SpineGuard Raises €2Million of Fresh Equity Finance

April 06, 2017

PARIS & SAN FRANCISCO–(BUSINESS WIRE)–SpineGuard (FR0011464452 – ALSGD), an innovative company that develops and markets disposable medical devices designed to make spine surgery safer, has announced the completion of a €2 million round of fresh equity.

These proceeds will be used to support SpineGuard’s growth strategy: accelerate the adoption of its smart drilling devices for spine fusion and the development of innovations derived from its proprietary DSG™ technology platform.

There were two steps for this round of fresh equity finance:
i) Round 1 in favor of a limited number of European institutional investors
ii) Round 2 in favor of certain managers, directors or consultants of the Company

Pierre Jérôme, CEO and co-founder of SpineGuard, said: “Following the successful launch of PediGuard Threaded and the first surgeries performed with our DSG™ integration module for ‘single-step’ screw insertion, these new proceeds will enable SpineGuard to reinforce DSG™ technology’s position as standard of care. I would like to warmly thank all those who subscribed to this equity round.

Terms of the equity funding

488,190 new ordinary shares with a nominal value of 0.20 Euros each have been created of which:

451,250 new ordinary shares issued in favor of a limited number of institutional investors in accordance with resolution #23 of the Extraordinary Shareholders meeting held on the 25th of June 2015 and in compliance with article L. 411-2 II of the French Monetary Code (Code monétaire et financier);

36,940 new ordinary shares issued in favor of certain managers, directors or consultants of the Company in compliance with the categories listed under resolution #10 of Extraordinary Shareholders meeting held on May 11, 2016, and in compliance with article L.225-138 of the French Code of commerce;

The issue price of the new shares is 4.00 euros per share, representing a discount of 9.37% to the weighted average share price of the last 20 days of trading prior to the funding;

The clearing and settlement (règlement-livraison) should take place by April 12, 2017.

A shareholder holding 1% of the Company’s shares prior to the equity funding that would participate to it would end with 0.91%.

Use of proceeds

The net proceeds strengthen SpineGuard’s financial resources, open up additional sources of funding and with its already existing resources1 will fund the implementation of its strategy, in particular:

– To reinforce its primary commercial focus on the US market and support certain geographies with strong potential for sales of the DSG™ technology;

– Business Development activities to sign new partnerships with the spine industry for co-developing other DSG™ Smart Screws;

– To broaden its proprietary technology offerings to new applications and functions (combination with surgical robots, bone quality measurement, entry point determination) as well as new surgical fields beyond spine (joint reconstruction, trauma, maxilla facial or dental).

Listing of the new shares

The new shares will bear the same rights than existing shares. They will list on Alternext Paris under the same ISIN code as the existing shares FR0011464452. The new shares should be listed and available for trade on Alternext Paris on April 10, 2017.

Once the equity funding is complete, the total number of issued shares will be 5,601,215.

Pursuant article 211-3 of the General Regulations of the Autorité des Marches Financiers (AMF), this operation does not require a prospectus submitted to the approval of the AMF.

SwissLife Banque Privée acted as sole manager and book runner for this equity funding.

Next financial press release: 2016 Half-year revenue: July 6, 2017

About SpineGuard®

Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery Co-founded in 2009 in France and the USA by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 50,000 surgical procedures have been performed worldwide with DSG enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

Disclaimer

The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.

1 The Company had €1,804k of cash at hand, is planning to receive €230k for French CIR 2016 and, under certain conditions starting 30 Sep.2017, can draw the third tranche of IPF loan for € 1,500k (refer to Note 17 of “2016 Rapport financier of the company)

Contacts

SpineGuard
Pierre Jérôme, +33 (0)1 45 18 45 19
Chief Executive Officer
p.jerome@spineguard.com
or
Manuel Lanfossi
Chief Financial Officer
m.lanfossi@spineguard.com
or
Europe / NewCap
Investor Relations & Financial Communication
Florent Alba / Pierre Laurent, +33 (0)1 44 71 94 94
spineguard@newcap.fr
or
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1-508-359-4005, x108

EOS imaging Announces First Sale of EOS System in Israel

April 05, 2017

PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopedic medical imaging, today announced the first sale of an EOS platform in Israel to Tel Aviv Sourasky Medical Center. The EOS platform has now been sold in 33 countries. The EOS platform is expected to be installed in April at The Dana-Dwek Hospital, one of the four main hospitals that make up the Tel Aviv Sourasky Medical Center.

