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February 7, 2008 Center for Military Biomaterials Research Sparks New Frontline Wound Treatment
January 30, 2008 Rutgers Biomaterials Technology Enables New Device for Reducing Bacterial Infection of Implants
October 19, 2007 Rutgers Biomaterial Debuts in Clinical Trials of New Stent
September 20, 2007 Lux Biosciences to Present at 2007 UBS Global Life Sciences Conference
August 13, 2007 REVA Medical Announces Enrollment of First Patients in the RESORB Clinical Trial
September 20, 2006 LUX Biosciences Gains Exclusive Worldwide License for Polyarylate Patent Estate from Rutgers University for Ophthalmic Use
May 29, 2006 Lux Biosciences Raises $36 Million in Series A Financing and Signs Agreement for Advanced Clinical Stage Product
January 3, 2006 FDA approves first medical device using NJCBM biomaterial
March 29, 2005 SurModics Obtains Exclusive Rights from Rutgers University to Biodegradable Polymers for Ophthalmology
March 10, 2005 Apogee Begins Test and Research Initiative for MEMS-Based Medical Device with University of Medicine and Dentistry New Jersey
February 1, 2005 Osteotech Enters into License Agreement with Rutgers Advancing Osteotech's Plexus Technology Program
November 23, 2004 Rutgers-developed Biomaterial Drives a Technology Transfer Story Toward Success
Nov. 23, 2004
NEW BRUNSWICK/PISCATAWAY, N.J. - The New Jersey Center for Biomaterials has generated what it hopes to be the beginning of a technology transfer success story that originated through the work of Rutgers University Professor Joachim Kohn in his search for improved biomaterials.
Kohn’s new biomaterial is a bioresorbable polymer. It was exclusively licensed early in 2004 by Rutgers’ Office of Corporate Liaison & Technology Transfer to a private medical device company, REVA Medical, Inc. (San Diego, Calif.), for incorporation into REVA’s stent devices. Stents are tiny tubular-shaped scaffolds that are inserted into diseased arteries to keep them open. The market for such devices currently exceeds $5 billion per year.
Scientists at REVA Medical and at Kohn’s Rutgers Laboratory collaborated to choose polymer compositions that would be ideally suited for use in the REVA stent. This process is usually a long and costly research project. With methods of combinatorial synthesis and computer modeling, however, Kohn’s group identified a promising polymer composition in an exceptionally short time.
Based on both the rapid development from concept to prototype, and the early success of pre-clinical studies, Boston Scientific Corporation (Natick, Mass.), the world’s leading stent company, announced on Nov. 16, 2004 that it had entered into a strategic alliance with REVA Medical. This alliance included a significant investment in REVA Medical.
“We regard REVA’s relationship with Boston Scientific as a pivotal chapter in our technology transfer initiative,” said Kohn, Board of Governors Professor of Chemistry and Chemical Biology at Rutgers and director of the center. “REVA has stent designs that add to the mechanical strength of our polymer, and with Boston Scientific’s involvement, we are hopeful the successes we have seen will continue and grow.”
REVA Chairman Bob Stockman said, “REVA’s close collaboration with Rutgers is the ideal example of industry sponsoring research on cutting edge technology developed in academia. The brilliance and productivity of Professor Kohn and his laboratory staff will contribute substantially to the ultimate commercialization of our bioresorbable stents.”
REVA President Bob Schultz added, “We undertook a careful and exhaustive search for an ideal polymer to suit our product specifications for durability, safety, uniqueness, and other critical properties in designing a next generation stent product. We worked closely with Professor Kohn and his group in selecting polymers and processes that would improve the material. They delivered beyond our expectations.”
Speaking for his research team, Kohn said, “We are grateful for the funding obtained through the National Institute of Biomedical Imaging and Bioengineering. This technology transfer story is an example of how NIH-funded research can move forward rapidly to contribute to improving health through application of basic sciences.”
