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THE MEDICAL TECHNOLOGY DATABASE
 
April 25th through July 18th, 2005
 
 

MEDICAL TECHNOLOGY JOURNAL
July 18th, 2005
 
 
 
CRYO-CELL International, Inc. (OTC:CCEL) (BULLETIN BOARD: CCEL), a company that provides blood cord storage services for new-borns, a stem-cell technology that has promise to protect these same new-borns from disease years in the future, reported that its revenue increased 12 percent for the quarter ended May 31, 2005. Revenue for the second quarter was $3.6 million compared to $3.2 million for the same quarter a year ago.
 
CRYO-CELL, located in Oldsmar, Florida, presently has over 80,000 clients and is accredited by the American Association of Blood Banks (AABB). The company reports that it operates in a Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP) compliant facility.
 
 
NutraCea (OTC:NTRZ) (BULLETIN BOARD: NTRZ) is bringing its FlexProtex COX-2 inhibitor product to market via an infomercial campaign to be broadcast on ITV Direct. The new product is for the treatment of arthritis and joint inflammation. The infomercial is scheduled to air in the United States on ITV direct on July 21, 2005.
FlexProtex is based on stabilized rice bran derivatives and other ingredients known as natural COX-2 inhibitors. The company indicates that the mechanism of COX-2 inhibition is also the basis for a number of pharmaceutical drugs.
 
Patricia McPeak, Founder and CEO of NutraCea, gave her reasons for the selection of ITV as the market avenue, "We selected ITV Direct because of their historical success in bringing dietary supplements to market and to introduce our novel stabilized rice bran products, such as FlexProtext, to the entire nation. Backed by many years of research and patents, which give us a unique positioning in the marketplace, we're very proud to be able to offer such high quality products at very reasonable prices by using the medium of direct-to-consumer selling."
 
NutraCea is focused on the development of nutraceuticals for natural arthritic relief and the lowering of cholesterol and all-natural "cosmeceutical" beauty aids. The company has also been in the news to provide low-cost nutrition to the world’s malnourished through the use of rice bran.
 
 

BrainCells Inc., oriented towards solving central nervous system diseases, has announced that it has closed a $17.7 million Series A round of funding. Lead investors in the round included Technology Partners, Oxford Bioscience Partners, and Bay City. The lead investors as well as the other investors on completion of certain milestones by BrainCells are expected to invest another $9.7 million.

THE MEDICAL TECHNOLOGY JOURNAL
July 15th, 2005
 
 
Vitae Pharmaceuticals announced that it has secured $15 million in equity financing as a result of its licensing and development agreement with GlaxoSmithKline. The company indicated that the funding was a result of the fact that it had met conditions of the closing, which included Federal Trade Commission clearance under the Hart-Scott-Rodino Act.
 
Vitae and GlaxoSmithKline entered into their alliance in June of 2005. That agreement was to develop and commercialize drug compounds used for the treatment of hypertension and related cardiovascular disorders. Intel Corporation, better known for its microprocessors, has collaborated with Vitae in the design of its drugs.

 
 
NanoViricides, Inc. (Pink Sheets:NNVC), a company that is developing a technology that selectively destroys viruses, and initially focused on the AIDS virus, has announced that the conditions of its Series A Convertible Debenture to be offered to select investors.
 
Eugene Seymour, MD, CEO, on announcement of the terms, indicated that the financing would enable the company to complete its HIV work, "The financing, when completed, is anticipated to be sufficient to allow the Company to complete its HIV drug Hivicide 1 preclinical work, and bring it to the point of applying for an IND with the Food and Drug Administration."

 
 
Kodak's Dental Systems Group, as part of its imaging and practice management system operations, now offers USB 2.0 connectivity for its KODAK 1000 Intraoral Video Camera System. The USB connection offers dentists the capability to easily interface the camera to a wide range of computer peripherals and PCs, simplifying the installation process and allowing dentists in multi-office environments to share in the costs and benefits of the KODAK 1000 system. According to Paul Tucker, Dental Market Manager at Kodak's dental systems group, "Our improved intraoral video camera delivers a streamlined, digital option our customers can use to quickly and easily acquire video images and access them from their desktops. We're pleased to add this new camera system to our growing portfolio of integrated digital imaging systems."
 
The KODAK 1000 System, besides not requiring any needed hardware to install, also comes with KODAK Dental Imaging Software version 6.0.5 to simplify image acquisition and management tasks.
 
 
THE MEDICAL TECHNOLOGY JOURNAL
July 14th, 2005
 
 
 
Solexa, Inc. (NASDAQ:SLXA) has completed a private placement valued at $24 million as the second and final closing of a $32.5 million placement. Solexa’s investors, Abingworth Management Limited, Amadeus Capital Partners Limited, Oxford Bioscience Partners and SV Life Sciences contributed $10.8 million to the round.
 
John West, Solexa's CEO indicated that performance results of its sequencing system would be announced sometime soon, "This financing demonstrates our investors' confidence in our ability to execute on our business plan to develop and market our next-generation sequencing systems based on Sequencing-by-Synthesis (SBS) and Cluster molecular arrays. In the coming months, as we move closer to product launch, we expect to be able to announce additional experimental results demonstrating the performance of our platform in high-end genetic applications."
 
Solexa’ genetic analysis platform is based on Sequencing-by-Synthesis and Cluster molecular arrays. The company has focused its product development efforts on integrating sequencing, gene expression, genotyping and micro-RNA analysis into the system. The company has planned for the SBS-Cluster genetic analysis instrument system to be ready before the end of 2005.
 
 
Life Science Angels has closed a total of $1 million in investments in three early stage companies. The companies include Athenagen, Inc., Pegasus Biologics, Inc. and Uptake Medical Corporation. Athengen is focused on angiogenesis-related diseases such as cancer, age-related macular degeneration (AMD) and rheumatoid arthritis. Pegasus is a bioimplant company and Uptake Medical is focused on lung therapy, which improves the functioning of the lung for those with lung diseases.

