Wow! ConforMIS Raises $89M to Expand Sales, Manufacturing, Technology

ConforMIS Adds $89M to Expand Sales, Manufacturing, Technology (Erin Kutz @ Xconomy) Burlington, MA-based ConforMIS, a medical device company with a newly FDA approved knee replacement system, announced today that it has secured $89 million in a Series E investment. The money comes from London-based AGC Equity Partners, New York-based Axel Johnson, government investment funds from Asia and the [...]

Interview: Paul Nichols of Bio2 Technologies Answers Questions About the State of Orthopedic Industry

An Inteview with Paul Nichols (Editor @ HealthPointCapital) We recently spoke with Paul Nichols, the current Executive Chairman of Bio2 Technologies who formerly worked with HealthpointCapital as President and CEO of Nexa Orthopedics. Learn what he has to say about the opportunities and challenges of the musculoskeletal industry and his advice for young companies. [...]

Simbionix Acquires 3D Arthroscopic Surgery Training Technology

Simbionix acquires arthroscopic surgery simulation technology (MedCityNews) Medical education company Simbionix has acquired for an undisclosed amount surgical simulation technology that helps doctors train for arthroscopic procedures. Simbionix’s acquisition of the Arthro VR product line from Spanish firm GMV will expand its customer reach among orthopedic surgeons, according to a statement from Cleveland- and Israel-based Simbionix. The [...]

A Report From the ArgoSpine Symposium in Paris

Report from the 16th Annual ArgoSpine Symposium HealthPointCapital is in Paris for the 16th annual ArgoSpine Symposium. Each year, ArgoSpine selects a theme for the event, and the latest is disorders in the junctional regions of the spine (previous topics have included the recent history of spine surgery and spine imaging). Industry presence is much lighter than [...]

The 7 Top Concerns for Orthopedic Spine Surgeons in 2012

7 Top Concerns for Spine Surgeons in 2012 (Laura Miller @ Beckers) Four spine surgeons discuss the topics weighing most heavily on them and their practices heading into 2012. Treating Medicare patients. Insurance company coverage for spinal procedures. Proving spine surgery is effective in the literature. Contracting at outpatient surgery centers. Spine surgeons are [...]

7 Spine Surgeons Answer – Would You Consider Using Robotic Technology in the or if Cost Were Not an Obstacle?

7 Spine Surgeons on Using Robotic Technology (Laura Miller @ Beckers) Q: Would you consider using robotic technology in the OR if cost weren’t an obstacle? Dennis Crandall, MD (Medical Director, Sonoran Spine Center, Mesa, Ariz.): Because of the precise tension or retraction tolerated on neural structures, I would be very hesitant to allow a [...]

Stryker Biotech Has Dodged All OP-1 Prosecutions Except One – Mark Phillips, the Former President

Stryker Pays $15M Fine in a DOJ Settlement After Unapproved OP-1 Clinical Study OP-1 Prosecutions Down To One (Walter Eisner @ OTW) The Boston Globe reported on January 20 that prosecutors dropped felony conspiracy and fraud charges against two remaining Stryker Biotech OP-1 sales reps on trial in Boston. Judge George O’Toole, Jr. of the [...]

18 Orthopedic Company Partnerships & Acquisitions Completed in the Last 6 Months

18 Orthopedic Device Company Partnerships & Acquisitions (Laura Miller @ Beckers) 1. Arthrex partnered with ThermoGenesis to market the ThermoGenesis Res-Q System for autologous platelet-rich plasma and bone marrow concentrate. 2. Bacterin signed a distribution agreement with Jeil Medical to distribute Jeil’s LeForte System. 3. Baxter International acquired Synovis, a provider of biologic and mechanical [...]

New Report: Venture Capital Investment Rose 22% Last Year

Study: Venture investment rose 22% in 2011 (OrthoSpineNews) Venture capitalists opened their wallets wider in 2011, investing $28.4 billion, up 22 percent, in 3,673 deals, up 4 percent, according to a MoneyTree Report today. Fourth-quarter investments totaled $6.6 billion in 844 deals, down 10 percent in dollars and an 11 percent decline in deals [...]

12 New Research and Development Projects Announced by Orthopedic Companies

12 Research and Development Projects for New Orthopedic & Spine Technology (Laura Miller @ Beckers) Here are 12 orthopedic and spine technology research and development projects. DePuy Orthopaedics recently announced its plan to spend $7 million on research and development equipment for its company by 2014. At the same time, it announced plans to spend [...]

Sales Reps From Stryker Biotech Escape Federal Charges in Off-Label Marketing Lawsuit

Stryker Biotech reps get off clean in off-label marketing suit (MassDevice) Federal prosecutors drop all charges against the 2 remaining Stryker Biotech sales reps after the company pleaded guilty to charges of off-label marketing and agreed to pay a $15 million fine. Federal prosecutors dropped all charges against the 2 remaining Stryker Biotech sales [...]

FDA Issues Guidance on IDEs for Knee Cartilage Repair/replacement

FDA issues guidance on IDEs for knee cartilage repair/replacement devices and drugs (MassDevice) The FDA issues new guidance on proper submissions for investigational device exemption and investigational new drug applications for products intended to repair or replace knee cartilage. The FDA this week issued new guidance on getting clearance for clinical trials of [...]

J&J’S Depuy to Stop Selling All Custom Devices After Receiving FDA Warning Letter

J&J’s Depuy to stop selling all custom devices in response to FDA warning (MassDevice) Johnson & Johnson subsidiary Depuy Orthopaedics decides to stop selling all custom devices following an FDA letter warning the company to file new PMA and 510(k) applications for several components. Johnson & Johnson subsidiary DePuy Orthopaedics decided to stop [...]

Pioneer Surgical Technology Expands Biomanufacturing Facility in Greenville, NC

Pioneer® Surgical Technology, Inc. Announces the Expansion of its North Carolina Biomanufacturing Facility (press release) Pioneer Surgical doubles the size of its Greenville, North Carolina biomanufacturing facility to accommodate growth of its biologics line, which includes the flagship product nanOss® Bioactive and the recently launched nanOss Bioactive 3D. Pioneer Surgical Technology today announces the [...]

Stryker Pays $15M Fine in a DOJ Settlement After Unapproved OP-1 Clinical Study

Stryker Reaches Settlement with the U.S. Attorney’s Office (press release) Kalamazoo, Michigan – January 18, 2012 – Stryker Corporation (NYSE:SYK) announced today that Stryker Biotech has reached a settlement with the U.S. Attorney’s Office for the District of Massachusetts. As part of the settlement, Stryker has agreed to plead to one misdemeanor [...]

MedShape Launches 2-Part PEEK ACL Fastener

MedShape Releases ExoShape Tissue Fastener (Elizabeth Hofheinz @ OTW) MedShape, Inc. has announced the full U.S. commercial release of the ExoShape Soft Tissue Fastener, a two-part PEEK Altera interference fixation device meant to simplify and improve soft tissue graft fixation during anterior cruciate ligament (ACL) reconstructive surgery. MedShape has shipped the first [...]

Korea Set to Approve Stem-Cell Drugs for Cartilage Repair

Korea Set to Approve Stem-Cell Drugs for Cartilage Repair (Biloine Young @ OTW) The officials of two South Korean biotechnology firms expect to receive Korean Food and Drug Administration (KFDA) approval for their stem cell drugs this month. Approval will pave the way for the world’s second stem cell-based medicines to enter the market. [...]

Knee Replacement Surgery Incidence Soars in Those Over Age 50

Knee Replacement Surgery Incidence Soars In Those Over Age 50 (Medical News Today) Researchers in Finland found that annual cumulative incidences of partial and total knee arthroplasty, commonly known as knee replacement surgery, rose rapidly over a 27-year period among 30 to 59 year-olds in that country, with the greatest increase occurring in patients aged [...]

The 10 Biggest Concerns for Orthopedic Surgeons in 2012

10 Biggest Concerns for Orthopedic Surgeons in 2012 (Laura Miller @ Beckers) Q&A with 4 orthopedic surgeons who discuss the following topics as we head into 2012. Balancing declining reimbursements with raising practice costs. Restricted access for Medicare patients. What the poor economy of 2011 means for joint replacement in 2012. Will 2012 [...]

DiFusion Technologies Lands $5.2M Funding for Antimicrobial Technology for Use in Orthopedic Implants

website DiFusion gets $5.2M of planned $16M funding (Austin Business Journal) Medical device maker DiFusion Inc. has received $5.2 million of a planned $16 million financing. The Georgetown-based company collected the capital from 54 investors, according to a Friday filing with the SEC. DiFusion, which was founded in 2008, is working on a new [...]

