2017 – Page 102 – Selby Spine

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.²Building 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.

Contacts

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

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

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 Zilretta^TM(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

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

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

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
spineguard@newcap.fr
or
US
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1 508-359-4005, x108

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.

READ THE REST HERE

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
917-322-2216
pschwartz@rxir.com

SAN JOSE, Calif., April 3, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that the highly respected journal Spine has published the 50^th peer-reviewed iFuse paper titled Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint – a Pooled Analysis¹. Compared to analyses performed in individual trials, pooling data from these three trials allowed a more statistically powerful determination of patient factors that could predict clinical outcomes after either surgery or non-surgical treatment for appropriately diagnosed patients with SI joint dysfunction.

The pooled analysis study included 423 patients from the three combined multicenter prospective trials, two of which were randomized controlled trials, in which 97 patients received non-surgical management (“NSM”) and 326 patients received SI joint fusion with the iFuse Implant™ from 2013 to 2015. Overall, positive effectiveness, durability and opioid user reduction responses were much higher in the iFuse Implant group compared to the NSM group. In the NSM group, there were no predictors of improved outcomes. In contrast, in the iFuse Implant group, smoking and opioid use were predictive of somewhat smaller improvements in pain relief and disability whereas higher patient age and longer duration of pain were predictive of larger improvements. Although statistically significant, the difference in treatment responses in these groups were clinically unimportant; that is, all subgroups had clinically large improvements after SI joint fusion with iFuse Implants.

“These results indicate that SI joint fusion with triangular iFuse Implants leads to better treatment outcomes compared to non-surgical management and that the extent of improvement with SI joint fusion is only modestly associated with smoking, opioid use, patient age and duration of pain,” said Daniel Cher, MD, Vice President of Clinical Affairs at SI-BONE and study co-author. “Some surgeons do not offer some treatments to smokers or opioid users; for SI joint fusion with iFuse Implants, however, smokers and opioid users had marked and clinically important responses.”

The company also announced that the iFuse Implant System has been used in more than 25,000 procedures worldwide and continues to be the Method of Choice for SI Joint Fusion^SM. Adoption of the iFuse Procedure™ has continued to grow as surgeons learn to include the SI joint as part of their routine low back pain diagnostic exam and insurance coverage for the procedure has expanded. Recently, Healthcare Service Corporation (HCSC), the 4^th largest commercial health plan in the U.S., established an exclusive coverage policy for iFuse for Blue Cross Blue Shield participants in Texas, Illinois, Montana, New Mexico and Oklahoma.

“These are two remarkable milestones that were made possible with over eight years of relentless dedication by our organization and thousands of health care providers who manage patients with SI joint disorders,” said Jeffrey Dunn, President and CEO of SI-BONE. “Together, we have raised awareness and educated thousands on SI joint diagnosis and treatment and with continued focus on education and clinical evidence, we are hopeful that all those suffering from chronic SI joint dysfunction who fail conservative care are able to obtain the appropriate therapy to help them.”

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac (SI) joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System (“iFuse”) from the Food and Drug Administration (FDA) in November 2008. The CE mark for European commercialization was obtained in November 2010.

The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using patented triangular titanium implants that create an interference fit within the ilium and sacrum. The triangular implant shape, combined with the press fit insertion, is designed to provide immediate fixation by minimizing rotational motion. The implants have a porous surface that provide an ideal environment for bone ongrowth and ingrowth², facilitating long-term fusion of the joint. The iFuse Implant is the only commercially available SI joint fusion device in the United States with significant published prospective clinical evidence that demonstrates safety, effectiveness and economic benefits, including three large multicenter studies, two of which are randomized controlled trials. Currently, there are 50 peer-reviewed publications supporting positive clinical outcomes, safety, biomechanics, and the economic benefits of the iFuse Implant (www.si-bone.com/results).

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

Dengler J, Duhon B, Whang P, Frank C, Glaser J, Sturesson B, Garfin S, Cher D, Rendahl A, Polly D, on behalf of the INSITE, iMIA, SIFI study groups. Predictors of Outcome in Conservative and Minimally Invasive Surgical Management of Pain Originating from the Sacroiliac Joint: A Pooled Analysis. Spine. Published Ahead-of-Print March 27, 2017. doi:10.1097/BRS.0000000000002169
MacBarb RF, Lindsey DP, Woods SA, Lalor PA, Gundanna MI, Yerby SA. Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants. Int J Spine Surg. 2017;11. [Accepted, publication pending]

SOURCE SI-BONE, Inc.

