Sutura, Inc.

Sutura, Inc.

March 09, 2005 08:36 ET

Sutura Receives ISO 13485:2003 Certification for SuperStitch


NEWS RELEASE TRANSMITTED BY CCNMatthews

FOR: SUTURA, INC.

MARCH 9, 2005 - 08:36 ET

Sutura Receives ISO 13485:2003 Certification for
SuperStitch

FOUNTAIN VALLEY, CALIFORNIA--(CCNMatthews - 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) 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) 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 Information

  • FOR FURTHER INFORMATION PLEASE 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