Tel Aviv Sourasky Medical Center (TAMC) is the second largest and one of the most progressive full-service healthcare treatment and research institutions in Israel. As a premier multidisciplinary academic medical center, the Center serves the greater Tel Aviv metropolitan area population of 3.5 million people accounting for over 42% of the entire population of Israel. TAMC is a national referral center for many major primary and specialty care services.

Marie Meynadier, CEO of EOS imaging, said, “We are pleased that Tel Aviv Sourasky Medical Center is the first site in Israel to acquire an EOS platform. Given its status as a national reference site for orthopedic care, a large number of Israeli patients will now have access to our technology. In addition, this sale further expands our global installed base and provides incremental validation for the EOS system and associated services.”

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS®, an innovative medical imaging system dedicated to osteo-articular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2016 revenues of €30.8 million and employs 132 people at December 2016, including an R&D team of 43 engineers. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Contacts

EOS imaging
Anne Renevot, +33 (0)1 55 25 61 24
CFO
investors@eos-imaging.com
or
NewCap
Financial communication and investor relations
Pierre Laurent / Valentine Brouchot
+33 (0)1 44 71 94 96
eosimaging@newcap.eu
or
Media Relations
Annie-Florence Loyer
+33 (0)1 44 71 00 12 / 6 88 20 35 59
or
The Ruth Group (US)
Press relations
Joanna Zimmerman, 646-536-7006
jzimmerman@theruthgroup.com

Medovex Corporation Partners with Technology Consult Berlin GmbH in Germany

ATLANTA, GA–(Marketwired – Apr 5, 2017) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that it has entered into a partnership with TCB – Technology Consult Berlin GmbH for distribution of its Denervex™ system throughout Germany. TCB is expected to provide sales, marketing and distribution services.

TCB, is a associated partner of Kalms & Partner Consulting (http://www.kalmsconsult.com/) based in Berlin, Germany offers a complete consultancy service for medical device manufacturers and selected services for pharmaceutical companies. The company offers sales and marketing, full distribution services, strategic and operational support in the fields of market access, health economics, reimbursement and business development.

Manfred Sablowski, Senior Vice President Global Sales & Marketing of Medovex, stated, “TCB – Berlin in Germany serves as a perfect call point fit for our mission to provide a successful distribution, sales and marketing foundation for our entry and expansion of our footprint of the DenerveX System in the most important market in Europe.”

On March 13, 2017, the Company previously announced that the reimbursement authority in Germany had renewed reimbursement payment coding for the DenerveX System technology for the treatment of the Facet Joint Syndrome for 2017.

The renewed reimbursement coding, effective immediately, was released in the Diagnosis-Related Group (DRG) system in 2017 in Germany. This new coding allows for hospitals and outpatient centers to receive reimbursement for the use of the DenerveX System for the treatment of the Facet Joint Syndrome in the spine.

According to Dennis Moon, Executive Vice President of Medovex, “The renewal of the reimbursement code for 2017 in Germany will be a significant driver for our European launch preparation for the DenerveX System. We look forward to targeting the German market through our new relationship with TCB – Berlin as the country is often recognized as a leader in early clinical adoption of new and cost effective technologies, being on the forefront of establishing reimbursement guidelines. Reimbursement is perhaps the most foundational element supporting adoption for a medical technology.”

