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Safe Orthopaedics Offers New Technologies to Treat Traumatic Injuries Due to Osteoporosis or Bone Metastases

February 15, 2017

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering innovative ranges of sterile implants combined with their single-use instruments for back surgery, now offers a transverse connector designed to rigidify the stabilisation of posterior spinal osteosynthesis, as well as cement injectable through the Cypress screw to enhance its anchoring strength in osteoporotic or metastatic bone.

Osteoporosis and bone metastatic disease are associated with reduced bone density, which makes the bone more brittle. Osteoporosis is a widespread condition, affecting mostly people over 65 and post-menopausal women. Also with ageing demographics, the prevalence of spinal fractures is rising.

The injection of cement into the vertebra enhances the anchoring strength of Cypress screws, thereby reducing the risk of postoperative instability and repeat surgery.

Dr Jörg Franke, orthopedic surgeon at the Magdebourg Hospital in Germany and member of the Safe Orthopaedics scientific committee, said: “The solution proposed by Safe Orthopaedics improves considerably the options in Cypress screw fixation, by increasing its anchoring strength irrespective of bone quality, with the added possibility of injecting cement into the vertebra during the procedure.”

Furthermore, with its preassembled instruments, the Safe Orthopaedics solution eliminates the risk of cement leakage as the injection is performed directly into the vertebra through a single-use screwdriver, which would be impossible to do with a reusable screwdriver. The injection of cement directly into a cannula inside the screwdriver’s handle also makes the procedure easier and thus reduces operating time.

Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics, said: “With these additions to our range, which meet our availability and modularity requirements, we are now able to offer more options to surgeons to treat bone injuries associated with osteoporosis and metastases. Our Oak screw, dedicated to the treatment of spinal fractures, will also be available in a cemetable version this year, to offer simultaneous correction and fixation of osteoporotic vertebral fractures using a percutaneous approach.”

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Full-year 2016 results on April 28, 2017 (after market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to make spinal surgeries safer by using sterile implants and associated single-use instruments. Through this approach, these products eliminate all risk of contamination, reduce infection risks and facilitate a minimally-invasive approach for trauma and degenerative pathologies—benefiting patients. Protected by 17 patent families, the SteriSpineTM kits are CE-marked and FDA approved. The company is based at Eragny-sur-Oise (Val d’Oise department), and has 30 employees.

For more information, visit: www.SafeOrtho.com

Contacts

Safe Orthopaedics
Thierry Lambert, Tél. : +33 (0)1 34 21 50 00
CFO
investors@safeorthopaedics.com
or
NewCap
Julien Perez / Valentine Brouchot
Investor Relations
Nicolas Merigeau
Media Relations
Tél. : +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu

Kerala’s First 3D Knee ArmorCoat System total knee replacement surgery performs at VPS Lakeshore Hospital

Kochi, Kerala, February 13, 2017 /India PRwire/ — In a first in the state, doctors at VPS Lakeshore successfully performed 3D ArmorCoat System total knee replacement surgery on a 66-year-old patient, Radhamani Bhaskaran, a native of Chengannur in Alappuzha.

The surgery was performed by a medical team under Dr. Jacob Varghese and Dr. Bibin Theruvil. According to the doctors, 3D Knee ArmorCoat system increases the stability and comfort level and enables patients to walk and climb without any difficulty.

“The conventionally replaced knee normally last only for 15-18 years. It necessitates complicated, costly and risky revision surgeries in the patients who have undergone knee replacement surgeries at a younger age. ArmorCoat with Vitamin-E poly has been specially designed after taking this factor in consideration,” said Dr. Jacob Varghese.

The ArmorCoat 3D Knee is rated with Gold Standard, a rating created for 3D Knee, popularly known as GOLD ON GOLD Knee, a knee replacement system designed to improve strength, stability, and flexion in patients. According to the doctors, 3D Knee produced 57 per cent less wear in lab tests compared to the premium performing Direct Molded insert components.

Explaining on the knee surgeries, Dr. Bipin Theruvil said that the insert acts a substitute for the cartilage and meniscus, which was worn away due to arthritis. “The femur moves on top of the inserted component and supports the weight of the body. The insert, therefore, can be prone to wear, particularly in a more active person. The wear can happen due to impact on the insert as well as degradation due to exposure to oxygen. The primary cause of revision surgery is wear, which can be reduced by Vitamin-E poly,” he said.

