-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, JYSx1sLlvTD05FUia3XuVsAw2lPZSzweYpXjwvKiY/6kec5G+2geo3aqvRYO+31z 678G3JnLFdp571TdPt5kSg== 0001068800-04-000587.txt : 20041013 0001068800-04-000587.hdr.sgml : 20041013 20041013144704 ACCESSION NUMBER: 0001068800-04-000587 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20041012 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041013 DATE AS OF CHANGE: 20041013 FILER: COMPANY DATA: COMPANY CONFORMED NAME: APPLIED DIGITAL SOLUTIONS INC CENTRAL INDEX KEY: 0000924642 STANDARD INDUSTRIAL CLASSIFICATION: COMMUNICATIONS EQUIPMENT, NEC [3669] IRS NUMBER: 431641533 STATE OF INCORPORATION: MO FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26020 FILM NUMBER: 041076823 BUSINESS ADDRESS: STREET 1: 400 ROYAL PALM WAY STREET 2: SUITE 410 CITY: PALM BEACH STATE: FL ZIP: 33480 BUSINESS PHONE: 5613664800 MAIL ADDRESS: STREET 1: 400 ROYAL PALM WAY STREET 2: SUITE 410 CITY: PALM BEACH STATE: FL ZIP: 33480 FORMER COMPANY: FORMER CONFORMED NAME: APPLIED CELLULAR TECHNOLOGY INC DATE OF NAME CHANGE: 19940606 8-K 1 appliedk.txt UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): October 12, 2004 APPLIED DIGITAL SOLUTIONS, INC. (Exact name of registrant as specified in its charter) MISSOURI 000-26020 43-1641533 -------- --------- ---------- (State or other (Commission File No.) (IRS Employer jurisdiction of Identification No.) incorporation) 1690 SOUTH CONGRESS AVENUE, SUITE 200 DELRAY BEACH, FLORIDA 33445 (Address of principal executive offices) 561-805-8000 (Registrant's telephone number, including area code) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4 (c) under the Exchange Act (17 CFR 240.13e-4(c)) SECTION 8 - OTHER EVENTS ITEM 8.01 OTHER EVENTS. On October 12, 2004, the Food and Drug Administration ("FDA") issued a letter stating that VeriChip(TM), a radio frequency identification ("RFID") microchip for human use, has been cleared for medical applications in the United States. The FDA's clearance follows the completion of a de novo application review of the product. Digital Angel Corporation, the Company's majority-owned subsidiary, is the manufacturer of VeriChip(TM), and has licensed the technology to VeriChip Corporation, the Company's wholly-owned subsidiary, for human applications. A copy of the Company's press release dated October 13, 2004, announcing the clearance, and the FDA's letter are attached to this Report as Exhibits 99.1 and 99.2, respectively. SECTION 9 - FINANCIAL STATEMENTS AND EXHIBITS ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS. (c) Exhibits. As discussed in Item 8.01 of this Report, the following exhibits are furnished as part of this Current Report on Form 8-K: Exhibit No. Description - ----------- ----------- 99.1 Press Release dated October 13, 2004. 99.2 Food and Drug Administration Letter Regarding Clearance of VeriChip(TM) for Medical Applications in the United States. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. APPLIED DIGITAL SOLUTIONS, INC. By: /s/ Evan C. McKeown -------------------------------- Name: Evan C. McKeown Title: Senior Vice President and Chief Financial Officer Dated: October 13, 2004 INDEX TO EXHIBITS Exhibit Number Description - -------------- ----------- 99.1 Press Release dated October 13, 2004. 99.2 Food and Drug Administration's Letter Regarding Clearance of VeriChip(TM) for Medical Applications in the United States. EX-99.1 2 ex99p1.txt EXHIBIT 99.1 PRESS RELEASE APPLIED DIGITAL FDA CLEARS VERICHIP(TM) FOR MEDICAL APPLICATIONS IN THE UNITED STATES DELRAY BEACH, FL and So. ST. PAUL, MN -- Applied Digital (NASDAQ: ADSX), a provider of Security Through Innovation(TM) and Digital Angel Corporation (AMEX:DOC) announced today that VeriChip(TM), the world's first implantable radio frequency identification (RFID) microchip for human use, has been cleared by the U.S. Food and Drug Administration (FDA) for medical uses in the United States. The FDA clearance follows the completion of a de novo application review. The Company will hold a conference call today at 10:30 am eastern time in order to discuss the FDA's decision, Company's marketing strategy and medical applications for VeriChip. Interested participants should dial (800) 472-8309. The conference ID is 1531948. The call will also be webcast and will be available on the Home Page of Applied Digital's web site at www.adsx.com. As previously disclosed, the FDA response is the result of the Company's 510(k) application and subsequent de novo application for the medical and healthcare uses of VeriChip, originally submitted in October 2003. Digital Angel Corporation is the manufacturer of VeriChip and has licensed the technology to VeriChip Corporation, a wholly owned subsidiary of Applied Digital, for human applications. The VeriChip Health Information Microtransponder System consists of an implantable RFID microtransponder, an inserter, a proprietary hand-held scanner, and secure database containing the patient approved healthcare information. About the size of a grain of rice, VeriChip is a subdermal radio frequency microchip. Once inserted under the skin in a brief outpatient procedure, the VeriChip cannot be seen by the human eye. Each VeriChip contains a unique 16-digit verification number that is captured by briefly passing a proprietary scanner over the insertion site. The captured 16 digit