The GentleWave System
Overview:
Sonendo is a MedTech company that was founded in 2006 by Fjord Ventures. For well over a century, root canal treatment (RCT) has depended primarily on files to remove infected tissue and tooth structure from inside the tooth. Files have limited reach inside complex root canal anatomy and can leave behind infected tissue and bacteria, leaving the tooth susceptible to reinfection. The minimally invasive approach of the GentleWave Procedure minimizes manual instrumentation and instead utilizes a powerful vortex of procedure fluids and acoustic energy that cleans the deepest, most complex portions of the root canal system.
Problem:
Standard root canal treatment does not adequately remove bacteria from the infected canal, which leads to higher odds of reinfection and erosion of the natural tooth.
What is a Root Canal? A root canal is designed to eliminate bacteria from the infected root canal, prevent reinfection of the tooth and save the natural tooth. When one undergoes a root canal, the inflamed or infected pulp is removed and the inside of the tooth is carefully cleaned and disinfected, then filled and sealed. (Source: what-is-a-root-canal)
Possible complications from manual instrumentation:
- Remove too much tooth structure, which may weaken the remaining tooth
- Leave behind infected tissue due to limited reach in complex root canal anatomy
- Break off inside the tooth, where they often cannot be removed
- Puncture through the tooth, leaving the tooth unsalvageable
- Create “smear layer” — a paste-like substance containing debris and bacteria
I think it goes without saying that when you hear the word “root canal”, you immediately get the heebie jeebies. The GentleWave System allows Endondtists to thoroughly clean all bacteria and infection out of roots as compared to the current standard RCT.
Technology:
The GentleWave System offers the following advantages:
- Minimally invasive: The GentleWave Procedure replaces much of the manual instrumentation in RCT with optimized procedure fluids, helping prevent the removal of excess tooth structure to maintain its natural functionality and structural integrity.
- Efficient cleaning: High-tech fluid delivery system delivers fluids throughout your root canal system, removing infection from the root canal system while preserving valuable tooth structure.
- One-visit procedure: In most cases, the procedure can be completed in one-visit, and because the process is so effective, the chance of needing a root canal retreatment later is significantly reduced.
The value in saving your natural tooth:
- Maintain bite and functionality for chewing
- Preserve the natural appearance of your tooth and smile
- Prevent neighboring teeth from shifting
- Protect other teeth from excessive wear
Mechanism of Action:
- SoundFLOW: Procedure Fluid Optimization
Fluid system utilizes: NaOCI, EDTA, and distilled water. The concentration of each fluid is adjusted for precise delivery to the root canal system. Fluids then go under a degassing process to eliminate gas bubbles in the fluid to prevent vapor lock. Vapor lock occurs when gas bubbles block access to the root canals. The degassing process also prevents gas bubbles from absorbing the acoustic energy. The constant refreshing of sodium hypochlorite ensures an effective removal of infected tissue from the root canal system.
2. SoundBAR: B(Broad-spectrum)A(Acoustic energy that)R(Resonates to reach through complex anatomy)
Fluids and energy meet inside the procedure instrument to come into contact with the soundBAR. Useful cavitation occurs as a result of the flow behavior inside the procedure instrument, which causes the formation of microscopic bubbles inside the fluid. Fluid bubbles then collapse and release energy that emanates throughout the root canal. It resonates with the natural frequency of anatomy and penetrates every feature of the root canal, including microscopic dentinal tubules. These microscopic bubbles differ from the bubbles removed during the degassing process. The vortical flow and acoustic energy of the fluid remove infected tissue, and may cause a slight negative apical pressure.
3. SoundResults:
Clinical Data:
Evaluation of Root Canal Debridement of Molars Using the GentleWave System:
Forty-five freshly extracted molars were randomly seperated into three treatment groups. The three treatment groups were: no treatment, treatment with standard rotary instrumentation and needle irrigation, and treatment with the GentleWave System and minimal instrumentation.
The rotary instrumentation and irrigation and GentleWave System groups resulted in cleaning 67.8% and 97.2% of the mesiobuccal and mesiolingual root canals of mandibular molars and the mesibuccal canals of the maxillary molars.