February 1, 2005
EATONTOWN, N.J., Feb. 3 /PRNewswire-FirstCall/ -- Osteotech, Inc.
(Nasdaq: OSTE) announced today that on February 1, 2005, it entered into a
License Agreement with Rutgers, the State University of New Jersey ("Rutgers")
for a polymer class developed at Rutgers, for use as part of the Plexus
Technology under development at Osteotech. Osteotech will pay Rutgers an
initial license fee of $50,000 within 30 days and will pay an additional
$250,000 upon the completion of the first two milestones specified in the
Agreement, but no later than 270 days from February 1, 2005. The Agreement
also calls for additional payments, aggregating $350,000, which are to be made
as each of three additional milestones are completed. Further, commencing no
later than 270 days after the effective date of the Agreement and continuing
until commercialization of the first product in a major market, the Company is
required to make quarterly minimum license maintenance fee payments to
Rutgers. Upon commercialization of products, Osteotech will pay Rutgers the
greater of royalties or the minimum license maintenance fees.
Mr. Richard W. Bauer, Osteotech's Chief Executive Officer stated, "We are
very pleased to enter into this Agreement with Rutgers University because it
represents a major milestone towards Osteotech being able to complete
development of and ultimately commercialize our Plexus Technology in a variety
of orthopaedic product applications utilizing donated musculoskeletal
allograft tissue. We consider Plexus a breakthrough technology for the
Company on a comparable scale to Grafton(R) DBM, which was introduced in the
early 1990's and completely revolutionized the concept of delivering
demineralized bone to the operative site while having a significant and
positive impact on the Company's operating income."
Mr. Bauer continued, "The Plexus Technology embodies a broad range of bone
and polymer composites that remodel into the patient's host bone while
satisfying the strength requirements of the most demanding weight-bearing
product applications. These performance benefits and the ability to mold
Plexus constructed graft implants into virtually any shape and size, will make
them the products of choice for surgeons' spinal and general orthopaedic
applications since the products will transform into the patient's host bone to
a degree unattainable by currently available allograft bone products alone,
metal or polymer implants. This means better and faster fusions for the
patient and surgeon when compared to existing industry graft implant
technology."
Mr. Bauer further stated, "In addition to the benefits to patient and
surgeons, the Plexus Technology also provides benefits to donor families.
Because of the performance requirement of bio-implants and how they are
currently produced, many donors cannot be utilized, and for those utilized, a
certain amount of waste occurs due to cutting and shaping. The Plexus
Technology, because of its ability to be molded, assures that all donors
procured can be utilized with a minimum of waste. This means that Osteotech
will be able to maximize the gift of donation which has been so unselfishly
given at the time of great personal loss to the donating family."
Mr. Bauer concluded, "The Plexus technology is proprietary to Osteotech
and is presently covered by ten patents issued and eight patent applications.
The Plexus development project is fully funded in 2005. The Company has
completed its feasibility work and is now moving into product development and
pilot manufacturing. Safety and performance studies on final formulations
utilizing our anticipated manufacturing process will be initiated this year.
The Company expects to meet with the FDA in early 2006 to discuss our
regulatory approval plan. We look forward to discussing this exciting
opportunity during our fourth quarter earnings conference call which will be
announced shortly."
Certain statements made throughout this press release that are not
historical facts contain forward-looking statements (as such are defined in
the Private Securities Litigation Reform Act of 1995) regarding the Company's
future plans, objectives and expected performance. Any such forward-looking
statements are based on assumptions that the Company believes are reasonable,
but are subject to a wide range of risks and uncertainties and, therefore,
there can be no assurance that actual results may not differ materially from
those expressed or implied by such forward-looking statements. Factors that
could cause actual results to differ materially include, but are not limited
to, our ability to successfully complete development of the Plexus Technology
and to commercialize products utilizing this technology, differences in
anticipated and actual product and service introduction dates, the ultimate
success of those products in the market place, the continued acceptance and
growth of current products and services, the impact of competitive products
and services, the availability of sufficient quantities of suitable donated
tissue and the success of cost control and margin improvement efforts which
factors are detailed from time to time in the Company's periodic reports
(including the Annual Report on Form 10-K for the year ended December 31, 2003
and the Form 10-Q for each of the first three quarters of 2004) filed with the
Securities and Exchange Commission. All information in this press release is
as of February 3, 2005 and the Company undertakes no duty to update this
information.
