M&A
Private equity firm Welsh, Carson, Anderson & Stowe ("Welsh Carson") has entered into an agreement with K2M to purchase the spinal company's outstanding shares and become its majority shareholder. K2M will continue to be run by existing management, which will own a minority stake in the company along with long-time investor Ferrer Freeman & Co. With the Welsh Carson investment, K2M plans to expand its worldwide salesforce and further invest in research and development. The terms of the transaction were not disclosed.
Global-Med Technologies Group (GTG) acquired OrthoIT, LLC for undisclosed terms. GTG plans to complete development of OrthoIT's minimally invasive non-fusion disk replacement, ReSumo Soft Disk System. After securing FDA approval, GTG will spin-off ReSumo to SpinalVu, Inc., its wholly-owned subsidiary. The terms of the acquisition were not disclosed.
Funding
Bio2 Technologies, a developer of tissue engineering scaffolds with a focus on the orthopedic market, announced that the company has raised $1.1 million of a planned $2 million round of financing. Specific investors were not disclosed.
Regulatory
On Wednesday, RepRegen announced receiving CE marking approval for StronBone. StronBone, a bioactive glass with Strontium, is the company's first commercialized product in its repair-and-regeneration platform of "smart" biologics for hard tissues. Other patent-pending products in this pipeline will focus on orthopedic and CMF applications. RepRegen was formerly known as BioCeramic Therapeutics.
Oxford Performance Materials (OPM) announced today that the Korean Food and Drug Administration (KFDA) accepted the company's OXPEKK-IG long-term implantable polymer. The KFDA approved the spinal device made by Sintea Plustek, a customer of OPM.
Product Introduction and Update
Integra announced the debut of DuraGen(R) Dural Regeneration Matrix - Spinal Matrix. The new product, a sutureless and absorbable collagen onlay, aims to help surgeons more efficiently repair the dura mater by negating the need for sutures.
SpineGuard reported sales of over 1,000 PediGuard units in 2Q 2010, a 125% increase over 2Q 2009. The PediGuard device is designed for safer pedicle screw placement in spine surgery, a large market considering over nearly one million spine procedures implementing pedicle screws were completed in 2009. SpineGuard co-founder and CEO Pierre Jerome expects extensive market expansion both domestically and internationally to drive PediGuard's future sales growth.
At the 2010 Annual American Orthopaedic Foot and Ankle Society (AOFAS) Summer Meeting in National Harbor, Maryland, Stryker will highlight the VariAx Fibula and VariAx Foot Locked Plate Systems, featuring low-profile designs with polyaxial locking. Also at the AOFAS meeting, Wright Medical Group plans to feature several products, including the Inbone Total Ankle System, which aims to make ankle replacement procedures more stable and accurate for surgeons by utilizing in-situ assembly of the modular ankle implants. Wright Medical will also highlight its Valor Hindfoot Fusion Nail System for fusion of the ankle joint; Xpansion Micrograting System for less-traumatic split-thickness skin grafting; and Biofoam Foot and Ankle Wedge System, a porous titanium that mimics bone.
Clinical
Biomimetic Therapeutics, Inc. presented the findings of its 52-week study comparing Augment Bone Graft to autograft in foot and ankle fusion surgery. After 52 weeks, 15 of 16 secondary endpoints were statistically significant for non-inferiority. Furthermore, augment compared favorably to autograft with clinical healing rates of 87.8% and 88.3%, and a therapeutic failure rate of 7.3% and 8.0%, respectively. Safety outcomes favored the Augment treatment group, which had fewer complications and infections compared to patients treated with autograft. An separate Biomimetic study quantified the medical costs of autograft procedures in the foot and ankle, observing a range between $1,100 and $2,400 depending on the harvest site.
Collaborations
Smith & Nephew signed a seven-year outsourcing deal with HP Enterprise Services. HP will provide international finance and administration services to Smith & Nephew's European operations.
