February 10, 2023
Dear BioFuse Shareholders,
I am pleased to provide an update for calendar year 2022. Allow me to introduce myself, I’m Scott Sanders, President of BioFuse.
I joined BioFuse on February 1, 2022, as its President. I have over forty years of experience in the medical device market, thirty-seven of which specifically in the surgical RF energy space, with senior positions including R&D, clinical, training, and sales/marketing at Gyrus, Olympus, and Medtronic. I have also participated in over 300 animal lab studies.
I was very excited to join the BioFuse team because I tracked this unique technology for years. I personally have seen our technology in numerous surgical procedures in eastern Europe. I was also able to use the BioFuse system in animal labs and can attest to its unique and differentiating attributes. In eastern Europe, the technology has been proven safe and efficacious in thousands of surgical procedures across a broad range of surgical procedures. BioFuse technology enables both the sealing and the welding of tissue structures. As such, our target market is both the $1.4 billion vessel sealing market and the $14 billion staples and suture market.
We had significant progress in 2022. To begin, I am happy to report that the war in the Ukraine did not materially impact the source of the basic science, the E.O. Paton Welding Institute in Kiev. The workforce did have a break in activity early in the confrontation but have since returned to Kiev and resumed their jobs. The USA BioFuse engineering team was in constant contact with the members of the institute, securing and transferring intellectual property, trade secrets and software.
The clinical evidence of our technology is now being presented at international medical conferences, and worldwide physicians are starting to learn about our technology. We had two international presentations. The first was September 21-23 in Dublin, Ireland at the 17th Scientific Conference of the European Society of Coloproctology. Next was October 19-21 at the 41st Congress of the European Society of Surgical Oncology in Bordeaux, France.
The development of our tissue sealing system is advancing rapidly as we have 3 systems at our USA testing facility with 6 more on the way. We have recently begun product testing and validation (needed for submission to the FDA so as to secure a second 510(k) clearance). Our goal is to complete the necessary testing for our vessel sealing system and submit such data to the FDA during the second quarter 2023. Once we obtain the 510(k) clearance, BioFuse will then commence with the commercialization of the vessel sealing capabilities. We will be utilizing our already identified independent distributor network.
The company’s next goal will be to begin the development of our first tissue RF welding instrument for use in end-to-end anastomosis (EEA) procedures. This instrument is used in colorectal procedures where a surgeon removes the diseased section of the bowel, and then reconnects via welding with the BioFuse device. In eastern Europe, we’ve already proven that the BioFuse system can be utilized in this procedure, next we’ll be repeating such for the FDA thus allowing us USA market access.
We have identified a few of the companies we can work with to develop this welding instrument. In our pipeline we will continue to develop additional RF welding instruments which can replace currently utilized sutures and/or staples.
The Company is pleased to announce the addition of Dr. Joseph Stauffer as Chairman of the Board of Directors. Since 2004, he has served as Chief Medical Officer in both public and private specialty device, pharma and biotech companies including his role as Global Medical Director at Abbott Labs. He is a US Navy Veteran and his background also includes practical experience as a physician, residency at Johns Hopkins University, MBA and Medical Review Officer with the FDA.
BioFuse is also excited to announce the addition of Roland Austrup to the Board of Directors as the initial appointee of Innventure, LLC. Roland is an accomplished hedge fund manager, independent company director and CFO of Innventure, a company that founds, funds, operates, and rapidly scales companies in strategic collaboration with multinational corporations. Innventure will provide BioFuse with valuable strategic advisory resources to accelerate the commercialization of our disruptive welding platform.
We are in the final stages of the $2mm equity raise at $0.86/share and are pleased to announce several new investors that include physicians, a family office and additional investments from current directors, shareholders and the exercise of warrants.
All of us at BioFuse are extremely proud of the progress we have accomplished during 2022. I will continue to update our shareholders of our progress in 2023.
Most important, I wish to thank you for your continued support which makes possible our ability to advance this unique and exciting technology.
Should you have any questions or feedback, please contact me at Scott.Sanders@BioFuseMedical.com.
Thank you,
Scott R. Sanders
President, BioFuse Medical Technologies Inc.