News ArchiveTyRx Pharma, Inc. Announces Food and Drug Administration (FDA) 510(k) Clearance of the AIGISRX™ Cardiac Rhythm Medical Device (CRMD) Anti-Bacterial Envelope -- MONMOUTH JUNCTION, NJ, (January 17, 2008) TyRx Pharma, Inc., a leader in the commercialization of implantable combination drug?device products, announced today the Food and Drug Administration (FDA) clearance of a Premarket 510(k) Application to market its AIGISRX™ CRMD Anti-Bacterial Envelope. CRMD post-implant infection including cases of ?super bug? or MRSA is a growing and potentially fatal complication. AIGISRX™ CRMD has two functions. It is intended to securely hold a pacemaker or implantable cardioverter defibrillator (ICD) in order to create a stable environment when implanted in the body. In addition, AIGISRX™ CRMD contains the antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in CRMD related endocarditis, including MRSA. This device is only intended to be used in conjunction with pacemakers and implantable cardioverter defibrillators (ICD).AIGISRX™ CRMD is constructed of knitted filaments of polypropylene coated with a proprietary resorbable polymer that elutes the antimicrobial agents rifampin and minocycline for a minimum of 7 days to reduce the risk of infection of the implanted CRMD following surgery. In in vitro studies, AIGISRX™ CRMD demonstrated antimicrobial activity against Methicillin Resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter aerogenes and Proteus mirabilis. AIGISRX™ CRMD also demonstrated in vivo effectiveness in reducing infection compared to control in a series of animal studies in which CRMDs were placed into AIGISRX™ CRMD envelopes and implanted into subcutaneous pockets inoculated with various bacterial strains, representing a majority of the infections associated with CRMD related endocarditis. Both AIGISRX™ CRMD and the controls (CRMD without envelope) were inoculated and observed for a minimum of 7 days to validate the presence of infection in the animals. The bacteria tested included Staphylococcus epidermidis, Acinetobacter baumanii, Staphylococcus capitis and Escherichia coli, and separately, Staphylococcus aureus which represent a majority of the infections reported in CRMD-related endocarditis. It should be noted that the in vitro and in vivo activity of the AIGISRX™ CRMD antimicrobials is variable against non-epidermidis strains of coagulase-negative staphylococci. According to a recent study presented during the Heart Rhythm Society Heart Rhythm 2006 Scientific Sessions (Boston), the University of Pittsburgh Medical Center noted that the 2003 national incident of infection for pacemakers was estimated to be 5.82% and for ICDs 3.71%. Recent market research indicates that more than 400,000 CRMDs are implanted each year in the U.S. According to Infection Control Today (8/2003), the average cost of each infection related to invasive medical devices varies from $34,000 to $56,000; these infections incur an annual financial burden up to $2.3 billion to the American healthcare system. The New England Journal of Medicine (New England Journal of Medicine, 2004;350:1422-9) states about half of the 2 million cases of nosocomial infection that occur each year in the United States are associated with indwelling devices. Infections associated with surgical implants are generally more difficult to manage because they require a longer period of antibiotic therapy and repeated surgical procedures. ?We are thrilled to have reached this value-creating milestone with the FDA clearance of AIGISRX™ CRMD,? said Bill Edelman, CEO of TyRx Pharma. ?With over 400,000 annual U.S. implants of CRMDs, we believe AIGISRX™ CRMD will become a valuable tool in the effort to suppress bacterial infection of CRMD pockets.? Mr. Edelman continued, ?We anticipate AIGISRX™ CRMD U.S. national commercial distribution to begin within the quarter following this FDA clearance, with full market release coinciding with the Heart Rhythm Society Heart Rhythm 2008, the premier conference on cardiac arrhythmias in San Francisco May 14-17, 2008.?