THE MEDICAL TECHNOLOGY JOURNAL
July 13th, 2005
 
 
 
HepaLife Technologies, Inc. (OTCBB:HPLF), a company that is giving its technical attention to the development of products for the treatment of liver diseases, an ailment the company indicates afflicts about 25 million Americans, has entered into a stock purchase agreement with Fusion Capital Fund II, LLC. As part of the agreement, Fusion Capital has agreed to purchase up to $15 million of newly issued stock over a period of 30 months. The agreement, which is subject to stipulations concerning the exact timing, price of the stock and amount of the investment, is expected to revolve around a program that involves 30 monthly payments of $500,000.00 each.
 
Mr. Harmel S. Rayat, one of the Directors at HepaLife Technologies indicated that the one-investor financing had a number of benefits, "Fusion's unique and innovative financing commitment will allow our Company to raise a significant amount of capital efficiently and on a cost effective basis from a single institutional investor. With the added capital, our management team can focus on HepaLife's core research activities, expanding and accelerating the scope of our science and working towards creating the first-of-its-kind artificial liver device and developing proprietary in-vitro toxicology and pre-clinical drug testing platforms."
 
HepaLife Technologies also noted that the patented PICM-19 cell line has potential in the development of the artificial liver device.

 
 
Emphasizing that the most widely used medical treatments are based on compounds derived from nature’s greenhouse, PhytoMedical Technologies, Inc. (OTCBB:PYTO), reported that it has entered into an agreement with Fusion Capital Fund II, LLC to finance the development and commercialization of its plant derived pharmaceutical and nutraceutical compounds.
 
Similar to Fusion Capital’s agreement with HepaLife, Fusion Capital has agreed to purchase $10 million in common stock over a period of 25 months. The agreement, which is subject to stipulations concerning the exact timing, price of the stock and amount of the investment, is expected to revolve around a program that involves 25 monthly payments of $400,000.00 each.
 
Mr. Harmel S. Rayat, a Director of PhytoMedical Technologies and also, HepaLife, commented on the investment and the PhytoMedical’s medical focus, "Fusion's unique and innovative financing commitment will allow our Company to raise a significant amount of capital efficiently and on a cost effective basis from a single institutional investor. Now our management team can focus on PhytoMedical's core research activities, expanding and accelerating the scope of our science and working towards developing clinically approved products for two of the most devastating disease states in America - diabetes and cachexia."
 
PhytoMedical also provided interesting statistics that illustrate what may be lost as tropical rain forests are turned indiscriminately into barren landscapes. The company reports that an estimated 300 important drugs still remain to be discovered from the 250,000 species of higher plants. The company says that only 15 percent of the plants so far have been studied for bioactive compounds. Underscoring the point, PhytoMedical reports that twenty of the best selling drugs come from natural plant sources.
 
Currently PhytoMedical is focused on the development of BDC-03, a plant derived compound that has potential to fight Cachexia through the promotion of a lower fat percentage, lower cholesterol and increased lean muscle mass. Cachexia, a real concern for those that have cancer or AIDs, can result in a lose up to 30 percent of lean muscle mass – a major factor that effects vital organs and often results in the death of the patient.  Cachexia is said to afflict 25 percent of all AIDs patients and 90 percent of all cancer patients.
 
The company also is focused on diabetes. An interesting result that the company noted from a study published in Diabetes Care, from the American Diabetes Association, was that one gram of cinnamon can lower blood sugar by an average of 18 to 29 percent. Significant reductions in triglycerides and LDL cholesterol were also noted in the study. These positive effects lasted for at least 20 days after the cinnamon treatment was stopped. PhytoMedical is currently working on synthesizing the active components in cinnamon.

 
 
Atonomics, a Point of Care company based in Denmark, has developed a biochip technology around a technology used in the design of cellular phones. Surface Acoustic Wave (SAW) technology, which forms the basis of SAW filters in cellular phones, is also the basis for Atonomics’ biochips.
 
According to the company’s web site, the technology developed requires just one drop of blood, as opposed to numerous pricks needed to perform traditional allergy analysis. The company reports that most allergy sufferers are not aware that a simple blood test, which requires just one drop of blood, can be used to diagnose their symptoms.
So how does the system work? The acoustic surface waveforms are extremely sensitive to differences in DNA structure. Because of this, unique and determinable waveforms are generated for specific types of genes. Different DNA structures or molecules have a different mass. When these collect on the surface of the sensor, the mechanical forces, which control the electrical oscillatory nature of the SAW device, are change, resulting in distinct waveform variations. The company reports that the disruption of acoustic surface waves as a direct result of specific DNA hybridisation and elongation reactions can be measured with low-cost instruments within 15 minutes. Besides allergy DNA reactions, the system can also be used to detect the delta 508 mutation of the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.
 
Atonomics goes on to estimate that about 11 million patients take allergy tests and the market is worth about $245 million. The company projects that if the 150 million Type 1 allergy sufferers took allergy tests, the total market would exceed $3 billion.

THE MEDICAL TECHNOLOGY JOURNAL
July 12th, 2005
 
 
 
CoreValve, which has developed a delivery system for percutaneous heart valve replacement, has closed a $24 million Series B round led by Apax Partners and joined in by HealthCap.
 
Jacques Seguin, MD, PhD, CEO at CoreValve commented on the investment and emphasized that the new technology offers a potential alternative to those who can not be treated with conventional open-heart surgery,  and as a less traumatic approach to all patients in need of heart valve replacement, "This significant cash infusion from experienced and successful investors is a dramatic endorsement of CoreValve's ReValving approach to percutaneous aortic valve replacement--a procedure that no doubt represents the area of legitimate excitement for the future of interventional cardiology. Not only will ReValving offer immediate hope to patients who are currently left untreated because of their high surgical-risk profile, but ReValving also will eventually offer all patients the opportunity to avoid the trauma of open-heart surgery."
 
