We have created a robust Quality Management System. This includes documents, GLP validations, and GLP test plans and reports. This is necessary to prepare for FDA
audits that occur when we initiate human clinic studies.
IsoTherapeutics is our primary manufacturing contractor for our
hydrogel and particle components, but from a risk mitigation perspective we are to establishing an additional supplier. For almost two years we have been working with Jay Simon, the GM for
North America, for Eckert & Ziegler to be our alternate. They engaged in detailed discussions of
our proprietary procedures and have visited our production site, and we are confident a supply agreement can be established.
We finalized and patented our support equipment from shipping to therapy. We are currently focusing on developing an inventory of each item.
We are continuously striving to reduce the production cost of IsoPet to enhance our potential profitability and to make it more affordable to the typical pet
parent. This requires paying close attention to every production step and standardization, setting the stage for possible future automation.
Marketing to pet parents, clinic owners, veterinarians, and oncologists is complex. Aside from utilizing advertisements in key journals and the social media, the
following activities are important:
1. Open new small animal and equine clinics that are reasonably close for pet parents to access.
a. This quarter we certified a new small animal clinic, Indian Creek Veterinary Hospital in Fort Wayne IN, and two new equine clinics, Myhre Equine Clinic in Rochester NH and Hopkinton Animal
Hospital in Weare NH.
b. We are currently in contact with several other clinics.
2. Participate in conferences to interface with the animal therapy community.
a. Last Quarter
VSPA Spring Conference in Saint Paul MN
American College of Veterinary Internal Medicine, ACVIM in Philadelphia PA
b. This Quarter
11th International Conference on Isotopes in Saskatoon Canada
Nigel Stevenson from Exubrion Therapeutics® and I presented a joint paper entitled “Precision Radionuclide Therapy for Treating
Veterinary Cancerous Tumors and Osteoarthritis.”
Washington State Veterinary Medical Association, WSVMA in Tacoma WA
c. Next Quarter
Veterinary Cancer Society, VCS in Reno NV
American Association of Equine Practitioners, AAEP in San Diego CA
d. Next Year
American College of Veterinary Internal Medicine, ACVIM in Minneapolis MN
American Association of Equine Practitioners, AAEP in Orlando FL.
International Radiation Protection Association (IRPA) and IRPA 16th International Congress and 69th Health Physics Society Annual Meeting in Orlando
Dr. Darrell Fisher submitted an abstract: “Direct Interstitial Injection: An Approach to Optimizing Therapeutic Ratios for Safe and Effective
Delivery of High-dose Radionuclide Therapy in Treating Solid Tumors”
– Darrell R. Fisher, Versant Medical Physics and Radiation Safety; Michael K. Korenko, Vivos, Inc.
3. Perform animal studies that result in publications in key journals.
a. Next quarter we will complete the VX2 tumor injection at Johns Hopkins Veterinary Clinical Trial Network within the approved IUCUC protocol.
This will result in two publications.
b. Next year we intend to follow-up with a new small animal study at JHU and an equine study at a university located near “equine territory.”
c. Longer term we will conduct other studies using mice models to support future indications for use, such as lung cancer.
4. Next quarter Dr. Bill Bradly, owner of the New England Equine Practice, will conduct an experiment to determine if IsoPet is effective in treating caudal heel pain syndrome, sometimes called navicular
syndrome. This is a complex syndrome, but if IsoPet is effective, this is a new and large market.