Zimmer Acquires Synvasive Technology for Its Advanced Cutting Systems

Zimmer Announces Acquisition of Synvasive Technology, Inc. (press release) Zimmer Strengthened by Addition of Innovative Instrumentation Systems and Advanced Surgical Cutting Technology Zimmer Holdings, Inc. (NYSE and SIX: ZMH) announced today that it has acquired Reno, Nevada-based Synvasive Technology, Inc. The acquisition will enhance Zimmer’s product portfolio through the addition of Synvasive’s STABLECUT® surgical saw blades, [...]

Q&a With Medtronics New CEO, Omar Ishrak

MassDevice.com Q&A: Medtronic CEO Omar Ishrak (MassDevice) Medtronic CEO Omar Ishrak tells MassDevice.com about how he screens potential acquisitions, his plan to re-shape the company and handling the controversy over the Infuse spine treatment. Just a few days into his tenure as CEO of Medtronic (NYSE:MDT), Omar Ishrak was confronted with a major crisis: [...]

Vincent GardèS Is the New CEO at Vexim, French Spine Startup

Vincent Gardès New CEO at Vexim (Biloine Young @ OTW) Vincent Gardès, a veteran of Stryker Corporation and Medtronic, Inc., has joined Vexim, a medtech company in Toulouse, France, as Chief Executive Officer. Gardes, with over 15 years of international experience in marketing, sales and general management in the medtech industry, is fluent in [...]

38 Orthopedic & Spine Device Company Executive Moves in 2011

38 Orthopedic & Spine Device Company Executive Moves in 2011 (Laura Miller @ Beckers) Former president of medication delivery company Baxter Healthcare Peter Arduini was named CEO of orthopedic device company Integra LifeSciences. He replaced Stuart Essig, who became chairman of the company’s board. Wright Medical Group’s chief technology officer Frank Bono was fired for “failing to exhibit [...]

KSpine Raises $2.5M to Treat Scoliosis

Minnesota medical device company targeting scoliosis raises $2.5 million (MedCityNews) A Minnesota medical device company has raised $2.5 million in its second round of financing, according to a Form D filing with the Securities and Exchange Commission. KSpine’s spinal implant to treat scoliosis requires a less invasive surgical procedure, the company says. Ross Longhini, KSpine’s [...]

Lanx Spine Expands Its Facilities and Its Management Team

Lanx Inc. Announces Corporate Expansion (press release) Expanded its corporate facility into a single 80,000-square-foot facility in Broomfield, CO for better surgeon training and prototyping capabilities. Various management changes: • Wayne Chrystal is the new VP Operations. He has more than 20 years of operations experience and previously served as vice president of operations [...]

AAOS Releases a Technology Overview on Metal-on-Metal Hip Implants

AAOS Releases TO on MoM Hip Implants (AAOS) Kristy L. Weber, MD, and Fareeha Shuttari-Khan, MPH With concerns by patients, clinicians, and regulators about metal-on-metal (MoM) hip implants on the rise, the AAOS Board of Directors commissioned a special technology overview (TO) on the topic. The TO focused on the following three questions: What are the [...]

Old Implants Have Edge on New Implants

Old Implants Have Edge On New (Biloine Young @ OTW) It is back to the drawing board for new hip and knee prosthesis. Reason? A five-year Australian study has found that the newer hip and knee replacement joints are performing no better—and sometimes worse—than the older, less expensive devices. The study concluded that [...]

Get Ready for the Chinese Total Joint Manufacturers! FDA Approves New Chinese Hip and Knee Implants

China Kanghui Receives FDA 510(k) Approval for Hip & Knee Systems (press release) Website China Kanghui Holdings (“Kanghui” or the “Company”), a leading domestic developer, manufacturer and marketer of orthopedic implants in China, today announced that the Company’s wholly-owned subsidiary, TGM Medical, Inc. (“TGM”), has received approvals from the FDA for its Helicon Hip System [...]

MTF Acquires PRP & PRFM Technologies From Cascade Medical Enterprises

Cascade Medical Enterprises, LLC Announces the Sale of Their Orthopedic Business (press release) WAYNE, N.J., Jan. 6, 2012 /PRNewswire/ – Cascade Medical Enterprises, LLC (CME), a leading company with proprietary platelet-rich plasma (PRP) and platelet-rich fibrin matrix (PRFM) technology for use in orthopedic therapeutic applications in soft tissue and bone repair, announced the sale of their technology to Musculoskeletal [...]