The Company’s patented DenerveX System, is not yet commercially available in the EU and the U.S. The DenereX System is designed to provide longer lasting relief of pain associated with the facet joint. Lower back pain is the second most common cause of disability in the U.S. for adults. Studies indicate that 10% of the U.S. adult population suffers from lower back pain and that 31% of lower back pain is attributed to facet joint pain.

The DenerveX System consists of the DenerveX Device Kit, containing a single use device, and the DenerveX Pro-40 Power Generator. The DenerveX system is designed to provide a minimally invasive treatment option which combines two actions into one device.

DenerveX is not yet CE marked or FDA cleared.

About Medovex:
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com.

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward- looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

SPINEWAY : Signature of a distribution agreement in Australia 1st Mont-Blanc implants

  Ecully, 5 April 2017

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine), announces the signature of a contract with an Australian distributor for the sale of its implants and instruments in Oceania.

The distribution agreement follows the approval of the Group’s flagship lines and reinforces Spineway’s international coverage.

The distributor, based in Sydney, specializes in orthopedics and is extremely experienced with the spine. It will sell Spineway’s Mont-Blanc, TwinPeaks, Kili, Ayers Rock and Blue Mountain lines. Its salesforce and distribution network will allow the Group to cover Sydney and Australia’s other major cities.

The first surgeries using Mont-Blanc implants have already taken place and were very successful.

Spineway thus establishes its know-how in overseas exports and should see its sales increase steadily in this new geographic area.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLAN FOR SMES)
Find out all about Spineway at www.spineway.com

Next communication:
2016 Annual Results – 26 April 2017, after market closes

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) – Talent INPI award (2015).
ISIN code: FR0011398874 – ALSPW     

Contacts:

Investor Relations
David Siegrist – Finance Director
Tel: +33 (0)4 72 77 01 52
finance.dsg@spineway.com
Financial Communication
Jérôme Gacoin / Solène Kennis
Tel: +33 (0)1 75 77 54 68
skennis@aelium.fr

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/524d353f-a4b8-4e92-8c9f-23188e2e1812

Acelity Names R. Andrew Eckert President and Chief Executive Officer

April 05, 2017

SAN ANTONIO–(BUSINESS WIRE)–Acelity L.P. Inc., a leading global advanced wound care company, today announced that it has named R. Andrew Eckert as President and Chief Executive Officer. Eckert succeeds Joseph Woody, who is leaving Acelity following the successful divestiture of the company’s LifeCell division earlier this year.

“We have a proven and experienced leader at the helm as we embark on a promising new phase in the transformation of Acelity,” said Buddy Gumina, Chairman of the Acelity Board of Directors. “Andy brings a significant set of expertise and experience from across the healthcare and technology sectors and will be a tremendous addition to the team as we concentrate on developing and expanding our industry-leading portfolio of advanced wound therapies.”

Eckert is a seasoned executive and brings to his new role considerable experience as chief executive of numerous public and private healthcare technology and services companies. He is the former CEO of TriZetto Corporation, a provider of world-class healthcare information technology and service solutions that was acquired by Cognizant Technology Solutions in 2014. In addition to TriZetto, Eckert has led five other companies, including CRC Health Group, Eclipsys Corporation, ADAC Laboratories, and most recently, Valence Healthcare in 2016. He serves as Chairman of the Board of Directors of Varian Medical Systems, and is a member of the Board of Directors of Becton, Dickinson and Company.

“This is a remarkable time for Acelity as we navigate the complex evolution of healthcare delivery in markets around the world,” said Eckert. “I welcome the challenge and look forward to leading Acelity’s talented team of more than 4,800 colleagues worldwide at this point in the company’s progression. We have an important opportunity to realize growth by embracing the shift to value-based care and delivering to patients and customers innovative products and therapies that address the burdens of treating chronic and acute wounds.”

“On behalf of the Acelity Board of Directors, I would like to thank Joe Woody for his leadership of the company since 2011,” added Gumina. “Joe introduced Acelity to the marketplace by successfully leading the integration of KCI, Systagenix and LifeCell to create a global leader in medical device and technology and oversaw a period of significant expansion in new product development and therapy adoption. With the successful divestiture of LifeCell, we look ahead to an exciting new chapter of growth and opportunity for Acelity.”

“I am proud of our achievements at Acelity during the past several years,” said Joe Woody. “As I reflect on what we accomplished, perhaps most important to me is the number of patients we are able to now reach with the Acelity portfolio. Looking ahead, I know that the passion and drive of everyone at Acelity to improve the lives of people around the world will lead to innovative new solutions in advanced wound therapy and as an ongoing shareholder of Acelity, I am very excited about the company’s next phase of growth.”

About Acelity

Acelity L.P. Inc. and its subsidiaries are a global advanced wound care company that leverages the strengths of Kinetic Concepts, Inc. and Systagenix Wound Management, Limited. Available in more than 90 countries, the innovative and complementary ACELITY™ product portfolio delivers value through solutions that speed healing and lead the industry in quality, safety and customer experience. Headquartered in San Antonio, Texas, Acelity employs nearly 5,000 people around the world.

Contacts

Acelity L.P. Inc.
Corporate Communications
Cheston Turbyfill, +1-210-515-7757
cheston.turbyfill@acelity.com
or
Investor Relations
Caleb Moore, +1-210-255-6433
caleb.moore@acelity.com

MicroPort Orthopedics Inc. Announces Launch of its EVOLUTION® Revision Tibial System and EVOLUTION® BioFoam® Tibia

April 05, 2017

ARLINGTON, Tenn.–(BUSINESS WIRE)–MicroPort Orthopedics Inc., a medical device company that develops and manufactures cutting edge joint replacement implants designed to help patients achieve full function faster, announced the launch of the EVOLUTION®Revision Tibial System and EVOLUTION® BioFoam® Tibia.

“MicroPort Orthopedics continues to grow its product portfolio with a steady cadence of product launches,” said Aurelio Sahagun, President, MicroPort Orthopedics. “These product launches demonstrate our commitment to help improve patient outcomes by giving surgeons a broad array of choices that allow them to treat their patients. We are excited to bring the benefits of the Medial-Pivot design to a revision system.”

The Evolution Medial-Pivot Knee System is built on 17 years of clinical success1 and addresses key issues that can improve satisfaction for patients undergoing total knee replacement. The EVOLUTION® Revision Tibial System is designed to offer surgeons intra-operative flexibility to meet individual anatomic patient needs, address fixation issues caused by poor bone stock, while maintaining the proven kinematic benefits of the Medial-Pivot design. The new system was designed by expert surgeons from Europe, Asia, Canada, and the United States and features all the benefits of the EVOLUTION® Medial-Pivot design.

In addition to its EVOLUTION® Revision Tibial System, MicroPort Orthopedics also announced the launch of its EVOLUTION®BioFoam® Tibia. This launch completes the EVOLUTION® Medial-Pivot Cementless System, which consists of the EVOLUTION®porous femoral component and the new EVOLUTION® BioFoam® tibial component. This system is designed to combine the unrivaled benefits of the Medial-Pivot philosophy with the advantages of early fixation without compromising the long-term demands that are required in today’s increasingly young and more active patients.2 Building on the success of the ADVANCE® BioFoam® Tibia, which reported survivorship of 98% at two years3, the EVOLUTION® BioFoam® Tibia will further enhance the product portfolio.

“I have used the MicroPort Medial-Pivot Knee System for three years,” said Dr. Brian de Beaubien, M.D., St. John’s Providence Park Hospital in Novi, MI. “The majority of my primary knees are cementless, and I do not use screws. In my experience with the ADVANCE®and now EVOLUTION®, BioFoam® has excellent fixation. I have been following x-rays now for several years, and I don’t see any radiolucencies or sclerotic lines around the keel, that would suggest movement of the component. The BioFoam® Tibia combined with the unique design of the EVOLUTION® Medial-Pivot Knee is truly different from anything else. It is my go-to knee.”

