I am pleased to provide a monthly update on our progress. I am responding to the feedback that the community appreciates the press releases, but would like more
FDA Pre-Submission IDE process:
Our next meeting with the FDA is scheduled for October 17. We submitted our draft of the new animal test plan for VX-2 tumors in rabbits at
Johns Hopkins University for FDA comments. Since RadioGel™ delivers a large dose with a small amount of activity it was necessary to fly a member of our team to JHU to determine if their PET and dose calibrators have adequate
sensitivity to address the FDA expectations.
As previously mentioned in our press release, we filed a hydrogel utility patent in the USA and PCT based on the last eighteen months of development work to
optimize our hydrogel component. We now have much stronger patent protection than the previous coverage from licensing the original Battelle technology.
Securing Component Production:
Qualifying alternate suppliers is part of our strategic approach of risk identification and mitigation to prevent any possible future interruption to our product
SciPoly produced three validation lots of polymer, which are currently being tested to confirm that they meet our specifications. They will become our preferred
supplier with two back-up suppliers.
Our yttrium-90 is supplied by Eckert and Ziegler. We have initiated
discussion for them to process their own Y-90 to supply our particles. If successful, that qualification will take many months. We would maintain our current supplier and have two particle
Continuous Improvement of Material Flow:
Every year we examine the demographics of our patient therapies and production runs to determine if we can improve our product flow and reduce material
To streamline the production process, we decided to standardize the unit volumes of hydrogel and particle solutions. We also decided to pre-mix both components
prior to shipping into a standard size vial. We currently send both components to the therapists to be combined at the clinics. We performed testing to confirm that the radiation effect of
premixing does not impact its rheology properties. This Important improvement will reduce the shipping costs, eliminate the mixing time at the regional clinics, reduce the low probability of
contamination during mixing, and simplify the regional clinic training.
We will demonstrate these improvements on our next IsoPet™ therapy scheduled in October.
We have spent significant resources on developing a great medical technology. We are now focused on bringing awareness of IsoPet® to more
veterinarians and with pet patients to increase the number of patients that we treat.
We have just augmented our current marketing effort by creating a Marketing Steering Board with veterinarians and other advisors that have germane experience. We
conducted our first Board call in September and plan to expand the membership and implement their suggestions.
Mike Korenko Sc. D
President & CEO Vivos, Inc.
Michael K. Korenko, Sc.D.
President & CEO