The E-plus total knee replacement insert component was developed by the US-based DJO Surgical. “E-plus was the first total knee replacement material to be offered to patients in the U.S. with vitamin E blended into the insert component in July 2001,” said Dr. Paul D. Maitino, Joint Replacement Specialist, Surgical Hospital of Oklahoma, USA and one of the designers of the knee.

The medical team added that this knee provide the best in class knee replacement solution in high demanding and active lifestyle. “The Gold Standard knee has among the lowest simulated wear rates for a total knee replacement in the U.S. I am very excited to offer our patients the highest level of technology available to maximise benefits in longevity and performance when it comes to knee replacement surgery,” added Dr. Jacob Varghese.

Notes to Editor

VPS Lakeshore, one of the largest, most comprehensive, independent multi-specialty hospitals in Kerala is recognized as a leader in medical education, groundbreaking research, and innovative,patient-centered clinical care. The hospital has become the hospital of choice to patients’ worldwide providing emergency, primary, and specialty care in virtually every field of medicine.

The advanced hi-tech healthcare facility ushers in world class standards in healthcare and offers diverse medical specialties, including Multi Organ Transplantation, Gastroenterology, G.I Surgery, Medical, Surgical Oncology, Joint Replacement, Accident & Trauma Orthopedics, Sports Medicine, Neurology, Neurosurgery Surgery, Cardiology, Cardiovascular Surgery, Gynecology & more…

VPS Lakeshore was incorporated as a public limited company in 1996 and in January 2003 the hospital officially opened its doors to integrated healthcare. Over the years, the hospital has emerged as a centre of international healthcare excellence for patients in India & abroad through a broad range of advanced clinical programs and the most cutting-edge treatments and diagnostic services.

Integra offers to buy J&J’s Codman business for $1.05 billion

Wed Feb 15, 2017

Medical device maker Integra LifeSciences Holdings Corp said on Wednesday it has offered to buy Johnson & Johnson’s Codman neurosurgery business for $1.05 billion in cash.

Integra, which makes products used in neurosurgery, reconstruction, wound and dental care, said Codman’s devices would bolster its pipeline of offerings for tissue ablation, spinal cord repair and cranial stabilization.

If the bid is accepted, it will add to Integra’s adjusted earnings per share by at least 22 cents in the first full year after closing and increase thereafter.

 

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Alphatec Spine Announces Appointment of David H. Mowry to its Board of Directors

CARLSBAD, Calif., Feb. 14, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today that its board of directors has appointed David H. Mowry as a member of the board of directors effective February 8, 2017.  Mr. Mowry will be replacing Siri S. Marshall who notified the Company that she was resigning from the Board, effective as of February 8, 2017.  Mr. Mowry is qualified as an independent director under the definition established by Nasdaq.

Mr. Mowry is President and Chief Executive Officer of Vyaire Medical, recognized global leader in the respiratory diagnostics, ventilation, and anesthesia delivery and patient monitoring market segments. Prior to Vyaire Medical, Mr. Mowry held senior leadership positions within orthopedics, spine and medical device industries, including Chief Operating Officer at Wright Medical until 2016 and President and Chief Executive Officer of Tornier from 2013 to 2015. Within the spine industry, Mr. Mowry served as Vice President of Operations and Logistics at Zimmer Spine. Mr. Mowry intends on limiting his board participation to Alphatec (outside of Vyaire) in order to fully engage with Alphatec and remain focused on helping the Company pursue its goals.

“Dave brings a wealth of proven business and leadership experience within the orthopedic and spine industries,” said Terry Rich, Chief Executive Officer of Alphatec Spine. “Dave has been a key mentor in my career and I am excited to work with him again.  His decision to join the board demonstrates confidence in our vision and ability to build a high-growth U.S. spine company through innovation and value creation.  We look forward to his counsel and benefitting from his impressive background and expertise.”

