MILESTONES
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Neff
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Paradigm Spine LLC (New York City) is funding trials for a newly developed diagnostic test for the prediction of idiopathic scoliosis. The trials will be conducted at Sainte-Justine University Hospital Center (Montreal). Paradigm has signed an agreement with Sainte-Justine to provide cash and other resources through 2008 to complete trials of the blood test, which was developed by Alain Moreau, PhD, director of Sainte-Justine's bone molecular genetics and skeletal malformations laboratories. Under the agreement, Paradigm will receive the exclusive worldwide license to commercialize, manufacture, distribute, or sublicense any device, genetic tests, therapeutic agents, or any future technology derived from the scoliosis research. "I believe we may be on the brink of discovering the secret to the causes of scoliosis that until now were so complex that children were diagnosed purely on visual examination—long after the disease had taken hold," said Marc R. Viscogliosi, Paradigm's chief executive officer.
Backed with $11 million in new venture capital funding, Predicant Biosciences (San Francisco) has acquired Pathwork Informatics (San Jose) and named the merged company Pathwork Diagnostics. The new company will develop and commercialize genomic diagnostic tests for oncology. Financial details of the transaction were not disclosed. Deborah J. Neff, Predicant's chief executive officer, has been appointed president and chief executive officer of Pathwork Diagnostics and will serve on the company's board of directors. Neff was formerly worldwide president of BD Biosciences (San Jose).
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Lukianov
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NuVasive Inc. (San Diego) has received conditional approval of an investigational device exemption (IDE) from FDA to begin enrollment for a clinical trial of its NeoDisc cervical disk replacement device. The company expects to begin enrolling patients in the trial by the fourth quarter of 2006, with a follow-up period of two years. "Having a product that is a first-option device that preserves motion and can be fully revised to other cervical procedures is a significant advancement in cervical spine surgery technology," said Alexis V. Lukianov, chairman and CEO of NuVasive.
Affinergy Inc. (Research Triangle Park, NC), a Duke University spinout that develops site-specific biological delivery systems, reports that it has purchased the physical assets of a biotech company and signed a five-year lease for a 20,000-sq-ft facility with advanced scientific infrastructure. The company also announced that it will receive funding for three new small business innovation research grants that total more than $575,000 in aggregate. The new grants will fund research in the areas of injectable growth factors, tendon healing, and click chemistry.
Genetic analysis product developer Sequenom Inc. (San Diego) announced the closing of a $33 million private placement financing with four institutional investors. The investors were Pequot Private Equity Fund IV LP; ComVest Investment Partners II LLC; LB I Group Inc., an affiliate of Lehman Brothers; and Siemens Venture Capital GmbH. "The financing provides Sequenom and its customers, collaborators, employees, and shareholders with a solid foundation on which the company can grow its core business, unlock the potential of its noninvasive prenatal diagnostics technology, and provide genetic analysis solutions more broadly and on an accelerated timetable," said Harry Stylli, PhD, president and chief executive officer of Sequenom.
Medrad Inc. (Indianola, PA) plans to build a new 120,000-sq-ft manufacturing facility in Victory Road Business Park in Clinton Township, Butler County, PA. The company expects to hire 100 employees to staff the new facility, with potential employment at the location anticipated to grow to 500 in five years. "This is a very exciting time for Medrad because another new facility illustrates the growth we continue to enjoy," said John P. Friel, Medrad president and CEO.
Raymedica (Minneapolis) has received FDA approval to begin enrolling patients in a U.S. clinical study to evaluate the potential benefits of its HydraFlex nucleus arthroplasty system, a nonfusion technology for the treatment of degenerative disk disease. "This is an important milestone for Raymedica, and I am appreciative of the work that our product development and regulatory team has done to secure FDA investigational device exemption (IDE) approval," said John J. Viscogliosi, chairman and CEO of Raymedica.
Wound care product manufacturer Advanced BioHealing Inc. (New York City) has concluded its acquisition of the assets and rights associated with the advanced wound care products Dermagraft and TransCyte from Smith & Nephew (London). Both products have been approved for marketing in the United States and other countries. Financial terms of the transaction were not disclosed. "The addition of these two products provides us not only an immediate, predictable revenue base upon which to grow the company, but also an access point within the marketplace for our next-generation products," said Kevin Rakin, CEO of Advanced BioHealing.
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Daulton
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Cardinal Health Inc. (Dublin, OH) announced that it has completed its acquisition of Denver Biomedical Inc., a designer and manufacturer of specialized medical products for chronic fluid management in the chest and abdomen. Terms of the agreement were not disclosed. "Well recognized by clinicians, Denver Biomedical's products are a great fit with our existing business," said Tom Daulton, vice president and general manager of special procedures for Cardinal Health. According to Cardinal Health, Denver Biomedical was the first company to receive FDA clearance specifically for an indwelling catheter for drainage of chronic pleural and ascitic fluids.
