CLX MEDICAL, INC. OTC BB: CLXN)
CLX MEDICAL, INC. www.clxinvestments.com) holds a 51% equity interest in Zonda, Inc. CLX has also invested, and holds a common stock position, in ActionView International, Inc.
CLXN Main Corporate Offices...
29970 Technology Drive
Suite 203
Murrieta, California 92563
Telephone: (951) 677-6735
Fax: (951) 677-6573
Zonda Corporate Office & Mailing Address
Zonda Inc.
17304 Preston Road
Suite 800
Dallas, Texas 75248
Ph: 214 438-3706
Fx: 972 733-6817
Zonda lab:
1781 Vineyard Drive #225
Antioch, Ca. 94509
Ph: (925) 755-0511
Fx: (925) 755-0811
Email:
General Information: info@zondaincusa.com
Sales/Distribution: sales@zondaincusa.com
CLXN Directors/Executive Officers
Vera Leonard 63 President and chief executive Officer
http://www.portfolio.com/resources/executive-profiles/1345872
Robert McCoy 63 DIR
James Bickel 69 DIR
Patrick Edgerton 62 DIR
Transfer Agent
Transfer Online
317 SW Alder St., 2nd Floor
Portland, OR 97204
Phone (503) 227-2950
Fax (503) 227-6874
CLXN Website
http://www.clxinvestments.com/
Authorized Shares:
Outstanding Shares: 1,575,935,668 as of Aug 11 2008
Zonda Patent Application
CLX recently announced plans to initiate clinical trials for Zonda's rapid point of care test for Chlamydia as part of the process to achieve FDA clearance for the product. CLX anticipates a mid to late first calendar quarter 2008 beginning for the clinical trials. Concurrently, CLX will be considering additional medical diagnostic products and technologies that may be acquired and/or licensed by CLX.
Investor Relations
Gemini Financial Communications
Email: investors@clxinvestments.com or abeyer@geminicommunications.com
Gemini Financial Communications
Andrew Beyer
951-677-8073
SEC Filings
http://www.secinfo.com/$/SEC/Registrant.asp?CIK=317438'
Zonda, Inc.
CLX also owns a 51% equity interest in Zonda, Inc., a privately held diagnostic testing company that produces diagnostic tests that serve the medical, bacterial food safety, cosmetic, beverage, pharmaceutical, veterinary, and environmental sanitation testing markets.
Zonda distributes its HandiLab products in Europe to both the OTC (over the counter) and POC (point of care) markets. The unique features and advantages of HandiLab have resulted in distribution expansion into most countries of Europe. Zonda is undertaking regulatory approval in the U.S. and Asia, as well as expanding the CE certification it has already earned in Europe. Distribution relationships are being negotiated with many additional companies around the world.
Zonda’s products for the food safety and environmental sanitation markets are unique to Zonda and are not offered or manufactured by any other company. All of Zonda’s food and environmental safety products provide savings in cost and time to these markets. Zonda’s introduction of QuikAlert was in response to the e-coli and Salmonella outbreaks that have affected the food supply over the past several years. QuikAlert is a useful screening tool that can be used to prevent the spread of bacterial food contamination and assure everyone of a safer food supply.