Rutgers Research Turns a profit --By Thomas Gaudio - 12/3/2007 NJBIZ To download the article, please click the link below:
Note: It is strongly recommended that for MS-Word and Acrobat documents you right click and select "Save Target As" to save the document on your computer instead of clicking on the link. You cannot save the Word document when it is open inside the browser. * You may need to download Acrobat Reader to view these files Connotate Recognized by KMWorld with 2007 KM Promise Award --Award bestowed for delivering high-value innovation and furthering the vision of knowledge managementNORTH BRUNSWICK, N.J. (November 7, 2007) --Connotate Technologies, Inc., the leading provider of solutions which transform information from the Web and enterprise into standardized,
reliable information and applications, today received the prestigious KM Promise Award 2007, a recognition sponsored by KMWorld, a leading
publication addressing the knowledge and content management market. Connotate?s Agent Community GEN2 solution goes far ?beyond search? to
supercharge the knowledge management processes of financial, publishing, pharmaceutical, research and government workers by enabling a Web2.0
ecosystem within the enterprise. Employing Agent Community GEN2 enhances organizational productivity by enabling end user creation of on-demand
applications and mashups from any number of Web and enterprise sources. Presented at the 2007 KMWorld and Intranets conference in San Jose, California, the award recognizes Connotate?s innovation in both technology and award-winning products. Combining machine intelligence, user empowerment and Enterprise 2.0 principles, Connotate?s solution enables businesses to leverage information found across the Web and enterprise. A coveted industry award for over 5 years, KMWorld Magazine recognizes a single vendor each year that has proven their ability to help organizations realize positive business results. ?Connotate's Agent Community Gen 2.0 is the only technology available that legitimately fulfills the goal of the Semantic Web," says KMWorld editor-in-chief Hugh McKellar. ?Connotate's Agent Community GEN2 solution is able to deliver highly targeted information from any data source--internal or external, structured or unstructured--to business users in virtually every industry. Connotate?s technology holds more promise than anything I?ve seen in the past five years." The KMWorld and Intranets conference is host to an annual awards ceremony for achievements and solution delivery in knowledge management. The awards nomination and evaluation process gives KMWorld the opportunity to closely assess and better familiarize itself with the latest developments in the knowledge management industry and recognize the visionaries and market leaders in the space. ?We are delighted to receive the 2007 KM Promise Award,? says Bruce Molloy, CEO of Connotate. ?We feel this award sends a strong signal about the value of our approach and completeness of our solution. We are committed to providing our customers with an excellent product that delivers high value.? Earlier this year, Connotate was also honored with being recognized as a ?Trend Setting Product of 2007? and as one of the ?100 Companies that Matter in Knowledge Management? for the third consecutive year. Connotate?s investors include Goldman Sachs; a relationship that includes a joint marketing agreement in which Goldman Sachs' Hudson Street Services offers Connotate?s solution to its investor client base. For more information on Connotate, visit our website at http://www.connotate.com. http://www.connotate.com/news_events/press_releases/pr_2007_11_07.asp Wellgen Inc. Completes $9.5 million Series C Financing -- Proceeds to Build Pipeline of Patented Nutraceuticals and Advance Product Development Programs
NORTH BRUNSWICK, N.J. (October 29, 2007) -- WellGen, Inc., a biotechnology
company using nutrigenomics to discover and develop food ingredients for
wellness products, today announced the completion of its Series C financing
totaling $9.5 million. The capital raised from this round of financing will
enable WellGen to advance its anti-obesity ingredient for functional foods,
including the launch of a human study that has already received Institutional
Review Board approval, and to conduct further studies of its recently patented
product WG0401, an enriched extract from black tea which has demonstrated
inflammation-fighting properties in multiple studies in humans.
The financing will also enable WellGen to complete equipping its state-of-the-art molecular biology and natural products chemistry laboratory, and to hire additional personnel. In addition, WellGen is working to fill its pipeline with new, scientifically validated ingredients with health benefits for food and beverage applications. The Company anticipates advancing several new ingredient candidates derived from its nutrigenomics platform technology before the year?s end. Investors in this round of financing include both new and existing WellGen shareholders. The Series C financing was substantially oversubscribed, leading WellGen?s board of directors to increase the size of the offering. Dr. Kathleen Mullinix, Chief Executive Officer of WellGen, said, ?We are very pleased with WellGen?s progress as we bring WG0401, our first ingredient, to market -- the result of years of painstaking scientific research. This financing will reinforce WellGen?s leadership position in the emerging field of nutrigenomics and functional foods.? In July 2007 a patent was awarded for WG0401 and its proven inflammation-fighting properties. WG0401 will initially be marketed as a functional food ingredient that promotes joint health and comfort, supports immune-system defense and anti-aging, and contributes to cardiovascular health. The Company is developing additional uses for the product.
Kathryn Uhrich presents at American Chemical Society Fall national meeting BOSTON (August 2007) ? Some 14,000 chemical scientists from around the world
attended the American Chemical Society fall national meeting held at the Boston
Convention & Exposition Center. One focus of the meeting was a series of four
sessions called ?Polymer Science of Everyday Things,? which included 24
presentations about ?how medical devices that people encounter and use every day
depend on polymer science." Kathryn Uhrich, PhD, Rutgers University professor of chemistry and chemical biology, gave a presentation, ?From Willow Bark to PolyAspirin: Discovery and Innovations,? which discussed applications for PolyAspirin (a novel polymer form of aspirin, or salicylic acid) used in medical device coatings for cardiac stents, as standalone stents and other products. ?Salicylic acid (SA)-derived polymers inhibit biofilm (bacteria) formation,? said Uhrich. ?Initial PolyAspirin uses include a drug-eluting coronary stent coating and carrier for antiproliferative agents developed by Polymerix. In this application, a stent is combined with a pharmaceutical agent and then placed into a human coronary artery to help prevent restenosis (when scar tissue reblocks arteries).
?In more recent studies sponsored by Bioabsorbable Therapeutics (Menlo Park, California), the same pharma-ceutical agents are released from a completely resorbable stent. The stent?s delivery of drug to the wounded artery is controlled by the PolyAspirin coating that gradually releases a drug into the vessel lining to prevent scar tissue growth, a frequent reaction that leads to restenosis. These biodegradable coatings are unique in that they are noninflammatory and targeted to disappear in six to nine months after providing their therapeutic effects and delivering other agents,? Uhrich said.
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Rutgers Scientists
Preserve and Protect Foods Naturally
Two items high on the list of public concerns are the need for greater food
safety and a growing demand for natural or organic food products.
Understanding this, chemists and food scientists at Rutgers, The State
University of New Jersey, joined forces to develop natural approaches to the
prevention of food contamination and spoilage.