April 03, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, announces that the planned transfer of the listing of its shares from the Euronext regulated market in Paris (compartment C) to the Alternext Paris multilateral trading facility will be submitted to the Shareholders’ Meeting of May 5, 2017 for approval.

The project will allow Implanet to be listed on a more appropriate market for the Group’s size, offering a better regulatory framework and suited to small and midcaps, the market capitalization of the company being approximately € 18 million with a free float of 90%. This planned transfer to Alternext Paris should simplify its administrative burden and reduce its listing costs while providing continued financial market access.

Subject to this project’s approval by shareholders at the upcoming Shareholders’ Meeting, and the consent of Euronext Paris SA, this listing will be carried out via the fast-track admission to trading of the Company’s existing shares without any new shares being issued.

Within the framework of its transfer to Alternext Paris, SwissLife Banque Privée will be Implanet listing sponsor.

In accordance with current regulatory requirements, Implanet would like to inform its shareholders of the possible consequences of a transfer:

In terms of protecting minority shareholders (non exhaustive list):

the protection of minority shareholders, should control change hands, will be ensured by Alternext Paris through the public offering mechanism, if the 50% threshold is exceeded in terms of capital or voting rights, either directly or indirectly and by one party or jointly;
furthermore, companies listed on Alternext Paris are only duty bound to inform the market, in terms of changes in the shareholding structure, of shareholdings moving above or below 50% and 95% of the company’s capital or voting rights;
however, in accordance with regulatory provisions and for a period of 3 months after its listing is removed from the Euronext regulated market in Paris, Implanet will remain subject to the mandatory public offering system and the continuance of information duties regarding the crossing of thresholds and stated intentions applicable to companies listed on the Euronext regulated market in Paris.

Regarding periodic financial information, less restrictive requirements in terms of financial information, including, and again without claiming to be exhaustive, the following:

extension of the timeframe for publishing half-year results – comprising a balance sheet, a P&L statement and comments regarding this period – to 4 months after the half-year ends;
a chairman’s report on the internal audit and corporate governance is no longer mandatory;
the company can choose which accounting system (French or IFRS) it uses when drawing up its consolidated accounts. However, as the Company’s accounts are already drawn up in IFRS, and in order to ensure transparency vis-à-vis its investors and shareholders, Implanet will continue to apply IFRS.

Being a non-regulated market, the transfer to Alternext Paris could lead to a change in the share’s liquidity versus when it was listed on the Euronext regulated market in Paris. The transfer could also lead certain investors, who prefer issuer shares listed on a regulated market, to divest their Implanet shares.

Lastly, Implanet intends to continue publishing accurate, detailed and honest information, making public any news or information liable to have a significant impact on its share price.

Indicative timetable of the transfer

March 27, 2017				The Board decides to submit the planned transfer of Implanet SA’s listing to Alternext to the Shareholders’ Meeting
April 3, 2017				Information published regarding the planned request for admission (1^st press release)
May 5, 2017				Shareholders’ Meeting to approve the transfer to Alternext Paris
May 9, 2017				Information published regarding the definitive transfer decision (2^nd press release)
July 10, 2017				Decision from Euronext Paris SA to admit shares for trading on Alternext Paris, shares
at the earliest				removed from the Euronext regulated market and first listing on Alternext Paris

Next financial press release: Q1 2017 revenue, on April 18, 2017

Annual general meeting: the combined general meeting of Implanet will be held on May 5, 2017 at 10:00 AM CET at the Company headquarters located Technopole Bordeaux Montesquieu, Allée François Magendie, 33650 Martillac, France.

You are invited to participate in the voting of the resolutions. For further information, please send your contact details to the following address: implanet@newcap.eu

About IMPLANET

Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.

Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.

IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

Disclaimer

This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements.

This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

Contacts

IMPLANET
Ludovic Lastennet
CEO
Tel. : +33 (0)5 57 99 55 55
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba
Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau
Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen
Tel.: +1 917 385 21 60
implanet@alphabronze.net

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