Novuson Surgical Inc.
Soundly Simplifying Surgery
Bothell, WA
Health Tech
Novuson has developed what we believe is the next generation of electrosurgical devices that are safer and more effective than current electrosurgical devices. We plan for our Direct Therapeutic Ultrasound surgical devices to disrupt the surgical device market, improving patient safety. Novuson is pre-revenue and in the prototype phase - - (Novuson has four prototype products (of which our 3mm Mini LS is close to regulatory clearance) and an energy console.)
$57,104
raised
50
Investors
$24.8M
Valuation
$0.64
Price per Share
$256.00
Min. Investment
Common
Shares Offered
Equity
Offering Type
$1.07M
Offering Max
Reg CF
Offering
Rewards
Get rewarded for investing more into Novuson Surgical Inc.:
$499+
Investment
StartEngine Owner’s Bonus
This offering is eligible for the StartEngine Owner’s 10% Bonus program. For details on this program, please see the Offering Summary section below.
Reasons to Invest
Safer Technology - Our patented DTU technology leaves no burned tissue, no charred tissue, and no carcinogenic smoke
Market Disruptor - Novuson’s technology solves the weaknesses of the two market-dominant electrosurgical solutions
Strategic Investments and Partnerships - Secured investment from major medical technology company and currently in negotiation for additional strategic partnerships
Overview
The first substantive innovation in vessel sealing & dividing in over 25 years
We believe Novuson’s patented technology is unprecedented for surgical and trauma procedures. It’s a trailblazing innovation in vessel sealing and dividing and hemostasis (bleeding control). The company is developing its direct therapeutic ultrasound (DTU) technology for coagulation and hemostatic control.
We believe our DTU technology speeds up surgeries and arms clinicians with rapid controls of bleeding associated with traumatic injuries. Novuson's solution does not transmit electricity through the patient, unlike market-dominant solutions, more importantly, no burned or charred tissue or any carcinogenic smoke is created in the process, resulting in safer procedures. This technology is built into a device with three configurations: the 3mm UltraStat Mini LS, 5mm UltraStat LS, and 10mm Maxx. Four total products are in the prototype phase, with one having its design for manufacturing (DFM) completed and its first production devices built out.
*Images are computer generated demo versions. Product is still currently under development
Novuson has completed the first build of its production validation test (PVT) articles. The next steps are to perform sterilization, safety, packaging, shipping, shelf-life studies, and other validation studies required by the FDA. We will file for 510k clearance with the FDA once these studies are complete.
The company was born out of the University of Washington’s highly regarded Applied Physics Laboratory’s Center for Industrial and Medical Ultrasound. Our founder and CEO is an alumnus and has designed biomedical instrumentation and devices for approximately 20 years.
the problem
Existing electrosurgical technologies lack safety & precision, leading to harmful consequences
According to our research, 33% of all surgeries experience complications. Does that number sound high to you?
That’s probably because 49% of those surgical complications were avoidable–– 77% of which were due to technical errors. If these tools were more safe, precise, and versatile, these devastating numbers could shrink. There is a need for innovative surgical solutions that improve patient outcomes and ultimately reduce hospital costs.
Source: Healy et al and Stokes et al
The two market-dominant electrosurgical solutions for sealing and dividing tissue are radio frequency (RF) and harmonic. Both solutions cause smoke, charring, and thermal damage to tissue with each application. Patients are already worried about the ailment that requires surgery. The last thing they should be worried about is the technology used to treat them.
Existing RF solutions run high-frequency electrical currents through the patient, and utilize that transmission. Harmonic solutions employ mechanically vibrating cutting bars, and utilize that friction heat. Both solutions achieve a level of success that is severely limited in speed, precision and range of application.
The cultivation of energy for those solutions also puts hospital buildings at risk. One out of every 200 uses of an electrosurgical device results in an adverse event, such as operating room fires or severe burns due to electrical arcing.
Surgical fires are not only a danger to patients but also to medical staff as a result of several factors including toxic gases and vapors that get released, as well as exposure to viruses and bacteria.
Source: Massarweh, N. N., Cosgriff, N., & Slakey, D. P. (2006)
Example of a surgical fire
The market
$6.4 billion total addressable market, electrosurgical devices used in 89% of all surgical procedures
The surgical device market is valued at an estimated $50 billion. Electrosurgical devices like ours are used in approximately 12% of surgical procedures. This translates to a total addressable market of $6.4 billion in 2020. The 5.2% CAGR can drive up our total addressable market to $8.8 billion by 2025.
