past year, and I look forward to helping the Company continue to transform its business and drive shareholder value.”

About Xtant Medical

Xtant Medical develops, manufactures and markets regenerative medicine products and medical devices for domestic and international markets. Xtant Medical products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant Medical can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as ‘‘continue,’’ ‘‘expects,’’ ‘‘anticipates,’’ ‘‘intends,’’ ‘‘plans,’’ ‘‘believes,’’ ‘‘estimates,’’ ‘‘strategy,’’ ‘‘will,’’ “can” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. The Company cautions that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to increase revenue; the ability to achieve expected results; the ability to remain competitive; the ability to innovate and develop new products; the ability to engage and retain qualified personnel; government and third-party coverage and reimbursement for Company products; the ability to obtain and maintain regulatory approvals; government regulations; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights and operate without infringing the rights of others; the ability to service Company debt and comply with debt covenants; the ability to raise additional financing and other factors. Additional risk factors are listed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (SEC) on April 2, 2018 and subsequent SEC filings by the Company, including without limitation its most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2018. Investors are encouraged to read the Company’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

SOURCE: Xtant Medical Holdings, Inc.

Company Contact

Xtant Medical
Molly Mason
mmason@xtantmedical.com
Xtant Medical Holdings, Inc.

AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan

17 August 2018 | By Ana Mulero 

In a comment submitted on the US Food and Drug Administration’s (FDA) recent action plan to promote medical device safety, the Advanced Medical Technology Association (AdvaMed) raised several concerns with the merit and logistics of the proposal.

The five-pronged action plan—revealed in April—consists of establishing a medical device safety net, exploring regulatory options for postmarket mitigations, spurring innovation towards safer devices and further strengthening cybersecurity.

It also involves plans for a major structural reorganization at FDA’s Center for Devices and Radiological Health (CDRH), which is expected to have an impact on the regulatory reviews, approvals and clearances of devices, to better support the total product life cycle.

The trade association expressed concerns with implying that devices cleared via the expanded abbreviated 510(k) program are safer compared to the traditional 510(k) pathway, whereas Johnson & Johnson expressed support for expanding the alternative to more moderate-risk devices.

The company also further stressed the trade association’s concerns around FDA’s statement that “the marketplace…does not provide strong incentives to make an established device safer in the absence of a new or greater-than-previously-understood safety concern.

“FDA should identify and overcome whatever internal obstacles prevent efficient practice,” said AdvaMed associate VP for technology and regulatory affairs Zachary Rothstein. “We note that at the time of this submission, our members’ experience indicates that FDA’s current use of emerging signals is subjective and, at times, lacks appropriate input from the manufacturer.”

But CDRH’s reorganization plans and advancing the use of RWE in support of regulatory decision-making were both endorsed by AdvaMed. The center’s RWE efforts, as well as those around advancing cybersecurity, are centered on developing the National Evaluation System for Health Technology, which is run by the nonprofit Medical Device Innovation Consortium (MDIC).

 

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Avista Healthcare Public Acquisition Corp. To Combine With Organogenesis Inc.

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:

Kekst (for AHPAC and Avista Capital Partners)

Daniel Yunger

212-521-4800

Daniel.Yunger@kekst.com  

Organogenesis

Angelyn Lowe

781-774-9364

alowe@organo.com

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

KFx Medical, LLC. Sues Stryker, Inc. for Patent Infringement

August 16, 2018

SAN DIEGO–(BUSINESS WIRE)–KFx Medical, LLC. announced it has sued Stryker, Inc. (NYSE: SYK) for its continued infringement of US Patent number 7,585,311 and related patents for knotless double row rotator cuff repair.

In 2015, when KFx successfully defended these patents versus Arthrex, Inc., Arthrex paid in excess of $35m in damages and interest for its infringement of these same KFx Knotless Double Row Fixation patents and fought KFx through the appellate court and was ultimately denied any further review by the Supreme Court of the United States.

KFx Medical, LLC has 5 agreements that license the same patents to other medical device companies, giving them the right to promote the use of products and techniques for knotless double row rotator cuff repair as claimed in US Patent number 7,585,311 and related patents and applications for the life of those patents.

About KFx Medical, LLC

KFx Medical LLC was founded in 2003 to develop products for tissue fixation in a variety of orthopedic surgical procedures performed on the shoulder, knee, foot, and ankle. KFx provides simple systems for orthopedic surgeons focused on sports medicine. The company is privately held. Investors include Alloy VenturesCharter Life SciencesArboretum VenturesMontreux Equity Partners, and MB Venture Partners.