Osteotech, Inc., headquartered in Eatontown, New Jersey, is a leading
provider of human bone and bone connective tissue for transplantation and an
innovator in the development and marketing of biomaterial and implant products
for musculoskeletal surgery. For further information regarding Osteotech or
this press release, please go to Osteotech's website homepage at
http://www.osteotech.com and to Osteotech's Financial Information Request Form
website page at http://www.osteotech.com/finrequest.htm.
JERSEY CITY, NJ (May 25, 2006): Lux Biosciences, a privately held biotechnology company specialized in the field of ophthalmic diseases, today announced the close of a $36 Million Series A Financing. The Series A Financing included equal participation of funds managed by HBM Partners AG, Novo A/S, and SV Life Sciences. As part of the transaction, Axel Bolte, investment advisor at HBM Partners, Thomas Dyrberg, M.D., Ph.D., partner at Novo A/S, and Lutz Giebel, Ph.D., general partner at SV Life Sciences, will join the Lux Biosciences board.
The company also announced that it had signed a worldwide license agreement with Isotechnika, Inc. (TSX: ISA) granting Lux exclusive worldwide rights to develop and commercialize Isotechnika's flagship Phase 3 product candidate ISA247, a next-generation calcineurin inhibitor, for the treatment and prophylaxis of all ophthalmic diseases. Lux plans to initially develop ISA247 as a treatment for uveitis, an inflammatory eye disease, but believes this compound offers a varied pipeline of product opportunities addressing important unmet medical needs within the ophthalmic field.
"We are very pleased to gain financing from these top venture investors and at the same time complete a major license agreement,” said Ulrich Grau, Ph.D., president and chief executive officer of Lux Biosciences. “Funding from this outstanding group of investors validates the strength of the Lux business strategy, product pipeline and management team. It also provides resources for moving our late-stage product candidate, ISA247, into human pivotal studies by early 2007, and will further support the advancement of additional product programs addressing important medical needs in ophthalmology."
Lutz Giebel, Ph.D., general partner at SV Life Sciences, commented, “The ophthalmology market is poised for major growth, analogous to what has happened in recent years in the field of rheumatology, as greater understanding about inflammation and new therapeutics that address the underlying disease process become available. I and my co-investor colleagues of HBM and Novo A/S believe that Lux Biosciences is well positioned for success within that space as a company with late-stage product opportunities that offer relatively near term commercialization potential and are addressed to major under-served market needs. Moreover, Lux benefits from a management team with exceptional expertise in drug development generally, as well as specific experience within the ophthalmic space."
About ISA247
ISA247 is a next-generation calcineurin inhibitor. The molecule has been studied in a randomized, double-blind, placebo-controlled Phase 3 clinical trial in moderate to severe plaque psoriasis in which it demonstrated an excellent efficacy profile, coupled with what appears superior safety compared to other calcineurin inhibitors (e.g. tacrolimus or cyclosporine A). Thus, ISA has the potential to become the calcineurin inhibitor of choice. Calcineurin inhibitors are the mainstay of immunosuppressive regimens for organ transplantation and a variety of autoimmune diseases.
Isotechnika is currently initiating additional Phase 3 trials in psoriasis and is conducting a phase 2b study for the prevention of rejection in solid organ transplantation. Lux initially plans to develop an oral form of ISA247 as a potential treatment for posterior, intermediate and panuveitis, a serious and potentially sight-threatening inflammatory disease of the eye. The company further believes that ISA247 has potential in several ophthalmic indications and as such represents a pipeline of product opportunities in the ophthalmic field.
