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.