2017 – Page 124 – Selby Spine

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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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.

EL DORADO HILLS, CA (PRWEB) FEBRUARY 14, 2017

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.

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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

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.

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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

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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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

COLUMBIA, Md. , Feb. 10, 2017 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ:OSIR) is pleased to announce that its Board of Directors, at a Board Meeting on February 7^th, 2017, confirmed the appointment of Messrs. Uwe Sommer and Thomas J. Knapp as Directors, upon recommendation of the Nominating Committee, and each will stand for election at the Company’s 2017 Stockholders’ Meeting. Mr. Sommer and Mr. Knapp each join Osiris as independent Board members.

“We are pleased to have Mr. Sommer and Mr. Knapp join Osiris at this important time,” said Peter Friedli, Chairman of the Board. “Both gentlemen have extensive and diverse business experience, and their contributions will be greatly appreciated.”

Mr. Sommer is a highly experienced leader in global marketing and sales, managing distribution in markets including Europe, Japan, the Middle East, Africa, and the United States. Mr. Sommer has held executive roles with Johnson & Johnson, Lindt & Sprüngli, Mars, Inc., and Procter & Gamble. Mr. Sommer has degrees in Economics from University Kiel (Germany) and Marketing and Economics from Penn State University.

Mr. Knapp has over 25 years of corporate and large legal firm experience with regulated industries, with experience including Federal and State regulatory matters, Federal government affairs, risk management, compliance, litigation, complex commercial transactions, and corporate governance. Mr. Knapp is presently Interim General Counsel and Corporate Secretary with Galena Biopharma, Inc., prior to which his experience includes serving as EVP, Chief Legal Officer, and Corporate Secretary of Sucampo Pharmaceuticals, Inc., as Vice President, General Counsel and Corporate Secretary at NorthWestern Corporation, and in senior in-house attorney positions at The Boeing Company and The Burlington Northern & Santa Fe Railway Company.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, is a leader in researching, developing and marketing cellular regenerative medicine products that improve the health and lives of patients and lower overall healthcare costs. Having developed the world’s first approved stem cell drug, Osiris works to further advance the medical field. Osiris’ research and development in biotechnology focuses on innovation in regenerative medicine – including bioengineering, stem cell research and viable tissue based products. Osiris has achieved commercial success with products in orthopaedics, sports medicine and wound care, including BIO^4®, a viable bone matrix, Cartiform^®, a viable osteochondral allograft, Grafix^®, a cryopreserved placental membrane, and Stravix^®, a durable placental allograft. Osiris, Grafix, Cartiform, and Stravix are trademarks of Osiris Therapeutics, Inc. BIO⁴ is a registered trademark of Howmedica Osteonics Corp. More information can be found on the company’s website, www.osiris.com. (OSIR-G)

For additional information, please contact:

Diane Savoie

Osiris Therapeutics, Inc.

(443) 545-1839

OsirisPR@Osiris.com

Source: Osiris Therapeutics, Inc.

News Provided by Acquire Media

FARMINGDALE, N.Y., Feb. 13, 2017 /PRNewswire/ — Misonix, Inc. (MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced that it received a deficiency letter from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, as a result of not filing its Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2016 (the “Q2 10-Q”) by February 9, 2017 and disclosing that the Company will not be able to file the Q2 10-Q within the five-day extension period provided in Rule 12b-25(b) under the Securities Exchange Act of 1934, as amended, together with its prior and ongoing failure to timely file its Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2016, was not in compliance with Listing Rule 5250(c)(1) of the Nasdaq Listing Rules (the “Rules”) for continued listing.

The Company has previously submitted a plan to Nasdaq to regain compliance with the Rules and Nasdaq has granted the Company an exception until March 13, 2017 to regain compliance. The Company is required to submit to Nasdaq an update to the original compliance plan not later than February 27, 2017.

As previously disclosed, on February 9, 2017 the Company filed its Form 10-K for the fiscal year ended June 30, 2016, and management currently believes that the Company will be in a position to file the aforementioned delinquent Quarterly Reports on Form 10-Q not later than March 13, 2017.

At this time, this notification has no effect on the listing of the Company’s common stock on The Nasdaq Global Market.

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s website at www.misonix.com

Safe Harbor Statement
With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s most recent Annual Report on Form 10-K, and any subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking statements.

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Current Issues in Spine

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

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

Consensus Orthopedics Names New President

Centric Medical™ Announces FDA Clearance of Metatarsal Hemi Implant System

Contacts

Orthopedic Devices Market Global Briefing 2017

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

Contacts

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

Breg Appoints Longtime Health Care Leader to Board of Directors

Related Links

Osiris Appoints Uwe Sommer and Thomas Knapp to its Board of Directors

Misonix Reports Receipt of Deficiency Letter from The Nasdaq Stock Market LLC

STAR Ankle Joint Replacements Last Long Term and Provide Relief for Patients

Medacta USA’s Spine Division Begins 2017 with Key Appointment, Significant Growth

Spinal Stabilization Technologies Announces Start of LOPAIN 2 Clinical Trial in South America for Lumbar Degenerative Disc Disease

$250K Pediatric Device Competition Now Accepting Proposals

First Single-Use Rigid Endoscope to be Demonstrated at AAOS