Alphatec Spine Pays Biomet/Cross Medical $18M to Settle Licensing Dispute

Alphatec Spine and Cross Medical Products Settle License Agreement Dispute (press release) CARLSBAD, Calif., Jan 5, 2012 (GlobeNewswire via COMTEX) — Alphatec Holdings, Inc. ATEC +0.58% , the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on [...]

Pioneer Surgical Announces 1st Human Use of Its Three-Dimensional Bone Graft

Pioneer® Surgical Announces First Human Use of nanOss® Bioactive 3D (press release) Pioneer Surgical today announces the first clinical use of nanOss Bioactive 3D, a three-dimensionally shaped addition to its flagship biologic bone graft product line, nanOss Bioactive. The new nanOss Bioactive 3D bone graft utilizes proprietary nanocrystalline hydroxyapatite as well as a collagen-based [...]

Spine 510(k) Clearances in December = 26

26 Spine Devices Receive FDA 510(k) Clearance in December (Laura Miller @ Beckers) Acculif TL-PEEK IBF Cage from Coalign Innovations. Renaissance System from Mazor Robotics. Axle PEEK Interspinous Fusion System from X-Spine Systems. Athena Pedicle Screw System from Royal Oak Medical Devices. Shield Kyphoplasty System from Soteira. VariLIFT Cervical Interbody Fusion System from Wenzel Spine. Zavation Cervical Plate System from Zavation. [...]

S&N Spins Off Its Biologics Arm Into a Private Equity JV Called Bioventus

SNN spins out biologics unit in JV with Essex Woodlands (Mass Device) Orthopedics giant Smith & Nephew shuffles its divisions again with the spinout of its biologics and clinical therapies division in a joint venture with Houston’s Essex Woodlands venture capital shop. British orthopedic titan Smith & Nephew (NYSE:SNN) shuffled its business deck yet [...]

Why Do Knee Implants Fail? Is It the Patient, the Surgeon, or the Device Itself?

Why Do Knee Implants Fail? (Biloine Young @ OTW) How often do total knee arthroplasties fail? And why do they? Richard D. Scott, M.D., of the Harvard Medical School, Boston, tells his patients that their implants are “not like a battery. You are going to have a definite reoperation rate that starts at [...]

Conmed/Linvatec to Distribute MTFs Sports Medicine Allograft Tissues and Platelet-Rich Plasma

CONMED Corporation Partners With the Musculoskeletal Transplant Foundation for Sports Medicine Applications (press release) CONMED Corporation (NASDAQ: CNMD) and the Musculoskeletal Transplant Foundation (MTF), the world’s largest tissue bank, have announced that CONMED’s subsidiary, CONMED Linvatec, will serve as the exclusive world-wide marketing representative for MTF’s sports medicine allograft tissues. Additionally, CONMED Linvatec [...]

Will the Metal-on-Metal Hip Litigation Reach $5B for Zimmer and DePuy?

Forbes blogger Peter Cohan estimates that orthopedic implant companies—including Warsaw-based Zimmer Holdings Inc. and DePuy Orthopaedics Inc.—will pay out $5 billion to cover legal claims that their all-metal hip implants have failed, causing new health issues. The metal pieces of the implants allegedly generate debris as they rub against each other, and the [...]

BioMimetic Therapeutics Gets Approval for Its Growth Factor in Europe

BioMimetic Therapeutics Announces Approval to Market GEM 21S in the European Union (press release) BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) announced today receipt of the CE Mark approval of GEM 21S Growth factor Enhanced Matrix in the European Union (EU). GEM 21S was approved in the EU with broader periodontal and alveolar bone regeneration indications for [...]

The High Cost of Failing Artificial Hips – a Personal Story

The High Cost of Failing Artificial Hips (NY Times) The most widespread medical implant failure in decades — involving thousands of all-metal artificial hips that need to be replaced prematurely — has entered the money phase. The Times’s Barry Meier, who has written a series of articles about hip replacements, answered selected questions [...]

Medtronic Paid Millions to Influential University of Wisconsin-Madison Chairman

Medtronic paid millions to influential UW chairman (John Fauber of the Journal Sentinel) Paul Anderson, an orthopedic surgeon at the University of Wisconsin-Madison, gets so much money from the medical device firm Medtronic that the university put its most stringent oversight on the relationship. One of the requirements is that Anderson, who has [...]

February 22, 2012

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