Our Stocks to Watch on Wednesday include Delcath Systems, Inc. (NASD: DCTH), S3 Investment Company, Inc. (OTC: SIVC), Bioject Medical Technologies Inc. (NASD: BJCT), SPACEHAB, Incorporated (NASD: SPAB), Integral Technologies, Inc. (OTCBB: ITKG) and Diguang International Development Co., Ltd. (OTCBB: DGNG).
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DELCATH SYSTEMS INC (NASD: DCTH)
"Up 55.86% on Tuesday"
Detailed Quote: http://www.otcpicks.com/quotes
Delcath Systems, Inc., a development stage company, engages in the development and testing of a system for the treatment of liver cancer. The company is primarily developing the Delcath system, in phase III clinical trial, that isolates the liver from the general circulatory system while treating the diseased liver with high doses of chemotherapeutic agents and then returns the blood exiting the liver to the general circulatory system only after the chemotherapy agent has been substantially removed from the blood by filtration outside the body. The Delcath system kit includes Infusion catheter, an arterial infusion catheter, double balloon cathetera, extracorporeal filtration circuit, filters, return catheter, and a series of introducers and related accessories. The company was founded in 1988 and is based in
DCTH News:
November 20 - Delcath Resumes Enrollment in Phase III and Phase II Trials
Delcath Systems, Inc. (NASD: DCTH) announced that the U.S. Food and Drug Administration (FDA) has notified the Company that patient enrollment may resume in the Phase III and Phase II clinical trials of the Delcath System. Current and prospective clinical investigation sites have been notified that study accrual can be resumed immediately. This decision follows Delcath’s meeting with representatives of the U.S. Food and Drug Administration (FDA), along with the Principal Investigator at the National Cancer Institute (NCI).
Resumption of study accrual follows a voluntary enrollment deferral announced by the Company on October 23, 2007 in response to an FDA inquiry into certain gastrointestinal adverse events observed in four patients enrolled in the studies of the Delcath System prior to protocol changes enacted earlier this year. During the meeting at the FDA, which was attended by senior reviewers from both the Drug and Device arms of the Agency, the Principal Investigator presented an analysis of the previously reported gastrointestinal toxicities and of the changes incorporated into the trial protocols to prevent a recurrence of (GI) toxicities. These changes had been previously approved by the NCI Institutional Review Board (IRB) and were subsequently approved by the Data Safety Monitoring Board (DSMB) for the Phase III trial. The Company has been notified in writing by the FDA that the studies can proceed with the amended protocol.
“We are pleased with the Agency’s prompt response to and resolution of this issue. We are very appreciative of the timely assistance of the NCI which allowed us to respond to the Agency less than a week after receiving the letter and their presentation of the data contributed greatly to the unusually quick resolution of this matter. A thorough analysis of the clinical facts surrounding these episodes combined with the clinical benefits demonstrated by the Delcath System for these extremely ill patients allowed for a balanced evaluation of FDA safety concerns,” said Richard L. Taney, President and Chief Executive Officer of Delcath Systems.
“We look forward to recruiting additional oncology centers for the expansion of our clinical trials as we believe that use of the Delcath System for the targeted, region-specific delivery of high-dose chemotherapeutic agents can bring significant clinical benefit to late-stage cancer patients with very limited treatment options, and consequently, poor prognoses, ” concluded Mr. Taney.
The Phase III Trial
The Phase III study, now resuming enrollment at the NCI, is testing the Delcath System for the regional delivery of melphalan to the liver to treat patients with metastatic ocular and cutaneous melanoma who have unresectable tumors in the liver. The Delcath System isolates the blood flow within the patient’s liver in order to allow significantly higher doses of the anti-cancer drug to be administered while limiting the toxicities that result from current systemic chemotherapy treatments.
Patients in the Phase III trial initially are randomized into one of two treatment arms, including immediate treatment with melphalan via the Delcath System or treatment with best alternative care. The study is designed to evaluate the duration of tumor response in each of the two study arms. Following guidelines established by FDA under a Special Protocol Assessment, when disease progresses in patients enrolled in the best alternative care arm of the trial, they are permitted to “cross over” and receive treatment with the Delcath System.
