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Bioject Medical Technologies Inc fka BJCT RSS Feed

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www.bioject.com

Bioject Medical Technologies Inc.

Bioject Medical Technologies Inc. (OTCBB: BJCT) is an emerging drug delivery company developing the world's leading technology for needle-free injection of liquid medications.

Bioject's technology works by forcing liquid medication at high speed through a tiny orifice held against the skin. This creates an ultra-fine stream of fluid that penetrates the skin, delivering medication in a fraction of a second. Bioject's systems are designed to deliver injected medications comfortably, accurately, and quickly - without the use of a needle.  Bioject was founded in 1985 to develop needle-free injection systems to improve the comfort and safety of routine injections. Since then, Bioject has developed a broad technology platform for delivering many different types of medications and vaccines to the subcutaneous and intramuscular depths. The company is currently developing systems and is in clinical trials for intradermal injections.

Bioject has developed a portfolio of injection systems based on its core technology. These include durable devices designed for heavy use in a professional healthcare environment, and small, lightweight injectors designed for home use. With partners, Bioject is also developing an inexpensive, pre-filled, disposable injection systems.  Bioject's strategy is to form strategic partnerships with leading pharmaceutical, biotechnology, and animal health companies. The company seeks to develop mutually beneficial agreements with these partners to develop customized injection systems to enhance the delivery of the partner's injected medication or vaccine. Bioject has alliances with leading pharmaceutical, biotechnology, and animal health companies.

Bioject Medical Technologies Inc.
20245 SW 95th Avenue
Tualatin, OR 97062

Phone: 503-692-8001
Fax: 503-692-6698
E-mail: investorrelations@bioject.com
Web: www.bioject.com

 

Financials

Bioject Medical Technologies Inc.is a fully reporting OTCBB stock: www.otcmarkets.com/pink/quote/quote.jsp

The company has recently confirmed that the share structure from the latest 10Q (3rd Quarter 2009) is still accurate: www.otcmarkets.com/edgar/GetFilingPdf

A/S: 100,000,000
O/S:   17,679,111 (confirmed by T/A on 4th March 2010)
Float: 13,800,000

The company has stated that at the current time they do not have any plans to dilute, as they recently closed a financing agreement with their largest shareholder. In the event they do need to dilute they would do it as a private placement which is usually done in the form of restricted shares that can not convert to common for 6 months, so we do not need to worry about dilution.

Transfer Agent
American Stock Transfer & Trust Company, LLC
59 Maiden Lane
Plaza Level
New York, NY 1003
Tel: (800) 937-5449 or (718) 921-8124
Web: www.amstock.com

Estimated Market Cap: $3,345,872 as of Mar 2, 2010

The Form 8K filed with the SEC for the company's financial year ending December 31st 2009 can be viewed here: http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=7133612

.

Recent / Upcoming News

April 7th 2010: Bioject announces that it has met the final milestone under its Development Agreement with Merial Limited ("Merial") by delivering devices with auto-disable nozzles to Merial for its next generation spring-powered companion animal vaccination device.   Bioject's President and Chief Executive Officer, Ralph Makar said "Merial has been an excellent partner and we appreciate the confidence Merial has in our needle-free technology. We are pleased to have completed this final milestone and look forward to using our new platform technology in its first commercial application".  Full press release www.businesswire.com/portal/site/home/permalink/

March 17th 2010: Bioject published 4th Quarter and End of Year 2009 financials showing that the operating loss and net loss allocatable to common shareholders has decreased by 65% over the previous financial year.   Bioject's President and Chief Executive Officer, Ralph Makar said "Recent positive events, such as the announcement of our strategic alliance with MPI Research, the elimination of our existing debt and the additional cash infusion, are encouraging as we strive for a better future and to increase shareholder value".  Full press release http://www.marketwatch.com/story/bioject-reports-december-31-2009-results-2010-03-17?reflink=MW_news_stmp

February 22nd 2010: Bioject announced in a PR approval from the Swedish Medical Products Agency to conduct a phase I clinical trial evaluating an HIV/DNA vaccine in collaboration with the Karolinska Institutet (KI) and the Swedish Institute for Infectious Disease Control (SMI) to be delivered to healthy volunteers by ZetaJet®  Full press release www.businesswire.com/portal/site/home/permalink/

February 16th 2010: Bioject announced in a PR full USDA license approval for Oncept canine melanoma vaccine, to be administered via a Canine Transdermal Device, which delivers the vaccine without the use of a needle.  The device was developed in conjunction with Bioject, Inc.  Full press release www.prnewswire.com/news-releases/merial-receives-full-license-approval-for-oncepttm-canine-melanoma-vaccine-84464667.html

January 5th 2010: Bioject announced that it has established a strategic alliance with MPI Research, a leading pre-clinical research organization with experience in the development of injectable therapeutics, which allows Bioject to gain access to a range of capabilities and resources needed for the company to explore drug+device opportunities, including access to pharmacologic, analytical, safety and other preclinical testing resources available at MPI Research.  Full press release www.businesswire.com/portal/site/home/permalink/

December 21st 2009: Bioject announced it completed a Series G Preferred Stock financing with each of Life Sciences Opportunities Fund II, L.P., Life Sciences Opportunities Fund (Institutional) II, L.P. (collectively, the “LOF”), and Edward Flynn for the purchase of an aggregate of 92,448 shares of its Series G Convertible Preferred Stock at a price of $13.00 per share. Gross proceeds from the sale were $1,201,834, payable by payment of $500,000 in cash and the cancellation of the $600,000 outstanding principal amount of and $101,834 accrued interest. Full press release www.businesswire.com/portal/site/home/permalink/

April 6th 2009: Bioject announced that the U.S. Food and Drug Administration (FDA) has granted market clearance for the Zetajet™ Needle-Free Injection Therapy System. Bioject’s new ZetajetTM system is the latest advance in needle-free delivery systems, offering a significant array of unique product features and patient benefits that can provide highly competitive differentiation to a wide variety of injectables market segments. Full press release www.businesswire.com/portal/site/google/

 

************************************************************************************************************************************************************************************

Possible Gamechanging News Due in May 2010

Results from a sequential phase I and II, controlled, double-blinded study to determine whether immune responses suggesting protection against influenza can safely be induced in young children. The study commenced in October 2006 and was completed in November 2009, with study completion date set for May 2010.  Good results from this study could be amazing for BJCT investors.

Clinical trials information www.clinicaltrials.gov/ct2/show/NCT00386542

*************************************************************************************************************************************************************************************

 

Needle-free Injection - What is it?

Bioject's needle-free injection technology works by forcing liquid medication at high speed through a tiny orifice that is held against the skin. The diameter of the orifice is smaller than the diameter of a human hair. This creates an ultra-fine stream of high-pressure fluid that penetrates the skin without using a needle.

Bioject's technology is unique because it delivers injections to a number of injection depths and supports a wide range of injection volumes. For instance, the Biojector 2000 can deliver intramuscular or subcutaneous injections up to 1 mL in volume. In addition, Bioject is developing a syringe for the Biojector 2000 that delivers intradermal injections that is currently in clinical trials.

Intradermal injection

Intradermal* injections are very shallow injections that deposit the medication between the layers of the skin. Many new DNA-based vaccines are delivered to the intradermal layer.

Subcutaneous injection

Subcutaneous injections are delivered to the adipose (fat) layer just below the skin. Many therapeutic proteins are delivered to the subcutaneous depth, such as human growth hormone.

Intramuscular injection

Intramuscular injections are the deepest injection type, delivering the medication into the muscle tissue. Most vaccines are currently delivered to the intramuscular depth.