Isotechnika and Lux are conducting a joint conference call and webcast regarding the alliance on ISA247at 9:00 a.m. EST/ 7:00 a.m. MT. The webcast may be accessed at http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=1497760.
Read the full press release.
January 3, 2006 -- A hernia repair device using a polymer from NJCBM's combinatorial library of polyarylates has received FDA approval for marketing.
This is an extremely exciting milestone and a major breakthrough given the fact that so few new degradable polymers enter into clinical use. The event 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, developed by TyRx Pharma, Inc., consists of a surgical mesh coated with a polymer which 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 New Jersey Center for Biomaterials (CBM) in Rutgers’ chemistry laboratories,” said Joachim Kohn, NJCBM director. “ 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.” 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. The novel tyrosine-based polyarylate, as it is 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 NJCBM and has now, as a first application, identified one of these polymers for the hernia repair device.
Click here for the Rutgers press release.
March 29, 2005
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--SurModics, Inc. (Nasdaq:SRDX), a leading provider of surface modification and drug delivery technologies to the healthcare industry, announced today that it has obtained an option to acquire an exclusive license from Rutgers, The State University of New Jersey, to two classes of biodegradable polymers for use in site specific delivery of drugs to the eye. These polymer families were developed by Dr. Joachim Kohn, Director of the New Jersey Center for Biomaterials and Professor at Rutgers.
"SurModics continues to expand our technology offerings in ophthalmology following our acquisition of InnoRx earlier this year," said Bruce Barclay, President and COO of SurModics. "By combining these polymer families with the drug delivery platform technologies acquired from InnoRx, we expect to be able to deliver a wide variety of drugs and other bioactive agents to the eye, treating such serious diseases as age related macular degeneration (AMD) and diabetic macular edema (DME), two of the leading causes of blindness in adults today, as well as glaucoma. This relationship with Rutgers demonstrates our commitment to offering leading-edge proprietary technologies to our customers for this important market."
"We are very pleased to enter into this agreement with SurModics, and I believe the company is particularly well suited to exploit our polymers in the ophthalmology market following its acquisition of InnoRx," stated Professor Kohn. "I am very impressed with both the technical ability of the scientific team at SurModics, and the company's proven track record of success."
SurModics now has seven distinct families of polymers available for use in site specific delivery of drugs to the eye. The two polymer classes from Rutgers join the two biodegradable polymer families, PolyActive(TM) and OCTODEX(TM), licensed by SurModics from OctoPlus, a company based in the Netherlands. In addition, SurModics' internally developed polymer families - Bravo(TM), Encore(TM) and Accolade(TM) - are available for this application. SurModics' existing Bravo(TM) Drug Delivery Polymer Matrix, a critical component of the CYPHER(R) Sirolimus-eluting Coronary Stent from Cordis Corporation, a Johnson & Johnson company, has been implanted in over 1,000,000 patients worldwide. The Bravo(TM) matrix is also used in the ophthalmic drug delivery system currently being developed by SurModics.
Biodegradable polymers have the ability to be combined with one or more drugs and applied to a medical device, or administered alone with a drug, yet are naturally degraded in the body over time. Both of the licensed polymer families from Rutgers, known as polycarbonates and polyarylates, are derived from the amino acid tyrosine, a naturally occurring substance in the body and have been under extensive evaluation by others for various applications.
The polycarbonates are a biodegradable, multiblock, polymeric drug delivery system based on two well-known polymers. Their biodegradability, extensive safety record, benign degradation products and tunable release properties make them an excellent choice for the controlled release of hydrophobic small molecule drugs. In addition, the polycarbonates are the class of polymers used by REVA Medical, Inc. in the development of a bioresorbable drug eluting stent. REVA and Boston Scientific announced a strategic alliance between their two companies late last year.