The percutaneous heart valve replacement technology that CoreValve is working on uses a catheter-and-self-expanding-frame approach like angioplasty and stenting. The company notes that the approach results is less trauma than open heart surgery and also provides substantial cost savings.

 
 
Transgene (Eurolist Paris : FR0005175080 - NASDAQ: TRGNY) has raised 34.9 million Euros in an oversubscribed subscription placement of 4,657,500 ABSA priced at 7.50 Euros. The company indicated that an extension is planned that may result in a further 18.7 million euros.
 
Transgene develops therapeutic vaccines and immunotherapeutic products for the treatment of oncology and infectious diseases.
 
 
Primera Biosystems, Inc, which is developing gene expression analysis systems and assays, has closed an $11 million placement of Series A Preferred Stock. Investors in the round lists include MPM Capital, Burrill and Company, and the Malaysian Technology Development Corporation. Primera plans to use the funds for the further development of instrument systems and disease specific diagnostic reagent kits.
 
Primera’s "STAR" (Scalable Transcription Analysis Routine) system is based on real-time PCR and DNA microarray technologies. The gene expression analysis system is characterized by faster speed, lower costs and high accuracy.

THE MEDICAL TECHNOLOGY JOURNAL
July 11th, 2005
 

In an effort to find a cure for cystic fibrosis, Structural GenomiX, Inc. (SGX) and Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT), affiliated with the Cystic Fibrosis Foundation, has entered into a three-year $15 million drug discovery program. As part of the agreement, CFFT will provide over $15 million to SGX. The funding will come in the form of technology access, funding and payments for specific research related developments. The agreement also will give SGX eligibility rights for royalty payments on product sales. In exchange, SGX will focus on product development.
 
Fundamental to SGX’s product development effort goal is the production of “correctors” of the delta F508 form of the Cystic Fibrosis Transmembrane Regulator (CFTR) protein. People with Cystic Fibrosis have genetics characterized by the delta F508 mutation. According to Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation and CFFT, "Our work with SGX over the past four years has produced significant advances in understanding the cellular defects that cause this difficult disease. SGX was the first to solve the structure of the mutant domain of the CFTR protein, which is present in 90 percent of people with cystic fibrosis."
 
According to the report, over 30,000 people in the United States alone are estimated to have cystic fibrosis. Furthermore there are over 10 million Americans who carry one copy of the defective gene. Those that inherit the disease, as a result of two parents who have a defective gene, in general will have lung disorders that often result in serious infections. Correctors offer hope in correcting this problem by enabling chloride transport across the lung epithelium.

 
 
Furthering its position in the general market for cancer therapeutics with a Series C Private Placement is Panacea Pharmaceuticals, Inc. The company has been working on product development related to the enzyme human aspartyl (asparaginyl) Beta-hydroxylase (HAAH). The company reports that HAAH over-expression has been observed in the tissue of over twenty tumor types that have been tested so far. These include pancreas, breast, ovary, liver, colon, prostate, lung, brain, and bile duct tumors. The company also says that “HAAH over-expression has been detected in 99% of tumor specimens (greater than 1000) tested to date and has not been detected in normal or adjacent non-affected tissue.”
 
The company in collaboration with MIT has indicated success with product developments formulated with HAAH in mind. According to Hossein A. Ghanbari, PhD, CEO and Chief Scientific Officer of Panacea, "We're excited by the continued strength of our findings in the HAAH cancer program. These include the recent milestone we achieved under our antibody development collaboration with MIT, as well as positive efficacy studies in animal models of human primary liver cancer and metastatic human colon cancer."
 
Investors in the Series C Private Placement, which raised about $7 million, were listed as Mitsubishi Corporation Life Sciences Venture, Olympus, JSR, Shin-Etsu Chemical, Fuji Photo Film, Dai Nippon Printing, and Tokio Marine and Nichido Fire Insurance.
 
 
 
Adlyfe, Inc., based in Rockville, Maryland, reports that it has developed a sensitive blood test for protein folding diseases. The test, based on synthetic peptides, detects an increase in defective proteins in the bloodstream. So far, Adlyfe has been able to detect prion diseases, which Mad Cow disease is one, in a number of animals. According to Alan S. Rudolph, CEO, the test allows for early detection of the disease before it has accumulated in the brain, "We are very encouraged by the early results of our test which show we can detect disease in blood and tissue samples from animals and humans. We look forward to offering a new test for early detection and diagnosis of these debilitating diseases."
 
Adlyfe reports that it now has 11 patents pending related to protein folding brain diseases, which also includes Alzheimer's and Huntington's disease.

 
 
As the present generation ages, and develops the associated medical problems, the ability to provide quality medical care at low cost is expected to become more difficult. One reason is that patient visits will rise without a corresponding rise in the number of doctors. Telemedicine, the capability to monitor and diagnose patients from a distance, is one solution to that problem. Low-cost medical instruments that interface via a wireless connection to the Internet, or in the case of Housecall Plus, through a telephone line and modem, are expected to be instrumental in that solution. According to Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management Division, "With the number of ICD patients expected to expand significantly over the next few years, physicians face an enormous challenge in managing regular follow-up visits for those patients. The version 2.1 software upgrade offers physicians even greater flexibility to provide excellent follow-up care more efficiently when using the Housecall Plus system."
 
St. Jude has just received approval from the U.S. Food and Drug Administration (FDA) for the software upgrade version 2.1 of its Housecall Plus remote patient monitoring system. That software is designed to remotely monitor implantable cardiovinverter defibrallator (ICD) patients. The new software version helps create PFD files of monitoring results and transmits them securely to the physician’s web site.
 