Dave H. Mowry commented, “Alphatec is at a pivotal point in its evolution with a strong portfolio of spinal fusion products, its focus on the U.S. market and its new, spine-experienced leadership team.  I have had the pleasure of working with Terry and several of his new commercial leaders in the past.  We share a common approach for delivering results and I am excited about being engaged with him and his team.  I look forward to contributing to the achievement of their strategic goals and supporting Alphatec’s future growth.”

Mr. Mowry, age 54, has served as President and Chief Executive Officer of Vyaire Medical since May 2016. From October 2015 to May 2016 he served as Executive Vice President and Chief Operating Officer and member of the board of directors of Wright Medical Group N.V. (Nasdaq:WMGI). Between September 2015 and November 2016 he was a member of the board of directors of EndoChoice Holdings, Inc. Prior to Wright Medical, Mr. Mowry served as President and Chief Executive Officer and member of the board of directors of Tornier N.V. from February 2013 until completing the merger with Wright Medical in October 2015 and as Chief Operating Officer of Tornier from 2011 to 2013. Prior to this, Mr. Mowry held executive leadership positions at Covidien, ev3, and Zimmer Spine.  Mr. Mowry receive a B.S. in Engineering from the United States Military Academy at West Point.

Further information regarding the Company’s appointment of David H. Mowry to its board of directors is set forth in a Current Report on Form 8-K that was filed with the U.S. Securities and Exchange Commission (SEC) on February 14, 2017 and is available on both the SEC’s website at www.sec.gov and the Company’s website at www.alphatecspine.com.

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a global medical device company that designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies. The Company and its affiliates market products in the U.S. via a direct sales force and independent distributors.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec Spine cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors.  Forward-looking statements include the Company’s ability to build a high-growth U.S. spine company through innovation and value creation and the Company’s ability to achieve its strategic goals.  The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K, as well as other filings on Form 10-Q and periodic filings on Form 8-K.  Alphatec Spine disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

Source: Alphatec Holdings, Inc.

Read more: http://www.nasdaq.com/press-release/alphatec-spine-announces-appointment-of-david-h-mowry-to-its-board-of-directors-20170214-00548#ixzz4YldHNmP3

Consensus Orthopedics Names New President

Consensus Orthopedics, a global total joint orthopedics leader, announced today the promotion of Curt Wiedenhoefer to President of Consensus Orthopedics. Mr. Wiedenhoefer previously served as COI’s Executive Vice President of Global Sales & Marketing. He brings over two decades of experience in orthopedics and is widely respected in the industry. Mr. Wiedenhoefer, who has an extensive background in medical electronic devices, has been instrumental in heading a new product line that will be launching at AAOS in San Diego this March.

“Curt combines deep knowledge of our company and capabilities with strong relationships in this market,” said Chief Executive Officer Colleen Gray. “He leads a solid team that is helping drive our orthopedic business to record sales.”

Curt Wiedenhoefer said “I am extremely grateful for the trust our CEO, Colleen Gray, and our Board of Directors, is placing in me to assume this new position, and I am privileged to help lead the exceptionally talented men and women of Consensus. I look forward to continuing to build upon Consensus Orthopedics’ unique ‘family’ culture and the value proposition we provide to all of our customers around the world.”

About Consensus Orthopedics, Inc.
With over 20 years of orthopedic design and manufacturing experience, Consensus Orthopedics is committed to providing proven and reliable total joint implants and instruments to the global market. Located in Northern California, Consensus is a dynamic and high-quality USA manufacturer of hip and knee implants which have a solid reputation for performance and reliability. Together, through a focus on patient care and clinician relationships, we are dedicated to creating one team and providing exceptional outcomes. Learn more at http://www.consensusortho.com.

Centric Medical™ Announces FDA Clearance of Metatarsal Hemi Implant System

February 14, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Centric Medical, a division of Life Spine, Inc., which focuses on developing surgical implants for the treatment of distal extremity pathology, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the Metatarsal Hemi Implant System. The Metatarsal Hemi Implant for the metatarsophalangeal joint is intended for use in the treatment of patients with degenerative and post-traumatic arthritis in the metatarsal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement or without bone cement.

