The 7 Top Concerns for Orthopedic Spine Surgeons in 2012

Posted on | January 27, 2012 | No Comments

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 trending toward hospital employment.
Technology costs and benefits.
How biologics will be incorporated into future spine care.

Read the Entire Answers @ Beckers here

Category: Spine, Trend

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

Posted on | January 26, 2012 | No Comments

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 robot to do that. Muscle retraction and other tasks seem more practical. Screw placement is a possibility if the tolerances can be certain and very fine.

Ara Deukmedjian, MD (Founder, Deuk Spine Institute, Melbourne, Fla.): Robotics may play a role in future spine care if payors allow it to. Health insurers are constantly trying to develop new policies and coverage determinations that further restrict access to quality spine care. Every stakeholder in healthcare is losing ground except the insurers because every new policy they adopt further restricts access to established treatments and thwarts new technology.

Insurers routinely refuse to cover new technology, for example artificial spinal discs were FDA approved years ago and there is ample evidence in peer reviewed journals that they are a safe and effective treatment for a common spinal condition (discogenic pain) yet most insurers won’t cover the procedure because they are deemed “medically unnecessary or experimental” by the insurer (but not by spine surgeons, hospitals or patients). By denying the procedure the insurance company is guaranteed to keep more of their ever escalating premium dollars for themselves which leads to greater profits for the insurer but diminished healthcare delivered to the insured, which truly is the insurer’s modus operandi.

It is a shame that the very organizations that were created to facilitate delivery of quality medical care and new technology are now obstructing it and enriching themselves further with the adoption of endless new policies aimed at further denying care to patients in desperate need of help.

Michael Gleiber, MD (Founder, Michael A. Gleiber, MD, PA, Jupiter, Fla.): I believe a spine surgeon needs to depend on his or her hands, anatomic landmarks and intuition to perform any operation correctly. If cost were not an obstacle, I still would rely on my surgical skill rather than use robotic guidance on routine cases. In areas of extreme deformity or severe trauma, I believe there is a role for guidance.

Purnendu Gupta, MD (Medical Director—Chicago Spine Center at Weiss Memorial Hospital, Associate Professor of Surgery in Orthopedics and Rehabilitation—University of Chicago): Unfortunately, cost is a huge issue right now, even for the technology we currently have. We are just at the point where the development of current technology may be stunted going into the future. One of the things that limited robotics in the past was image guidance. Now technology has advanced so we are seeing additional benefits in our practice. I think there will be some advantage to robotics for spine surgery in the future, but I don’t know exactly where the impact will be or if it will add the same value as it has in other specialties, such as cardiology.

Read all answers at Beckers

Category: Robotics

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

Posted on | January 26, 2012 | No Comments

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 U.S. District Court for Massachusetts agreed to dismiss all criminal charges against Jeff Whitaker and William Heppner. Charges against a third rep, David Ard, had been dropped earlier during the trial when the company agreed to plead guilty to a minor misdemeanor crime of misbranding a product and paid a $15 million fine.

The company had faced 13 felony charges.

Category: Clinical Studies, Ethics

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

Posted on | January 25, 2012 | No Comments

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 products for soft tissue repair, for $325 million.

4. Cascade Medical Enterprises sold its PRP Technology to Musculoskeletal Transplant Foundation.

5. Integra LifeSciences acquired Ascension Orthopedics for $65 million in cash.

Category: M&A

New Report: Venture Capital Investment Rose 22% Last Year

Posted on | January 25, 2012 | No Comments

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 from the third quarter of 2011. The report is by PricewaterhouseCoopers LLP and the National Venture Capital Association (NVCA), based on data from Thomson Reuters.

By region, Silicon Valley topped investments for the full year with $11.6 billion, with New England following a distant second with $3.2 billion and New York Metro at $2.7 billion. By state in the fourth quarter, California again dominated with $3.78 billion in 340 deals, up from the $2.75 billion in the fourth quarter of 2010 but down from the 346 deals a year ago. Massachusetts ranked second at $740.69 million in 91 deals. That’s higher than the $541 million invested in last year’s comparable quarter, with the same number of deals.