Contacts

KFx Medical, LLC
Tate Scott
President and Chief Executive Officer
Tate.Scott@kfxmed.com
619-742-2010
www.kfxmedical.com

CoreLink, LLC Announces 510(k) Clearance for Foundation™ 3D Anterior Lumbar (ALIF)

August 16, 2018

ST. LOUIS–(BUSINESS WIRE)–CoreLink, LLC, a vertically integrated manufacturer of spinal implant systems, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market The FoundationTM 3D Anterior Lumbar (ALIF) Interbody device. This marks the launch of the latest addition to CoreLink’s Foundation 3D Interbody Cage family.

Jay Bartling, CEO, said, “The Foundation 3D ALIF demonstrates our increasing capabilities with 3D printing titanium alloy. We’re proud to have the largest ALIF cage footprint on the market, which will allow surgeons to maximize endplate contact area and hold up to 8cc’s of graft.”

Prior to the newly 510(k) cleared ALIF device, CoreLink released 3 other sterile-packaged Foundation 3D interbody cages: Cervical, Straight Lumbar, and Curved Lumbar.

“I have been very pleased since converting to Foundation 3D Cervical last year. I am excited about the Mimetic Metal technology and have had great clinical outcomes with very happy patients.” said Todd Stewart, MD.

Foundation 3D ALIF leverages CoreLink’s proprietary Mimetic Metal™ technology that mimics key characteristics of natural bone – 100% open-pore architecture and micro roughened porosity with significant hydro-wicking properties. The new ALIF design also features patent pending StrutSure™ technology which creates a combination of load-sharing support structure and interconnected lattice designed to provide optimal balance between strength, stiffness, and stability. This unique structure minimizes implant material density, providing good imaging characteristics. Foundation 3D devices have a low modulus that may reduce stress shielding and enable the benefits of Wolff’s Law.

CoreLink will be exhibiting at the North American Spine Society’s annual meeting in Los Angeles, September 26-28, where the portfolio of Foundation 3D Products will be featured.

About CoreLink

CoreLink, known as The Source for Spine™, internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems and leverages this expertise through collaboration and a dedication to empowering its surgeons and improving the lives of their patients.

Be a part of something at The Source.

(Photo: Business Wire) Foundation 3D

www.corelinksurgical.com

Contacts

CoreLink, LLC
Courtney Sheedy, 888-349-7808

BONESUPPORT – CERAMENT® G Approved by Health Canada

Lund, Sweden, 18:00 CET, 16 August 2018 – BONESUPPORT™, an emerging leader in orthobiologics for the management of bone voids, announces that its antibiotic-eluting product CERAMENT G has been approved by Health Canada.

CERAMENT G is the first and only CE-marked gentamicin-eluting injectable ceramic bone graft substitute on the market.  CERAMENT G sales have been growing strongly based on the clinical benefits it delivers when used for indications where infection may be present or of concern.

BONESUPPORT is currently conducting the FORTIFY trial to assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial  include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union.  The trial will also evaluate the safety of CERAMENT G in these patients. The trial will enroll up to 230 patients at up to 30 centers in the US and Europe.

Positive data from the FORTIFY trial will be used to support BONESUPPORT’s PMA (Premarket Approval) filing for CERAMENT G   in the US, where the product is expected to be launched in 2021. 

Emil Billbäck, CEO of BONESUPPORT said: “We are looking forward to commercializing CERAMENT G in Canada following its approval by Health Canada. CERAMENT G will be the first injectable antibiotic eluting ceramic bone graft substitute to be launched on the Canadian market. We are currently in dialogue with potential distributors to assist us in bringing this novel product to orthopedic surgeons managing bone voids where infection is present or an important risk.”

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis), ortho-oncology, foot and ankle, and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking at opportunities to expand its product offering in the US and has entered into a strategic agreement with MTF Biologics and Collagen Matrix Inc. to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

For more information contact:

 

BONESUPPORT AB

Emil Billbäck, CEO

+46 (0) 46 286 53 70

 

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

 

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 18.00 CET on 16 August 2018.

 

Pip Batty

Account Manager

 

3 London Wall Buildings

London Wall

London EC2M 5SY

Tel: +44 (0)20 7282 1022

Mob: +44 (0)7808 642 922