The Phase II Trial
The Phase II clinical trial, also resuming enrollment at the NCI, is testing use of the Delcath System for the organ-specific delivery of the chemotherapeutic agent melphalan in patients with specific tumors in the liver, including primary liver cancer, metastatic neuroendocrine tumors, adenocarcinomas in the liver, and metastatic melanoma in the liver of patients who previously received isolated hepatic perfusion, but whose cancer has since returned.
S3 INVESTEMENT NEW (OTC: SIVC)
"Up 50.00% on Tuesday"
Detailed Quote: http://www.otcpicks.com/quotes
S3 Investment Company, Inc. (http://www.s3investments.com/) is a holding company with two subsidiaries doing business in the
SIVC News:
November 20 - S3 Investment Company Announces $21.7 Million in 2007 Revenues for Redwood Capital Client
S3 Investment Company, Inc. (OTC: SIVC), a holding company with two subsidiaries doing business in the China market, announced that the 2007 fiscal year revenues (audited) for Changzhou Haijie Metallurgical Machinery Manufacturing Co. Ltd. (CMMC), a reverse merger client of S3's Redwood Capital, Inc. subsidiary, exceeded $21.7 million.
An audit of the company's financials is an important milestone in the planned reverse merger of Changzhou Haijie Metallurgical Machinery Manufacturing Co. into a
Redwood Capital provides an array of services to private Chinese companies and utilizes its extensive network of investment banking relationships to facilitate the client's listing on a
"The audited 2007 revenue numbers of Changzhou Haijie Metallurgical Machinery Manufacturing Co. clearly validates Redwood's belief that this is an excellent candidate for reverse merger into the
Changzhou Haijie Metallurgical Machinery Manufacturing Co. Ltd. is located in the Xinbei District of the Changzhou High and New Technology Industrial Development Zone, which lines the southern bank of the
Historically, Changzhou Haijie Metallurgical Machinery Manufacturing Co. was a sub-plant of Baosteel Group, one of the most profitable steel enterprises in the world, with an annual production capacity of about 20 million tons. The main products of Changzhou Haijie Metallurgical Machinery Manufacturing Co. include complete sets of metallurgical equipment and spare parts, electrical power equipment (including wind-driven generator boxes and large scale transformers), automotive parts, mechanical engineering parts, and large gearboxes.
Changzhou Haijie Metallurgical Machinery Manufacturing Co.'s fabrication, machinery and assembly products are already distributed internationally to a select few significant foreign companies, and with its planned entry into the
To sign up to receive information by email directly from S3 Investment Company when new press releases, investor newsletters, SEC filings or other information is disclosed, visit www.s3investments.com/investor
BIOJECT MEDICAL (NASD: BJCT)
"Up 27.75% on Tuesday"
Detailed Quote: http://www.otcpicks.com/quotes
Bioject Medical Technologies, Inc., together with its subsidiaries, engages in the development, manufacture, and distribution of needle-free drug delivery systems to pharmaceutical and biotechnology industries primarily in the United States. Its products include Biojector 2000 that enables healthcare professionals to deliver measured variable doses of medication through the skin, either intramuscularly or subcutaneously, without a needle; drug reconstitution system, which allows for the transfer of diluents to reconstitute powdered medications into liquid form and withdrawal of liquid medication into a syringe without the use of a needle; and Vitajet, a home-use self-injection solution for insulin. In addition, the company is developing Iject, a single prefilled disposable injector for self injection and pre-filled Biojector syringes. It has licensing and/or development agreements with Serono Laboratories, Inc., Merial, and the Centers for Disease Control and Prevention. The company was founded in 1985 and is based in
BJCT News:
November 20 - Bioject Announces Convertible Debt Financing
Former and Current Board Members, CEO and Executive Officers Participate
Bioject Medical Technologies Inc. (NASD: BJCT), a leading developer of needle-free injection therapy systems, announced it has entered into convertible debt financing with Mr. Ed Flynn, a private investor, who will be rejoining the Board of Directors. In addition to the funding provided by Mr. Flynn, Bioject’s CEO and other executive officers and a member of the Board are also participating in this round of funding. Pursuant to these agreements, the Company has received or has commitments to receive an aggregate of $615,000.
