Navigation Links
PreMD Announces FDA Decision on POC Skin Cholesterol Test
Date:1/15/2008

Company to Immediately Address FDA Ruling

TORONTO, Jan. 15 /PRNewswire-FirstCall/ - Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME) announced today that it has received a non-substantially equivalent (NSE) letter from the U.S. Food and Drug Administration (FDA) regarding the 510(k) submission for an expanded regulatory claim on its point-of-care (POC) skin cholesterol test. The company expects to evaluate its options as part of the plans to address this issue.

"We are very disappointed with this decision by the FDA regarding our 510(k) submission. We believe we have provided adequate information to support clearance and continue to believe that our product merits clearance by the FDA," said Brent Norton, president and chief executive officer of PreMD. "The company is pursuing the next steps in addressing the decision and we will work through the process as expeditiously as possible. We continue to believe that this test fulfills a need for screening asymptomatic patients for risk of cardiovascular disease. Furthermore, our recent clinical achievements such as our presentation at the American Heart Association and scheduled publication in the American Journal of Cardiology for April show that we are supported in our belief of the strength of our product. The company has adequate cash to support operations through the near term. However, we will continue to evaluate and decrease spending throughout the organization to ensure our ability to execute the necessary tasks."

The FDA's primary grounds for rejecting the claim relate to the clinical utility of evaluating skin cholesterol with carotid wall intima thickness (CIMT) as the clinical endpoint. PreMD submitted the 510(k) application to the FDA in June 2007 based on a study design that was previously accepted as appropriate by the FDA. Subsequently, the FDA requested additional information regarding statistical clarification on the data submitted. The company promptly provided the information requested and believes that it addressed those concerns to the best capabilities of the company. PreMD was not aware of the FDA's issue or concerns from previous discussions.

About PreMD Inc.

PreMD Inc. is a leader in predictive medicine, dedicated to developing rapid, non-invasive tests for the early detection of life-threatening diseases. PreMD's cardiovascular products include a line of non-invasive skin cholesterol tests, planned to be marketed and distributed by AstraZeneca Pharmaceuticals. PreMD's other skin cholesterol products include PREVU(x) LT, a skin cholesterol test designed for use in the life insurance industry. The company's cancer tests include ColorectAlert(TM), LungAlert(TM) and a breast cancer test. PreMD's head office is located in Toronto, Ontario and its research and product development facility is at McMaster University in Hamilton, Ontario. For more information about PreMD, please visit http://www.premdinc.com.

This press release contains forward-looking statements. These statements involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the success of a plan for regaining compliance with certain continued listing standards of the American Stock Exchange, successful development or marketing of the Company's products, the competitiveness of the Company's products if successfully commercialized, the lack of operating profit and availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, product liability, reliance on third-party manufacturers, the ability of the Company to take advantage of business opportunities, uncertainties related to the regulatory process, and general changes in economic conditions.

In addition, while the Company routinely obtains patents for its products and technology, the protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. PreMD is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

(x) Trademark


'/>"/>
SOURCE PreMD Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. PreMD Provides Update on 510(k) Application for PREVU(x) POC
2. PreMD Inc. Provides Corporate Update
3. PreMD Announces Valuable Data on PREVU(x) LT Life Insurance Product
4. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
5. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
6. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
7. HEI, Inc. Announces Sale of RFID Division Assets
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
9. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
10. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
11. Brooke Franchise Corporation Announces Selected July Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology: