Novuson, Inc.- Ultrasound Medical Devices for Bloodless Surgeries

Novuson Surgical’s patented Focused Ultrasound surgical tool technology allows for rapid, precise, automated, and bloodless surgeries. Our technology dramatically reduces surgery times, improves patient outcomes, and drives significant cost savings for the healthcare system.

After 9 years of development, Novuson was founded in 2014 by University of Washington Applied Physics Lab researchers. With NIH grants and exclusive license to 7 granted US patents, we have developed and proven functional prototypes of the first product system to be built on the Novuson platform.

Uncontrolled bleeding is the #1 complication of surgeries worldwide, accounting for the highest number of complication events, the highest surgery-related mortality, and highest cost adder to surgical procedures worldwide ($100B+ annually). More than 75% of the 76 million annual US surgeries currently make use of energy applying bleeding control (or “hemostatic ablation”) tools, though all currently available technologies are limited in performance and application.

Traditional methods of contolling bleeding during many surgeries involve 45-60 minutes of work by a highly specialized physician. Surgeons clamp, cut, and suture in a race against blood loss.

Time in the Operating Room is the single most expensive aspect of modern hospital care, costing as much as $500 per minute. Novuson’s technology not only reduces OR time, but also dramatically cuts anethesia use and blood product consumption. More importantly still, our technology will significantly improve patient outcomes and decrease recovery times. 

Current ablation devices are effective only for small cross sections of tissue (<5mm thick, 10mm long), but no current energy delivering ablation devices can handle large tissue sections encountered in many common surgeries and trauma contexts. In a common kidney surgery (partial nephrectomy) for example – no current surgical ablation device can help in this operation because the organ is too large, thick, and complex. Novuson’s UltraStat surgical clamp quickly and thoroughly ablates planes of tissue across sections up to 30mm thick and 100mm wide.

Novuson Surgical devices were designed to target the approximately 2 million U.S. procedures per year where traditional ablation tools simply can’t be applied.

With Novuson technology, complex procedures that previously took 40-60 minutes of highly specialized care now are accomplished in as little as 3 minutes, in a fully automated procedure that creates no collateral damage to healthy tissue, without a single drop of blood.

Novuson’s is the first and only technology capable of rapid, precise ablation of thick tissue across an entire organ cross section. No solution currently exists for the rapid and thorough ablation of soft tissues of thicknesses greater than 5mm.

By generating a focused plane of ultrasound energy from the working surface of surgical clamps, Novuson cauterizes tissue in a precisely controlled plane between the clamp faces. The energy ablates the tissue from the inside out, precisely where the clinician intends and nowhere else. Our automated system applies just enough therapy to fully control bleeding and stops automatically when the procedure is complete.

The Novuson TUS technology has been shown to fully ablate soft tissue to thicknesses up to 30mm, and to accomplish this without collateral tissue damage, in a procedure time of under 3 minutes. This level of performance is unprecedented and disruptive to its market.

One Novuson system at $22,000 will save a hospital over $1,200,000 in one year.

Adoption of a single Novuson system will save a hospital over $1.2M annually in direct costs, and considerably more in indirect savings resulting from:

• Shorter procedure times,
• Lower risk for error,
• Reduced blood product usage,
• Reduced anesthesia usage,
• Shorter recovery stays, and
• Generally improved surgical outcomes.  

By combining positive outcome economics for hospitals with a dramatically enhanced workflow experience for surgeons, Novuson is well positioned to disrupt significant and growing surgical markets motivated by the promise of “bloodless surgery.”

Novuson delivers significant cost savings to hospitals, expands access to care, and significantly improves patient outcomes. 

The Novuson system is integrated to the working surfaces of a surgical clamp. Treating an entire organ cross section at once, the device applies energy, ablates the tissue, and automatically terminates therapy when complete.

The device locks in and holds itself for the length of the procedure (average time of 3 minutes) and stops itself when cross section has been fully cauterized. The device monitors completion of surgery in real time so that just enough therapy is applied to control bleeding and no more.

Novuson devices cauterize the tissue exactly where needed with pinpoint precision – 1mm to the side of the cross section and the tissue is completely unaffected.