Mr. Flynn, a private investor and previous Board member of Bioject, has provided additional funding to assist in moving the Company forward as the new CEO pursues new opportunities. The funds will give Bioject financial strength to carry it into the next year, allowing Bioject to expand its needle-free technology with current collaborators as well as to seek new opportunities. In his willingness to rejoin the Board, Mr. Flynn will add years of business experience and insight to Bioject’s Board. In addition, the financial support from the CEO and other executive officers and a member of the Board indicates their commitment to make the Company successful.
“I am pleased to be once again an active participant of the Board of Directors and look forward to being involved in moving Bioject to the next level. I have always supported the Company and believe this technology brings future clinical advancements into use today,” said Mr. Flynn. “With the increase in self injections at home and the need to remove needles as a possible spread of infectious disease, Bioject is positioned to address these issues and improve our health care system for everyone.”
“Mr. Ed Flynn has been a long time supporter, Board member and advocate for Bioject and its needle-free injection therapy (NFIT) systems,” said Ralph Makar, President and CEO of Bioject. “We are very pleased to have Mr. Flynn rejoin our Board of Directors and we sincerely value his significant contributions and business expertise as we move Bioject to the next level.”
In addition to the convertible financing, the Company has requested and successfully entered into a Forbearance Agreement with Partners for Growth, LP (“PFG”) with respect to its outstanding term and convertible debt agreements. PFG has agreed to forbearance until no later than June 1, 2008, and has agreed not to declare an Event of Default or exercise other remedies under the PFG loans with respect to certain specified events. The Company has agreed to pay down $550,000 of its revolving line of credit and to reprice PFG’s convertible debt note and warrants to $0.90 per share.
As anticipated, the Company received Nasdaq Deficiency Letters on November 15, 2007 and November 19, 2007. The November 15 letter indicated that Bioject has failed to comply with stockholders’ equity, market value of listed securities and net loss from continuing operations requirements for continued listing, as set forth in Marketplace Rules(s) 4310c(3). The November 19 letter indicated that Bioject has failed to comply with the minimum bid price requirement for continued listing set forth in Marketplace Rule 4310c(4) because for 30 consecutive trading days the bid price of Bioject’s common stock has closed below the minimum $1.00 bid requirement. The November 15, 2007, letter states that Bioject has until November 30, 2007 to provide Nasdaq with a specific plan to achieve and sustain compliance with the Nasdaq Capital Market listing requirements. In the event the Company is unable to deliver a plan acceptable to Nasdaq, Bioject would expect to receive notification that its securities will be delisted. At that time, the Company has the option to appeal the Staff's decision to a Nasdaq Listing Qualifications Panel. The November 19, 2007, letter states that Bioject will be provided 180 calendar days, or until May 19, 2008, to regain compliance with the minimum bid price requirement. If, at any time prior to May 19, 2008, the bid price of Bioject’s common stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, Nasdaq will notify Bioject that it is in compliance with the minimum bid requirement.
"In anticipation of the financing requirements and the Nasdaq notification, the Company took a proactive stance by raising capital and beginning to execute on our new customer-focused business strategy, which we believe will allow us to become compliant with the Nasdaq requirements,” said Mr. Makar. “Bioject is currently discussing new opportunities with several new potential partners as well as current partners to expand its technology in new and exciting areas. The dose-sparing clinical studies that are currently under way should be finished and data available next year, which could present some exciting areas for expansion as well as new directions in the delivery of some vaccines. We are very optimistic about our future and are looking forward to a very productive next few years,” said Mr. Makar. We have made many positive changes this year in the Company and feel we are well positioned to move forward with success in the near future.”