Source: Global MD&D Market Report EMS Summit, Statistics MRC ID: 283193, Grand View Research Oct 2016, Markets and Markets (2916860), BCC Research (HLCO93A)
For every surgery completed, there’s an 89% chance the surgeon used an electrosurgical device. The technology behind the essential device was likely radio frequency (RF) or harmonic. Radio frequency devices transmit electricity from one end-effector to the other. The electricity cauterizes and the tissue is then cut with a built-in razor knife. Harmonic devices generate an ultrasonic waveguide to create a mechanical motion at the clamping end-effector. Friction is created, which cauterizes and burns through the tissue.
The solution
Innovations in precision, safety, & versatility for electrosurgical solutions
Patients and surgeons deserve innovation to achieve successful operations. Our solution does not run electricity through the patient, burn or char their tissue, or generate any carcinogenic smoke in the operating room. Novuson’s electrically neutral design makes it safer and cleaner than conventional technologies.
*Images are computer generated demo versions. Product is still currently under development
Our technology debuts in an improved surgical device for sealing and dissecting tissue, as well as whole organ cauterization. Our devices come in three configurations for a wide range of clinical applications. Medical professionals can choose between the 3mm UltraStat Mini LS or the 5mm UltraStat LS models for sealing/dissecting and the 10mm Maxx model for whole organ cauterization.
Each device has jaws that clamp down on tissue. Confined energy is created between these jaws, delivering a controlled, uniform therapy zone. We do this without passing an electric current through the patient–– an unprecedented level of performance.
*Images are computer generated demo versions. Product is still currently under development
Novuson has a “Razor-Razor Blade” business model. Our applicator unit sales are based on the number of surgical procedures performed, and there are 410 million annual surgical procedures worldwide. Our generator sales are based on the number of surgical suites the equipment is placed in, and there are 405K surgical suites world-wide. We will enter the market through direct sales at ambulatory surgical centers (ASCs). Our key opinion leaders there will conduct surgical studies with various procedures and publish the results. Traction with ASCs will jumpstart Novuson to develop strategic partnerships for distribution in hospital systems.
OUR TRACTION
We raised $5 million & won the NIH STTR Award
Our accomplishments result from our innovative technology and the industry relationships we cultivate. We raised $5.57 million through series A financing and two convertible notes. Our Novuson platform device won the National Institute of Health’s (NIH) STTR Award for the perioperative device. We were awarded the HemoClamp SBIR grant ($1.5 million) and the Periop SBIR grant ($1.47 million). Four prototypes have been developed, with one in the process of design for manufacturing. Final reports were submitted to NIH with all grant milestones achieved.
*Images are computer generated demo versions. Product is still currently under development
In early 2019, we began collaborating with med-tech companies. Three months later, we achieved the first tranche milestone: sealing in under 3 seconds. The following year, we achieved the second tranche milestone: dividing in under 5 seconds.
Additional partnership milestones:
Licensing agreement formed with the University of Washington in 2015
Cooperative research and development agreement formed with Madigan Army Medical Center in 2016
Participated in a pre-meeting with the FDA in 2017
Distribution agreement in Italy in 2018
Received term sheet for strategic partnerships in China in September 2021
Product development milestones:
Filed international patents in 6 countries in 2020
Demonstrated 1st production validation test articles that meet Novuson's value proposition in March 2021
Two new patents were awarded in January 2021
Newest patent was awarded in October 2021
why invest
Major partnerships & agreements can help us become the premier electrosurgical device manufacturer
It takes a collaborative team of surgeons and medical professionals to ensure outstanding patient outcomes. That’s why we are employing partnerships and agreements to become the leading electrosurgical device manufacturer.
Success comes from synergy. Novuson is currently in discussions with five major medical device manufacturers to secure strategic partnerships and licensing agreements. These relationships will provide extraordinary growth opportunities. We want “Novuson” to pop into the head of every medical professional who needs new electrosurgical devices.
Novuson plans to grow with nimble product development efforts. We hope to launch a new product every six to nine months and currently have three additional prototypes ready for design for manufacturing. Interest from major electrosurgical device manufacturers to integrate Novuson’s technology could further diversify our market presence.
The current technologies that seal and divide tissue do not prioritize the safety of patients and the success of surgeons. It’s time to finally cut through the limitations and risks with innovation.
*Images are computer generated demo versions. Product is still currently under development
We envision this part of your journey with Novuson as an exciting ribbon-cutting ceremony. It celebrates the future of surgical improvement. Your investment is like that shiny pair of scissors that cuts the ribbon and exhilarates the crowd. Would you like to do the honors?
Offering Summary
Company | : | Novuson Surgical Inc. |
Corporate Address | : | 11824 North Creek Parkway North,Suite103, Bothell, WA 98011 |
Offering Minimum | : | $10,000.00 |
Offering Maximum | : | $1,070,000.00 |
Minimum Investment Amount(per investor) | : | $256.00 |
Terms
Offering Type | : | Equity |
Security Name | : | Common Stock |
Minimum Number of Shares Offered | : | 15,625 |
Maximum Number of Shares Offered | : | 1,671,875 |
Price per Share | : | $0.64 |
Pre-Money Valuation | : | $24,817,635.20 |
*Maximum Number of Shares Offered subject to adjustment for bonus shares. See Bonus info below.
