In July, 2016, we submitted the matching funds for our $60,948.00 U.F. Contracts and Grants award. XDG funded $30,474.00 and U.F. correspondingly funds/matches an additional $30,474.00 towards costs of independently validating the Digi-Clamp®. We expect to begin the actual trials and document our testing results by Fall/Winter, 2016.
We continue to file the required XDG Patent registrations for both our Domestic and International protection. The international “PCT” (Patent Cooperation Treaty) filings have been submitted and continue to be filed & registered with the assistance of XDG’s Patent Attorney (David Saliwanchik, Esq). The countries where we have filed the PCT include: Canada, China, Europe (EPO- European Patent Office comprised of several countries), Japan and of course, the United States.
We also on July 11,2106, agreed to pay for the renewal of the patent application which will become due in October 23, 2016. We will have to submit payment by September 9, 2016, and expect to provide our payment in the month of August of this year. This renewal is due for our Canada and EPO (Europe) patent applications. As other renewals become due, we plan to also pay and renew those legal renewal fees. Those fees will have to be paid by XDG, and we will continue to confirm this commitment with our legal patent attorney.
A draft of the I.R.B (Institutional Review Board) report/summary has been completed by Dr. Roig along with Carlos Hondal’s “non-medical” assistance for documentation of our process in our validation of the polydactyly removal procedure with the use of the Digi-Clamp® . A similar “IRB” will be drafted and subsequently reviewed by U.F. IRB review board for the Digi-Clamp® procedure in removing skin tags. Once the two IRB summaries are completed, we expect them to be published and shared in both the academic and medical communities. XDG will share the final IRBs with all our shareholders, stakeholders and friends at that particular occasion!
Our engineering firm assisting with our Prototype development, Medical Tool and Technology (MT & T), continues to work closely with XDG. We have built approximately 100 to 150 quality disposable Digi-Clamps® to use in our Validation trials (see item #1. Above). We have continued to successfully use the disposable Digi-Clamp® in “compassionate care” situations with documented waivers from all patients without any set-backs. We continue to be very excited regarding our future and look optimistically towards the completion of our validation trials this year!
We noted in our previous Winter 2015 update, the other products being considered by XDG. We will continue to review in the next few quarters or year, the retail version (disposable “take home skin tag kit”) and veterinary (bloodless castration device) versions of the prototypes. They are still under development and will require longer development times.
We continue to negotiate and meet with a firm out of Jacksonville in assisting us in steps to better commercialize and take our product(s) to market. We believe that we will have definite success in the test validation for empirical data (see item # 1 and # 5 above). This validation is expected in the fourth quarter of 2016 and will contribute to the continued positive valuation of our company.
Dr. Roig, who had an unfortunate accident in the first quarter of this year, has recovered well and we all feel that we are back on track with our goals and aspirations. Selected Milestones with our UF (University of Florida Research Foundation, Inc.) License agreement have had to be revised and we have submitted the revised Milestones to UF for their review. We expect to hear back from them by the end of the fourth quarter of this year (Dec. 2016).
Thank you for your continued faith and support of XDG in this venture. Please make sure to have a great summer and excellent fall. We expect to provide you with another “update” by the end of the fourth quarter of 2016. Our best and warmest wishes from Dr. Roig and Carlos Hondal to you and your families.