The researchers employed natural antimicrobial agents derived from sources such as cloves, oregano, thyme and paprika to create novel biodegradable polymers or plastics to potentially block the formation of bacterial biofilms on food surfaces and packaging. ?We mated natural substances with controlled-release, biodegradable polymers that could inhibit or prevent the formation of bacterial biofilms,? explained Ashley Carbone, a graduate student at Rutgers who constructed the polymer compounds that were tested. ?The natural substances we chose have general antimicrobial activities against many different kinds of microorganisms,? Professor Kathryn Uhrich said. ?Therefore, the polymers into which we incorporated these natural substances have the potential to affect a much broader spectrum of microorganisms than organism-specific drugs,? Uhrich said. Another advantage comes out of the Rutgers researchers? decision to focus on the biofilms, rather than attempting to attack the individual bacteria. This avoids the potential of increasing the antimicrobial resistance of specific bacteria, an emerging problem in medical circles brought on by the overprescription of antibiotics. ![]() An additional positive feature stems from the use of polymer ?backbones? to which the natural agents were incorporated. These polymers are biodegradable due to their specific chemical composition and the nature of the bonds that hold them together, Uhrich explained. ?As they degrade in the presence of water and/or enzymes, they slowly release their active antimicrobials,? Carbone said. ?A slow and controlled release of the food-based antimicrobial would offer great advantages in the food industry, providing protection over an extended time and extending the shelf-life of the food product.? The retail marketing sector may benefit from the Rutgers innovation. With the growing consumer interest in natural foods, shoppers may be more attracted to products containing natural antimicrobial ingredients rather than the synthetic chemical additives currently in use to protect against contamination and spoilage.
Lux Biosciences
Expands Biomaterials Technology License From Rutgers for Controlled Ocular
Delivery of Pharmaceuticals JERSEY CITY, N.J. ? (May 22, 2007) -- Lux Biosciences, Inc., a privately held biotechnology company specialized in the field of ophthalmic diseases, announced today that it has expanded its existing technology licensing agreement with Rutgers, The State University of New Jersey. The new agreement adds exclusive access for ophthalmic use to some of the University's polycarbonate intellectual property estate, in addition to the polyarylate patent portfolio that Lux Biosciences licensed from Rutgers in September 2006. This additional technology platform gives Lux Biosciences access to a broader range of polymers that are all bioerodible and based on similar monomeric building blocks, which provides a broader range of features for the controlled long-term delivery of medications to the eye. Financial Terms of the agreement were not disclosed. "These second-generation polycarbonates are a valuable addition to the Lux Biosciences portfolio of licensed Rutgers technologies that gives us further flexibility in choosing the best possible technology and tailoring it to the molecule at hand," said Ulrich Grau, Ph.D., president and chief executive officer of Lux Biosciences. The license includes several issued patents that specifically disclose methods of generating drug release formulations for peptides using polymers as the drug delivery matrix. A specific polycarbonate polymer is currently being explored clinically as a next generation bioerodible and radio-opaque vascular stent by Rutgers' partner in this field. "Second-generation polycarbonates are among the most advanced biomaterials currently available. I am convinced that this class of biomaterials will find significant medical applications in drug delivery, medical devices, and regenerative medicine," said Board of Governors Professor Joachim Kohn who led the team of Rutgers researchers and students who invented this technology.
Hugo Dooner and
Paul Falkowski named members of the National Academy of Sciences Two distinguished faculty members of Rutgers, The State University of New Jersey, have been elected to the National Academy of Sciences (NAS), one of the highest honors an American scientist or engineer can achieve. Hugo K. Dooner, a professor at the Waksman Institute of Microbiology and in the Department of Plant Biology and Pathology at the School of Environmental and Biological Sciences; and Paul G. Falkowski, a professor in the Department of Geological Sciences and the Institute of Marine and Coastal Science, were among the 72 new members from across the nation chosen May 1. Dooner is known primarily for his research into the genetics of maize (corn) that has demonstrated the adaptability of its genome and its propensity for reorganizing the mobile DNA elements that carry the genes. Falkowski has gained recognition for his achievements in understanding the photosynthetic processes and evolution of marine phytoplankton, and the role of the ocean in the global biogeochemical cycle. The two scientists join a select group of 19 NAS members from Rutgers. The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the advancement of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by Congress in 1863, the academy is required by mandate to advise the federal government on scientific and technical matters.