Voting Rights of Securities Sold in this Offering
Voting Proxy. Each Subscriber shall appoint the Chief Executive Officer of the Company (the “CEO”), or his or her successor, as the Subscriber’s true and lawful proxy and attorney, with the power to act alone and with full power of substitution, to, consistent with this instrument and on behalf of the Subscriber, (i) vote all Securities, (ii) give and receive notices and communications, (iii) execute any instrument or document that the CEO determines is necessary or appropriate in the exercise of its authority under this instrument, and (iv) take all actions necessary or appropriate in the judgment of the CEO for the accomplishment of the foregoing. The proxy and power granted by the Subscriber pursuant to this Section are coupled with an interest. Such proxy and power will be irrevocable. The proxy and power, so long as the Subscriber is an individual, will survive the death, incompetency and disability of the Subscriber and, so long as the Subscriber is an entity, will survive the merger or reorganization of the Subscriber or any other entity holding the Securities. However, the Proxy will terminate upon the closing of a firm-commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933 covering the offer and sale of Common Stock or the effectiveness of a registration statement under the Securities Exchange Act of 1934 covering the Common Stock.
Investment Incentives and Bonuses*
Time-Based:
Friends
Invest within the first 48 hours and receive 20% bonus shares.
Super Early Bird Bonus
Invest within the first week and receive 15% bonus shares.
Early Bird Bonus
Invest within the first two weeks and receive 10% bonus shares.
Amount-Based:
Tier 1 | $5,000+
Invest $5,000+ and receive 5% bonus shares.
Tier 2 | $10,000+
Invest $10,000+ and receive 10% bonus shares.
Tier 3| $25,000+
Invest $25,000+ and receive 25% bonus shares.
*All perks occur when the offering is completed.
Investors will only receive a single bonus, which will be the highest bonus rate they are eligible for, with the exception of “audience-based” bonuses.
If a company offers an “audience-based” bonus, this bonus only will stack with any other bonus you are eligible for. An “audience-based” bonus is a bonus that is available to a qualified group of investors based on campaign-specific criteria - such as previous investors, existing customers, or Testing-the-Waters (TTW) reservation holders. An issuer can only offer a single audience-based bonus.
For example, a 10% audience-based bonus (i.e. prior investors) + a 10% OWNer’s bonus would receive an aggregate of 20% bonus shares.
Insider Investment Notice: Officers, directors, executives, and existing owners with a controlling stake in the company (or their immediate family members) may make investments in this offering. Any such investments will be included in the raised amount reflected on the campaign page.
The 10% StartEngine Owners' Bonus
Novuson Surgical Inc. will offer 10% additional bonus shares for all investments that are committed by investors that are eligible for the StartEngine Crowdfunding Inc. OWNer's bonus.
This means eligible StartEngine shareholders will receive a 10% bonus for any shares they purchase in this offering. For example, if you buy 100 shares of Common Stock at $0.64 / share, you will receive 110 shares of Common Stock, meaning you'll own 110 shares for $64. Fractional shares will not be distributed and share bonuses will be determined by rounding down to the nearest whole share.
This 10% Bonus is only valid during the investors' eligibility period. Investors eligible for this bonus will also have priority if they are on a waitlist to invest and the company surpasses its maximum funding goal. They will have the first opportunity to invest should room in the offering become available if prior investments are canceled or fail.
Investors will only receive a single bonus, which will be the highest bonus rate they are eligible for.
Irregular Use of Proceeds
The Company might incur Irregular Use of Proceeds that may include but are not limited to the following over $10,000: Vendor payments. Any expense labeled “Travel and Entertainment”. Inter company debt or back payments. Salary payments made to one’s self, a friend or relative.
Show More
Most recent fiscal year-end:
Prior fiscal year-end:
Total Assets
$61,579.00
USD
$428,635.00
USD
Cash And Cash Equivalents
$12,539.00
USD
$347,061.00
USD
Accounts Receivable
$0.00
USD
$0.00
USD
Short Term Debt
$682,501.00
USD
$43,858.00
USD
Long Term Debt
$170,000.00
USD
$45,602.00
USD
Revenues And Sales
$9,432.00
USD
$0.00
USD
Costs Of Goods Sold
$0.00
USD
$0.00
USD
Taxes Paid
$0.00
USD
$1,801.00
USD
Net Income
-$1,130,587.00
USD
-$733,033.00
USD
Risks
A crowdfunding investment involves risk. You should not invest any funds in this offering unless you can afford to lose your entire investment. In making an investment decision, investors must rely on their own examination of the issuer and the terms of the offering, including the merits and risks involved. These securities have not been recommended or approved by any federal or state securities commission or regulatory authority. Furthermore, these authorities have not passed upon the accuracy or adequacy of this document. The U.S. Securities and Exchange Commission does not pass upon the merits of any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering document or literature. These securities are offered under an exemption from registration; however, the U.S. Securities and Exchange Commission has not made an independent determination that these securities are exempt from registration.
