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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."
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