WellGen Completes
Human Study Paving Way for Nutrigenomics to Play Important Role in Mainstream
Product Development NEW BRUNSWICK, N.J., (April 10,2007) -- WellGen, Inc. today announced that it has completed a pivotal study demonstrating that its nutrigenomics technology platform can successfully predict biological activity of natural products in humans. WellGen is a biotechnology company that uses nutrigenomics to discover and develop proprietary functional food ingredients. "The fundamental principle of nutrigenomics is that food ingredients can control the expression of genes that determine human wellness or disease," said Dr. Kathleen P. Mullinix, WellGen CEO. "Our study has shown that WellGen's methodology is valid for discovering natural substances that can positively affect human health through gene expression." Using a proprietary ingredient standardized for certain theaflavins in black tea, WellGen's study has proven that the ingredient's inflammation- fighting properties can be identified and quantified by the company's technology such that the findings can be effectively and efficiently translated to consumer applications. "This is a big step for WellGen and a major step for bringing nutrigenomics into mainstream product development in the food and beverage industry. We have completed the loop that validates WellGen's discovery process, and now we are moving toward commercializing our first functional ingredient for food applications," said Dr. Mullinix. This recently completed double-blind randomized human study has confirmed that the WellGen approach of using cell cultures containing specifically targeted genes is highly predictive in determining that a plant or food extract can positively affect the same gene expression profile in humans. WellGen's proprietary ingredient, WG0401, delivered consistent activity against inflammation across the entire WellGen discovery and development process, which includes cell based assays, animal testing, and human inflammatory biomarker studies. Inflammation plays an important role in many health states and is linked to such health concerns as arthritis, cardiovascular disease, cancer, and type II diabetes. WellGen's proprietary ingredient, WG0401, provided protection to healthy volunteers who were given a potent inflammatory challenge. Healthy volunteers treated with the WellGen extract had inflammatory biomarker levels ranging between two- to six-fold less than the placebo group when challenged with an inflammation-inducing bacterial lipopolysaccharide. As a proof of efficacy in humans, WellGen uses quantitation of biomarkers of inflammation to demonstrate the biological activity of its proprietary ingredients that have shown positive results in laboratory and animal tests. WellGen uses relevant and quantifiable biomarkers to streamline an ingredient's evaluation in humans by reducing the duration of human trials and obtaining objective data. Examples of validated biomarkers include glucose levels as related to diabetes or cholesterol levels related to heart health/cardiovascular risk. Study Leads to Additional Structure-Function Claims for Supporting Immune System DefenseIn addition to the potent anti-inflammatory benefits already known for the ingredient, the human study of WG0401 demonstrated immune system defense support. Based on the analysis of the biomarkers used in the studies, WellGen, Inc. discovered that its WG0401 enhances the response of the immune system to a bacterial challenge. Thus these results indicate that WG0401 can be beneficial in immunoregulation. WG0401, a food ingredient that is derived from black tea and is characterized by an enriched theaflavin content, will be available commercially this year. WellGen's inflammation program, its first research initiative, was set up to develop proprietary ingredients with meaningful benefits for functional food applications. WellGen is also in late stage development of a model to prove the same lab-to-man paradigm with a program focused on developing proprietary ingredients for foods that can affect the genes involved in adipocyte (fat cell) development. The objective is to discover functional food ingredients that will combat obesity. WellGen has employed a process that includes gene expression analysis, cell based assays, animal studies and ex vivo human studies to identify potential candidates that will interfere with fat cell development. The lead ingredient in this program has successfully completed that process and will enter a human biomarker study in the third quarter of 2007.
TyRx Pharma, Inc. Announces Presentation of the Results of an In-Vivo Efficacy Study
Regarding PIVIT™ CRM at the May 11th Heart Rhythm Society Meeting in Denver, CO
Monmouth Junction, NJ, (March 19, 2007) -- TyRx Pharma, Inc. announced today acceptance for presentation during the Heart Rhythm 2007 Society meeting, (May 9-12, 2007, Denver, CO) the paper entitled, ?Prevention of Experimental Pulse Generator Pocket Infection by an Encapsulating Antibacterial-Coated Mesh?. Victor Parsonnet, M.D., Director of the Pacemaker and Defibrillator Center in the Department of Surgery at Newark Beth Israel Medical Center (Newark, NJ), Principal Investigator, will present the paper. Dr. Parsonnet was a co-founder of the North American Society of Pacing and Electrophysiology (NASPE) in 1978. Dr. Parsonnet has written more than 700 publications, book chapters and text books, and has made numerous presentations in the fields of cardiac pacing and vascular and cardiac surgery. TyRx Pharma sponsored the study. On October 16th TyRx Pharma, Inc., filed a Premarket Application for PIVIT™ CRM, an innovative mesh pouch coated with TyRx?s proprietary bioresorbable polymer. These polymers contain the antimicrobial agents, rifampin and minocycline, and are designed to enclose a pacemaker or ICD pulse generator when implanted in the body. PIVIT™ CRM acts to provide protection from microbial colonization of the pulse generator during surgical implantation. According to a recent study presented during the Heart Rhythm Society 2006 Scientific Sessions (Boston) the University of Pittsburgh Medical Center noted that the 2003 national incident of infection for pacemakers was estimated to be 5.82% and for ICDs 3.71%. Recent market research indicates that more than 500,000 pulse generators are implanted each year. ?We are excited to be working with renowned individuals such as Dr, Parsonnet,? said Bill Edelman, CEO of TyRx Pharma, ?His study results help to validate the performance of our PIVIT™ CRM concept.?On January 28th, TyRx announced a strategic alliance with C. R. Bard for the licensing of certain TyRx technologies and proprietary know-how and co-development with a Bard subsidiary utilizing TyRx technology and manufacturing know-how with certain products of a Bard subsidiary. On December 6th, TyRx was awarded ISO 9001:2000 and ISO 13485:2003 certification in addition to being certified as compliant with the Canadian Medical Devices Directives (CMDCAS), signifying compliance with internationally recognized standards in design, development and manufacturing of medical products.