number links to the database via encrypted Internet access. The previously stored information is then conveyed via the internet to the registered requesting healthcare provider. ABOUT VERICHIP(TM) VeriChip is a subdermal RFID device that can be used in a variety of security, financial, emergency identification and other applications. About the size of a grain of rice, each VeriChip product contains a unique verification number that is captured by briefly passing a proprietary scanner over the VeriChip. The recommended location of the microchip is in the triceps area between the elbow and the shoulder of the right arm. The brief outpatient "chipping" procedure lasts just a few minutes and involves only local anesthetic followed by quick, painless insertion of the VeriChip. Once inserted just under the skin, the VeriChip is inconspicuous to the naked eye. A small amount of radio frequency energy passes from the scanner energizing the dormant VeriChip, which then emits a radio frequency signal transmitting the verification number. In October 2004, the U.S. Food and Drug Administration (FDA) cleared VeriChip for medical applications in the United States. VeriChip is not an FDA-regulated device with regard to its security, financial, personal identification/safety applications. VeriChip Corporation is a wholly owned subsidiary of Applied Digital. ABOUT APPLIED DIGITAL Applied Digital develops innovative security products for consumer, commercial, and government sectors worldwide. Our unique and often proprietary products provide security for people, animals, the food supply, government/military arena, and commercial assets. Included in this diversified product line are RFID applications, end-to-end food safety systems, GPS/Satellite communications, and telecomm and security infrastructure, positioning Applied Digital as the leader of Security Through Innovation(TM). Applied Digital is the owner of a majority position in Digital Angel Corporation (AMEX: DOC). For more information, visit the company's website at http://www.adsx.com. ABOUT DIGITAL ANGEL CORPORATION Digital Angel Corporation develops and deploys sensor and communications technologies that enable rapid and accurate identification, location tracking, and condition monitoring of high-value assets. Applications for the Company's products include identification and monitoring of pets, fish, livestock, and humans through its patented implantable microchips; location tracking and message monitoring of vehicles and aircraft in remote locations through systems that integrate GPS and geosynchronous satellite communications; and monitoring of asset conditions such as temperature and movement, through advanced miniature sensors. For more information about Digital Angel, visit the company's website at www.DigitalAngelCorp.com. Statements about the Company's future expectations, including future revenues and earnings, and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and the Company's actual results could differ materially from expected results. The Company undertakes no obligation to update forward-looking statements to reflect subsequently occurring events or circumstances. Contact: CEOcast, Inc. for Applied Digital Ken Sgro, 212-732-4300 ksgro@ceocast.com Allen & Caron Inc. for Digital Angel Corporation Investors: Mike Lucarelli, 1-212-691-8087, m.lucarelli@allencaron.com, Media: Len Hall, 949-474-4300, len@allencaron.com EX-99.2 3 ex99p2.txt Exhibit 99.2 [SEAL] DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service - ------------------------------------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 12 2004 James Santelli Vice President, Finance and Chief Financial Office Digital Angel Corporation 490 Villaome Avenue South Saint Paul, Minnesota 55075-2443 Re: K033440 Evaluation of Automatic Class III Designation VeriChip(TM) Health Information Microtransponder System Regulation Number: 21 CFR 880.6300 Classification: Class II Product Code: NRV Dear Mr. Santelli: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your petition for classification of the VeriChip(TM) Health Information Microtransponder System, a prescription device, as per 21 CFR 801.109, that includes the VeriChip(TM) Pocket Reader and the VeriChip(TM) with the insertion device. The VeriChip(TM) Pocket Reader is indicated for use as a portable instrument that non-invasively reads the ID number of an implantable microchip that is inserted into the arm of the patient. When activated, the VeriChip Pocket Reader displays a unique identification number that may be used to access the patient's identity and authorized health information from a secure database. The VeriChip(TM) is indicated for use as a miniature, implantable microchip that is inserted into the subcutaneous tissue of the patient. The VeriChip(TM) provides the patient a unique identification number that may be used to access a database containing the patient's identity and health information. FDA has determined that this device, and substantially equivalent devices of this generic type, should be classified into class II. This order, therefore, classifies the VeriChip(TM) Health Information Microtransponder System, and substantially equivalent devices of this generic type into class II under the generic name, Implantable Radiofrequency Transponder System for Patient Identification and