 

 

Bioject's Products

 

ZetajetTM

The Bioject research and development team has developed a new spring-powered injector known as the ZetajetTM, which is based on the design of the Biojector® 2000 (B2000) for performance but uses a spring for its power source. The pressure profile of the Zetajet has been documented by in vitro testing to be virtually the same as that of the B2000, which has given millions of injections. The B2000 is a needle-free jet injection device that provides up-to-date jet injection technology and eliminates or reduces complications associated with others previous devices (eg, cross-contamination from patient to patient, lacerations at the injection site, difficult device cleaning, cumbersome tanks, etc).1-12 The intended use of this device is to provide a low-cost, needle-free injection system that delivers SC, IM, or ID injections via a simple change of the syringe. There is no need to adjust the device or technique for different injection types. This new needle-free system offers an additional feature - an auto-disable syringe that prevents re-use of the syringe. The syringe may be used to perform reconstitution with manual movement of the syringe plunger; however, once the injection is given, the syringe is disabled with the plunger tip remaining in the syringe to prevent any possible re-use.

Zetajet Study

A study comparing the use of Zetajet  was conducted at a clinical centre in 2009. After meeting all eligibility criteria, a total of 60 healthy subjects were enrolled in this study and were given three injections.  After each injection, a subjective evaluation was made related to the injection site, and questions were asked regarding the patients’ perceptions of the injection. Immediately after each injection, the injection sites were evaluated by a trained healthcare professional and within 5 minutes after the injections, the degree of pain with each injection was elicited from the subjects. The injection sites were also evaluated immediately following for local reactions (bruising, redness, and wheal formation). The follow-up was completed 24 hours after the initial injection and consisted of injection site evaluations.

The study reconfirmed the capability of a spring-powered device to successfully provide three types of injection (SC, ID, IM) that was originally proven using the Vitavax, a precursor device that led to the development of the Zetajet. The device was well received by the clinical investigators and clinicians who used the device during the study. Comments received throughout the trial regarding the ease of winding, loading, and administering the injection by the clinical investigators was very positive. On the assessments by injection type, all three injection methods with Zetajet received very positive ratings with more than 96% overall receiving Extremely Favorable and Favorable ratings.

In conclusion, the results of this clinical trial indicate that the Zetajet needle-free injection system is preferred compared to a traditional needle and syringe system. It also demonstrated the subjective injection effectiveness of the Zetajet jet injection system for SC, ID, and IM injections.With these unique advances in delivery technology, the Zetajet is anticipated to provide the optimal injection therapy system for both developed and developing countries to provide a safer and more effective method for delivering their parenteral injectables.

The full study report can be downloaded here http://www.bioject.com/pdf/Zetajet%20DDT%20Article%20February%202009%20Low%20Res.pdf

          

Biojector® 2000 Needle Free Injection System

The Biojector® 2000 is a durable, professional-grade injection system designed for healthcare providers. The Biojector® 2000 is the only needle-free system in the world cleared by the FDA to deliver intramuscular injections. The system can also deliver subcutaneous injections, and is being used for intradermal injections in clinical trials.

Cool.clickTM

Cool.clickTM is a needle-free injection system designed for delivery of Saizen® recombinant human growth hormone. Serono, the manufacturer of Saizen, is the first company to offer a needle-free delivery system for human growth hormone injection that is cleared by the FDA.

SeroJetTM

SeroJetTM needle-free injection system designed for delivery of Serostim, Serono’s high-dose recombinant human growth hormone formulation that is the leading treatment for AIDS wasting. Serostim has been the most extensively tested in AIDS wasting and the only biotechnology-derived drug approved for AIDS wasting by the FDA in the USA, which has granted Serostim orphan drug status, and marketing exclusivity, in the United States until August 2003.

The Bioject Drug Reconstitution Vial Adapter Kit

The Vial Adapter Drug Reconstitution Adapter Kit includes a blunt plastic device that replaces a fill needle for accessing medication vials, making syringe filling completely needle-free. The Vial adapter is designed to fit all standard syringes and all standard 13mm vials. The system is a convenient method for the withdrawal of medication and the transfer of diluents for reconstitution without the use of a needle.

Bioject Needle-Free Vial Adapter

The Bioject® needle-free drug reconstitution vial adapter is a non-sharp plastic device that replaces a fill needle for accessing medication vials making syringe filling completely needle-free. The vial adapter is designed to fit all standard syringes and fits on a drug vial with a 13 mm neck. The system is a convenient method for the withdrawal of medication and the transfer of diluents for reconstitution without the use of a needle.

 

 

 

 

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