Ablates tissue from the inside out, which means the clamp surface never becomes hot, and therefore never adheres to tissue or generates smoke (as current ablation tools do).

Patients are left with the same just scar tissue as would be formed with staples and stitches, except our cauterization happens more uniformly and rapidly, and no foreign bodies (i.e. staples) are left inside the patient. Patents will experience faster recovery times and lower chances of having to operate again by completely controlling bleeding during the procedure itself.

“This will change surgery forever” was the general sentiment from a University of Washington commissioned survey of applicable surgeons.

Over the last 9 years, the Novuson founders have established scientific credibility via compelling proof of concept trials. We are now transitioning from an R&D company to a manufacturing and marketing company, delivering product systems at a national then global scale.

Our technology’s performance has been solidly demonstrated, both in ex vivo tissue samples and in vivo swine trials. Now we need to invest in product development, manufacturing, and 510k FDA clearance, as well as fill out our technical and management teams with proven producers.

A highly regarded FDA consulting firm in Washington (Drug and Device Development) has issued a Position Letter indicating our FDA classification to be 510K.

We hold 7 granted US utility patents, 2 of which have been extended internationally, via the “PCT” process. Novuson owns worldwide exclusive license to these patents.

We have received support from a number of organizations:

Madigan Military Medical Center (Joint Base Fort Lewis/McChord) invited us to join them in a Cooperative Research and Development Agreement (CRADA), in which Madigan would conduct our human subjects trials at no cost to Novuson.

National Institute of Health (NIH) has awarded us multiple grants: Phase 1 STTR grant of $225K completed with a Perfect Score. $1.5M is anticipated in October 2015 for Phase2 of the STTR award, and an additional $1.5M in 2016

Alliance Surgical is our sales and distribution partner.

Our next step is to integrate the lab prototype into a product-ready clinical system suitable for 510K clearance by the FDA and use in human trials. We project 14 months are needed before we launch into the US general surgical market. We will first sell our system to the top general surgery hospitals in the North American market before expanding to Europe and Japan where we will use local distributing partners to enter the general surgery markets.

Christoph Mack • President & CEO

20+ year technology entrepreneur, with emphasis on MedTech device missions. Founder and CEO of X2 Biosystems, Synapse Device Development, ReJuVey Therapeutics, WaveScan Diagnostics, and others. Created more than 20 biomedical research partnerships with NCAA universities. Holder of 21 granted utility patents and named on an additional 30+ pending. Innovation awards from ASME, IDSA, Wired Magazine, MDDI “Medical Device of the Year.” Named one of “Seattle’s 10 Most Influential People” by Seattle Magazine.

Stuart B Mitchell, PhD • Chairman, CSO, Inventor of the Technology, Co-Founder

Over 20 years experience in biomedical instrumentation, 10 years in acoustic device and 15 years in tissue response to stimuli. Inventor of Novuson’s technology, conceptualized the market space, and developed the business strategy. Managed million dollar corporations/projects for 30 years. Started ACCES with Jean Maixner, grew to a multi-location practice with 70% CAGR, successful exit via merger with nationwide company, 7000% ROI.

Francesco P Curra, PhD • CTO, Expert in HIFU Software Control, Co-Founder

Over 15 years of experience in medical acoustics and ultrasound effects in biological media. Developer and inventor of state of the art simulation software for ultrasound therapy, innovative therapy-imaging transducers, and ultrasound-based temperature monitoring methods. Therapeutic and imaging ultrasound consultant to national and international companies including Cutera, Kona Medical, BioSense Webster (J&J), and Advanced Surgical Technology Research Laboratory. Developer and teacher of “Ultrasound Imaging” course of the Graduate Student Program in Biomedical Imaging at the UW.

Juan A Asensio, MD, FACS, FCCM, FRCS, KM • CMO, Advisor of Surgical and Trauma Surgery Applications

World renowned trauma surgery expert with over 400 published papers on surgical interventions and trauma management and co-authored 15 books. An active Academic Trauma Surgeon for over 25 years, Dr. Asensio’s research focus includes shock, exsanguination, cardiothoracic, and vascular injuries as well as complex pancreatico-duodenal and complex hepatic injuries. Drs. Asensio and Mitchell have collaborated for over eight years on various acoustic hemostasis-related projects.