Musculoskeletal News Roundup 3-Jul-13
BY ANDREW VAHRADIAN, JULY 3, 2013
Nextremity Solutions raised $10 million through a private placement transaction. The company plans to utilize the new capital to accelerate the growth of its existing product portfolio and pipeline.
aap Implantate entered a joint venture agreement in which an undisclosed Private Equity firm based in the British Virgin Islands would acquire 67% of the shares of aap´s reconstructive implant subsidiary, aap Joints GmbH, for a consideration of €3.0 million ($3.9 million) in cash. aap Joints GmbH focuses on reconstructive implants (hips, knees, shoulder) and related products.
ArthroCare Corp. announced the completion of its acquisition of ENTrigue Surgical, Inc., which designs and develops implants, disposables and instruments for endoscopic sinus surgery, for $45 million in an all cash transaction. In addition, the previous shareholders of ENTrigue will have the right to receive contingent consideration on each anniversary of the closing for each of the next five years based on the increase in net sales during each twelve-month period of ENTrigue products multiplied by an agreed upon factor. Going forward, ENTrigue will operate within ArthroCare’s ENT product area as a complement to its ArthroCare Coblation and Rapid Rhino product lines.
The Australian Therapeutic Goods Administration (TGA) introduced its Database of Adverse Event Notifications (DAEN) for medical devices, which incorporates data on adverse events reported to the TGA from a wide range of sources, including from members of the public, GPs, other health professionals and from the therapeutic goods industry. The database, which will be updated monthly and includes reports dating back to January 1971, is being made available to the members of the public as part of the TGA's initiatives to be more transparent regarding its activities and to help stimulate the reporting of adverse events.
The Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) developed an early warning system to communicate potential safety concerns with therapeutic products. Both regulatory authorities will apply the agreed upon procedures independently to communicate potential safety concerns identified with therapeutic products through their existing therapeutic product vigilance processes.
PRODUCT INTRODUCTION & UPDATE
Orthofix International, in collaboration with the Musculoskeletal Transplant Foundation (MTF), announced the full market release of its Trinity ELITE Allograft with Viable Cells and VersaShield Amniotic Membrane tissue forms through both of its Spine Fixation and U.S. Extremity Fixation distribution channels. Trinity ELITE is a third generation allograft with viable cells and aims to provide surgeons with a viable grafting alternative to autograft. The product is designed to provide an enhanced handling experience for the surgeon by being fully moldable.
Bioventus entered an exclusive license agreement with Pfizer Inc pertaining to Pfizer's bone morphogenetic protein (BMP) portfolio of development programs and associated intellectual property. The portfolio includes a next-generation BMP in development, designed to offer additional options to currently-marketed BMP products, and the rights to rhBMP-2 in indications and fields previously reserved to Pfizer. Bioventus has also acquired an exclusive option to a BMP program for soft tissue indications as well. Pfizer has agreed to transfer to Bioventus all existing development work for the BMP assets and to undertake certain early-development activities relating to the BMP product. Additionally, Pfizer will manufacture rhBMP-2 and supply it to Bioventus. Under the terms of the license agreement, Pfizer received an upfront payment and will be eligible to receive milestone payments and royalties on any sales.
Bioventus announced that all Smith & Nephew biologics and clinical therapies businesses in Australia and Poland will consolidate and be rebranded under the Bioventus name.
Johnson & Johnson opened the new Kendall Square Innovation Center, in Cambridge, Massachusetts with the aims of helping to foster early-stage biotech companies looking to get novel products off the ground. The new 9,000-sqaure-foot center is one of four incubators J&J has opened around the world and it will work with and connect businesses, academia and early-stage product developers. Other centers are currently operating in Shanghai, San Francisco and London.