Updates
Meet Novuson's CEO, Dr. Stu Mitchell, for Q&A
2 days ago
As part of our investor relations Dr. Mitchell likes to meet investors (current or potential) and answer questions and have an open group discussion. I'll also present an overview of the discussion we are having with potential strategic partners. The next date is Tuesday May 31st at either 10 AM or 4 PM. Please register using this link https://calendly.com/sbmitchell-1/meet-novuson-s-ceo-dr-stu-mitchell-for-q-a.
Looking forward to meeting everyone!
Novuson Named to the 5 Best Medical Device Companies 2022
5 days ago
Meet Novuson's CEO, Dr. Stu Mitchell, for Q & A
5 days agohttps://calendly.com/sbmitchell-1/meet-novuson-s-ceo-dr-stu-mitchell-for-q-a
Stuart Mitchell
Meet Novuson's CEO, Dr. Stu Mitchell, for Q & A
1 hr Web on Wednesday 5/18/22 at 10 AM. conferencing details provided upon confirmation.
As part of our investor relations Dr. Mitchell likes to meet investors (new, existing, & potential) and have an open discussion. Limit slots are available so sign up soon.
Follow this link to register
https://calendly.com/sbmitchell-1/meet-novuson-s-ceo-dr-stu-mitchell-for-q-a
Novuson Value - No Smoke
9 days agoDr. Gatta MD, FACS Joins Novuson's Medical Advisory Board
17 days ago
Message from Our Founder
23 days ago
I'd like to say thanks and welcome to all of our new investors and hello to those following Novuson. Whether you have already invested or not Novuson strives to build lasting relationships our investors. Our goal is to build a community of investors that influence others and help Novuson with our mission to improve surgical safety and precision.
Stu Mitchell
Founder and CEO
Novuson
Notice of Material Change in Offering
24 days ago[The following is an automated notice from the StartEngine team].
Hello! Recently, a change was made to the Novuson Surgical Inc. offering. Here's an excerpt describing the specifics of the change:
Issuer is extending campaign end date and updating financial information.
When live offerings undergo changes like these on StartEngine, the SEC requires that certain investments be reconfirmed. If your investment requires reconfirmation, you will be contacted by StartEngine via email with further instructions.
Novuson's New Patent Issued
26 days agoNovuson continues to expand our intellectual property! Don't miss this opportunity to help improve surgical safety and precision.
Surgical Devices: The what, when, why. How do we make them safer and more precise?
about 1 month agoDr. Stu Mitchell, Novuson's CEO, will provide a brief history of surgical energy devices. He'll discuss the types of procedures they're used for and why they are used even though they have harmful side effects. Lastly, Dr. Mitchell will give a comparison of the dominant technologies on the market to Novuson's DTU. Please click the calendly link below and select which day/time you can attend. (Mon 4/25 at 3:00PM PDT or Tue 4/26 at 10:00AM PDT)
DR. JONATHAN GELBER JOINS NOVUSON'S MEDICAL ADVISORY BOARD
about 1 month agoNOVUSON WELCOMES DR. JONATHAN GELBER TO OUR ADVISORY BOARD
Dr. Gelber is a board-certified orthopedic surgeon with a fellowship in sports medicine from the Cleveland Clinic and a masters degree in biomedical engineering from Columbia University.
Jonathan chose to pursue an additional degree in Biomedical Engineering to help bridge the gap between engineers and surgeons. He believes that working together will help the most patients that we can.
Dr. Gelber Stated: “I look forward to helping Novuson advance care for surgical patients by enabling their doctors to provide the best surgical treatments possible."
linkedin: linkedin.com/in/jonathangelber
Dr. Derek Khorsand, Novuson’s Chief Medical Officer states: “We at Novuson are thrilled to announce that Dr. Jonathan Gelber will be joining our Medical Advisory Board. Dr. Gelber brings a wealth of experience in the orthopedic space and his addition will open up tremendous opportunity for Novuson to grow and add to the already large clinical domains where our products aim to improve patient care and safety.”
Stuart Mitchell, Novuson President and CEO is excited to have Dr. Gelber on the team. “As a surgeon and an engineer, Dr. Gelber will bring a surgeon’s perspective into the engineering design process which will result in tools that address specific surgical needs”
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