Other features of the Housecall Plus system include real time doctor-to-patient communication, real-time electrograms, surface ECGs, signals and settings of the ICD, delivered therapies and stored electrograms. Housecall Plus also supports a number of St. Jude’s medical devices. These include St. Jude Medical's Atlasand Epic line of ICD and cardiac resynchronization therapy devices and pacemakers.

THE MEDICAL TECHNOLOGY JOURNAL
July 8th, 2005
 
 
 
As the lead partner of a regional consortium, the University of Washington was awarded a $15.4 million grant to develop an advanced, portable medical diagnostic system that can be used to quickly diagnose diseases anywhere a health worker can walk to. From the list of companies involved in the project, which includes Nanogen, the silicon microarray company, Micronics, the lab-on-a-card company, and PATH, a non-profit health strategy company, the road points to a device that combines the latest miniaturized microfluidic analysis and sampling technology with the latest genetic clinical analysis technology.

Commenting on the group was Paul Yager, lead investigator on the project and Vice Chair and Professor at the University of Washington’s Department of Bioengineering, "This is a formidable group. Each partner brings vital skills and experience to the mix. I believe this combination is what led to our being selected from such a wide range of applicants and it's what will make our efforts successful.”
 
The award is one of 43 research projects that have been funded through the $436 million Grand Challenges in Global Health initiative. The initiative is specifically focused to improve health care and provide treatment for the diseases of the poor, the majority of diseases. That market is considered under served because of market dynamics and differences in cost of living in different geographic areas.
 
The target size for the final working system is expected to fit in a pocket, or about the size of a handheld computer.
 
 
 
Sirna Therapeutics, Inc. (NASDAQ:RNAI), a company that has taken a RNAi approach to solve medical problems, reports that it has completed the initial closing of a $28.01 private placement of its common stock and warrants. Venture capitalists included Sprout Group, Oxford Bioscience Partners, and Venrock Associates. The funds are planned to further the development of Sirna-027 in AMD (age-related macular degeneration). The funding is also expected to go towards two preclinical programs involving Hepatitis C and Dermatology.
 
 
 
NanoViricides, Inc. (Pink Sheets:NNVC) as a better way to reflect the company’s nanomedicine focus has changed its name from Edot-com.com, Inc. to NanoViricides, Inc. and stock symbol from ECMM to NNVC - effective July 5, 2005.
 
NanoViricides, Inc. is developing nanomaterials for viral therapy based on technologies developed by Theracour Pharma. The five viruses the company lists as targets include HIV, HCV, Herpes, Asian (bird) flu and Influenza.
 
The company defines a NanoViricide as a nanoparticle that contains an encapsulated active pharmaceutical ingredient, which is designed for a specific type of virus. The NanoViricide, once in the blood stream, is designed to locate, attack and immobilize specific virus particles. Once the virus particle is immobilized, perhaps analogous to an insect in a spider’s web, the active pharmaceutical ingredient is injected into the virus by the NanoViricide particle. The injection results, like the spiders bite, in the death of the virus particle (through the collapse of the virus cell wall). The company first plans the development of HIV drugs first, then to license to pharmaceutical companies in 2006.

 
 
Anadys Pharmaceuticals, Inc. (NASDAQ:ANDS), an anti-infective medicines company, reports that as a result of the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act, the company will receive an initial payment of $20 million from Novartis. The original agreement with Novartis was for the development and commercialization of ANA975 for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV). The company also indicated that in addition to the $20 million payment, it is now eligible for $550 million in regulatory and commercial milestone payments. These payments are contingent on the development and commercialization of ANA975.
 
 
 
Soon, one may just put a pair of eyeglass- like devices on when the cell phone rings. One will then be all set to play a lively video game with a far away friend or have a serious video teleconference with a business partner. With Kopin’s nanotechnology based microdisplays, Orange’s video service, MicroOptical’s Kopin-enabled eyewear and Samsung’s cell phone one may have all that one needs to both work and play in the modern world.
 
In this scenario, of the not to distant future, one will be delivered movies, TV, photos, web sites or perhaps games through Orange SA mobile video service, then see the results with virtual big-screen eyewear provided by MicroOptical Corporation. The infrastructure is just about there. The recent order from MicroOptical for Kopin’s CyberDisplay 230 K microdisplays will provide the necessary hardware component to get the production lines moving.
 
Orange SA, a unit of French Telecom, which already has 52 million customers in 16 countries, will bundle together the complete package. That package will include MicroOptical binocular video eyewear and Samsung’s SGH-D600 cell phone as the “Orange World” wireless multimedia service. The complete system has already been demonstrated at the European Research and Innovation Exhibition in Paris and will be available to Orange’s customers in October of 2005.
 
Will the product be a hit? The dual eye display, consisting of quarter-inch diagonals provides a 12 inch big screen virtual image. The eyewear itself only weighs 2.5 ounces. The device does accept composite video input (NTSC or PAL), so the eyewear can be plugged into devices such as DVD players, and even perhaps screenless portable laptops.
 
Future applications may include special eyeglasses to adjust for even the most severe vision problems. MicroOptical also has a strategic alliance with Essilor International, a company with over 25,000 employees, for ophthalmic eyewear devices. Essilor manufactured over 180 million lenses in 2004.

THE MEDICAL TECHNOLOGY JOURNAL
July 7th, 2005

 
 
Depomed, Inc. (NASDAQ:DEPO) as a result of the approval of Glumetza for the treatment of Type II diabetes from the U.S. Food and Drug Administration, has received a $25 million dollar payment from Biovail Corporation. According to John W. Fara, Ph.D., Chairman of Depomed, "As anticipated, Biovail made the milestone payment to us within the time frame called for in our agreement. We now look forward to the launch and commercialization of the product in the United States and Canada and beginning to generate royalties from product sales in those regions." Depomed expects to receive further payments from Biovail as product sales begin in the United States and Canada. To reduce the royalty rate, Biovail has the option of making a $35 million buy-down payment.
 
