• We filed for a trademark on the term “Precision Radionuclide Therapy” so we can now use the TM mark.

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.

• We enhanced the polymer production process by eliminating a carbon filtering step. We also ran a dozen production runs to scale up the polymer production volume and to understand and reduce variables for reproducibility. All changes were supported by validation testing.
• In parallel, we were analyzing the PET data from the VX2 animal testing to determine if we can enhance the IsoPet characteristics while remaining within specifications. We increased the standard polymer concentration in IsoPet hydrogel. The improved product has a lower gelation initiation temperature and greater strength to help lock in the phosphate particles.

• After working with the Eckert & Ziegler senior management team in the US we will now obtain the Y-90 from their Wilmington MA plant to reduce shipping costs. The new Y-90 price will result in an approximate $1,000 decrease per therapy. Germany will remain as an alternate source of Y-90.
• Later this year we intend to  demonstrate our enhanced production flow and perform verification testing to qualify the new source of Y-90 as required by our quality management system.

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

b.     This Quarter

c.     Next Quarter

d.     Next Year

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.