Elwin R. Orton
Receives Luther Burbank Award Alexandria, VA (March 2007). Elwin R. Orton is one of 12 outstanding members of the horticultural community who will be honored by the American Horticultural Society (AHS) during its Great American Gardeners Awards Ceremony and Banquet on June 1, 2007. Orton is this year?s recipient of the AHS?s Luther Burbank Award, given for extraordinary achievements in the field of plant breeding. Orton is a researcher and professor at Rutgers University in New Jersey, where he spent many years teaching plant propagation. He also developed the Woody Ornamentals Breeding Program to produce new cultivars with increased winter hardiness, pest and disease resistance, low maintenance needs, and attractive, compact habits. His research has involved intra- and interspecific hybridization among more than 20 species of hollies, six species of Pyracantha, and three species of dogwoods (Cornus spp.), as well as intergeneric hybridization of Franklinia alatamaha and Gordonia lasianthus. Among Orton?s many plant introductions are Ilex opaca ?Portia Orton? and the Stellar? series of hybrid dogwood (C. kousa x C. nuttallii). He considers C. x Venus? from his Jersey Star? series (C. kousa x C. nuttallii), selected as one of the Pennsylvania Horticultural Society?s 2007 Gold Medal Plant Award winners, to be the best large-bracted dogwood he has ever seen. For more information about the AHS?s Great American Gardeners Awards, please contact Jessica Rozmus, Education Programs Coordinator at (703) 768-5700 ext. 137 or jrozmus@ahs.org. Photos are available upon request.
Rutgers Incubators
Help Develop New Food Products (CBS/AP) NJ, (January 7, 2007) -- Goat chops, goat sausage and goat loins aren't appearing on most American menus today, but Jim Lechner is working to change that. The New Jersey goat farmer knows that there's a demand for his meats in the ethnic market, including Muslims seeking halal meat. He's hoping a food "incubator" at Rutgers University will help him sell his product to high-end restaurants and turn his goat meat into a gourmet porduct. Since 2001, the Food Innovation Center at Rutgers has helped develop and refine ideas for new products grown and manufactured in New Jersey. These incubators, so-named because they "hatch" ideas, exist across the country to help food producers keep up with a changing American diet and palate. They offer sophisticated guidance to assist farmers and entrepreneurs with business development plans, market research and focus groups, and in some cases manufacturing. The U.S. Department of Agriculture has awarded $10 million in grants, including $1 million to Rutgers, to provide technical and business development assistance to agricultural producers for new food ventures or to add value to existing ones. In New Jersey, where the food industry is estimated at more than $8.1 billion annually, Rutgers' Food Innovation Center helps small farmers and entrepreneurs develop new products such as organic gelato and fresh-cut asparagus in microwaveable pouches. The center has operated as part of Rutgers for years, ad will get its first dedicated building in 2008. The $7.4 million, 23,000-square foot building, in Bridgeton, will offer food processing equipment, technical and business support services, office space and manufacturing and storage space.
Wise Young, Joachim
Kohn and James Fiordeliso honored at 27th Annual Thomas Alva Edison Patent Award
Dinner Basking Ridge, NJ, (November 2, 2006) -- Three Rutgers researchers were recognized at the festive patent award dinner hosted by the R&D Council of New Jersey. Wise Young, Ph.D, M.D. received The Educator of the Year Award. Dr. Young, founding director of the W.M. Keck Center for Collaborative Neuroscience and a professor at Rutgers is recognized as one of the world's outstanding neuroscientists. Dr.'s Joachim Kohn and James Fiordeliso were recognized for their Biomaterials Patent, "Polyarylate Containing Derivatives of the Natural amino Acid L-tyrosine."
TyRx Pharma, Inc. announces
Submission of a Premarket Application for PIVIT™ CRM, an Innovative Mesh Pouch Designed
To Hold and Reduce Bacterial Colonization of a Pacemaker or Implantable Defibrillator Pulse
Generator (ICD) Monmouth Junction, NJ, (October, 16, 2006) -- TyRx Pharma, Inc. announced today that it has filed a Premarket Application for PIVIT™ CRM, an innovative mesh pouch coated with a proprietary bioresorbable polymer containing the antimicrobial agents rifampin and minocycline designed to enclose a pacemaker or ICD pulse generator when implanted in the body. PIVIT™ CRM acts to provide protection from microbial colonization of the pulse generator during surgical implantation. According to a recent study presented during the Heart Rhythm Society 2006 Scientific Sessions (Boston) the University of Pittsburgh Medical Center noted that the 2003 national incident of infection for pacemakers was estimated to be 5.82% and for ICDs 3.71%. ?We are extremely excited to have reached this value-creating milestone with the filing of a Premarket 510(k) Application for PIVIT™ CRM,? said Bill Edelman, CEO of TyRx Pharma. ?With over 500,000 annual implants of pulse generators, we believe PIVIT™ CRM will become a valuable tool in the effort to suppress microbial colonization of pulse generators during surgical implantation. This is the third in a series of combination medical products that TyRx will launch this year. In July, 2006, FDA granted TyRx 510(k) clearance for PIVIT™ AB, TyRx?s Antimicrobial Surgical Mesh coated with rifampin and minocycline. In December 2005, FDA granted 510(k) clearance for PIVIT™, TyRx?s 1st bioresorbable polymer coated surgical mesh product. The unique properties associated with the PIVIT™ surgical mesh products provide excellent handling characteristics that facilitate precise placement during surgical repair of soft tissue defects, leaving less implant material following the resorption of the bioresorbable polymer coating. According to Infection Control Today (8/2003), the average cost of each infection related to invasive medical devices varies from $34,000 to $56,000; these infections incur an annual financial burden up to $2.3 billion to the American healthcare system. The New England Journal of Medicine (N Engl J Med 2004;350:1422-9) states about half of the 2 million cases of nosocomial infection that occur each year in the United States are associated with indwelling devices. Infections associated with surgical implants are generally more difficult to manage because they require a longer period of antibiotic therapy and repeated surgical procedures. For more information about TyRx, please visit www.tyrxpharma.com.