Depomed, Inc. focuses on the development of oral-delivery based, time-released drug formulas. The company has also received approval for its time-release tablets (Proquin XR) for the treatment of urinary infections and has a Phase II trial underway for a post herpetic neuralgia treatment (Gabapentin GR).

 
 
In the United Kingdom, the International Development Secretary Hilary Benn announced that £60 million would be available to eradicate polio. The funding is expected to be used to vaccinate 500 million children to ensure that polio can not resurface. 20 million is expected to be available by the end of 2005 with the remaining 40 million pounds available in the 2006 to 2008 time frame. The report indicated that polio still afflicts 12 nations. These were listed as Yemen, Nigeria, Indonesia, Sudan, India, Ethiopia, Pakistan, Afghanistan, Niger, Mali, Cameroon and Angola. The report also indicated that in 2004 over 90 percent of the 1,255 cases were found in Africa.
 
 
Galapagos (Euronext Brussels, GLPG; Euronext Amsterdam, GLPGA) a genomics-based drug discovery company, has entered into an agreement with Novartis Pharmaceuticals, Inc. relating to its SilenceSelect technology. As part of the agreement, Galapagos will receive payments for that technology and its research services. Onno van de Stolpe, CEO of Galapagos, commented on the agreement, "We are very pleased that Novartis Pharmaceuticals has decided to work with Galapagos for its expertise in knock-down technology and cellular assays. This collaboration will allow Novartis Pharmaceuticals UK Limited to utilize our SilenceSelect target discovery engine in a very beneficial way. We are confident that our technology will perform well in the hands of Novartis. Our SilenceSelect platform has proven to deliver for our other partners, opening significant opportunities for continued collaboration."
 
Novartis plans to utilize the research and technology from Galapagos to validate drug targets. This will be done through the analysis of  protein functions found in the primary cells of humans.

THE MEDICAL TECHNOLOGY JOURNAL
July 6th, 2005

 
 
First is was wireless, now San Diego, according to the San Diego Union Tribune, is set to receive approximately $100 million from The National Institutes of Health. According to the newspaper, the goal of the grants is to develop a better understanding of genes to further develop drugs and treatments. The grants are part of a $300 million nationwide program called the Protein Structure Initiative to determine the three dimensional shape of proteins.
 
The Tribune also reports that two companies will administer the funds. These include, Structural Genomix (SGX), responsible for $48.5 million and The Scripps Research Institute, responsible for $52.7 million. 
 
Stuctural Genomix reported that it will allocate half of the funding, which it says came from the National Institute of General Medical Sciences and is called a National Institutes of Health (NIH) Cooperative Agreement Award,  to institutions and use the other half for its own research.  Institutions that are expected to receive funding as part of the grant are the University of California ay San Diego, the Burnham Institute and the Genomics Institute of the Novartis Research Foundation – according to the Tribune.
 
According to Dr. Stephen K. Burley, SGX's chief scientific officer "We are pleased that SGX's comprehensive protein structure research efforts to date laid the groundwork for this NIH award. Understanding of protein structures plays an integral role in comprehending complex biological systems and in developing the next generation of drug targets and medicines. This award gives SGX an unprecedented opportunity to favorably impact both basic biomedical research and the drug discovery process."

 
 
Westside Medical Imaging, located in Beverly Hills, California, now offers one of the most precise medical imaging technologies on the market. The company has made available its 64-Slice CT scanner, in an off-hospital site location, for the quick analysis of coronary abnormalities before they become a major problem. The company also indicates that the CT Scanner can also be used to detect diseases such as cancer before other common tests reveal them.
 
Noting the stealth-like nature of heart attacks, Norman Lepor, M.D., a cardiologist at Westside, also commented on the very fast CT test, "Nationally, about 50% of heart attack victims have no warning symptoms. With the 64-slice CT scanner, we can detect signs of potential cardiovascular problems in just a few seconds." The 64-slice CT allows for the precise identification of both calcified and non-calcified plaques and allow for the early initiation of treatments to prevent heart attacks and sudden cardiac death.
 
Another cardiologist at Westside, Hooman Madyoon, M.D., pointed out that the test was noninvasive, “Because the technology takes such a clear image of the fast-moving heart muscle and arteries, we can now identify potentially life threatening coronary artery disease at its earliest stage, without discomfort to the patient because the procedure is noninvasive."
 
Westside also said its faciolity is used to educate physicians on the benefits of noninvasive CT-coronary angiography. The system used at the facility is the Siemens SOMATOM Sensation Cardiac 64, which the company says is used in 11 of the top 15 hospitals in America. Unlike the hospitals though, the test is streamlined and doesn’t require repeat trips – according to the the company.

 
 
Novavax, Inc. (NASDAQ:NVAX), noted for its micellar technology, a topically applied drug delivery system based on oil and water nanoemulsions, has completed $4 million in financing as a result of a stock offer of 4,000,000 shares priced at $1.00 a share.
 
Novavax currently offers prescription pharmaceutical products and prenatal vitamins. One of its products based on micellar nanoparticles is ESTRASORB. That topical emulsion lotion is used to deliver estrogen  to help manage vasomotor symptoms in postmenopausal women. Another planned micellar based product, Androsorb, a topical testosterone treatment,  has completed Phase I trials.

THE MEDICAL TECHNOLOGY JOURNAL
July 5th, 2005
 
 
Isolagen, Inc. (AMEX:ILE), a company focused on the development and commercialization of autologous cellular therapies for soft and hard tissue regeneration, announced positive results for its Phase II dental study for the treatment of interdental papillary insufficiency. Dr. Michael McGuire, Past President of the American Academy of Periodontology and a clinical researcher in tissue engineering stated, "The results are very encouraging. The Isolagen Process appears to offer the potential to grow gum tissue which is something that no other product or treatment has ever been shown to do before."
 