The polyarylates represent a delivery system for the controlled release of small molecules as well as proteins and other large molecules. Both polycarbonates and polyarylates have been extensively evaluated to demonstrate their safety. Further, it has been shown that these polymers can be made into durable films, coated onto medical devices and used to deliver a variety of large and small molecules with tunable elution rates.
About SurModics, Inc.
SurModics, Inc., a leading provider of surface modification and drug delivery solutions, licenses its patented technologies to medical device, diagnostics, pharmaceutical and biotechnology companies around the world. A significant portion of SurModics' revenue is generated through royalties on the sale of coated products. SurModics' Internet address is www.surmodics.com.
About Rutgers University
Established in 1766, Rutgers is America's eighth oldest institution of higher learning and one of the nation's premier public research universities. Serving more than 50,000 students on campuses in Camden, Newark and New Brunswick/Piscataway, Rutgers offers more than 280 bachelor's, master's, doctoral and professional degree programs. The university is home to 29 degree-granting schools and colleges, and more than 150 specialized centers and institutes. With 320,000 living alumni, Rutgers graduates are major contributors to all sectors of contemporary life.
About Professor Joachim Kohn
Professor Joachim Kohn is a Board of Governors Professor of Chemistry and Chemical Biology at Rutgers and an Adjunct Associate Professor of Orthopedics at the New Jersey Medical School. He currently serves as director of the New Jersey Center for Biomaterials. He is a fellow of the American Institute for Medical and Biological Engineering (AIMBE) and served as the secretary-treasurer of the Society for Biomaterials. He is the principal investigator of an NIH funded postdoctoral training program in tissue engineering and implant science. His research interests focus on the development of new biomaterials for prostheses, implantable drug or gene delivery systems, and tissue regeneration scaffolds. He has published 200 scientific manuscripts and reviews, and is an inventor on 37 patents.
Forward Looking Statements
Certain statements contained in this press release may be deemed to be forward-looking statements under federal securities laws, and SurModics intends that such forward looking statements be subject to the safe harbor created thereby. Factors that may cause actual results to differ from the forward-looking statements include those described in the "Risk Factors" and other sections of SurModics' filings with the Securities and Exchange Commission. SurModics does not undertake an obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: SurModics, Inc.
Phil Ankeny, 952-829-2700
Joint Study of Transdermal Drug Delivery Device Engineering Samples Advances Solution toward Commercialization
NORWOOD, Mass.—(BUSINESS WIRE)—March 10, 2005— Apogee Technology, Inc. (AMEX:ATA), a global provider of silicon-based innovations for specialized commercial applications, announced it has signed an agreement with the University of Medicine and Dentistry New Jersey's (UMDNJ) Laboratory for Drug Delivery to conduct research and testing on the company's proprietary, MEMS-based transdermal drug delivery device.
Apogee selected the Laboratory for Drug Delivery at UMDNJ to study the compatibility of representative large molecule drugs with Apogee's patent-pending transdermal solution. The device is designed to be part of an alternate delivery solution for new and existing large molecule drugs currently used to treat various conditions, such as diabetes, infectious disease, acute pain and chronic pain. Completion of preliminary studies by UMDNJ is expected by year-end, followed by the testing of Apogee's solution for use with selected target drugs for commercialization in 2007.
"Apogee Technology is rapidly moving forward in developing our drug delivery solution, and we know the experts at UMD New Jersey are the right team to help us create the best product available," said Dr. Nevenka Golubovic-Liakopoulos, Manager of New Product Development for the MEMS Division at Apogee Technology. "This technology has the potential to open new markets for drugs and delivery methods not yet in use beyond trials, so it's not only a meaningful solution for health care but also could be a growth driver for Apogee as a technology innovator."
According to a recent Research and Markets report, the market value for transdermal drug delivery is projected to be $12.7 billion in the year 2005 and is expected to increase to $21.5 billion in the year 2010. Apogee has designed its transdermal delivery device on a micro-electromechanical systems (MEMS) platform. It offers multiple benefits in the use of proteins, vaccines and other large-molecule pharmaceuticals that currently provide therapies for the management of disease and chronic pain conditions.