The Metatarsal Hemi Implant has a round head and tapered stem that is fixated to the first metatarsal. The round head resurfaces the metatarsal head at the metatarsophalangeal joint. The Metatarsal Hemi Implant utilizes a cobalt chrome and highly polished “mirror” finish head that minimizes friction between articulating surfaces, reducing cartilage wear. The implant comes in 5 sizes to accommodate varying patient anatomies, and has an anti-rotational stem to increase implant stability.

The Metatarsal Hemi Implant joins a growing portfolio which includes innovative osteobiologic products, as well as the groundbreaking TARSA-LINK Stand-Alone Wedge Fixation System, the market’s first stand-alone osteotomy wedge with built-in fixation. The system was released to the market in September 2016.

About Centric Medical

Centric Medical is dedicated to improving the quality of life for patients with distal extremity symptomatology, increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Centric Medical, which is privately held, is based in Huntley, Illinois.

Contacts

Centric Medical
Ms. Amanda Rains
Director of Marketing
arains@centricmedical.com
847-884-6117

Orthopedic Devices Market Global Briefing 2017

LONDON, Feb. 14, 2017 /PRNewswire/ — Orthopedic devices are used for restoring skeletal structure and joint movements in various fractures, abnormal growth of bones, soft tissue damage, trauma or other deformities. These devices are implanted by surgical procedures or can be externally attached through minimally invasive procedures. Orthopedic devices can be classified as joint implants, internal and external fixation devices.

Americas was the largest region in the orthopedic devices market in 2016, accounting for around 40% of the market share. Europe was the second largest region accounting for over 30% of the market share. Asia was the third largest region accounting for around 16% of the market share.

Biodegradable implants are increasingly being used in trauma orthopedic surgeries. Biodegradable implants are used to replace a missing biological structure, support a damaged biological structure, and enhance the existing bone structure. Biodegradable products such as reabosorbable polymers composed of polyglycolic acid and poly lactic acid manufactured in the form of plates, screws, and pins are replacing traditional devices like plates and screws which are more expensive. Surgeons are preferring biodegradable implants to replace conventional implants, as biodegradable implants can be engineered to provide temporary support for bone fractures; can degrade at a rate matching new tissue formation; can eliminate the need for second surgery, are highly useful in fracture fixation in children; and result in less implant related infections. For instance, Stryker Corp. offers orthrobiologics such as bone repair biodegradable products that are used in bone regeneration and bone healing, soft tissue regeneration and muscle connection to bone.

Download the full report: https://www.reportbuyer.com/product/4693467/

About Reportbuyer
Reportbuyer is a leading industry intelligence solution that provides all market research reports from top publishers
http://www.reportbuyer.com

For more information:
Sarah Smith
Research Advisor at Reportbuyer.com
Email: query@reportbuyer.com
Tel: +44 208 816 85 48
Website: www.reportbuyer.com

SOURCE ReportBuyer

Life Spine Achieved 38% Revenue Growth over Previous Year and Launched 27 Products in 2016 Including the Broadest Expandable Offering in Market

February 14, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that revenues for 2016 grew by 38% as compared to 2015. Additionally, Life Spine launched 27 products in 2016 including four best-in-class products and one product that was first-to-market.

In 2016 Life Spine launched multiple expandable interbodies including the LONGBOW® Lateral Expandable A/P Spacer System and the PROLIFT® PLIF/TILF Expandable Spacer System. LONGBOW is the first-to-market product that offers controlled in-situ expansion for maximum endplate coverage, minimal anatomical disruption, and post packing capabilities. Additionally, LONGBOW was selected by Orthopedics this Week for the prestigious Spine Technology award because of its game changing innovation. PROLIFT features an all titanium implant that restores disc height, in-situ, for minimally invasive PLIF and TLIF. Furthermore, the implant is provided pre-sterile for safety and convenience. With these new additions, Life Spine has the broadest, fastest growing suite of expandable products in the market.

In addition to the rapidly growing expandable product offering, Life Spine added three new retractor systems with independently angulating blades to round out its procedural product offering. The CALYPSO™ Midline Retractor System offers snap on quick release blades with anatomically shaped teeth to conform to the facets for improved retraction. The MIS TLIF Retractor system features modular taps that anchor to the pedicles and allow for optimal disc space distraction. Finally, the CENTRIC Lateral Expandable Retractor System boasts an open frame design that increases visibility of patient anatomy accommodating both the plier style and traditional style knob expansion.

