Reveal's Rollout Strategy
The Company has set modest goals for the first two years, focusing on areas where regulatory issues present path of least resistance. In its 1st and 2nd year of operation, Reveal Therapies intends to:
1. Deliver product performance outcomes that have predictable repeatability and reliability, accessible to all cancer patients in a truly cost effective manner; and,
2. Provide clinical marketing and training for distribution partners that achieves clinical classroom and didactic instructions with certification and ongoing performance auditing; and,
3. Facilitate partner development of new and follow-on discoveries supported with the same marketing, training, certification and auditing support.
Thus, the number of patients we intend to treat in the 1st and 2nd years are:
(1) US, veterinary – 3 clinical treatment sites, over 500 canine and equine patents treated
(2) US, Human – the 1st 10 person FDA facilitated human trial with the microfluidic BioPACK™.
(3) China, Human – 2 sites, 190 patients treated
Reveal believes access for treating humans can begin within the first 12 months overseas and for compassionate care patients in the US within 18 months from initiating an Investigational Device Exemption process with the FDA [18-24 months from company start].
2. Completion of veterinary safety study
3. Release of the first clinical veterinary units
4. Launch of human use under CE mark
5. Initiation of IDE with FDA
6. Launch of human use under FDA approval
7. Launch of first education seminars for Channel Distribution Partners
8. Transfer of clinical operations to Channel Distribution Partners
Achieving these objectives will cost approximately $35 million dollars, and no more, possibly even slightly less!
Costs will be controlled through careful outsourcing of kit assembly (sub kit components are "off-the-shelf", pre FDA approved or cleared components) and direct patient management. Reveal will employ a "train-the-trainer" philosophy allowing the clinicians and clinical sites experience and confidence in adding treatment with the BioPACK™. The BioPACK™ therapy will be able to deliver superior outcomes to conventional chemotherapy, at substantially reduced costs (price-points).
1. Deliver product performance outcomes that have predictable repeatability and reliability, accessible to all cancer patients in a truly cost effective manner; and,
2. Provide clinical marketing and training for distribution partners that achieves clinical classroom and didactic instructions with certification and ongoing performance auditing; and,
3. Facilitate partner development of new and follow-on discoveries supported with the same marketing, training, certification and auditing support.
Thus, the number of patients we intend to treat in the 1st and 2nd years are:
(1) US, veterinary – 3 clinical treatment sites, over 500 canine and equine patents treated
(2) US, Human – the 1st 10 person FDA facilitated human trial with the microfluidic BioPACK™.
(3) China, Human – 2 sites, 190 patients treated
Reveal believes access for treating humans can begin within the first 12 months overseas and for compassionate care patients in the US within 18 months from initiating an Investigational Device Exemption process with the FDA [18-24 months from company start].
Overall Milestones
1. Completion of units to be used in canine trials2. Completion of veterinary safety study
3. Release of the first clinical veterinary units
4. Launch of human use under CE mark
5. Initiation of IDE with FDA
6. Launch of human use under FDA approval
7. Launch of first education seminars for Channel Distribution Partners
8. Transfer of clinical operations to Channel Distribution Partners
Achieving these objectives will cost approximately $35 million dollars, and no more, possibly even slightly less!
Costs will be controlled through careful outsourcing of kit assembly (sub kit components are "off-the-shelf", pre FDA approved or cleared components) and direct patient management. Reveal will employ a "train-the-trainer" philosophy allowing the clinicians and clinical sites experience and confidence in adding treatment with the BioPACK™. The BioPACK™ therapy will be able to deliver superior outcomes to conventional chemotherapy, at substantially reduced costs (price-points).
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