Questions and Answers from the company.
cyber-care.net
Questions and Answers
We have monitored your inquiries to the company and our new investor relations toll-free number. We understand your frustration at not getting every phone call answered personally, but we will make every effort to respond to the most frequently asked questions through our website. The following questions and answers have been updated as of June 22, 2000. We will periodically update this section to ensure information remains current.
Q: When did CYBeR-CARE receive approval from the FDA?
A: CYBeR-CARE received a faxed copy of the FDA notification midday on Friday, June 16, 2000. That was our first notification and we issued a press release immediately.
Q: What products have been approved by the FDA?
A: CYBeR-CARE announced on June 16, 2000 that it received 510k market clearance (Regulatory Class II) from the FDA to market and sell its Electronic HouseCall„ (EHC 400 & 600) systems.
On May 26, 2000, CYBeR-CARE was informed by the FDA that EHC 200 does not require approval prior to sale or marketing.
Q: How does EHC 100 & EHC 200 differentiate from the other products?
A: EHC 100 & EHC 200 are not Internet protocol based products at this time.
Q: What is the difference between EHC 400, EHC 500 & EHC 600?
A: EHC 400 and EHC 500 stations have identical functionality. The only distinguishing feature is the packaging. EHC500 is one piece while the 400 is two pieces. Both products are Internet protocol based and have the same peripheral accessories; however, EHC 400 is a desktop patient station and EHC 500 is designed to be a portable patient station. EHC 400 and EHC 500 can be used for both individual patients and groups. EHC 600 is a care provider station.
Q: Has EHC 500 been approved by the FDA?
A: CYBeR-CARE will submit the EHC 500 to the FDA for special 510k clearance. A fast track process will be utilized since the EHC 500 is the functional equivalent of EHC 400, which previously received FDA clearance.
Q: Why was EHC 500 not included in the recent FDA ruling?
A: As a rule, it is preferable to submit these devices separately for approval. Moreover, the product is not ready for production, unlike EHC 400 & 600 which are currently being produced.
Q: What remains to be worked out on the EHC 500?
A: The company is working to reduce the weight of the EHC 500 to meet design goals. EHC 400 and
EHC 500 perform identical medical monitoring functions.
Q: Does EHC 100 need FDA approval?
A: CYBeR-CARE does not believe EHC 100 will need FDA approval, however, the company has requested the concurrence of the FDA on this issue.
Q: Do EHC systems sold outside the U.S. require FDA approval?
A: No. To date, we have a letter of intent with Xender, Inc., a Taiwanese electronics manufacturer and agreement with publically traded SIIC Medical Science and Technology (Group) Limited.
Q: What EHC technology was used in the Mayo Clinic trials?
A: The Mayo Clinic has used the EHC 400 and its equivalent developmental products exclusively in all its trials with CYBeR-CARE. These products all use the Internet transmission protocols.
Q: Have you recently updated your website?
A: Yes. CYBeR-CARE has updated its website to incorporate all recent EHC product developments.
Q: Is CYBeR-CARE in a quiet period?
A: As of June 22, 2000, we are not in a quiet period, but we have decided not to respond to every inquiry in light of pending litigation. Please continue to call our 800# and/or e-mail address. While we will not respond to every question, we will try to ensure your questions are answered through our website Q&A section.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: The statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, development of new products, government approval processes, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed in the Company's filings with the Securities and Exchange Commission.
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