Category: Financial, Funding

12 New Research and Development Projects Announced by Orthopedic Companies

Posted on | January 24, 2012 | No Comments

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 $20 million on manufacturing equipment.
Eminent Spine, a Georgetown, Texas-based medical device company, has recently completed and released the results of a study of its King Cobra Anterior Cervical Plate in which none of the 25 patients experience complications.
Israel-based medical device company Expanding Orthopedics has launched a post-market study in Europe to assess its XPED Expanding Pedicle Screw System for spinal fusion. The study will enroll up to 50 patients and test the usability of the products for 24 months postoperatively.
Surgeons at the Hospital for Special Surgery are working on studying the outcomes of joint replacements for patients over the age of 50 after they return to regular activity. The study is looking at long-lasting joint implants, including a “30-year knee” implant approved by the FDA which withstood the simulation of 30 years in use.
Anderson Orthopaedic Research Institute has partnered with the Cleveland-based medical device companyImageIQ for joint replacement research using three dimensional imaging analytics to enhance orthopedic implant wear studies. The data generated from the research will be used to reduce the frequency of joint replacement implant failures and improve the quality of life for patients.
Read more

Category: New Technology

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

Posted on | January 24, 2012 | No Comments

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 managers charged with illegal off-label promotion and of lying to the FDA.

Judge George O’Toole Jr. of the U.S. District Court for Massachusetts agreed to drop all criminal charges against Jeff Whitaker and William Heppner in a lawsuit charging Stryker Corp subsidiary Stryker Biotech with illegally promoting off-label uses of its OP1 bone-growth products.

Whitaker and Heppner were cleared on grounds that Stryker Biotech had already pleaded guilty to off-label marketing and had paid its $15 million criminal fine, court documents show.

Category: Ethics, Lawsuits

FDA Issues Guidance on IDEs for Knee Cartilage Repair/replacement

Posted on | January 24, 2012 | No Comments

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 products intended to repair or replace knee cartilage.

The guidance covers devices, biologics and hybrid products, outlining required items to include in submission documents for investigation device exemption or investigation new drug applications.

The new guidance is the finalized form of a draft in the works since July 2007, and includes sections detailing clinical study schedules and non-clinical data considerations in response to comments the agency received during the draft process.

Category: Clinical Studies, FDA

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

Posted on | January 23, 2012 | No Comments

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 selling all custom fitted devices in response to an FDA warning following an inspection of the Warsaw, Ind.-based company’s facilities.

This week the FDA’s Centers for Devices & Radiological Health released a letter warning Depuy that certain custom devices and components sold by the company need new PMA or 510(k) applications.

Category: FDA

Pioneer Surgical Technology Expands Biomanufacturing Facility in Greenville, NC

Posted on | January 23, 2012 | No Comments

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 grand opening of its newly expanded Greenville manufacturing facility. The location houses the primary manufacturing operations for Pioneer Surgical’s biologic products sold in the United States and Europe.

Category: biologics, Strategic

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

Posted on | January 20, 2012 | No Comments

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 charge and pay a non-tax deductible fine of $15 million. As a result of this resolution, the Department of Justice has agreed to dismiss all thirteen felony charges against Stryker Biotech contained in a 2009 federal grand jury indictment. Stryker had previously disclosed in March 2009 that its Biotech division was the target of a federal grand jury investigation being conducted by the U.S. Attorney’s Office for the District of Massachusetts. With today’s announcement, Stryker believes it has realized its goal of obtaining an appropriate resolution of this matter.

Category: Clinical Studies, Ethics, Governance

MedShape Launches 2-Part PEEK ACL Fastener

Posted on | January 20, 2012 | No Comments

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 full launch instrumentation sets to its sales agents to support surgeon demand for the product following a successful soft launch during 2011.

Category: Sports Medicine

Korea Set to Approve Stem-Cell Drugs for Cartilage Repair

Posted on | January 18, 2012 | No Comments

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.

The first drug is called “Cartistem”, produced by Medipost, Inc. for treatment of degenerative arthritis and knee cartilage defects. The second is a stem cell-based anal fistula drug made by Anterogen, Co. Officials of both companies expects their drugs to be approved by the KFDA by mid-January.

Category: Stem Cells

Knee Replacement Surgery Incidence Soars in Those Over Age 50

Posted on | January 18, 2012 | No Comments

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 50 to 59 years. According to the study published in Arthritis & Rheumatism, a peer-reviewed journal of the American College of Rheumatology (ACR), incidences were higher in women throughout the study period.

