Amedica Corporation Announces New Leadership Appointment to Guide Next Phase of Rapid Growth

Amedica Corporation, a spinal and reconstructive implant and instrument manufacturer focused on proprietary silicon nitride ceramic material platforms, today announced leadership appointments designed to drive the company's ambitious growth initiatives in the United States and abroad. 

To support the clinical and commercialization activities that will drive the company's growth, Amedica has appointed orthopaedic surgeon B. Sonny Bal, M.D., M.B.A., J.D., to its Board of Directors.

"As we enter our next stage of development and look forward to commercializing new generation of products, having a forward-thinking industry leader, like Sonny, on the board of the company is invaluable to our organization," said Max Link, chairman of Amedica's Board of Directors.

Nanodiamond Coatings Could Prevent Shedding of Metal Debris in Hip Implants

The safety of metal hip implants could be improved by nanodiamond coatings, a study by University of Alabama at Birmingham researchers has found. Although the coating itself could also shed particles, it appears that these are nontoxic and therefore safer than metal particles. By studying the nanodiamond particles interacting with macrophages in a dish, researchers concluded that the debris from the nanodiamonds should not cause toxicity or inflammation. Metal particle shedding releases metal ions into the bloodstream, which can cause inflammation and damage to the muscle and bone, as massive recalls by companies such as DePuy shows.

A 5th Circuit judge in Texas rules that preemption does not apply in a product liability lawsuit over a Stryker Corp. hip implant.

A federal judge in Texas ruled that preemption does not apply in the case of a product liability lawsuit over an allegedly defective Stryker Corp. (NYSE:SYK) hip implant.

Alton Bass sued Stryker in October 2009, 2 years after receiving undergoing hip replacement surgery involving 4 Stryker devices: a shell, an Accolate TMZ Plus hip stem, a V40 alumina femoral head and a Trident 0 alumina insert.

ConforMIS adds 22 patents to patient-specific implants and instrumentation systems portfolio.

ConforMIS, Inc. today announced it has completed its most productive period to date in the development of its intellectual property with the addition of 22 issued patents to its portfolio since January 2011. The core of its portfolio covers patient-specific implants and patient-specific instrumentation systems spanning applications in knee, hip, shoulder, small joint, and spine. With these recent patent awards, ConforMIS now owns or exclusively licenses more than 50 issued patents.

The company, a leader in the area of patient-specific implants and instrumentation systems, already possesses a substantial intellectual property portfolio consisting of more than 300 patents and patent applications. The IP portfolio covers a broad range of related areas including imaging software, image processing, implant design, surgical techniques, instrumentation, and manufacturing. Over the past year, ConforMIS has received a number of patents specifically in the area of patient-specific implants and instrumentation systems. A partial list is provided below.

New Minimally Invasive Hip Retractor Revolutionizes Anterior Hip Replacement Procedures

TeDan Surgical Innovations, industry leader in surgical access instrumentation, announces the launch of the Phantom Series MIS Anterior Hip Retractor System. TeDan Surgical's revolutionary hip retractor utilizes a system of adjustable surgical arms with attachable retractors, enabling surgeons to perform the entire procedure without a fracture table or a surgical assistant.

Dr. Lawrence Menendez and Dr. Daniel Allison, Orthopedic Surgeons at the University of Southern California Medical Center, partnered with TeDan Surgical to design and develop this innovative retractor.

U-M develops new system to reduce incidence of retained surgical instruments

It may sound like something from a TV medical drama, but the incidence of surgeons leaving something behind in the body is very real at hospitals across the country.

For decades, surgical teams have relied on counting -- and recounting -- the sponges, needles, blades, retractors, and other items used during operations.

But the University of Michigan Health System has created a new system using state-of-the-art technologies to insure that no foreign objects are left behind during surgery, reducing potentially serious medical errors.

Custom Spine achieves ISO-13485 and receives CE Mark for all current products

In an effort to support global expansion plans, Custom Spine announced that it has achieved ISO-13485 and received CE Mark for all its current products sold in the U.S. This approval allows the Company to commercialize its products into the international market.

Mahmoud Abdelgany, President of Custom Spine commented, "We are excited to receive CE clearance and to take the next steps into distributing our products in the international arena. This is a significant milestone for Custom Spine, and we are looking forward to working with our international partners in offering our products outside of the U.S."

Custom Spine's product portfolio includes its flagship pedicle screw system, ISSYS LP. The advanced design of ISSYS LP allows the surgeon to fully seat the screw against bone providing 63% greater shear force resistance than traditional unseated screws, while maintaining full polyaxial motion of the screw head. Also included in the product portfolio is Pathway AVID,

Fears of faulty 'toxic' hip replacement implant

Today many newspapers and TV stations have reported that medical regulators have launched an investigation into a type of hip replacement called a metal-on-metal (MoM) device (DePuy ASR hip replacement implant). The concern is that as the hip replacements wear down, metal particles can be released from the artificial hip, react with the soft tissue (such as muscle and ligaments) surrounding the joint and enter the bloodstream. In 2010, the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a product recall for DePuy ASR, a brand of MoM artificial hip. This meant that surgeons were told not to implant DePuy ASR hip replacements and return any unused implants to the manufacturer.

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

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.

Can you tell us about your background and experience in the orthopedic sector?

PAUL NICHOLS: My career in the orthopedics sector began in 1985, when I was recruited by Sutter Biomedical, a San Diego manufacturer of orthopedic implants and postoperative rehabilitation products. I wore many management “hats” during my ten years at Sutter, including oversight of the Small Joint Orthopedics division. This business unit manufactured silicone implants for hand and foot surgery and was the primary competitor to the Wright Medical Swanson product line. In 1994, I was presented with the opportunity to purchase the assets of the SJO division, which led to the formation of Avanta Orthopaedics, Inc. (now a part of Small Bone Innovations) and subsequently to Futura Biomedical (products now owned by Tornier).

Sector Snapshot: The Orthopaedic OEM and Supplier Markets

In 2009, ORTHOWORLD estimated annual global orthopaedic supplier market sales to be approximately $2 billion. At that time, slowing growth in the orthopaedic original equipment manufacturer (OEM) sector was reflected in the supplier side, though competition remained high and consolidation/collaborations continued around the globe. To this day, the orthopaedic supplier market remains highly fragmented and competitive.

On the OEM side, seven multinational OEMs – Stryker, DePuy/J&J, Zimmer, Medtronic Sofamor Danek, Synthes, Smith & Nephew and Biomet – each with $1 billion or more in annual orthopaedic device sales, currently hold the predominant share of the orthopaedic device market. The ten largest orthopaedic OEMs account for approximately 90% of the market. These leaders rely heavily upon independent suppliers for the manufacturing of implants, instruments, cases and other elements of an implant system.