Dr. Lindner, Senior Vice President of Medical and Business Affairs, also commented on the positive results, "Based on these positive results, the company and its clinical experts expect to prepare protocols for Phase III Pivotal trials to assess the efficacy and safety of our dental product candidate for the treatment of interdental papillary insufficiency. These clinical trials will be traditional double blind, internal and placebo controlled studies and will be designed to assess the therapeutic efficacy and safety of our dental product candidate as an aesthetic product for improving the appearance of gum tissue.”
 
The company,however, indicated that although the Investigator determined that the results were superior to the placebo, the linear measurements did not provide statistically significant data. This, however, was attributed to a lack of accuracy with the measurement instrument. The company plans to investigate other forms of measurement.
 
Autologous cellular therapy, according to the company, uses a patient’s own cells, multiplies them, and then injects them back into the patient.

 
Neurome Selected for Grant to Develop Needle-less Vaccines
 
Neurome, Inc. has reported that it has been selected for a grant from the Foundation for the National Institutes of Health through the Grand Challenges in Global Health Initiative. The grant would be for the development of a needle-free vaccine delivery system to be developed over the course of the next three years. The new system aimed for is also expected to be simple, not require complex equipment and be able to be administered without the need for specialized training. In order to address the challenge, the plan is to develop the vaccines for specific receptors in airway or intestinal epithelium (external lining) to protect against infectious organisms.

According to Warren Young, Ph.D., President and Chief Operating Officer of Neurome, "This project continues the process from our successful application of Neurome's TOGA gene discovery tools toward the development of technologies and therapeutic products that promise to have a significant impact on global health."

 
 
Cevena Bioproducts, Inc. has secured $6.0 Million in funding to commercialize its ViscoFiber product, a beta-glucan concentrate, derived from oats and barley through a patented fractionation process. The new product is used to improve the health of the heart and offers satiety benefits.
 
ViscoFiber is presently in clinical trials to evaluate its effect on cholesterol levels, glycemic response for heart health and efficacy for gastrointestinal health.
 
The lead investor for the funding was The Business Development Bank of Canada's Venture Capital Group. Others investors that participated included Golden Opportunities Fund, Foragen Technologies, Inc and AVAC, Ltd.

THE MEDICAL TECHNOLOGY JOURNAL
July 1st, 2005
 
 
 
NutraCea (OTC:NTRZ) (BULLETIN BOARD: NTRZ) has reported that it has entered into a binding letter of intent with Food Trading Dominicana S.A., the largest rice milling company in the Dominican Republic. Under the plan, Dominicana is to become the manufacturing and distribution hub for RiSolubles for the Caribbean, Central and South America. To accomplish this, NutraCea will construct a rice processing facility that will have the capacity to generate one million servings per day. The rice processing facility will convert rice bran, a byproduct of rice, which has in the past been not used, to a nutritious and inexpensive source of food.
 
The company will supply initially RiSolubles, NutraCea’s primary product, to minimum of 100,000 children per day during the construction phase of the facility. RiSolubles forms the basis of a highly nutritious drink, which will be given to the children.
The agreement was met with an enthusiastic response from government and the two companies. Rafael Alburquerque, Vice President of the Dominican Republic was quoted as saying, "This is a very important initiative, not only from a business and economic perspective, but from a humanitarian one that we believe will benefit the most underprivileged population of our country."
 
Paul Gautreaux and Juan Jose Agramonte, the co-owners of Food Trading Dominicana, S.A., indicated their desire to move with the plan and to help commercialize NutraCea’s other products that deal with the treatment of a number of common medical problems, "As the largest rice processing mill in the Dominican Republic, we are eager to move forward on this new joint venture with NutraCea. Food Trading Dominicana has played an important role in the economic success within the Dominican Republic and has played an ongoing role in providing support for meaningful social progress within the country. We are pleased to be able to be a partner in this initiative within the Dominican Republic as well as potentially other countries within this hemisphere. Additionally, we plan to commercialize NutraCea's proprietary, patented formulations, which target specific health concerns such as cardiovascular disease, arthritis and diabetes through our existing and expanding retail distribution."
 
Bradley Edson, President of NutraCea noted that the economic model for the project has already been tested, "NutraCea is pleased to be able to partner with an established Dominican company to launch our international initiative. Our technology enables us to transform thousands of metric tons of rice bran, a by-product of rice milling, into a powerful nutritional drink that can benefit the nation's children. This social and economic model has already been tested in Guatemala, El Salvador and Nicaragua, and is now ready to be demonstrated on a commercial basis."
 
Margie Adelman, Senior Vice-President of NutraCea, indicated that the Dominican Republic will be the final proving ground for the product and the world hunger program, "Our intention is to work with our joint venture partner to create a large central procuring and processing entity with its operations anchored in the Dominican Republic for exportation of the processed and finished products throughout the Caribbean and Central and South America. We feel the Dominican Republic represents the ideal economic and political partner to demonstrate NutraCea's worldwide initiative to increase world food supplies and significantly impact world hunger. We believe that this project will become a model system for the expansion of our operations throughout South and Central America."
 
 

BioPhysics Assay Laboratory (BioPAL), Inc., with its gadolinium nanocolloids and microspheres, indicates it has devised a readily usable technology to image and track injected stem cells. The technology is expected to be central in the determination of the effectiveness of stem cells for the regeneration of cells in specific organs and areas. The technique involves the labeling of stem cells with nanometer sized colloids and the precise determination of the number of delivered cells to the target anatomical tissue, bone or organ. The microspheres role in the process is to determine the quantity of living tissue in a region and the blood flow to a region. The company says that with the technology, a researcher can determine the amount of living tissue that has grown as a result of a stem cell treatment.
 
