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ORTHOWORLD » Other Articles of Interest

Articles of Interest

April 08, 2014 | Integra LifeSciences Appoints Mark Augusti as CVP, President, Orthopedics & Tissue Technologies

Mr. Augusti will be responsible for the management of the Spine and Extremities divisions, including strategic direction, portfolio management and evaluation of corporate development opportunities.

Prior to joining Integra, Mr. Augusti served as CEO at Bioventus and spent nine years with Smith & Nephew in a series of leadership roles, most recently as President of Smith & Nephew's Biologic Division. He served as Smith & Nephew's President of the Orthopaedic Trauma & Clinical Therapies Global Business and Senior Vice President and General Manager of the Trauma business. Prior to that, he spent 13 years at GE Medical Systems in various sales, marketing and strategic management roles, both in the U.S. and internationally.

Read the full release online.

April 01, 2014 | Gainesville Sun: New biotechs have plenty of ideas, no lab space

Anthony Clark of The Gainesville Sun notes that start-up companies in his region face a challenge to locate lab space to support their efforts, once they outgrow university labs and incubators. Specifically,

"Grants and venture capital that finance many biotech companies are often restricted to product development and cannot be spent on real estate, while developers and lenders are reluctant to take a chance on building and financing high-cost space for companies that have not established a track record of profitability and cannot guarantee a long-term lease."

One developer, however, noted that banks appear to be interested in assembling deals to support new lab facilities in the region. Companies that have inhabited lab space in the area include Nanotherapeutics, RTI Surgical and Exactech.

Read Mr. Clark's full article in The Gainesville Sun online.

March 25, 2014 | Round2Funding Investment Portal Launches to Connect Investors with Early Stage Healthcare Companies

From BONEZONE news: MEDTOWN Ventures launched Round2Funding, an invitation-only investment portal directly connecting accredited investors and vetted healthcare companies, to focus on healthcare startups seeking $1 to $5 million in investments and to allow investors to anonymously evaluate these healthcare companies.

Round2Funding is hosting a pitch competition, The Main Event, in Atlanta on May 17. Learn more at www.round2funding.com/main-event. Companies will be showcased to accredited Investors and receive feedback from experienced entrepreneurs, industry professionals and accomplished investors.

Read more at BONEZONEpub.com.

Learn even MORE! From Tech Flash in the Atlanta Business Chronicle:

“Early stage inventors are creators, and building a business that is going to commercialize that product brings a great deal of “conflict” decision-making,” Medtown Managing Director and Co-founder Chris Fair said. “That transition is hard and the inventor normally does not have that DNA in them.”

“If you think of company development like child development, we get involved after elementary school, work with them through the high school years and when they are stable and ready to head off to college, we transition out,” Fair said. “It is not our goal to be operating these companies long term, but to provide them the tools to succeed so they can do it on their own.”

MEDTOWN's operating team brings extensive experience from companies like DePuy, Genzyme, OrthoPediatrics, RTI Biologics and Zimmer. Read deeper coverage by Urvaksh Karkaria from the Atlanta Business Chronicle.

March 17, 2014 | The Journal Gazette: Biomet growth plan to add 150 jobs

Biomet's $40.5 million Warsaw expansion would create 150 jobs by 2018, though job types to be created have not been revealed. The project calls for capital improvements such as building renovations, 3-D printing and optical scanning technology and upgrades to Biomet’s Global Center of Excellence surgeon education program.

Biomet officials said the project will go forward only if county and state tax breaks and other incentives are approved. The Indiana Economic Development Corp. in August 2010 approved almost $3 million in tax credits and training grants for Biomet, which announced plans to create 278 jobs at that time. Kosciusko County approved additional incentives on the $26 million investment.

Read the full article in The Journal Gazette online.

March 13, 2014 | 3-D Printing and IP: Can They Coexist?

Analysts have predicted that by 2018, 3-D printing will result in a loss of $100 billion per year in IP, globally. Enforcing IP against 3-D printer infringers will be challenging. What should companies should do to protect their portfolios?

Learn more from John Boger in BONEZONE online.

March 06, 2014 | FDA publishes Summary Information for MONOVISC Injectable Intra-articular Device PMA

Anika Therapeutics received FDA approval to market MONOVISC single-injection treatment for knee osteoarthritis pain, indication for patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetominophen). Information now available from FDA includes:

 

Or, access the full summary page from FDA online.

