Reveal's Plan of Action
Reveal's plan of action for moving the technology from the lab is to go into full animal trials in dogs under FDA IDE safety rules; and by extension, opening the technology up to pets within six months. This will allow us to build better data and establish a full body of evidence for predictable, repeatable: reliability and scalability; very quickly.
The second round of actions will take the device through the full FDA IDE process to market approval, as well as an Asian/International CE mark, establishing and certifying the BioPACK™ within 15-18 months.
The third round of actions will open-up the device into direct human treatment and establish its presence in Medical Centers of Excellence. This will allow Reveal to radically expand the BioPACKs™ availability and cost effectiveness for both humans and pets.
As a first step in the US, we will partner with the University of California Davis, which is world renowned for its veterinary medical practice, to conduct canine trials that will validate product efficiency and help to refine patient management protocols for human use. In addition, canine patients are ideal candidates for the wearable BioPACK™ in the immediate future. Results from veterinary trial will allow Reveal Therapies to open discussions with the U.S. FDA for a direct path to approval as a device in humans.
At the same time, Reveal intends to pursue a CE™ certification for the Reveal BioPACK™. And pursue introduction of the BioPACK™ into China and Asia, under a CE certification. Because of regulatory circumstances, introduction into China will likely allow the BioPACK™ to be available for human use faster than the FDA approval path alone. Reveal's Management has had experience with other medical devices, in China, and those channels remain open for Reveal's BioPACK™.
Reveal then plans to launch the BioPACK™ in clinics located outside the US that are currently serving patients from US medical institutions, under the recent and rapidly growing phenomena of "Medical Holidays". Medical Holidays are optional for many US health care plans that insure "US-Like" quality of care at significantly reduced costs of care and greater access. Patients receive treatment under the same performance requirements found in the US, but in clinics where new technologies are brought to market quicker due fewer regulations, taxes, and government oversight. Institutions such as Mayo, Harvard Medical, Cleveland Clinic and many other centers of excellence have networks of medical providers overseas that routinely provide interventional therapies for their patients. These institutions provide quality oversight to insure maximum safety and efficacy. Reveal's products have received great interest from these network providers, who are interested in partnering to provide BioPACK™ access to their patients. These partners will aid in the underwriting of and oversight of clinical trials, patient screening, treatment, and follow-on care.
Reveal will also facilitate the dissemination of our results through independent non-profit foundations under trusted, but independent leadership, whose sole mission is to propagate accurate and unbiased analysis of differing cancer therapies, no matter who makes them available! These foundations will be allowed to discuss, consider, and compare Reveal Therapies immunotherapy science and treatment approach, with other approaches in ways that Reveal Therapies itself cannot do, because it will be constrained by FDA rules and regulations. The power of the outreach potential provided by an allegiance with honest and unbiased foundations and other non-profits that target particular cancers and patients should not be underestimated. It has the potential to dramatically increase the level of accurate and compelling alternatives.
The second round of actions will take the device through the full FDA IDE process to market approval, as well as an Asian/International CE mark, establishing and certifying the BioPACK™ within 15-18 months.
The third round of actions will open-up the device into direct human treatment and establish its presence in Medical Centers of Excellence. This will allow Reveal to radically expand the BioPACKs™ availability and cost effectiveness for both humans and pets.
As a first step in the US, we will partner with the University of California Davis, which is world renowned for its veterinary medical practice, to conduct canine trials that will validate product efficiency and help to refine patient management protocols for human use. In addition, canine patients are ideal candidates for the wearable BioPACK™ in the immediate future. Results from veterinary trial will allow Reveal Therapies to open discussions with the U.S. FDA for a direct path to approval as a device in humans.
At the same time, Reveal intends to pursue a CE™ certification for the Reveal BioPACK™. And pursue introduction of the BioPACK™ into China and Asia, under a CE certification. Because of regulatory circumstances, introduction into China will likely allow the BioPACK™ to be available for human use faster than the FDA approval path alone. Reveal's Management has had experience with other medical devices, in China, and those channels remain open for Reveal's BioPACK™.
Reveal then plans to launch the BioPACK™ in clinics located outside the US that are currently serving patients from US medical institutions, under the recent and rapidly growing phenomena of "Medical Holidays". Medical Holidays are optional for many US health care plans that insure "US-Like" quality of care at significantly reduced costs of care and greater access. Patients receive treatment under the same performance requirements found in the US, but in clinics where new technologies are brought to market quicker due fewer regulations, taxes, and government oversight. Institutions such as Mayo, Harvard Medical, Cleveland Clinic and many other centers of excellence have networks of medical providers overseas that routinely provide interventional therapies for their patients. These institutions provide quality oversight to insure maximum safety and efficacy. Reveal's products have received great interest from these network providers, who are interested in partnering to provide BioPACK™ access to their patients. These partners will aid in the underwriting of and oversight of clinical trials, patient screening, treatment, and follow-on care.
After the 1st and 2nd year
Large distribution partners will be used to deploy the BioPACK™ medical device and therapy into multiple medical centers in the US and abroad. As a medical device, Reveal’s natural partners for distribution are the big three service companies: Fresenius, Gambro and DaVita. To provide for the volume of patients expected, large networked patient care centers will be invited to become partners via the establishment of Reveal's therapy as a full, end-to-end service program. Natural partners in this aspect of operations are dialysis centers, oncology clinics, academic medical centers such as Stanford, Harvard, University of California (UCLA, UCSD & UCSF), and Mayo Clinics and large networked patient care centers such as Cancer Centers of America.How will Reveal get the message out?
From within Reveal Therapies, the promotion of the BioPACK™ therapy, and is associated promotional materials will be largely education content for caregivers, patient advocacy groups, disease related annual national, regional and local congresses, and patient advocacy events. As our results get broader dissemination, Reveal's BioPACK™ will become synonymous with cancer treatments that actually make the patient feel better during therapy than they did prior to their cancer diagnosis.Reveal will also facilitate the dissemination of our results through independent non-profit foundations under trusted, but independent leadership, whose sole mission is to propagate accurate and unbiased analysis of differing cancer therapies, no matter who makes them available! These foundations will be allowed to discuss, consider, and compare Reveal Therapies immunotherapy science and treatment approach, with other approaches in ways that Reveal Therapies itself cannot do, because it will be constrained by FDA rules and regulations. The power of the outreach potential provided by an allegiance with honest and unbiased foundations and other non-profits that target particular cancers and patients should not be underestimated. It has the potential to dramatically increase the level of accurate and compelling alternatives.