Source: https://www.jendodon.com/article/S0099-2399(15)00599-3/fulltext
Larger studies need to be conducted, but this data shows positive evidence in favor of the GentleWave System being highly more effective than standard root canal treatment.
Market:
According to Colgate, the national average costs for root canals are $762 for a front tooth, $879 for a premolar, and $1,111 for a molar. The increase in price is due to the fact that molars can have up to three roots, whereas front teeth only have one root. Thus, the more roots equates to more time and a higher cost.
According to the American Association of Endodontists, more than 15 million root canals are performed every year in the US. There are roughly 41,000 root canals performed every day.
(Source: https://www.marketresearchfuture.com/reports/root-canal-market-4742)
Financing:
Jan. 6, 2020- Venture Round: $86MM led be EW Healthcare Partners, with participation from RedMile Group, ArrowMark Partners, and Broadfin Capital along with existing investors.
July 5, 2019- Venture Round: $17MM
Sept. 18, 2017- Growth: $50MM led by General Atlantic
Dec. 13, 2016- Series E: $35MM led by DiNovA Capital
Aug. 22, 2014- Series D: $35MM led by Meritech Capital Partners
Mar. 24, 2014- Debt Financing: $10MM led by Oxford Finance
Jun. 4, 2013- Series C-1: $18MM led by Orbimed
Jun. 28, 2012- Series C: $9.2MM led by Orbimed
Aug. 10, 2011- Series B: $5.9MM
Dec. 1, 2010- Series A: $2.9MM
Total Funding Amount: $271.1MM. Considering the size of the latest round of funding, along with the ipo window very much being open, I would think there’s a decent chance Sonendo goes public 2H21 or early 2022.
Sonendo also acquired TDO Software in October of 2018.
Team:
The team has over 100 years of operating experience. Led by President & CEO Bjarne Bergheim, who was formerly a member of Fjord Ventures. Andrew Kirkpatrick serves as COO having previously served in the same capacity at Accuray, a global provide of innovative cancer treatment technologies, as well as a nuclear engineer in the US Navy. Michael Watts serves as CFO having previously been the CFO for the HydroFacial company. Michael also has held senior financial leadership roles with Johnson & Johnson, Zimmer Holdings, and Danaher. Mehrzad Khakpour, PhD, serves as CTO and has pioneered research on the application of fluid dynamics in various medical devices and biological systems.
Summary:
Overall, the GentleWave System represents a significant advance in root canal technology. From the clinical data, we can see that the procedure results in the cleaning of 97.2% of the root canal as compared to the current standard of 67.8%. This increased efficiency restores an infected tooth back to its natural state, and preserves the tooth from further infection and damage. In addition, the GentleWave System increases the probability that a patient will not have to come back for retreatment.
Another interesting wrinkle in the Sonendo story is the acquisition of TDO Software. The Digital Office Software is the only Endodontist software in the world that seamlessly integrates practice management, imaging, social media, referral, and CBCT imaging. This acquisition further accelerated Sonendo’s growth and will continue to be a key asset going forward.
Having performed more than 600,000 root canals with the GentleWave System, Sonendo is one of the fastest growing companies in the world. Given that there are roughly 15 million root canals performed in the US every year, the company is just scratching the surface in terms of market penetration. The TDO Software acquisition will allow Sonendo to push the GentleWave System to all the Endodontists using the software, further accelerating growth and market penetration.
Given the recent $86MM raise, I would bet that Sonendo goes public in the not so distant future, especially considering how strong the healthcare equity capital markets have been. Sonendo is a company to watch as they continue to transform how root canals are treated.
Questions:
- Does the GentleWave System require any sort of maintenance? If so, how frequent?
- In what cases is the GentleWave System unable to complete the procedure in one-visit?
- Watching the video above it seems like there might be a high learning curve on how to operate the system in regard to finding the optimal fluid percentages. How are doctor’s educated and what does that timeline look like?
- Does the recent 2022 Fee Schedule rule by CMS hurt Sonendo? How does this effect unit economics?
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