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Lux Biosciences
Establishes European-Based Operations
JERSEY CITY, N.J.,( Sept. 18) - Lux Biosciences, Inc.,
a privately held biotechnology company specialized in the field of ophthalmic diseases,
today announced that it has established Lux Biosciences GmbH in Frankfurt, Germany as a
wholly owned subsidiary with the mission to create the infrastructure for the company's
European activities. By developing a product pipeline in the US and Europe simultaneously,
Lux intends to create significant synergies in drug and market development. In addition,
this effort builds on Lux's recent milestones, including: 1) securing from its partner
Isotechnika, Inc, an exclusive, worldwide license for LX211, its next generation calcineurin
inhibitor, for ophthalmic treatments; and 2) getting an exclusive, worldwide license with
Rutgers University for access to its polyarylate patent estate for ophthalmic use.
Lux Biosciences
Gains Exclusive Worldwide License for Polyarylate Patent Estate from Rutgers
University for Ophthalmic Use
JERSEY CITY, N.J., (Sept. 13, 2006) - Lux Biosciences, Inc., a privately held biotechnology company specialized in the field of ophthalmic diseases, today announced it has entered into an exclusive license agreement with Rutgers, The State University of New Jersey, to access their polyarylate patent estate. Lux expects to work in partnership with Rutgers to leverage the assets for the treatment of eye diseases affecting the ocular surface or the back of the eye. Potential therapeutic benefits include sustained therapeutic drug levels at or near the site of the disease, resulting potentially in superior efficacy, while limiting systemic exposure to the drug thus potentially minimizing side effects. Additional advantages include continuous drug delivery over long periods of time, increasing patient convenience and compliance. Financial terms of the agreement were not disclosed. "Exclusive access to the Rutgers polyarylate patent estate is a very exciting opportunity for Lux as we pursue novel treatment options for a variety of eye diseases," said Ulrich Grau, Ph.D., president and chief executive officer of Lux Biosciences. "We believe that this technology will provide Lux a competitive advantage in the development of important proprietary ophthalmic therapies that will overcome critical drawbacks of current treatment options." The license includes approximately 10 issued patents and several patent applications as well as use of a combinatorial library of 114 polymers with a range of physical properties. Lux, the Center for Biomaterials at Rutgers University, and the Director of the Center and inventor of the polyarylate technology, Professor Joachim Kohn, will also collaborate in the context of a research agreement. Lux will access the technology, the expertise, and the state of the art infrastructure at the Center to develop bioerodible, polymers capable of eluting drug molecules as a platform for ophthalmic drug products. About the Polyarylate Technology Polyarylates are a family of polymers derived from the naturally occurring amino acid tyrosine (an "aryl" amino acid) and naturally occurring diacids, such as glutaric or adipic acid. The combinatorial library available at Rutgers consists of 114 polymers with varying physical features, such as glass transition temperature which is critical for molding of the polymer into specific shapes. The polymer matrix allows for hydrogen bonding and other stabilizing interactions with the embedded drug molecule and is, thus, also well suited for natural drug products such as peptides. The polymer is bioerodible; when exposed to body fluids it breaks down slowly into the monomeric building blocks (tyrosine derivatives and diacids) and is resorbed. Meanwhile, the embedded drug elutes slowly, providing therapeutic drug levels, for instance over the course of one year, at a near-constant rate. A polyarylate polymer, developed by a Rutgers partner company, has been successfully used as coating of a mesh for hernia repair, and has been cleared by FDA recently. The technology, which has been invented at Rutgers, is covered by a large patent estate with remaining patent life ranging from 2010 to the mid-2020s. About Lux Biosciences Lux Biosciences is a privately held biotechnology company dedicated to the identification, optimization, development and commercialization of products for the treatment of ophthalmic diseases. More information on Lux Biosciences can be found at www.luxbio.com.