Some of the other key milestones that attributed to the 2016 growth include:

  • Six 510K approvals for a total of 61 since inception.
  • Expanded the sales footprint to over 27 countries outside of the US.
  • Continued the commitment to education by conducting 77 PULSE (Physician Ultimate Life Spine Experience) labs at the Huntley, IL facility.
  • The only company of their size to offer a full line of procedural product solutions including access instrumentation, implants, neuro monitoring, and biologics.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Price will defer to physicians, says ex-AMA lobbyist who’s known him since ’94

By NEIL VERSEL – February 2017

There are plenty of unknowns about newly installed Health and Human Services Secretary Dr. Tom Price, but two things are pretty clear: He knows the intricacies of the healthcare industry and he is deferential to the role of physicians.

Friday, Price became the 23rd HHS secretary after the Senate confirmed his nomination in the wee hours by a 52-47 vote that broke strictly along party lines. An orthopedic surgeon who previously represented suburban Atlanta in Congress, Price is the first physician to head HHS since Dr. Louis Sullivan in 1989-93.

“It’s significant that he’s a physician,” said Julius W. Hobson, a senior policy advisor in the Washington office of law firm Polsinelli. “They have different viewpoints” than other bureaucrats, said Hobson, a former American Medical Association lobbyist who has known Price since 1994.

“He, [Steven] Mnuchin at Treasury and [James] Mattis at Defense are probably the cream of the crop in this administration in terms of experience and knowledge,” Hobson said.

Hobson noted that Price has long been involved in organized medicine, via the AMA, the Medical Association of Georgia and, yes, the controversial Association of American Physicians and Surgeons. “Even in the House, he was active in the AMA,” Hobson noted.

In shaping healthcare policy, Price always has physician interests in mind. “He will first and foremost look at how public policy will affect the practice of medicine,” according to Hobson.

 

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Breg Appoints Longtime Health Care Leader to Board of Directors

CARLSBAD, Calif., Feb. 13, 2017 /PRNewswire/ — Breg, Inc., a premier provider of integrated solutions that help improve the quality and lower the cost of the orthopedic episode, today announced the appointment of Ken Paulus to the company’s board of directors.  Mr. Paulus has more than 25 years of experience leading integrated delivery systems and physician networks.

Mr. Paulus previously served as president and chief executive officer of Allina Health, one of the nation’s largest integrated delivery systems.  Under his leadership, Allina Health grew to encompass more than 100 hospitals and ambulatory care clinics and received the Davies award for offering one of the industry’s most integrated and advanced information systems.  Prior to Allina, Mr. Paulus was president and CEO of Atrius Health System, the largest integrated physician group in New England, and a research affiliate of Harvard Medical School.  He also served as chief operating officer of Partners Community HealthCare, a major teaching and research affiliate of Harvard Medical School.

“Ken brings a unique perspective and years of experience in health care delivery to our board,” said Brad Lee, president and CEO, Breg. “He will contribute greatly to our goal of extending Breg’s leadership in the orthopedic industry, particularly in providing comprehensive solutions to patients and caregivers that enhance and improve the quality of the entire orthopedic episode.”

In addition to Breg, Mr. Paulus serves on the boards of directors of Health Grades, Team Health and Cogentix Medical.  He earned a bachelor’s degree in biology from Augustana College and a master’s of health care administration from the University of Minnesota.

About Breg, Inc.
Breg provides remarkably easy products, services, technology and consulting to improve the quality and lower the cost of the orthopedic episode, from conservative treatment to pre- and post-surgery. The second largest U.S. provider of orthopedic bracing, Breg is a partner to 6,000 orthopedic surgeons and 90 percent of Integrated Delivery Networks who provide sports medicine and rehabilitation products to one million patients annually. Breg’s interconnected programs and total solutions are designed to fit specific customer needs, giving time back to providers and patients alike to focus on what’s most important. Breg is a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry. Founded in 1989, Breg is based in Carlsbad, CA. Visit www.breg.com.

SOURCE Breg, Inc.

Related Links

http://www.breg.com