Health Information. This order also identifies the special control applicable to this device, entitled, "Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information." FDA identifies this generic type of device as: 21 CFR 880.6300 Implantable Radiofrequency Transponder System for Patient Identification and Health Information Page 2 - Mr. Santelli An implantable radiofrequency transponder system is intended to enable access to secure patient identification and corresponding health information. This system may include a passive implanted transponder, inserter, and scanner. The implanted transponder is used only to store a unique electronic identification code which is read by the scanner. The identification code is used to access patient identity and corresponding health information stored in a database. In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)) (the act), devices that were not in commercial distribution prior to May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976 (the amendments)), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA rulemaking process. These devices remain in class III and require premarket approval, unless and until the device is classified or reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the act (21 U.S.C. 360c(i)), to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and Part 807 of the FDA regulations (21 CFR 807). Section 513(f)(2) of the act provides that any person who submits a premarket notification under section 510(k) for a device may, within 30 days after receiving an order classifying the device in class III under section 513(f)(1), request FDA to classify the device under the criteria set forth in section 513(a)(1). FDA shall, within 60 days of receiving such a request, classify the device. This classification shall be the initial classification of the device type. Within 30 days after the issuance of an order classifying the device, FDA must publish a notice in the Federal Register classifying the device type. On August 4, 2004, FDA filed your petition requesting classification of the VeriChip(TM) Health Information Microtransponder System into class II. The petition was submitted under section 513(f)(2) of the act. In accordance with section 513(f)(1) of the act, FDA issued an order on July 22, 2004, automatically classifying the VeriChip(TM) Health Information Microtransponder System in class III, because it was not within a type of device that was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, which was subsequently reclassified into class I or class II. In order to classify the VeriChip(TM) Health Information Microtransponder System into class I or II, it is necessary that the proposed class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use. Page 3 - Mr. Santelli Based on the information submitted in the petition for the VeriChip(TM) Health Information Microtransponder System, FDA has determined that the VeriChip(TM) Health Information Microtransponder System can be classified in class II with the establishment of special controls. FDA believes that class II special controls provide reasonable assurance of the safety and effectiveness of the device. The potential risks to health associated with the device are: adverse tissue reaction; migration of implanted transponder; compromised information security; failure of implanted transponder; failure of inserter; failure of electronic scanner; electromagnetic interference; electrical hazards; magnetic resonance imaging incompatibility; and needle stick. The special controls document aids in mitigating the risks by identifying performance and safety testing, and appropriate labeling. Thus, in addition to the general controls of the act, an Implantable Radiofrequency Transponder System for Patient Identification and Health Information is subject to the following special control: Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information. Section 510(m) of the act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of an Implantable Radiofrequency Transponder System for Patient Identification and Health Information and, therefore, the device type is exempt from the premarket notification requirements. Thus, persons who intend to market this device type need not submit to FDA a premarket notification submission containing information on an Implantable Radiofrequency Transponder System for Patient Identification and Health Information, unless they exceed the limitations on exemptions in 21 CFR 880.9 (e.g., different intended use or fundamental scientific technology). A notice announcing this classification order will be published in the Federal Register. A copy of this order and supporting documentation will be on file in the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and will be available for inspection between 9 a.m. and 4 p.m., Monday through Friday. Page 4 - Mr. Santelli As a result of this order, you may immediately market this device, subject to the general control provisions of the Act and the special controls identified in this order. If you have any questions concerning this classification order, please contact Gail Gantt, R.N. at (301) 594-1287. Sincerely yours, /s/ Donna-Bea Tillman Donna-Bea Tillman, Ph.D Director Office of Device Evaluation Center for Devices and Radiological Health -----END PRIVACY-ENHANCED MESSAGE-----