Bioject Medical Technologies Inc., based in
SPACEHAB INCORPORATED (NASD: SPAB)
"Up 26.67% on Tuesday"
Detailed Quote: http://www.otcpicks.com/quotes
SPACEHAB, Incorporated provides commercial space products and services to NASA, international space agencies, Department of Defense, and private customers worldwide. It develops and operates space flight hardware assets, and provides manned and unmanned payload processing services. The company operates in three segments: SPACEHAB Flight Services, Astrotech Space Operations, and SPACEHAB Government Services. The SPACEHAB Flight Services segment offers a range of engineering, research, logistics, integration, operations, and ground support services. The Astrotech Space Operations segment provides facilities and support for the preparation of satellites and payloads for launch on expendable launch vehicles. The SPACEHAB Government Services segment offers large-scale government program technical support and specialized engineering analysis, products, and services to NASA and other customers. SPACEHAB also provides end-to-end space access solutions, space systems development, mission integration, and pre-launch processing facilities and services. The company was founded in 1984 and is headquartered in
SPAB News:
November 19 - SPACEHAB Supporting Key Milestones under NASA Space Act Agreement
Company Unveils Initial Details of ARCTUS
SPACEHAB, Incorporated (NASD: SPAB), a leading provider of commercial space services, announced that in accordance with the milestone requirements of the previously announced Space Act Agreement (SAA) with NASA, the Company hosted a formal Systems Requirements Review of its Advanced Research and Conventional Technology Utilization Spacecraft (ARCTUS) on October 25-26 at its Houston Headquarters facility. Attendees included representatives from NASA, the Federal Aviation Administration, United Launch Alliance, Cimarron, Inc., and Lockheed Martin.
The unfunded SAA, signed in June 2007, facilitates the Company’s development of a commercial transportation system capable of ferrying cargo between Earth and Low Earth Orbit. SPACEHAB has engaged key suppliers to support major elements of the ARCTUS program including launch services provider, United Launch Alliance, spacecraft bus component supplier, Lockheed Martin Space Systems, Cimarron, tasked with mission control center development and integration, and Odyssey Space Research, LLC, providing trajectory analysis and integration services.
“Our ARCTUS solution is a low cost, low risk design solution that seamlessly integrates flight proven components and does not require the development of a new launch vehicle,” said Rick Fitts, ARCTUS Program Manager. “With the arrival of the ARCTUS pressure shell mockup into our
Capable of delivering and returning pressurized cargo to and from Low Earth Orbit, ARCTUS will supply a critical ‘means to an end’ for two distinct, yet complementary, space transport needs. First, ARCTUS supports NASA’s requirement to fill the International Space Station (ISS) cargo transport gap between the space shuttle’s planned 2010 retirement and when its replacement Constellation program becomes operational in 2015. Second, ARCTUS provides SPACEHAB with an additional means of space access in support of the Company’s previously announced microgravity processing initiatives, many of which are destined for production and processing on the ISS.
Consistent with the terms of the SAA, SPACEHAB conducted its Program Management Plan review in June 2007. In addition, a spacecraft Concept Review, including representatives from all ARCTUS spacecraft systems providers, was held on November 8, 2007 at Lockheed Martin’s facilities in
INTEGRAL TECHNOLOGIES INC (OTCBB: ITKG)
"Up 20.00% on Tuesday"
Detailed Quote: http://www.otcpicks.com/quotes
Integral Technologies, Inc. is the developer of an innovative electrically conductive resin-based material called “ElectriPlast™,” a highly conductive recipe that can be molded into virtually any shape or dimension associated with the range of plastics, rubbers and other polymers. Our IP consists of ElectriPlast™ and over 118 applications of ElectriPlast™ in various industries. To date, we have received 36 patents on ElectriPlast™ applications, 32 have been issued, 4 have been allowed and are awaiting issuance, and 82 are pending. Various examples of industries where ElectriPlast™ can be used are antennas, shielding, lighting, circuitry, switch actuators, resistors, and medical devices, to name just a few. The company is currently introducing these new products and ElectriPlast™ technology on a global scale.
ITKG News:
November 20 - Integral and Jasper Issue Update on ElectriPlast(TM) Product and Development
Integral Technologies, Inc.’s (OTCBB: ITKG) (“Integral”) and Jasper Rubber Products, Inc. (“Jasper” or “Jasper Rubber”), through their CEO’s William Robinson and Douglas Mathias respectively, today made the following comments relating to Integral’s ElectriPlast™ product and the commercialization progress which has been made since Jasper became Integral’s manufacturing partner.
From Integral:
Since our last statement to the Company’s shareholders we have continued on our path to 1/ advance our product, ElectriPlast™, both technically and in its manufacturability, so as to be able to deliver a world class product to a growing and varied customer base for a variety of applications, 2/ we have achieved this by securing a manufacturer of ElectriPlast™ pellets, Jasper Rubber (http://www.jasperrubber.com/), 3/ protect our intellectual property surrounding our ElectriPlast™ technology by obtaining patent approvals and 4/ file new patents on applications as they are discovered.
We have been able to reach this point through the efforts of our manufacturing partner Jasper Rubber. Not only has Jasper refined and solidified the production process of ElectriPlast™ but Jasper personnel have provided valuable administrative support in the areas of sales, engineering, pricing, and quality control.
We are pleased to report that we are successfully conquering these goals, and we believe that Integral is now able to deliver its ElectriPlast™ product to its customers. This will now allow us to establish ourselves as the only possessor of the most highly electrically conductive resin based material in the world today.
Intellectual Property Portfolio
The Company continues to expand and develop its IP, Patents and Patent Pending portfolio around its ElectriPlast™ technology. To date, the Company has submitted for approval 118 patents based on ElectriPlast™ and its varied uses. We have received 36 patents on ElectriPlast™ applications, 32 have been issued, 4 have been allowed and are awaiting issuance, and 82 are pending. This is an increase of 20 over last year, and the Company expects the allowed to increase in 2008 as several applications will fall within the three year time frame it usually takes to finish the patent process. Therefore, we believe that the progress that has been made securing our intellectual property is of paramount importance to our future, and the long term value creation for our shareholders.
Product Advancement
Integral has spent several years developing and perfecting our breakthrough technology ElectriPlast™. In the past the Company only had the ability to blend small batches of product in order to share our technology with potential customers. This hampered our ability to develop and expand not only our customer base but our material science into the more popular resins. This has now been rectified with the exclusive manufacturing agreement, signed this past summer, between Jasper Rubber of Jasper
We have now compounded 19 different plastic materials, but the process and product mix are much more complex than just compounding some resin. We have experimented with different pellet sizes, and with multiple variances of the form factor characteristics that come from these tests. These numerous factors together, would each be a separate raw material formulation. While we have blended 19 base resins, when considering the number of variables it would be result in near 100 new proprietary formulations. For example, we may have one resin with a dozen variables, so that one base plastic would be responsible for 13 formulas in our data base.
Marketing Activities
We continue to receive requests and needs for highly conductive polymers from all parts of the globe on a variety of applications as varied as our current patent portfolio. With the refinement of our manufacturing process now completed we have been able to present ElectriPlast™ to our patient customer base. This is accomplished by first, establishing a non-disclosure agreement between all parties. This allows the flow of information to be shared in order to understand what material needs might be used on a particular project. Samples in the form of ElectriPlast™ plaques or pellets will then be sent to a customer with processing data. We also have the capability and capacity to have molds built and parts molded or extruded should the customer need. This facilitation has allowed us with confidence to produce, deliver and demonstrate a material that a customer can then use to begin their research and development. A number of companies have visited Jasper and are currently molding parts and or establishing a research and development phase.
Client Specific Application Development
The ElectriPlast™ sales cycle process is arduous. It begins with testing and continues through engineering, design, tooling, inventory adjustment, production part testing and finally the purchase order.
We are working with 43 potential customers at the present time in the market areas of: Antenna, Apparel, Appliance, Audio & Visual, Automotive, Battery, Cable, Computer, Electrical, Heating, Heavy Equipment, Industrial, LED’s, Military, Mining & Construction, Power Delivery, Shielding, Sporting Goods, and Wiring.
With Jasper currently able to produce in excess of 50,000 pounds of ElectriPlast™ per month we are in a position to receive sales orders and deliver upon such.
Manufacturing
Through our new relationship with Jasper Rubber, founded in 1949, we have secured a manufacturer of innovative rubber and plastics development.
Jasper manufactures a full range of products under three facilities totally 330,000 square feet with an 800 person work force. Jasper currently manufactures a variety of goods for major appliance, oil filter, and automotive industries including several Fortune 500 companies. Since our exclusive manufacturing agreement was completed with Jasper several important steps have been taken. Jasper purchased state of the art machinery which has been integrated into their premises. The equipment although readily available had to be changed and in many instances had to be customized to meet exact specification in order to produce an ElectriPlast™ pellet. This work was done by Jasper’s experienced work force. The machinery development stage has now been implemented and future equipment modifications and expansion will be much easier.
Our focus for 2008
2007 has been a busy year for Integral and Jasper. We have established and implemented an exclusive manufacturing agreement, bought and customized newly acquired pelletizing machinery and completed tests on this machinery in order to finalize an agreement on a pricing matrix from Jasper to Integral. We will continue to expand our sales and marketing activities, focusing primarily on customer needs based on the ElectriPlast™ technology. That said; we believe that the bulk of our sales activities will be conducted through partners and third party suppliers with established industry distribution.
While sales and marketing are becoming the key area of focus for us going forward, we realize that our most valuable asset is our technology. It is important that we maintain our leading industry position and continue to invest in innovation. This objective will be implemented by expanding and protecting our intellectual property, while sharing the cost of innovation with our partners and customers.
From Jasper:
The year 2007 has been filled with enthusiasm and hard work by many individuals marketing and manufacturing ElectriPlast™. The sales effort is developing at a controlled pace as it moves from communicating the initial capabilities of the material to new customers, into designing, prototyping and testing of new applications. These efforts are time-consuming, but necessary, as new designs must be created and proven, due to the innovative nature of ElectriPlast™. Also, the new design must be manufactured and tested before production tooling and commercialization can occur. The basic manufacturing techniques have been established and the equipment is currently being utilized for material development and prototyping. We continue to be excited about the future of ElectriPlast™ and believe 2008 will lead us to commercial success.
Conclusion:
In conclusion, with interest having been received for hundreds of applications of ElectriPlast™ from Fortune 500 companies in industries such as automotive, aircraft manufacturing, communications, computers, consumer electronics, medical devices and others, we believe that Integral has moved from the R&D stage of the development of its ElectriPlast™ technology to the next phase being a commercial enterprise.
On behalf of Integral Technologies and Jasper Rubber we would like to thank you for your continued support. It has been an exciting run and we look forward to a very productive 2008.
Yours sincerely,
William Robinson, Chairman & CEO
Integral Technologies, Inc.
Doug Mathias, CEO & President
Jasper Rubber Products, Inc.
DIGUANG INTERNATIONAL DEVELOPMENT CO (OTCBB: DGNG)
"Up 15.38% on Tuesday"
Detailed Quote: http://www.otcpicks.com/quotes
Diguang, through its subsidiaries, specializes in the research, development, production, sale and distribution of backlights and backlight technologies. A backlight is the typical light source of a liquid crystal display (LCD). The Company is focused on providing LED and CCFL backlights for international producers of televisions, monitors, cellular phones, digital cameras, DVDs and other home appliances. Diguang currently develops an average of approximately 50 new products per month. Diguang is a Nevada corporation with its manufacturing subsidiary located in Shenzhen, PRC, and its sales and marketing subsidiary located in the British Virgin Islands.
DGNG News:
November 20 - Diguang International Wins Large Contract from Samsung SDI
Diguang International Development Co., Ltd. (OTCBB: DGNG) ("Diguang"), an emerging, China-based leader in the manufacture of CCFL and LED backlights for the LCD display industry, announced that it has entered into a contract with Samsung SDI Co., Ltd.
Diguang's Mobile Phone Strategic Business Unit is expecting to deliver to Samsung estimated monthly shipments of 500,000 mobile phone backlight units per model beginning in early to mid-2008, with expected shipments in 2008 under the contract to total a minimum of 10 million units. The contract may be renewed upon the agreement of both companies.
"Today's announcement is a major milestone for Diguang in further increasing our international presence," said Song Yi, President and Chief Executive Officer of Diguang International. "The Samsung SDI contract calls for the highest in technical and quality control standards, and meeting its challenges will position us with stronger competitive advantages than ever before."
"We plan to use the operations devoted to this contract as reference sites for other SBUs within the Company," Mr. Song continued. "By emulating successful practices, each SBU will account for itself under our newly announced structure. We are excited to be moving ahead with an expanded product line and innovations at the operational level, supporting the expansion of our international distribution channel."
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