March 03, 2014 | Stryker Enters Marketing Relationship with the PGA Tour

The centerpiece of Stryker's on-site PGA tournament presence will be The Stryker Mobility Zone, a joint health destination designed to educate tournament attendees about hip and knee treatment options, featuring:

  • Orthopaedic surgeons who will interact with fans and provide education and joint health assessments.

  • A fan engagement area featuring a Putting Challenge and the chance to meet Champions Tour members
    Fred Funk and Hal Sutton.

  • Information about the Fisher House Foundation, a network of homes built on the grounds of major
    military and Veterans Affairs medical centers where military and veterans' families can stay for free
    while a family member receives medical treatment.

Read more about this marketing initiative online.

February 11, 2014 | Pre-Flight Checklist: What it Takes to Get an Idea Off the Ground

For most innovators, the first phase of development is the most invigorating. You may feel that the hard work has been done; all that remains is to hammer out a few details. At this point, the work has just begun.

A strong start will set the stage for a smooth flight through subsequent phases of development leading to a successful market launch. What three elements will keep an innovator grounded and allow ideas to take flight?

Find out at ORTHOPRENEURpub.com.

February 05, 2014 | Five Steps to Regulatory Strategy Development

Regulatory requirements continue to evolve and grow in complexity. A solid regulatory plan and execution can maximize opportunities to achieve regulatory goals and provide a competitive advantage. Mark D. Kramer, RAC, draws a 5-point guide for BONEZONE:

  • Identify Product Attributes
  • Conduct Regulatory Intelligence
  • “Triangulate” and Document
  • Verify the Strategy’s Viability
  • Make the Strategy a Living Process

 

Follow each step in the process at BONEZONEpub.com.

January 29, 2014 | Dr. Richard Steadman to Retire From Surgical Practice at Steadman Clinic

Dr. J. Richard Steadman, founder of The Steadman Clinic and the Steadman Philippon Research Institute,  has announced that he is retiring from his active surgical practice.
 
Dr. Steadman will continue to consult with his physician colleagues at The Steadman Clinic, focusing on the practice of evidence-based medicine to return patients to their active lifestyles.  He will also continue as co-chairman of the institute, the charitable entity known throughout the world for its research into the causes, prevention and treatment of orthopaedic disorders.

 

Read the full announcement online.

January 24, 2014 | Selene G. Parekh, M.D. uses Google Glass during foot/ankle procedure

Dr. Parekh conducted the procedure while wearing the Google Glass technology and broadcast live streaming video via the Internet. The technology allowed for hands-free recording video without the OR disruption of a video crew and related risk of infection. Additionally, it provided viewers the surgeon's unique vantage point during the surgery.

Nextremity Solutions, an orthopaedic device company which specializes in forefoot surgery implants, recently obtained Google Glass and will evaluate its applications in its surgeon training initiatives. The company will work with Dr. Parekh to ensure that the technology is used in a manner most beneficial to surgeons.

Read the full release from Nextremity Solutions online.

January 21, 2014 | FDA Update: 2014 Priorities, 510(k) Communication Timeline, VCIP

BONEZONE is summarizing numerous FDA plans for 2014, including:

  • FDA's list of 2014 priorities
  • FDA 510(k) communication timeline for applicants
  • FDA's Voluntary Compliance Improvement Program (VCIP)

 

Get a quick scan of these initiatives and a wealth of guidance on all matters Legal, Clinical & Regulatory at www.BONEZONEpub.com.

January 15, 2014 | Transcript Published for FDA Orthopaedic and Rehabilitation Devices Panel on Spinal Spheres

FDA's Orthopaedic and Rehabilitation Devices Panel has published its transcript from the meeting regarding the classification of spinal sphere devices. The meeting occurred on December 12, 2013. Based on the information collected and materials presented, FDA recommends that spinal sphere devices for use in arthrodesis procedures be regulated as Class III devices requiring a PMA.

The devices are manufactured from metallic or polymeric materials and designed for insertion between vertebral bodies from L3-S1 to promote fusion and stabilization, and are presently regulated under Product Code NVR.

View the full transcript here.