WellGen, Inc. Appoints Dr. Kathleen P. Mullinix as New Chief Executive Officer
NEW BRUNSWICK, NJ (September 14, 2006) - WellGen, Inc., a biotechnology company using nutrigenomics to discover and develop food ingredients for wellness products, today announced the appointment of Dr. Kathleen P. Mullinix as its new President and Chief Executive Officer. She succeeds Dr. David A. Evans, who passed away suddenly on June 1, 2006. Dr. Mullinix brings more than 30 years of industry experience to the CEO position at WellGen. Her background encompasses significant achievements in the biotechnology industry and considerable management experience in the corporate, government and academic sectors. She has been a successful entrepreneur throughout her career and has launched multiple successful ventures. Richard Laster, Chairman of WellGen, said, ?We are very pleased to have attracted someone with the skills and talent of Kathleen Mullinix to lead WellGen forward at this crucial stage in its development. Through our licenses, research and patents, WellGen is developing a stable of highly promising bioactive ingredients for the food, therapeutics and dietary supplements markets. Dr. Mullinix?s deep knowledge in the field of biotechnology and experience in intellectual property will be instrumental in helping the Company achieve its goals of bringing its unique product benefits to market.? WellGen holds exclusive licenses to technology that can identify health and wellness benefits of foods and food ingredients related to the expression of certain genes. WellGen also has license to a wide range of food and plant-based bioactive substances for the prevention and treatment of disease. The Company has a growing intellectual property estate that includes issued patents and numerous pending patent applications, all of which are related to its mission of using its nutrigenomics technology platform to identify proprietary compounds that affect certain genes that the company has targeted. WellGen is developing its compounds that are based on scientific evidence for multiple uses related to enhancing and maintaining wellness. Prior to joining WellGen, Dr. Mullinix advised investors on biotechnology and pharmaceutical business opportunities with her company Kathleen P. Mullinix & Associates, which she founded in 2002. Before that, Dr. Mullinix served as the founder, chairman, CEO and president of Synaptic Pharmaceutical Corporation. There she led the company from its inception as she developed and implemented the company?s strategies for scientific research, business and intellectual property, making it a research-driven public biotechnology company and then an emerging pharmaceutical company. Before founding Synaptic Pharmaceutical, Dr. Mullinix served for six years as vice provost for Columbia University. In this role, she brought Columbia to a leadership position in the commercial development of university intellectual property assets. Additionally, she was instrumental in the development of The Audubon Research Park that has transformed the Columbia Presbyterian Medical Center?s Washington Heights neighborhood. From 1972-1981, Dr. Mullinix held two positions with the National Institutes of Health, and served the organization by assisting with strategic matters involving the scientific direction of the NIH intramural program and implementing a novel research program in molecular biology. Dr. Mullinix holds a Bachelor of Arts degree in Chemistry from Trinity College, a Ph.D. in Chemical Biology from Columbia University and was a National Institutes of Health Postdoctoral Fellow at Harvard University. She currently serves on the Board of Directors of The Jackson Laboratory, Cylex, a privately held diagnostics company and Intellect Neurosciences, Inc., a privately held biotechnology company. About WellGen WellGen, Inc., based in New Brunswick, NJ, is a biotechnology company that is discovering and developing products for food, therapeutics, and dietary supplement markets. WellGen's technical platform is a method of screening the effect of food and related substances on the expression of genes associated with human health conditions. The company has developed proprietary substances that help reduce risk and severity for a variety of diseases. Please visit www.wellgen.com for more information.NanoDynamics Broadens Nanotech Toolkit with Nine Plasma Synthesis Patents from Rutgers University NEW YORK CITY, NY (May 17, 2006) - NanoDynamics, Inc. announced at NanoBusiness 2006, the NanoBusiness Alliance Conference, that it has licensed nine issued and pending patents from Rutgers, The State University of New Jersey, covering an innovative low-energy route to plasma-based synthesis as well as products enabled by the versatile technique. An innovative variation on the widely used materials processing technique for producing coatings and structural parts, the new plasma process reduces energy consumption by more than 50 percent. A leading nanomaterials and nanotechnology manufacturing company, NanoDynamics plans to commercialize the technique and assess resulting material characteristics for a variety of commercial products including durable, wear-resistant parts, high-efficiency LED lighting and tougher ceramics for lightweight combat armor. "Nanotechnology in its most fundamental form is the manufacture and manipulation of materials at the atomic scale. From precipitation techniques to vapor deposition, it is the process and tools for engineering at that level that form the critical platform for developing new materials and products. This enabling plasma synthesis technique broadens NanoDynamics? proprietary toolkit for delivering commercial-grade products from basic nanomaterials to unique nanostructures that have significance on the performance of high value products much further up the supply chain,? said Keith Blakely, CEO of NanoDynamics. With the widest range of applications of any thermal spray technique, plasma spraying is a broadly applicable tool for producing a dense coating of a variety of materials including metals, ceramics, polymers and composites. The spraying method involves melting powdered materials in a jet of plasma gas heated to temperatures greater than 5,000?C. The plasma gas propels the molten powder toward the substrate where the material cools to form a dense, strong deposit layer. Much of the energy expended in the conventional plasma spray process is spent inefficiently heating the plasma gas to those extreme temperatures. In contrast, NanoDynamics? newly licensed technique reduces wasted energy by concentrating heat on the material itself rather than the plasma gas carrier. In addition to making plasma spray processes more efficient for conventional uses, the low-energy technique allows for novel material combinations which result in entirely new uses for the coating process. ?A low-energy plasma spray technique is key to the commercial viability of nanostructured ceramics,? said Bernard Kear, Ph.D., professor and director of Rutgers' Center for Nanomaterials Research. "This process represents a significant advancement in plasma spray science." The market for coatings is growing at an annual rate of about 4.8 percent, according to the market analyst firm Freedonia Group, and will reach more $4.8 billion in US sales by 2009. In the ceramic coatings market, a $1.1 billion market it itself, according to BCC Research, plasma spray coatings account for more than 62 percent of the market. In 2004, this represented about $690 million in US sales, but is expected to reach more than $1 billion by 2009. In order to address these markets, NanoDynamics intends to employ the plasma spray method to expand its product offerings in a variety of areas, including improved soldier survivability. With today?s average soldier carrying up to 140 pounds of materiel with insufficient ballistic protection, reducing that load while improving protection represents a significant need. Already well into development on a solid oxide fuel cell that provides light-weight, portable power, NanoDynamics will employ the plasma technique to synthesize proprietary ceramics for use in developing lighter, tougher combat armor.