Category: Clinical Studies, Joint Replacements

The 10 Biggest Concerns for Orthopedic Surgeons in 2012

Posted on | January 18, 2012 | No Comments

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 bring a technology boom or bust?
Dealing with patients who have unrealistic expectations.
More orthopedic surgeons are heading toward hospital employment.
Merging into large orthopedic groups and finding hospital partners.
Maximizing revenue in orthopedic groups.
Quality rating in orthopedic and spine care.
Increased patient responsibility in healthcare spending.

Category: Trend

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

Posted on | January 17, 2012 | No Comments

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 product designed to prevent postoperative infections.

In May 2011, the company, which had been based in Austin, signed a multi-year lease with the The Texas Life-Science Collaboration Center in Georgetown. The TLCC, about 30 minutes north of Austin, is a nonprofit accelerator that provides mentoring and other incubation services geared toward life sciences, as well as biotech infrastructure such as wet labs. The complex was built through a collaboration with local universities and colleges and with input from health care organizations.

Category: Funding, Spine

Zimmer Acquires Synvasive Technology for Its Advanced Cutting Systems

Posted on | January 16, 2012 | No Comments

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, as well as the eLIBRA® Dynamic Knee Balancing System™ for soft tissue balancing.

Category: M&A

Q&a With Medtronics New CEO, Omar Ishrak

Posted on | January 12, 2012 | No Comments

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: The Spine Journal devoted its entire June issue to to exposing problems with growth proteins, including a repudiation of some of the research surrounding Infuse.

The ensuing clamor, which included federal investigations into allegations that Medtronic’s paid consultants may have concealed the risks of Infuse, prompted 1 of Ishrak’s first public statements as the new face of Medtronic.

“For several years Medtronic has been leading the industry in reforms designed to eliminate or mitigate conflicts of interest. We will continue to investigate questions surrounding researchers’ potential conflicts of interest, refine our policies as warranted, and strive to lead the industry in ethical and transparent business practices,” he said, and soon put his money where his mouth was.

Category: Management, Trend

New President at Amedica, Spine Startup in Salt Lake City

Posted on | January 12, 2012 | No Comments

Eric Olson is the new President of Amedica Spine, succeeding Ben Shapley.

Eric Olson is the President of Amedica Spine Division. Mr. Olson has in excess of 20 years’ experience in the orthopaedic and spinal device markets. Most recently, he was the Executive Vice President of Sales & Marketing for Axial Biotech, Inc. Previously, he was the Vice President of Sales & Marketing for Facet Solutions, Inc. He has also held senior sales and marketing positions with Medtronic Neurological and Smith & Nephew. Mr. Olson holds an undergraduate degree in Behavioral Science and Health Administration from the University of Utah. He also completed a Masters level internship program, from the same institution.

Category: Management, Spine

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

Posted on | January 12, 2012 | No Comments

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 French and Spanish as well as English.

Gardès started his career in 1995 with Stryker Spine as Product Manager, Europe. In 1996, he was promoted to the position of Sales & Marketing Manager, Knees & Spine, at Stryker Spain. After returning to France in 1999, he served as Team Leader Hips, Europe, and then Group Product Manager Spine, Global, for Stryker Orthopaedics until 2002.