MEMS devices, which are produced using high-volume semiconductor manufacturing techniques, surpass standard ICs in functionality due to the presence of very small mechanical devices, such as microphones and accelerometers, that sense and interact with the outside world. The extraordinary size reduction, system integration, improved reliability and performance afforded by MEMS technology deliver enormous value in a wide range of markets and applications, including automotive airbag systems, large screen televisions, inkjet printers, blood pressure sensors, hearing aids and optical switches.
"Participating in this leading-edge industry research with Apogee Technology is an exciting opportunity for our faculty and students to contribute value to a real-world application that could bring relief to millions of people," said Dr. Bozena Michniak, Director of Laboratory for Drug Delivery at UMDNJ. "We anticipate that combining our drug delivery expertise and perspective in drug properties with Apogee's technological insight and inventions will increase the likelihood of success for a new type of delivery mechanism that will benefit patients and the pharmaceutical and healthcare communities."
Apogee Technology's acquisition of MEMS intellectual property in 2004 has enabled accelerated design and development of products for worldwide markets. Since acquiring the IP portfolio, Apogee has quickly advanced the existing product design for a viable transdermal drug delivery solution. In November 2004, Apogee received the first engineering samples for its advanced design and those are now being tested at the Laboratory for Drug Delivery at UMDNJ. Other MEMS-based products now in development at Apogee are intended to address industrial and automotive sensor applications, with anticipated shipments in the second half of 2005.
About Apogee Technology, Inc.:
Apogee Technology is a fabless semiconductor company that designs, develops and markets silicon based products that incorporate proprietary technologies. The Company's patented all-digital, high efficiency Direct Digital Amplification (DDX(R)) technology has been used by over 20 major consumer electronic brands in a wide range of audio products with over 30 million ICs sold. The company is developing new System-on-Chip (SOC) products using its analog and digital circuit designs, and proprietary Micro-Electromechanical Systems (MEMS) technology and manufacturing processes for the consumer, automotive, communications and medical markets. The Company operates a worldwide marketing and sales organization and has offices in the US, Hong Kong and Japan. For more information please visit our web site at: http://www.apogeeddx.com.
About the Laboratory for Drug Delivery, UMDNJ:
The New Jersey Center for Biomaterials is dedicated to improving patient care and public health through the development and commercialization of future generations of biomaterials. Since 1997, the Center has been building a nationally recognized resource in biomaterials and Biomaterials Science with a major emphasis on industrial interactions. The Center's scientific focus is on design, synthesis, characterization and fabrication of new materials for tissue engineering and drug delivery and on understanding cell-material interactions to develop new medical implants and devices. As a formal consortium of New Jersey's premier public institutions of higher education working closely with industry, the Center coordinates academic, technical and clinical resources to:
-- Stimulate innovative basic and applied research in biomaterials science
-- Foster novel and productive research teams and partnerships to address the cutting edge challenges in biomaterials science
-- Support shared core facilities to enhance collaborative inter-disciplinary inter-institutional research
-- Serve as a focal point for biomaterials education and professional development
-- Facilitate technology transfer and the commercialization of innovative materials for biomedical applications.
DDX(R) is a registered trademark of Apogee Technology, Inc. All other product names noted herein may be trademarks of their respective holders. Certain statements made herein such as, but not limited to with respect to chronic pain, anxiety, depression and other conditions and those sections that use the words "anticipate," "hope," "estimate," "project," "intend," "plan," "expect," "believe" and similar expressions are intended to identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve known and unknown risks and uncertainties, which could cause the actual results, performance or achievements of the company to be materially different from those that may be expressed or implied. Please refer to the company's risk factors as set forth in the company's filings with the Securities and Exchange Commission, including its reports on Forms 10-KSB and 10-QSB.
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