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| Statement |
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| The results from our preclinical work support our hypothesis that CellFX nsPFA ablation can produce highly differentiated and market-leading safety and efficacy compared to traditional thermal modalities, including cryosurgery and radiofrequency ablation |
| As awareness of our novel technology sits throughout the industry, we are also incredibly excited to have Dr |
| Dunnington's industry-leading minimally invasive approach further validates our CellFX nsPFA technology and overall mission to further improve the lives of patients and physicians |
| The 90-day evaluation has now been completed, and we're pleased with the positive results |
| We believe the benefits of CellFX technology will improve clinical outcomes for many thyroid disease patients and be much more readily adopted by physicians, increasing the number of patients who can be treated |
| We are very fortunate to have two of the preeminent surgeons in the field on our team as we advance our product development and clinical studies |
| Pulse Biosciences is receiving significant support from highly-esteemed physicians in the field of cardiology, who have been impressed with our CellFX nsPFA preclinical study results |
| We've done the work in the clinic, and we've done the work on the engineering side, and we're extremely excited about where we're going with nsPFA, CellFX, and we're really excited to bring these results to you |
| As we share these preclinical results awareness of the benefit of CellFX nsPFA is growing, and attracting industry leaders from across the globe who see the positive impact of their engagement and want to be involved with advancing the technology as quickly as possible, to deliver improved clinical outcomes to their patients as well as many others |
| We think we're very strong in that area |
| With the preclinical data we've generated to date, we retain our belief that the CellFX nsPFA cardiac clamp provides a significant improvement over current thermal modalities and tracks with our expectations to file a 510(k) submission to the FDA by the end of the first quarter of 2024 |
| We think that not only are we going, to be able to address a lot of these thyroidectomy patients, but because of our better safety, the efficacy and the healing profile, we think we can reach a good number of those 8 million "watchful" waiting patients |
| The Pulse team continues to explore and develop new clinical areas where our novel technology can have a large positive impact on human health |
| In the lab, we consistently see the clear advantages in our CellFX nsPFA cardiac ablation plant compared to other energy modalities, as evident by a consistency in achieving transmural ablations in 1.25 seconds, independent of tissue type or thickness, which is roughly a 20th of the time it takes for radiofrequency ablation |
| So, we believe strongly that this IP is very strong |
| So, we're pretty excited about the position we're in |
| We are excited to leverage this shared interest to continue our momentum into the clinic and view this external interest as a testament to the immense potential of CellFX nsPFA and future cardiac ablation market adoption |
| And that's why we're so excited about it, and we believe that the CellFX nsPFA can accelerate surgeon adoption |
| And we think that we've done an amazing job there |
| Dunnington's belief and our belief that the speed, lesion quality and inherent safety of CellFX nsPFA-powered cardiac ablation devices, starting with our CellFX nsPFA cardiac clamp, that will enable a simpler, faster, safer and more efficacious procedure that has the potential to both expand adoption and increase procedure growth in this market |
| We view this positive reception from the medical leaders as confirmation that our CellFX nsPFA technology can have a significant clinical impact in cardiology |
| We are also encouraged by recent comments and earnings conference calls from companies in the cardiac surgery market and industry analyst, as to the size and growth of the cardiac ablation market, and we believe our highly differentiated solution can capture a large portion of this expanding opportunity |
| Ad brings unparalleled academic experience, helping to launch new medical technologies, which we believe complement very well the clinical experience of our Chief Medical Officer for Cardiac Surgery, Dr |
| Their immediate commitment shows how our scientific and engineering expertise is indicative of a strong future market adoption of our technology |
| We believe CellFX nsPFA can deliver safer and more effective ablation of cardiac tissue |
| As a final point, it's important to note that while our cardiac clamp and cardiac catheter both represent significant product opportunities in surgery and electrophysiology, respectively, they also represent a validation of CellFX nsPFA in cardiac ablation, and we believe will be the first of a portfolio of CellFX nsPFA devices in cardiac ablation as we deliver on our goals to provide comprehensive solutions for the treatment of AF and significantly improve the lives of patients |
| These opportunities are only being considered if they align with our business goals, to create value by accelerating our timelines to market and facilitating health innovation that has the potential to significantly improve the quality of life for patients |
| We believe this capability will lead to a procedure that is easier to perform with significantly reduced procedure times |
| Ralph Tufano found the results extremely compelling and suggested that CellFX nsPFA could be a significant advancement in the treatment of symptomatic benign thyroid nodules |
| So we see great opportunity for us in the future in this space, and we think this market is ever evolving |
| Statement |
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| This differs from current microsecond ablation technologies where physicians may use suboptimal parameters to protect surrounding cellular tissues, and as a result, sacrifice efficacy for safety |
| One of the problems with thermal ablation modalities like RF or microwave, is that the treated volume shrinks down into a ball of fibrotic tissue that can persist for a very long time |
| So clearly, there are challenges with their use |
| So a lot of the safety issues that you see in ablation, in cardiac ablation in particular, have to do with the fact that thermal modalities are used |
| And most of these go untreated |
| These devices have been available for decades, but still have relatively low adoption and penetration |
| But most of these patients choose to just live with their condition, instead of having surgery for some people, the cure might be worse than the disease |
| And that's a possibility for us in the future |
| Actual results may differ materially from those expressed or implied as a result of certain risks and uncertainties |
| A large percentage of patients with benign thyroid nodules forgo surgery and thermal oblation because of their inherent risks and scarring |
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