TVGR, Sutura Receives ISO 13485:2003 Certification for SuperStitch
Wednesday March 9, 8:36 am ET
FOUNTAIN VALLEY, Calif.--(BUSINESS WIRE)--March 9, 2005--Sutura®, Inc. ("Sutura®"), a California-based medical device company, today announced the completion of a successful audit leading to a number of certifications for the manufacture of the Company's SuperStitch® closure product line. The audit verified compliance with the quality standards required in the medical device industry, including ISO 9001:2000, ISO 13485:2003, European Directive 93/42/EEC Annex II and Health Canada's Canadian Medical Device Regulations.
Specifically Sutura received the ISO 13485:2003, "Medical devices-Quality management systems-Requirements for regulatory purposes" certification and the ISO 13485:2003 Canadian Medical Devices Regulations (CMDCAS) for the Canadian market.
The ISO 13485:2003 is a newly established and internationally recognized standard developed to ensure that companies provide medical devices that consistently meet regulatory requirements. In order to obtain the certification, Sutura demonstrated the ability to consistently meet strict requirements for quality management systems applicable to medical devices and related services.
In addition, Sutura's 20,000 square foot facility in Fountain Valley, California has been recertified for both the ISO 9001:2000 Quality Management Systems - Requirements, and the Council Directive 93/42/EEC Annex II, excluding section 4, for the European market.
"We are extremely pleased to receive these certifications and re-certifications which demonstrate Sutura's commitment to maintain the highest manufacturing standards," said Robert Hill, Vice President of Operations. "It is a credit to our people and their dedication to delivering the highest quality products to the medical community."
Egbert Ratering, Sutura's acting CFO and Executive Vice President of European operations added, "Having these certifications for manufacturing quality paves the way for customer confidence in our SuperStitch® closure product line, particularly as we introduce the "As Simple As 1-2-3 Concept" SuperStitch worldwide."
On November 22, 2004, Sutura, Inc. announced that it had signed an Agreement and Plan of Merger with Technology Visions Group, Inc. (OTCBB:TVGR - News) of San Marcos, California. The merger is now proceeding through due diligence and satisfaction of closing conditions.
About Sutura, Inc.
Sutura, Inc. (www.suturaus.com) is a medical device company that has developed a line of innovative, minimally invasive vessel closure devices to suture the puncture created in the femoral artery during catheter-based procedures, primarily in the fields of cardiology and radiology. The SuperStitch devices allow physicians to close the femoral puncture site using the catheter sheath introducer to access the femoral artery wound. Sutura believes that its products will allow a physician to more quickly and safely conclude catheter-based procedures and, in addition, allow the patient to become ambulatory sooner than with traditional methods of managing arterial puncture wounds. Sutura has received 510(k) clearance from the FDA to sell its F8 & F6 SuperStitch devices in the United States and has the CE Mark permitting sale in Europe. Sutura has also met all of the registration requirements for selling the SuperStitch devices in Australia. Sutura's headquarters are in Fountain Valley, California. "Sutura®" and "SuperStitch®" are registered trademarks of Sutura, Inc.
About Technology Visions Group, Inc.
TECHNOLOGY VISIONS GROUP, INC. (OTCBB: TVGR - News) is an intellectual property holding company that identifies, develops, and/or acquires new and innovative technologies for commercialization through licensing or joint ventures. The company's business objective is to take base technologies, develop and/or enhance these technologies until commercially viable products are possible, and license these technologies and any products resulting from the technologies to affiliated or unaffiliated entities. The Company operates as an applied research and development company and technology portal that employs and retains independent engineers, research consultants, research institutes, universities and other consultants as needed to develop and analyze potential technologies.
Forward-Looking Information Is Subject to Risk and Uncertainty
Certain statements in this press release may contain projections or "forward-looking" information (as defined in the Private Securities Litigation Reform Act of 1995) that involve risk and uncertainty. The words "aim", "plan", "likely", "believe", "expect", "anticipate", "intend", "estimate", "will", "should", "could", "may", and other expressions that indicate future events and trends identify forward-looking statements. These statements are not guaranties of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are based upon assumptions as to future events that may not prove to be accurate. Actual outcomes and results may differ materially from what we express or forecast in these forward-looking statements. As a result, these statements speak only as of the date they were made and we undertake no obligation to publicly update or revise any forward-looking statements. Our actual results and future trends may differ materially from our forward-looking statements depending on a variety of factors including the acceptance of the SuperStitch devices by medical providers and the marketplace in general and the success of the proposed marketing plan, the continued growth of the vessel closure marketplace and Sutura's ability to continue to meet necessary regulatory compliance standards.
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Contact:
Sutura, Inc.
Barry Forward
Corporate Communications
866-676-8386
www.suturaus.com
OR
Technology Visions Group, Inc.
James B. Lahey
President & CEO
(760) 752-8654
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Source: Sutura, Inc.
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