Grapefruit USA Inc (GPFT)

[recon]

The FDA release will not affect their 510k submission at all people, here is an email I received from them. It is my understanding that the process with the radiologist review is almost complete and is going VERY well. Better than anticipated in fact. Dean is being very thorough and will be submitting very soon. If any of you want to be on their mailing list just let them know.


I have heard from many shareholders regarding the FDA’s press release that was issued today in regards to radiation exposure from CT, Nuclear Medicine and Fluoroscopy imaging devices. The goal of this e-mail is to communicate Imaging3’s Management point-of-view that this will NOT affect our current 510(k) submission for the Dominion Volumetric Imaging Scanner (DViS).

Two key paragraphs (paragraphs 10 & 11) of the press release are copied below and are worth comment and help explain what the FDA is doing and what these changes mean to Imaging3, its Shareholders, Customers and Employees. A link to the FDA website and release is also listed below.

From the FDA Statement:

“The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners. The agency intends to hold a public meeting on March 30-31, 2010, to solicit input on what requirements to establish.

Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.”

This link http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm200085.htm will take you to the full press release from the FDA.

After reading the press release Dean Janes quickly determined that this press release does not impact the current 510(k) now in progress for the Imaging3’s DViS imaging system.

The FDA is at the early stages of this process as indicated by the public meetings they will hold on the topic and they discuss the need for a National Registry and Dose Registry to track patient life-time exposure to radiation. These databases are far from complete. While I don’t know this definitively I do not believe that work on these databases has even begun. These databases are major, multi-year process to build let alone integrate them with imaging devices nationwide and other data source that would be needed to make these system viable for the healthcare system generally.

In summary, the FDA will not have these initiatives converted into policies or laws any time soon. Imaging3’s Senior Management believes that we will be past FDA approval for the DViS when these new regulations hit the books.

As we learn more about these policy changes we will keep you informed.

One last thing, many of the requirements that are listed in the press release are doable now with the DViS. Even if this was implemented much sooner than we think is possible we do not think that it would be a major problem.
Best regards,

Mike Nessen
Vice President, Business Development
Imaging3, Inc.
3200 W. Valhalla Dr.
Burbank, CA 91505
[e-mail]
800-900-9729 ext. 102 (office)
818-260-0930 ext. 102 (office)
818-260-0445 (fax)