Zonda is expanding into the largest medical sector, the clinical laboratory market, with its introduction of its LabQuik product line. The LabQuik product line of culture confirmation spot tests, stains and reagents are offered at very competitive prices
http://www.zondaincusa.com/index.php'
QuickAlert Video (e-coli test product):
http://www.zondaincusa.com/index2.php?id=video
NEW! HandiLab Testing Device Video:http://www.zondaincusa.com/videos/HL-Procedure/HandiLab.html
State of Incorporation: Nevada
Corporate Address:
PO Box 475
Rio Vista, CA 94571
Telephone 925-755-0511
Fax 925-755-0811
Zonda - Management
Patrick L. Edgerton - Chairman, Vice President of U.S. and European Distribution
Vera Leonard - President/CEO
Pavel Holik - Director of Commercial Operations
Ms. Leonard has considerable successful experience in leadership positions with major medical manufacturing and distribution companies. From 1999 to 2003 Ms. Leonard served as vice president of U.S. sales for Quidel Corporation, a Nasdaq listed company that specializes in rapid, point-of care diagnostic tests, Ms. Leonard led negotiations on agreements that added approximately $8 million in annual revenue and helped to grow revenues from $32 million to $51 million in 3 years. She delivered an unprecedented 6 consecutive quarters of financial performance that met or exceeded expectations and saved more than $1,500,000 annually for the company from renegotiations of growth incentive plan, implementation of net pricing strategy and elimination of GPO administration fees. Under Ms. Leonard's leadership, the company received awards for outstanding sales performance and distribution partnering from industry-leading distributors 3 years in a row and 4 years total. She restructured the sales and support organization to establish standards of performance, goal-driven compensation plan, territory-level budget and forecast management while developing individuals for promotion to levels of greater responsibility and leadership. From 2004 to 2005 Ms. Leonard served as director of vendor relations for Henry Schein, Inc., a Fortune 500 distributor of medical and dental supplies to office-based practices worldwide. In this position, she launched 6 new products; negotiated semi-exclusive distribution rights on three innovative new products; designed a product launch template that was adopted for standard use by the entire medical marketing team; negotiated an exclusive special pricing agreement on market-leading product to maximize competitive conversions; and completed an in-depth pricing analysis by vendor, sales division and SKU to assess pricing strategies and assure competitive positioning while maximizing profitability. From 2005 to 2007 Ms. Leonard served as President of Vera Leonard, Inc., an alliance that provides business consulting, leadership development, sales training and executive coaching to individuals and corporations. Previous to these positions, Ms. Leonard served as sales representative, sales manager, regional sales manager, and national sales manager for medical manufacturing and distribution companies where she developed an extensive firsthand knowledge of the medical supply field. These companies ranged from start-ups to major U.S. and international firms.
Clinical Sample Storage
In preparation for planned clinical trials for Zonda's rapid point of care test for Chlamydia, the tests that will be used in the trials have been placed in an FDA compliant, GMP approved secure storage facility provided by Sentry Logistic Solutions ("Sentry"), a leading provider of temperature-controlled storage and third party logistics.
Sentry offers refrigerated, ambient, frozen and ultra low storage, logistics and distribution services for a broad range of clinical and commercial biopharmaceutical materials and components. Its experienced staff and 53,000 square-foot facility can handle virtually any storage need and enhance a client's supply chain capabilities.
In anticipation of the initiation of clinical trials scheduled for the mid- to late-1st calendar quarter of 2008, Sentry has received a sufficient supply of Chlamydia tests in bulk and will disseminate them for use in the trials as appropriate. Sentry will also provide additional services related to the storage and distribution of the tests including cold chain logistics, labeling and packaging.
For additional details regarding Sentry's capabilities and services, please visit http://www.sentrylogistic.com/services.php.
Vaildation Studies
IIT Research Institute (IITRI) (http://www.iitri.org) will serve as the laboratory that will conduct a validation study for Zonda's rapid point of care test for chlamydia.
A major purpose of the validation study is to perfect the testing protocol in preparation for the clinical trials as part of the process to achieve FDA clearance for the product.
IIT Research Institute has provided non-clinical research and development services to the U.S. government and to sponsors in the pharmaceutical, biotechnology, chemical, agrichemical, and personal products industries for more than 40 years. IITRI scientists work closely with its sponsors to plan and implement programs in drug discovery, efficacy evaluation, and non-clinical development. Data from GLP-compliant programs conducted at IITRI are commonly used to support Investigational New Drug applications (INDs), New Drug Applications (NDAs), and other submissions to regulatory agencies around the world.
IITRI operates more than 125,000 square feet of state-of-the-art laboratory and support space in its Chicago facility.
Clinical Trials
American Health Partners, LLC (AHP), under which AHP will assist with the launch of medical diagnostic testing in CLX subsidiary operations. The first product for which CLX is expected to utilize AHP's market readiness process and distribution management system is Zonda's rapid point of care test for Chlamydia.
The professional services agreement outlines the services that AHP is expected to provide, including preliminary market validation for product efficacy, establishment of clinical trials protocol to meet the appropriate regulatory requirements, completion of clinical trials, assistance with targeted regulatory approvals for distribution of products within the United States, a market readiness audit, a manufacturing plan, a marketing plan, and a distribution plan to include the identification of and a contract with "1st Choice" distributors.