About MicroPort Orthopedics Inc.
Established in January 2014, MicroPort Orthopedics Inc. is a multinational producer of orthopedic products and a proud member of the MicroPort Scientific Corporation family of companies. From its headquarters in Arlington, Tennessee, MicroPort Orthopedics develops, produces, and distributes innovative orthopedic reconstructive products. The company’s U.S.-based manufacturing and logistics capabilities deliver high quality hip and knee products to patients and their doctors in over 60 countries, including the U.S., EMEA, Japan, Latin America, and China markets. For more information about MicroPort Orthopedics, visit http://www.ortho.microport.com/.

About MicroPort
MicroPort Scientific Corporation is a leading medical device company focused on innovating, manufacturing, and marketing high-quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 20 seconds in thousands of major hospitals around the world, MicroPort maintains world-wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Electrophysiological, Endovascular, Neurovascular, Surgical, Diabetes Care and Endocrinal Management, and others. MicroPort is dedicated to becoming a patient-oriented global enterprise that improves and reshapes patient lives through application of innovative science and technology. For more information, please refer to: http://www.microport.com.

Forward-Looking Statements
Some information contained in this press release contains forward-looking statements. These forward-looking statements include, without limitation, those regarding our future financial position, our strategy, plans, objectives, goals and targets, future developments in the markets where we participate or are seeking to participate, and any statements preceded by, followed by or that include the words “believe,” “intend,” “expect,” “anticipate,” “project,” “estimate,” “predict,” “is confident,” “has confidence” and similar expressions are also intended to identify forward-looking statements. Such statements are based upon the current beliefs and expectations of MicroPort’s management and are subject to significant risks and uncertainties. MicroPort Scientific Corporation undertakes no obligation to update any of the statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and other factors that could cause actual future results to differ materially from current expectations include, but are not limited to, general industry and economic conditions, PRC governmental policies and regulations relating to the medical device manufacturing industry, competition in the medical device manufacturing industry, our ability to develop new products and stay abreast of market trends and technological advances, our goals and strategies, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, fluctuations in general economic and business conditions in China.

This document is for information purposes only and does not constitute or form part of any offer or invitation to sell or the solicitation of an offer or invitation to purchase or subscribe for any securities of MicroPort Scientific Corporation, and no part of it shall form the basis of, or be relied upon in connection with, any agreement, arrangement, contract, commitment or investment decision in relation thereto whatsoever.

Sources:
1. A long term clinical outcome of the Medial Pivot Knee Arthroplasty System Macheras, George A. et al. The Knee , Volume 24 , Issue 2 , 447 – 453.
2. Global Data, 2013.
3. Waddell et al. Early radiographic and functional outcomes of a cancellous titanium-coated tibial component for total knee arthroplasty. Musculoskelet Surg. 2015 Sept; 100: 71.

All rights reserved.
Copyright © 2017 MicroPort Scientific Corporation

Contacts

LaVoie HealthScience
Sharon Correia, 617-412-8779
scorreia@lavoiehealthscience.com

Milestone Scientific Announces Regulatory Marketing Clearance to Sell Epidural and Intra-Articular Instruments and Disposables in Australia

LIVINGSTON, NJ –(Marketwired – April 04, 2017) – Milestone Scientific Inc. (NYSE MKT: MLSS), a medical R&D company that designs, patents, incubates and commercializes a growing portfolio of innovative injection technologies, today announced that it has been granted marketing clearance for its epidural and intra-articular instruments and disposables in Australia.

Milestone’s Dynamic Pressure Sensing® (DPS) capability in the CompuFlo® Epidural instrument provides feedback that allows anesthesiologists to correctly identify the epidural space, which has the potential to significantly reduce complications and malpractice compared to conventional techniques. DPS technology is also incorporated into the CompuFlo® Intra-Articular instrument to provide precise computerized drug injections into intra-articular joint spaces in osteoarthritis patients. CompuFlo® Intra-Articular provides drug delivery accuracy, reduces patient discomfort and prevents needle deflection.