January 14, 2014 | How Surgeons can Prepare for the Changing U.S. Orthopaedic Landscape in 2014

In 2014, a number of Federal regulatory changes are expected to increase patient volume, decrease practice revenue and lead to more administrative burdens. Orthopaedic practices need to prepare now in order to maintain profitability. Thomas C. Barber, M.D., orthopaedic surgeon and Chair of AAOS’s Council on Advocacy, outlines these coinciding changes and provides insight on plans for:

  • More patients, less revenue
  • Additional administrative burdens
  • How to get ready

 

Read the full article on ORTHOPRENEURpub.com.

January 09, 2014 | ISTO Technologies names George W. Dunbar, Jr. President and CEO

George W. Dunbar, Jr., was appointed President and Chief Executive Officer, effective immediately.  Mitchell Seyedin, Ph.D., will continue to serve as Executive Chairman and will remain on the Board. Mr. Dunbar's former experience includes serving as president, chief executive officer and later chairman of Aastrom Biosciences.

ISTO develops proprietary products for spinal therapies and sport medicine applications, intended for the repair and regeneration of damaged or injured cartilage and bone. 

Read the full release from ISTO Technologies online.

January 07, 2014 | Changes at the helms of SkelRegen, ETEX

SkelRegen, a leader in small molecule musculoskeletal tissue regeneration and the first to identify multiple small molecules that are osteoinductive and target different aspects of the skeletal tissue formation pathway, has appointed Todd F. La Neve, J.D. as CEO.

Stephen R. La Neve, former SkelRegen CEO, will continue to serve as co-founder and director and recently accepted the position of President and Chief Executive Officer at ETEX.

Read the full releases from SkelRegen and ETEX online.

January 02, 2014 | The Price Tag for Product Commercialization

Have you tried to calculate the cost to commercialize your orthopaedic device idea? Many of us have. A product development budget will put you in a strengthened position to control costs, minimize surprises and make your idea a success.

Read on at ORTHOPRENEURpub.com.

December 16, 2013 | M&A Activity Updates: MAKO/Stryker, Wright Medical/MicroPort

MAKO Surgical stockholders voted at a special meeting to approve the adoption of the Agreement and Plan of Merger providing for the merger of MAKO with Stryker. The parties expect that the transaction will close on December 17, 2013, whereupon MAKO will be delisted from NASDAQ.

Full release available online.

Wright Medical has been advised by MicroPort Scientific that the Hong Kong Stock Exchange granted clearance of the disclosure circular required for its shareholder meeting to approve the acquisition of Wright’s OrthoRecon business. MicroPort has scheduled a shareholder meeting for January 3, 2014 to approve the transaction. Wright now expects the closing of the transaction to occur on or about January 9, 2014.

Full release available online.

December 11, 2013 | Meeting Materials Published for FDA Orthopaedic and Rehabilitation Devices Panel on Spinal Spheres

FDA's Orthopaedic and Rehabilitation Devices Panel has published meeting materials regarding the classification of spinal sphere devices. The meeting occurs December 12.

The devices are manufactured from metallic or polymeric materials and designed for insertion between vertebral bodies from L3-S1 to promote fusion and stabilization, and are regulated under Product Code NVR. View the documents at FDA.gov.

December 10, 2013 | ORTHOWORLD Position Paper on Healthcare Reform

As the healthcare reform initiative moves through the halls of Washington, we will undoubtedly be
debating what treatments do and do not work and what options should be made available to the
American people. When we enter these heated discussions, it is imperative that the facts be examined that
allow evaluation of medical procedures and their effectiveness in returning the health and productivity of
the citizenry. Orthopaedic care has clearly demonstrated its efficacy. Without question. It has changed
tens of millions of lives for the better, forever.

Orthopaedic problems and interventions affect us all at one time or another in our lives. The National
Center for Health Statistics estimates that nearly 108 million American adults reported bone and joint
medical conditions in 2005.1 That’s nearly half of all Americans over the age of 18. Musculoskeletal
disorders and conditions are the leading cause of disability in the U.S. and the most frequently cited
reasons for limitations in daily activities of life, with 15 million Americans aged 18+ limited by arthritis,
back or neck problems, fractures, connective tissue conditions, etc. More Americans report
musculoskeletal conditions than either circulatory (heart disease, stroke, etc.) and respiratory
(emphysema, asthma, hay fever, bronchitis, etc.) problems and musculoskeletal conditions remain the
greatest cause of lost work days and medical bed days in the U.S.(ibid)

Continue reading this position statement here in PDF format.

Read the press release.

Prepared by ORTHOWORLD Inc.
Published August 5, 2009