Category: Management, Spine, Startups

38 Orthopedic & Spine Device Company Executive Moves in 2011

Posted on | January 12, 2012 | No Comments

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 appropriate regard for the company’s ongoing compliance program,” according to a company report.
Interventional Spine named Stephen T. Colaiezzi senior vice president. He previously worked with Stryker, Medtronic and Aesculap.
Leslie H. Cross, former CEO of DJO Global, was elected to the Alphatec Spine board of directors as the non-executive chairman of the board. While with DJO Global, Mr. Cross helped the company’s revenues grow from $30 million-$966 million.
Ascendx Spine recently appointed Maria Pilar Debelius-Kinsey as the company’s new sales and marketing manager in Europe. She has served in management and sales positions at Medtronic and SpineVision.
Former Smith & Nephew executive Joseph DeVivo has become president of minimally invasive medical device company AngioDynamics, which focuses on vascular surgery. At Smith & Nephew, Mr. DeVivo led the company’s $2 billion orthopedic business.
Former COO of Medtronic Michael DeMane was appointed president and CEO of Nevro, a spinal device company. Mr. DeMane filled the space vacated by founder and CEO Konstantinos Alataris, who remained as director of the company.
Andrew Ekdahl became president of DePuy Orthopaedics after serving DePuy and its parent company Johnson & Johnson for 20 years. He also serves on the DePuy Franchise Global Management Board.
Former president of Medtronic AVE Europe Romano Ferrari became chairman of Ascendx Spine. In his new role, he will execute the company’s commercialization efforts internationally.
Former Worldwide President of DePuy Orthopaedics David K. Floyd will soon be the CEO of OrthoWorx, a Warsaw, Ind.-based orthopedic device company. Mr. Floyd was a founding member of the OrthoWorx board of directors and previously served as president and CEO of AxioMed Spine.

Read all 38 at Beckers

Category: Management

KSpine Raises $2.5M to Treat Scoliosis

Posted on | January 11, 2012 | No Comments

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 board chairman, told MedCity Newsthat KSpine will use the investment to fund clinical trials of the device.

Category: Funding, Spine

Lanx Spine Expands Its Facilities and Its Management Team

Posted on | January 11, 2012 | No Comments

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 at Complex Technologies.

• Michael Hughes is the new Sr VP International. He previously worked at Biomet and Interpore Cross.

• Pamela Snyder is the new VP Clinical/Regulatory Affairs. She last worked as Director of Clin/Reg at Spineology.

• Paul Hickey is the new Sr VP Marketing and R&D. He has experience at Zimmer and Zimmer Spine.

• Dana Klapper Cohen is the new General Counsel.

Category: Management, Spine

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

Posted on | January 10, 2012 | No Comments

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 clinical outcomes in patients with MoM hip replacements?
What are some predictive factors related to MoM hip replacement outcomes?
What is the prevalence of adverse clinical problems related to MoM?

Category: Metal-on-Metal

Old Implants Have Edge on New Implants

Posted on | January 9, 2012 | No Comments

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 30 % of the new joints were performing worse than were the older versions.

The researchers obtained their data from a comprehensive Australian national registry database and performed an outcome analysis on all new hip and knee prostheses introduced into the market between January 1, 2003, and December 31, 2007. The prosthesis had to have been used on at least 100 occasions.

Category: Clinical Studies, Joint Replacements

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

Posted on | January 8, 2012 | No Comments

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 (“HHS”), Milestone Knee System (“MKS”) and related surgical instruments.

Mr. Libo Yang, CEO, stated, “We are very pleased that our recent acquisitions not only have laid a strong foundation for our future growth but also provide us with strong momentum for 2012. With successful FDA approvals for TGM’s HHS and MKS, we are well-positioned to launch these products this year to kick start our reconstructive joint segment. We have a good start in 2012 and will continue to implement our business opportunities and growth strategies.”

About China Kanghui Holdings

Category: FDA

MTF Acquires PRP & PRFM Technologies From Cascade Medical Enterprises

Posted on | January 8, 2012 | No Comments

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 Transplant Foundation (MTF) and distribution by ConMed Linvatec for the worldwide orthopedic, dental, and wound care markets.

Category: M&A, PRP

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

Posted on | January 8, 2012 | No Comments

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 treating conditions related to the aging spine, today announced that it has reached a global settlement agreement of two pending lawsuits. In the first lawsuit, Cross Medical Products, Inc. (a subsidiary of Biomet, Inc.) claimed that Alphatec Spine had breached the April 23, 2003 license agreement with Cross Medical by failing to make certain royalty payments. In the second lawsuit, Alphatec Spine claimed that a subsidiary of Biomet, Inc. EBI, LLC, infringed a patent owned by Alphatec Spine.

Category: Lawsuits, Patents

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

Posted on | January 6, 2012 | No Comments

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 biopolymer to promote bone growth in the posterolateral spine.

Regarding Pioneer’s latest product introduction, Mr. Shane Ray, General Manager – Biologics for Pioneer stated, “We are extremely excited to start the clinical phase of nanOss Bioactive 3D. Three-dimensional shapes are popular in spine surgery and with this addition, we now have one of the most extensive biologic portfolios on the market.”

Category: biologics