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).
1. In November, 2015 the United States Patent and Trademark Office (USPTO) notified XDG of the tentative approval of the trademark application for the Digi-ClampTM. XDG is now under the “notice of publication” period. This is required for all Trademark applications and we should receive a final, formal approval in the next quarter of 2016. Once we receive the final, formal approval from the USPTO, we will use the following symbol: “®” to show we have a registered Trademark with the USPTO. (Currently the “TM” used with the Digi-ClampTM name indicates that a trademark application has been submitted and is pending final approval with the USPTO. (Application Serial number is 86581103.) An excerpt from the USPTO notification is included below for your information:
1. XDG is happy to announce that on July 30th XDG signed the formal License Agreement and Equity Agreement with UF’s Office of Technology and Licensing (“OTL”) and the UF Research Foundation, which oversees the OTL. The new agreement allows XDG more control of the company’s future and the strongest representation of the company’s goal to take XDG’s products successfully to market.
2. XDG submitted the Florida High Tech Corridor (“FHTC”) Grant Application to the UF Department of Pediatrics in July 2015. The grant application will be reviewed and forwarded to the FHTC, a State of Florida agency, for evaluation and funding determination. These grants have to be submitted through participating universities in the state of Florida or other similar organizations. XDG’s relationship with UF as part of the license agreement and equity agreement (see update 1 above) correlates with UF’s assistance in XDG’s submission of this grant.
3. In March 2015 XDG filed a Trademark application for “Digi-ClampTM” with the U.S. Patent and Trademark Office (USPTO). An initial response/review from the USPTO was received on July 2, 2015. XDG should have any final updates on this application by the end of 2015. The USPTO has informed all applicants that this review process can take between 4-6 months.
4. Prototype development: XDG met with Medical Tool & Technology, “M T & T” (Mr. Richard Helmig and Scott Wheeler)in June and July 2015. The engineering firm is helping XDG develop the (medical) disposable version of the “Digi-ClampTM” and eventually, the (retail)disposable version of the clamp for XDG. More specific updates on the status of the disposable clamps should be available by the end of the next quarter of 2015. A disposable “Digi-ClampTM” has been developed and used with final adjustments for better compression being implemented.
The retail version (disposable “take home skin tag kit’) and veterinary (bloodless castration device) versions of the prototypes are still under development and will require longer development times.
5. Tax returns for XDG Technologies were filed in June 2015.
6. XDG is in initial discussions with a firm out of Jacksonville to assist in better commercializing and take XDG’s product(s) to market. This firm specializes in helping startup firms with operational and marketing procedures in the medical industry.
7. New office mailing address: XDG has a new office phone and mailing address. The new address is:
XDG Technologies, LLC
One Biscayne Tower
2 South Biscayne Blvd., STE 3760
Miami, FL. 33131
Office Phone: (305) 503-9912
Office Fax: (305) 503-2801
Thank you for your continued faith and support of XDG in this venture. We appreciate it !!!
As the most recent winner for the FIU track of the Miami Herald Business Plan Challenge, XDG CEO and Co-Founder Carlos Hondal was asked to pitch why other start ups should participate in this year’s challenge.
After winning first place in The Miami Herald Business Plan Challenge, XDG Technologies has continued growing and developing this summer to improve standard of care for babies born with extra fingers and toes, and adults affected by skin tags:
The United States Food and Drug Administration has provided a preliminary determination that the XDG Clamp will be classified as a “Class 1” “manual surgical instrument for general use”
We were selected as one of the four finalists to pitch to potential angel investors and venture capital investors at the VenturePitch Orlando conference on August 26th. Watch XDG Technologies Co-Founder and CEO Carlos Hondal presenting the XDG Clamp at the event by clicking here.
We have applied to present at other medical device conferences inside and outside of Florida to continue development and exposure for the XDG Clamp.
We are also applying for state and national grants for medical device development to continue progressing through the medical device start up process.
We will always work with total effort to make this venture a success. Our mission is to help both the human condition of the children/adults affected by polydactyly/skin tags and the financial condition of the stakeholders in our company.
Please visit this space regularly for updates in the months to come.
XDG Technologies Co-Founder and CEO Carlos Hondal has been selected to present at the 3Q VenturePitch Orlando Conference on August 26th. XDG Technologies was one of four startup companies selected to present at the conference.
VenturePitch Orlando is an event held quarterly by Florida Venture Sourcing. Four startup companies pitch to a panel of active Florida seed and early-stage investors. The event also features networking opportunities with Florida tech entrepreneurs, investors, service providers, economic development professionals, and students.
The XDG Clamp, invented by a doctor, was judged a ‘simple, elegant solution’ for skin tags and extra fingers or toes.
XDG Technologies won first place in the Miami Herald Business Plan Challenge’s FIU Track.
“When you see a simple, elegant solution to health issues that affect millions of people worldwide, you have to take notice,” said John Fleming of Biztegra and a Challenge judge. “The XDG device could greatly improve the standard of care for children born with extra fingers or toes and for people suffering with skin tags. The company’s founders demonstrate the ingenuity and passion for creating products that can positively change people’s lives.”
The winners’ circle contains concepts in healthcare, fashion, athletics and tech. One theme running through many of the plans: community connection. To rise to the top, winners had to make a strong case for how they planned to execute their business plan.
On the FIU Track, XDG Technologies, a medical product to relieve polydactyly, the condition of extra fingers or toes, and remove skin tags, was the winning plan.
Who will win the 16th annual Business Plan Challenge? Twenty-nine business ideas are still in the mix.
Having the right ingredients in the plan to win over our judges isn’t easy: They were looking at the viability of the business model, the team, marketing strategy, financial projections and more. And a good idea alone won’t get you very far: Our judges were looking for a strong plan for execution.