Two of the company’s executives helped explain the technology. Ernest Groman, Ph.D., VP R&D, said, "Our cell tracking nanocolloids are unique materials that have powerful properties including low toxicity, stability to sterilizing procedures and high assay sensitivity. In fact, the ability to image a gadolinium-based nanocolloid with MRI was thought to be impossible, but we have discovered a new technology that we have designated Proton Cascade which makes this important new contrast agent highly effective."
 
Christopher Reinhardt, Ph.D., President and CEO, added, "BioPAL labeled microspheres are easy to use, very robust and have high sensitivity yielding superior measurements of blood flow and new tissue generation. Detection down to the level of single microspheres is possible. We are confident that all of these new products will play a central role in helping to bring effective cellular therapies to patients as soon as possible."
 
One concern with stem cell technology are stem cells that don’t reach the desired target destination. Stem cells lodged in non-targeted locations have the potential for unwanted side effects. BioPAL’s technology can also be used to help determine the percentage of stem cells that don’t reach their target region.
 
 
 
Immunicon Corporation. (NASDAQ:IMMC) has completed the sale of 4,137,902 shares of common stock generating gross proceeds of $19.7 million. Immunicon is focused on the development and commercialization of cell- and molecular-based human diagnostic and life science research products. Within that realm the company has concentrated its efforts on cancer disease management. Specifically its platforms are used for the selection and analysis of rare cells that circulate in the blood stream, such as tumor cells and endothelial cells.

The Medical Technology Journal
June 30th, 2005

 

Torax Medical Inc. has completed a $10 million Series B round of financing. The round was led by Thomas, McNerney & Partners. Other investors included , Mayo Medical Ventures and Sanderling Ventures. The company intends to use the proceeds for pre-clinical testing of an implant for the treatment of gastroesophageal reflux disease (also referred to as GERD or acid reflux). According to the company, chronic acid reflux affects about 20 million people in the United States.
 
Todd Berg, Torax Medical's CEO indicated that the technology under development would overcome limitations of present day treatments of the problem, "We believe our proprietary technology has the potential to correct the underlying defect of GERD and help millions of the people who suffer from this disease. Our objective is to provide a measurable cure for this high health-risk condition in a way that is minimally invasive to the patient."

 
 
Topping off a $5.7 million Series A round in 2004, Exagen Diagnostics, Inc. has completed a $7 million Series B round of financing. Participants in the new round included Tullis-Dickerson & Co., the round leader, as well as vSpring Capital and Wasatch Venture Fund.
 
Waneta Tuttle, Ph.D., Exagen’s President, outlined the budget for the funds, "This round of funding gives Exagen the resources to accelerate our go-to-market plans and advance our pipeline. We plan to be the first provider of genomic marker IVD kits for breast cancer that enable widespread use in any CLIA-certified laboratory. Our first tests are the Key2 Breast Cancer Prognosis panel of products that detect changes in DNA copy number in both hormone receptor-positive and hormone receptor-negative tumors."
 
Exagen’s IVD kits are used to predict the risk of the advancement of a disease and a patient's individual response to a specific drug planned for treatment. The company in addition to its breast cancer tests, plans tests for hepatitis C in order to determine if a patient will respond to treatments with interferon and ribavirin.
 

STMicroelectronics’ and Acacia’s Microlaboratory Agreement Signals  Chip Industry 's Advance Into the Forefront of Medical Technology  

STMicroelectronics, which first introduced its genetic Polymerase Chain Reaction (PCR) MEMS-based silicon chip in 2002, has furthered its involvement with the biotechnology market through a co-development agreement with CombiMatrix Group, a unit of Acacia Research Corporation (NASDAQ: CBMX) (NASDAQ:ACTG). The agreement, which will received financial support from STMicroelectronics, will seek to integrate CombiMatrix’s ElectroChemical Detection Technology (ECD), with STMicroelectronics In-Check Lab-on-Chip platform for applications in the point-of-care diagnostics market.

One of the goals of the project is to develop a feature rich and more sensitive technology than current fluorescent/optical detection technology.
 

The Medical Technology Journal
June 29th, 2005
 
 
 
pSivida Limited (NASDAQ:PSDV) and the Singapore General Hospital have reported  on PhaseIIa clinical trials as a result of the use of BrachySil, a new brachytherapy treatment for inoperable primary liver cancer. Results of the trial, conduted at Singapore General on eight patients, indicated tumor regression with what appears to be no significant adverse affects.  The patients were evaluated at three and six months periods following treatment.
 
According to Gavin Rezos, Managing Director of pSivida, "This report confirms the excellent results for BrachySil that we previously announced at the 12-week interim study time point, and will provide not only a robust foundation for future clinical development and regulatory filing, but also a springboard for our ongoing licensing activities with partners looking to enhance their own portfolios of specialist cancer therapies."
 
Dr. Pierce Chow, Senior Consultant, Hepatobiliary and General Surgery at Singapore General Hospital, also expressed optimism about the treatment, "From the perspective of patients suffering with advanced cancer of this kind, BrachySil  promises to offer the possibility of an effective, safe and relatively pain-free treatment, which can potentially improve both the duration and quality of life. We, at the SGH, are very encouraged by the promising data seen to date with BrachySil(TM) and are optimistic that subsequent clinical trials will continue to show positive results in this and other serious cancer indications."
 
Among many of the attributes of the technology is that it  is a simple procedure that permits the patient to be discharged from the hospital the next day. BrachySil, is a micron-sized nanostructured silicon particle administered through a needle directly into tumors. Within the BrachySil is  radioactive 32-phosphorus (32-P) used to induce tumorcide.
 