Leonard Osser, Chief Executive Officer of Milestone Scientific, stated, “We are pleased to announce regulatory marketing clearance to sell our epidural and intra-articular instruments and disposables in Australia. Australia represents a sizable market for our technology with more than 300,000 live births per year and approximately 1.8 million residents with osteoarthritis. The CompuFlo® Epidural and Intra-Articular instruments provide new clinical tools to enhance the safety and reduce pain associated with epidural and intra-articular procedures.”

About Milestone Scientific Inc.

Milestone Scientific Inc. (MLSS) is a leading medical research and development company that designs and patents innovative injection technology. Milestone’s computer-controlled systems make injections precise, efficient, and virtually painless. For more information please visit our website: www.milestonescientific.com.

Safe Harbor Statement

This press release contains forward-looking statements regarding the timing and financial impact of Milestone’s ability to implement its business plan, expected revenues, timing of regulatory approvals and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions, future business decisions and regulatory developments, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone’s control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and the risk factors detailed from time to time in Milestone’s periodic filings with the Securities and Exchange Commission, including without limitation, Milestone’s Annual Report for the year ended December 31, 2016. The forward looking statements in this press release are based upon management’s reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

CONTACT INFORMATION

  • Contact:
    David Waldman or Natalya Rudman
    Crescendo Communications, LLC
    Email: mlss@crescendo-ir.com
    Tel: 212-671-1020

Flexion Therapeutics Announces Issuance of Two New Patents

BURLINGTON, Mass., April 04, 2017 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the U.S. Patent and Trademark Office has issued two new patents covering the company’s lead investigational product candidate ZilrettaTM (FX006). The new patents further strengthen the existing patent estate surrounding Zilretta. The patents cover the injectable formulation comprised of controlled or sustained-release microparticles that contain triamcinolone acetonide in a poly lactic-co-glycolic acid co-polymer (PLGA) matrix.

The first new patent, U.S. Patent No. 9,555,048, is entitled “Corticosteroids for the Treatment of Joint Pain” and includes claims directed to treatment of pain or inflammation in patients. The claims also include treatment of a variety of indications associated with pain and inflammation. The second new patent, U.S. patent, U.S. Patent No. 9,555,047, is entitled “Corticosteroids for the Treatment of Joint Pain” and includes claims directed to methods of manufacturing injectable extended-release microparticles that combine triamcinolone acetonide and PLGA.

“The issuance of these patents bolsters our strong intellectual property position,” said Michael Clayman, M.D., President and Chief Executive Officer of Flexion. “We have great confidence in the strength of our IP, and these new patents provide additional protection for our lead product candidate.”

Zilretta’s composition of matter, method of use and method of manufacturing patents provide protection into 2031.

About Zilretta™
Zilretta is being investigated as the first intra-articular, extended-release treatment for patients with osteoarthritis (OA) related knee pain. Zilretta employs proprietary microsphere technology combining triamcinolone acetonide — a commonly administered, short-acting corticosteroid — with a poly lactic-co-glycolic acid (PLGA) matrix. In February 2017, Flexion announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application for Zilretta in OA of the knee. Under the Prescription Drug User Fee Act (PDUFA), the agency has established a user fee goal date of October 6, 2017. To date, nearly 700 patients have been treated with Zilretta in clinical trials.

About Flexion Therapeutics
Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesia for the millions of U.S. patients who receive intra-articular injections for OA related knee pain annually.

Forward-Looking Statements
Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion and the strength of Flexion’s patents related to Zilretta, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; the risk that we may not be able to maintain and enforce our intellectual property, including the two newly-issued patents related to Zilretta; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

Corporate Contact:

Scott Young
Sr. Director, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7194
syoung@flexiontherapeutics.com

Media Contact:

Danielle Lewis
Lazar Partners
T: 212-867-1768 
flexionpr@lazarpartners.com

Investor Contact:

David Carey
Lazar Partners 
T: 212-867-1768 
dcarey@lazarpartners.com

Integra LifeSciences Announces Expansion of Credit Facility to include new $700 million term loan

PLAINSBORO, N.J., April 04, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today announced that it has increased its credit facility with its bank group led by Bank of America, N.A.