NanoDynamics also plans to use the Rutgers technology to prepare florescent nanomaterials for high-efficiency LED
(light-emitting diode) lighting. With characteristic durability, low heat and long-life, LEDs are a promising replacement for
older lighting technologies such as fluourescent and incandescent. LEDs are expected to increasingly shift from niche applications
into the approximately $12 billion general illumination market within the next five years. However, the materials used today to
make the white LEDs needed for homes and offices emit an excess of ultra-violet light, which results in a lower-efficiency light
output and degrades the lights? plastic housing over time. By employing the new technique to incorporate florescent nanomaterials in
inorganic materials, NanoDynamics can produce a commercially viable lighting package technology that increases light output and LED life.
About NanoDynamics
NanoDynamics is a diversified technology and manufacturing company utilizing nanoscale engineering to address some of the world's
biggest challenges. With nano-enabled solutions in the fields of energy, water processing, life sciences, electronics, advanced materials and consumer products, NanoDynamics is committed to delivering the power of nanotechnology to the global marketplace. For more information, visit the company's website at www.nanodynamics.com
Rutgers OTC honored 48 researchers at
Patent Award Dinner
Rutgers OTC hosted the 6th Biennial Patent Award dinner held on at Winnants Hall, New Brunswick, New Jersey on April 18th. The event begin with a cocktail reception followed by dinner and an awards reception. Presenters included Ececutive Vice President, Phillip Furmanski; Associate Vice President, Michael Breton; and Director, William Adams. This year's event honored Rutgers researchers who had a patent issue in calendar years 2004 and 2005. FDA Approves First Medical Devise Using Rutgers Biomaterial NEW BRUNSWICK/PISCATAWAY, N.J. (January 3, 2006) - Rutgers scientists and TyRx Pharma, Inc., have announced the Food and Drug Administration’s clearance of a new medical device for hernia repair that incorporates a biodegradable technology developed at the university. This action signals a paradigm shift in the application of biomaterials from permanent prosthetic replacements toward regenerative medicine, in which materials help the body to repair itself and are then resorbed. The device consists of a surgical mesh coated with a polymer developed using a Rutgers bioresorbable technology. The polymer gives the surgical mesh improved handling characteristics that facilitate precise placement during the surgical repair and leave less implant material following the resorption of the coating. Hernias occur when musculature fails and one part of the body protrudes through the resulting gap or opening into another part of the body. And although a hernia can theoretically develop almost anywhere, most are in the groin and abdominal areas. The partially degradable device has been developed and will be marketed by TyRx Pharma, Inc., a medical device company founded in 1998. “The company’s early research was conducted at the Rutgers-based New Jersey Center for Biomaterials (CBM) in Rutgers’ chemistry laboratories,” said Joachim Kohn, CBM director and Board of Governors Professor of Chemistry and Chemical Biology at Rutgers, The State University of New Jersey. “This is an example of a close and strong academic-industry interaction that led to a relatively fast entrance of the product into the medical market.” Kohn pointed out that the technology was invented in 1997 and has progressed along a fast and efficient track to FDA approval – a process that usually takes 10 years or more.The invention was made with initial research support from the National Institutes of Health and demonstrates how a federal agency’s funding can reap benefits for the American public. On a local level, the company and the invention from which it grew have already led to economic benefits for New Jersey through the creation of some 30 new jobs. “There are only a handful of synthetic, degradable polymers that have an FDA approval history – therefore, the approval of the TyRx device employing a new biomaterial represents a major breakthrough for regenerative medicine,” Kohn said. The novel tyrosine-based polyarylates, as they are known chemically, arose from an adaptation of combinatorial chemistry to biomaterials. “Our approach uses two sets of starting materials that are combined with each other in all possible combinations,” Kohn said. “In this way, we can create a large variety of related polymers from a small number of initial starting materials.” The result in this case was a library of 112 structurally related materials created in parallel, each one potentially useful in a wide range of medical implant applications. TyRx has licensed this entire library of polyarylates from Rutgers and has now, as a first application, identified one of these polymers for the hernia repair device. The New Jersey Center for Biomaterials, based at Rutgers, is a cooperative research initiative sponsored by Rutgers, the University of Medicine and Dentistry of New Jersey and New Jersey Institute of Technology. TyRx Pharma, Inc. designs, develops and commercializes innovative combination medical devices and drug delivery products using patent protected tyrosine-derived polyarylates. |
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