AHP (http://www.ahpartners.com) has over 30 years of experience in the marketing and distribution of professional medical products and has experience in preparing products for market launch in the United States.
Safis Solutions (http://www.safis-solutions.com), an Indianapolis-based regulatory compliance consulting company serving pharmaceutical, medical device and biotech companies worldwide, has been retained as a sub-contractor of American Health Partners, LLC (AHP), which has been engaged by CLX to assist with the launch of medical diagnostic testing products in its subsidiary operations. Safis Solutions is providing ongoing consulting services in the areas of regulatory approvals and quality systems for Zonda and additional potential future medical diagnostic technologies acquired by CLX.
Contract Research Organization (CRO) for the clinical trials for Zonda's rapid point of care test for chlamydia.
Trial Care International, LLC (http://trialcareintl.com/index.html) specializes in the management of Phase I-IV clinical trials in a wide range of therapeutic areas and provides clinical management, monitoring, auditing and regulatory services to the pharmaceutical and biotech industry through partnering and long-term relationships with its clients.
TCI offers a full range of clinical services specializing in: protocol design, project management, investigator recruitment and selection, document collection and supply shipping, contract and grant administration, investigator meeting coordination and facilitation, monitoring, GCP auditing and regulatory consulting.
4/30/08 LOI for FDA approved CLIA waived test kit
CLXN announced that after a period of initial due diligence and negotiations, the company has progressed to a letter of intent to acquire a rapid diagnostic device for the medical market.
The due diligence process will continue as CLX pursues a definitive agreement and the close of the acquisition of the device. Once CLX has reached a mutually agreed upon point in its due diligence process, it will announce the name of the device and the market that it serves.
The acquisition target presents considerable synergies with the product line of Zonda, Incorporated, a majority owned subsidiary of CLX that has developed a rapid point of care test for chlamydia. CLX is currently preparing to initiate clinical trials for the Zonda chlamydia test as part of the effort to achieve FDA clearance for the product. The company recently announced a validation study to perfect the testing protocol in preparation for the clinical trials.
:) 2008 UPDATED PRODUCT LAUNCHES!!!! :)
Chlamydia: - Clinical trials underway for FDA clearance. Targeted to Launch at the end of Q2 2008
Gonorrhea: - Targeted to Launch Q3 2008
Strep-A: - Targeted to Launch Q3 2008
Yeast: - Targeted to Launch Q3 2008
Get the latest NEWS Releases:
http://finance.yahoo.com/q?s=CLXN.OB
Get the Latest SEC info:
http://finance.yahoo.com/q/sec?s=CLXN.OB
Get the Latest Company Events:
http://finance.yahoo.com/q/ce?s=CLXN.OB
FACTS ABOUT HandiLab
*Rapid
*Self-Contained
*Point of Care and OTC (self testing)
...... Dianostic System
Core technology
Proprietary enzyme detection system (patent pending) consisting of a synthetic substrate which, in the presence of an enzyme specific to the infectious disease, causes a chemical reaction.
This reaction, when coupled to a developing agent, causes a color to appear on the tip of the swab.
Competing Technologies to HandiLab
*Culture
*Nucleic Acid Probe
*Antigen Detection
*Polymerase Chain Reaction (PCR)
Advantages of HandiLab
*NOequipment needed
*NOexpensive instrumentation necessary
*NOadditional reagents to store
*NOoff-line extraction; self-contained
*NOexpensive employee training
*3easy steps
*FASTresults at point-of-care
*DIAGNOSEand treat patients in same visit
Customers for HandiLab
Point of Care - Doctors Offices
Laboratories
Public health/STD Clinics
University Health Clinics
Over The Counter (OTC) Pharmacies
What does CLIA waived mean?
http://www.fda.gov/cdrh/clia/cliawaived.html
A list of CLIA waived tests since 2000:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/.../testswaived.cfm
http://www.zondaincusa.com/documents/Hungarian%20PCR-HandiLab2.pdf
http://www.zondaincusa.com/documents/Poster_Session.pdf
http://www.unicorp.hu/docs/b_handylab_uk.pdf
http://investorshub.advfn.com/boards/read_msg.asp?message_id=29188980
|
1 |
|
3
Thread abonnieren