The expanded credit facility includes the following terms:

  • An increase in the credit facility from $1.5 billion to $2.2 billion, consisting of an expanded term loan of $1.2 billion with no change to the existing revolving line of credit of $1.0 billion;
  • The $700 million incremental term loan will be made available in a single drawing on a delayed basis, at the time of closing the Codman Neurosurgery acquisition;
  • An increase in the Company’s maximum consolidated total leverage ratio to 5.5 times EBITDA, as calculated per the credit agreement, for an incremental 25 basis point rate as well as a 5 basis point incremental commitment fee;
  • No other changes in pricing terms or commitment fees; and,
  • No change in maturity of the credit facility (December 7, 2021).

“We are pleased to announce that we have secured the financing for our planned acquisition of Codman Neurosurgery under favorable credit terms,” said Glenn Coleman, chief financial officer, Integra LifeSciences.  “We continue to expect the acquisition to close in the fourth quarter of 2017, and with this new agreement in place, retain the strength and flexibility of our balance sheet.”

Integra LifeSciences plans to use $700 million of the incremental term loan, together with borrowings from the existing revolving facility, to finance the acquisition of Codman Neurosurgery from Johnson & Johnson, which was previously announced on February 15, 2017. Borrowings from the existing revolving facility will also be used to cover fees and expenses incurred in connection with the credit facility expansion and for general corporate purposes.

The incremental term loan will be made available upon closing of the Codman Neurosurgery acquisition.  As a result, Integra LifeSciences will not incur a material financial impact related to this financing until the closing date of the acquisition, which is expected to be in the fourth quarter of 2017. Around the time of closing, Integra will provide an update to its 2017 financial outlook.

As previously stated on February 15, 2017, Integra expects the Codman Neurosurgery transaction to be accretive to adjusted* EPS by at least $0.22 in the first full year after closing and increasing thereafter, and to GAAP EPS by the end of the third year.

About Integra

Integra LifeSciences is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care.  Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies.  For more information, please visit www.integralife.com.

Forward-Looking Statements

This news release contains “forward-looking statements”, including statements regarding the proposed transaction and the ability to consummate the proposed transaction. Statements in this document may contain, in addition to historical information, certain forward-looking statements. Some of these forward-looking statements may contain words like “believe,” “may,” “could,” “would,” “might,” “possible,” “should,” “expect,” “intend,” “plan,” “anticipate,” or “continue,” the negative of these words, other terms of similar meaning or they may use future dates. Forward-looking statements in this document include without limitation statements regarding the planned completion of the proposed acquisition, the benefits of the proposed acquisition, including future financial and operating results, Integra’s or the Codman Neurosurgery business’s plans, objectives, expectations and intentions and the expected timing of completion of the proposed acquisition.   It is important to note that Integra’s goals and expectations are not predictions of actual performance.  Actual results may differ materially from Integra’s current expectations depending upon a number of factors affecting the Codman Neurosurgery business and Integra’s business and risks and uncertainties associated with acquisition transactions.  These factors include, among other things: successful closing of the proposed acquisition; the risk that competing offers will be made for the Codman Neurosurgery business before the binding offer is accepted; the risk that the binding offer may not accepted on a timely basis or at all; the ability to obtain required regulatory approvals for the proposed acquisition (including the approval of antitrust authorities necessary to complete the proposed acquisition), the timing of obtaining such approvals and the risk that such approvals may result in the imposition of conditions, including with respect to divestitures, that could materially adversely affect Integra, the Codman Neurosurgery business and the expected benefits of the proposed acquisition; the risk that a condition to closing of the proposed acquisition may not be satisfied on a timely basis or at all, the failure of the proposed acquisition to close for any other reason and the risk liability to Integra in connection therewith; access to available financing (including financing for the acquisition) on a timely basis and on reasonable terms; the effects of disruption caused by the proposed acquisition making it more difficult for Integra to execute its operating plan effectively or to maintain relationships with employees, vendors and other business partners; stockholder litigation in connection with the proposed acquisition; Integra’s ability to successfully integrate the Codman Neurosurgery business and other acquired businesses; global macroeconomic and political conditions; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any; physicians’ willingness to adopt and third-party payers’ willingness to provide reimbursement for Integra’s and the Codman Neurosurgery business’s existing, recently launched and planned products; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; and other risks and uncertainties discussed in Integra’s filings with the SEC, including the “Risk Factors” sections of Integra’s Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent quarterly reports on Form 10-Q. Integra undertakes no obligation to update any forward-looking statements as a result of new information, future developments or otherwise, except as expressly required by law. All forward-looking statements in this document are qualified in their entirety by this cautionary statement.

