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

SpineGuard Reports 23% Revenue Growth to €2.2m for 1Q 2017

April 03, 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, reported today that its first-quarter 2017 revenue grew by 23%, to €2.2 million.

Pierre Jérôme, CEO and co-founder of SpineGuard, said: “In line with former quarters, SpineGuard is starting 2017 with strong growth driven by great momentum in the US and the traction of PediGuard Threaded, the latest addition of our smart, single-use drilling probes. This is very promising given that our DSG integration module for ‘single-step’ screw insertion is in limited release and therefore not yet significantly contributing to our revenue.”

Global revenue in the first quarter of 2017 increased 23% to €2,169k, compared with €1,760k in the first quarter of 2016. At constant exchange rate (cc), the growth rate was 20%.

2,397 PediGuard units were sold in the first quarter of 2017 compared with 2,134 in the first quarter of 2016, including 1,377 (57%) in the United States, where revenue grew 30% (25% cc) to €1,901k compared with €1,377k.

Recent events:

16 Jan. 2017 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new DSG™ (Dynamic Surgical Guidance) integration module to use in combination with Zavation’s spinal fusion system to make its pedicle screws “smart”.
6 Feb. 2017 Patent grant by the US Patent Office for the application of SpineGuard’s Dynamic Surgical Guidance technology for a new application: bone quality measurement.

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.

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
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Ottobock Buys Boston-Based “Active” Prosthetic Maker BionX

David Holley, March 29, 2017

BionX Medical Technologies, a Boston-area company that makes a prosthetic foot and ankle product that uses robotics technology, has been acquired by Ottobock, a German prosthetics company with North American headquarters in Austin, TX.

The deal was announced earlier this month. Financial terms weren’t disclosed, so it’s hard to tell how good an outcome it is for investors and shareholders. BionX raised more than $60 million in equity and debt funding since its inception, including $17 million in late 2015. The company’s investors include General Catalyst, WFD Ventures, Sigma Partners, Gilde Healthcare, and ZGC Shiner Investment.

BionX was founded as iWalk in 2006 by Hugh Herr, an MIT Media Lab professor who runs the school’s Center for Extreme Bionics and who himself is a double amputee below the knees. The company’s device, called the Empower Ankle, uses robotics to propel an amputee forward while adapting to his or her walking style; the actively driven ankle joint tries to replace the function of muscles and tendons. Ottobock says the device can give the user more energy while walking.

 

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Cesca Therapeutics Announces Senior Management Promotions

RANCHO CORDOVA, Calif., April 03, 2017 (GLOBE NEWSWIRE) — Cesca Therapeutics Inc. (Nasdaq:KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced the following senior management promotions, effective immediately.

  • Ms. Haihong Zhu, who most recently served as Director of Sales, has been promoted to the newly-created position of General Manager of ThermoGenesis, Cesca’s device division.  Ms. Zhu has been with Cesca since 2004, serving in various technical and sales positions, and contributed significantly to the establishment of Cesca’s commercial presence in China.
  • Dr. Dalip Sethi, who has served as Director of Clinical Research (USA), has been promoted to the position of Senior Director of Research and Development.  Dr. Sethi, who has been with the Company since 2012, will spearhead Cesca’s clinical development of novel cell therapy methods for treating vascular and orthopedic diseases.
  • Mr. Jeff Cauble, most recently holding the position of Director of Finance, has been promoted to the position of Principal Accounting Officer.  Mr. Cauble has been with Cesca since 2010 and has served in various accounting management positions of increasing responsibility.

“These senior team members have contributed greatly to our success in developing and commercializing our proprietary cell-based therapies and devices, and I am delighted to recognize their ongoing leadership and commitment to the company through these promotions,” said Chris Xu, interim Chief Executive Officer of Cesca. “We are fortunate at Cesca to have a deep and seasoned management team, and with these key individuals assuming expanded roles, we believe we have the team in place to successfully shepherd Cesca Therapeutics through its next phase of growth.”

About Cesca Therapeutics Inc.

About Cesca (www.cescatherapeutics.com):  Cesca is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics.

Forward-Looking Statement
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics’ forward-looking statements is set forth under the caption “Risk Factors” in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

Investor Contact: 
Rx Communications
Paula Schwartz
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pschwartz@rxir.com