One of the features of the technology, as opposed to other methods, is that the radioactive material is immobilized and because of this apparently has little negative effect on adjacent healthy tissue.  According to pSivida, the  “key finding is that BrachySil microparticles remain in the tumor with no or insignificant detectable radioactive leakage. This observation is a very significant outcome for the trial. Unlike other liver brachytherapy approaches that involve delivery via the hepatic artery which, in some cases, results in radioactivity becoming associated with healthy tissue, BrachySil  is administered directly into tumors restricting radioactivity to the tumor itself.”

 
 
MemoMind Pharma, an affiliate of Austria-based Ebewe Pharmaceuticals has announced the availability of MempProve, a neuropeptide tablet, that is used to improve short term memory. The company indicates that the drug has the capability to improve short term memory in middle aged and older adults, on average, by 15 percent.
 
Thomas Crook, PhD, former Chief of the National Institute of Mental Health's Geriatric Psychopharmacology Program, noted how fortunate we are to have the Age Related Memory Problem (ARMP) tablet,  "Age-related memory problems are a very real issue for millions of adults. As we all get older, we are extremely fortunate to have this easily-administered neuropeptide tablet available to help counter ARMP and preserve vital memory function."
 
To further validate the product, MemoMind pointed to a placebo controlled trial published in the journal International Clinical Psychopharmacology. In that test, memory was shown to improve significantly with the peptide.
 
 
Supratek Pharma  Inc. has reported the discovery of a new drug target that the company considers  a key to stopping the spread of aggressive and deadly forms of cancer.   Dr. Francis  Bellido, President of Supratek,  in reporting the development first explained the cancer growth mechanism,  "This is very exciting news in cancer research. Ultimately, the cause of death for most cancer patients is metastasis, the spread of cancer from primary to distant  sites. This is the first step towards developing drugs capable of halting this  deadly process."
 
Identified as the potential culprit, which allows cancer to spread quickly, is  a protein secreted by cancer cells known as the Metastasis Associated Protein. This protein is said to induce the formation of blood vessels with the intended function of nourishing the cancer cells.  Dr. Bellido noted that the protein is now the subject of the company’s  present efforts,  since  its function in cancer progression has just been realized,   "The protein has been studied for years, but its role in cancer progression eluded scientists until now. Our research team  has been working diligently to translate this new knowledge into new  antimetastatic therapies."
 
Supratek also noted that several drug candidates have been identified for the new target. The company is optimistic that a new drug treatment will arise much faster than is the usual case in medical research.
 

 

The Medical Technology Journal
June 28th, 2005
 
 
 
In an effort led by the Bill & Melinda Gates Foundation, the Grand Challenges in Health Initiative has offered 43 grants with a total value of $436.6 million. The grants are for the development of medical technology to serve the needs of the world’s poorest countries. With the announcement the initiative listed a wide range of projects that are to be the focus of the research.
 
The initiative is supported by an existing $450 million commitment from the Bill & Melinda Gates Foundation, a $27.1 million commitment from the Wellcome Trust, and $4.5 million from the Canadian Institutes of Health Research (CIHR).
 
The Gates Foundation is credited with the establishment of the Grand Challenges in 2003, in partnership with the National Institutes of Health. Bill Gates, co-founder of the Bill & Melinda Gates Foundation with the announcement noted how little research was directed towards the diseases of the poor, "It's shocking how little research is directed toward the diseases of the world's poorest countries. By harnessing the world's capacity for scientific innovation, I believe we can transform health in the developing world and save millions of lives."
 
 

IsoRay Medical, Inc. with the close of its latest round reported that it has raised over $10 million in the last 18 months. The company offers a proprietary medical isotope, Cesium-131, for the treatment of prostrate cancer. The isotope is considered a low-level radioactive treatment alternative. According to Roger Girard, CEO of IsoRay, "We believe Cesium-131 to be a very effective option for men choosing brachytherapy to treat their prostate cancer. We expect it to kill the cancerous cells more rapidly, with a shorter duration and with less side-effects. This will allow patients to return to a normal lifestyle within a very short time period."
 
The company plans another funding round in October of 2005. The company notes that over 230,000 men will be diagnosed with prostrate cancer in the United States this year.

The Medical Technology Journal
June 27th, 2005
 
 
Orqis Medical Corporation, which has developed the Cancion CRS cardiac recovery system, has announced the close of its Series D round. The round, which brought in $22.7 million, is expected to be used for further evaluation of the company’s heart therapies. According to Marvin Konstam, M.D., Medical Director at Orqis Medical, "This financing will allow Orqis Medical to complete scientific and clinical validation of its novel hemodynamic discovery that continuous blood flow augmentation to the descending aorta treats underlying mechanisms responsible for heart failure. This discovery could be a significant advance in the treatment of patients who suffer from heart failure."
 
The Cancion CRS cardiac recovery system is used to treat, according to the company, “the underlying disease progression of congestive heart failure.” The company’s technology is also focused on the treatment of cardiac patients that have been considered untreatable with present modern day medicine.
 
Investors in the round included Boston Scientific Corporation, Lighthouse Capital Partners and previous investors.
 
 
 
Diseases without markets, a problem that keeps much of the world sick, has been given more attention through a grant from the Bill & Melinda Gates Foundation. The four-year grant, for $5.4 million, was announced by BIO Ventures for Global Health (BVGH) at BIO 2005. The company estimated that 90 percent of global disease receives less than 10 percent of health research funding.
 
Richard Klausner, MD, Executive Director of the Gates Foundation's Global Health program alluded to the biotech’s industry’s capability to easily eradicate most of the world’s diseases, "The biotech industry has tremendous potential for developing new therapeutics, vaccines and diagnostics against diseases of the developing world. For too long, funding, market, and information barriers have prevented biotech companies from realizing this potential. We believe that BIO Ventures for Global Health will provide the means to help industry overcome some of these barriers. We congratulate BVGH in taking leadership in helping to bring the potential of biotechnology to improving health equity in our world."