*Non-GAAP Financial Metrics

Adjusted EPS is calculated by dividing adjusted net income attributable to diluted shares by diluted weighted average shares outstanding. The measure of adjusted net income consists of GAAP net income from continuing operations, excluding: (i) global enterprise resource planning (“ERP”) implementation charges; (ii) structural optimization charges; (iii) certain employee severance charges; (iv) acquisition-related charges; (v) convertible debt noncash interest; (vi) intangible asset amortization expense; and (vii) income tax impact from adjustments and other items.

A reconciliation of Integra’s estimate for accretion to adjusted EPS is not available because estimates for acquisition-related charges, interest expense associated with financing transactions that have not yet closed, and tax rate will not be available until the transaction closes.

The Company believes that the presentation of the various adjusted metrics provide important supplemental information to management and investors regarding financial and business trends relating to the Company’s financial condition and results of operations.

Contacts:

Integra LifeSciences Holdings Corporation

Investor Relations:
Angela Steinway
(609) 936-2268
angela.steinway@integralife.com

Michael Beaulieu
(609) 750-2827
michael.beaulieu@integralife.com

Mazor Robotics Expects to Report Record First Quarter Revenue of Approximately $11.5 Million

April 05, 2017

CAESAREA, Israel–(BUSINESS WIRE)–Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical guidance systems, announced today that driven by the strength in Mazor X system sales and increased procedure volume, the Company expects to report record first quarter revenue of approximately $11.5 million. During the first quarter the Company received purchase orders for six Mazor X systems in the U.S., including two trade-in orders from customers who had previously purchased Renaissance systems. In addition, it received a purchase order for a Renaissance brain module upgrade in the international market. In the year-ago first quarter, the Company reported revenue of $6.4 million and received purchase orders for five Renaissance systems.

“The launch of the Mazor X and the rollout of this advanced surgical platform is progressing as planned and to our satisfaction. The first quarter’s results bring the total number of Mazor X systems orders since we began its sale in the second half of 2016 to 40 systems. Additionally, systems have been installed at numerous key sites across the U.S. and have been used clinically in dozens of patient procedures in 2017,” commented Ori Hadomi, Chief Executive Officer. “Our commercial partnership is yielding increased penetration into the U.S. market which leads us to be increasingly optimistic about our growth opportunities in 2017.”

Mazor ended the first quarter with a backlog of 14 Mazor X systems and the Company expects to deliver these systems in 2017. The Company ended 2016 with a total order backlog of 21 Mazor X systems. The Company will report its financial results for the first quarter ended March 31, 2017 in May and will issue a press release with the date, time, dial-in credentials and webcast details.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the Company’s expectations and growth opportunities for 2017, the expected revenue for the first quarter of 2017, the amount of and timing of recording of additional revenue from backlog, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on May 2, 2016 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

Contacts

U.S. Contacts:
EVC Group
Investors
Michael Polyviou, 212-850-6020
mpolyviou@evcgroup.com
Doug Sherk, 646-445-4800
dsherk@evcgroup.com