Hubly Electric Drill

Patients with hydrocephalus, traumatic brain injury, intracranial hemorrhage, cancers of the nervous system, brain tumors, epilepsy, and subdural hematomas often undergo surgical treatments which rely on intracranial access. Intracranial access today is performed both inside (180,000 procedures U.S. annual) and outside (20,000 U.S. annual) of the operating room. The current bedside procedure relies on an inaccurate, hand-crank drill deficient of any safety features. This shortcoming is manifested by the 40% misplacement rate of catheters during intracranial access procedures and the 3-attempt average for functional catheter placement. Today with the hand-crank drill, an average of 4.5mm of drill plunge occurs per procedure. 50% of bedside and 10% of operating room intracranial access procedures yield patients’ suffering from infection, hemorrhage, stroke, neurological injury, and death. Our company is solving the problem of high failure rates for intracranial access procedures both inside and outside of the operating room. 

The thrice patent-pending Hubly Drill —innovative both at the bedside and in the OR—includes a drill with (1) automatic stop, based on pressure-sensing current-monitoring, to provide brain plunge prevention but restart as needed; (2) LED pressure indicator during drilling for increased control while drilling; (3) battery power—rather than wired, electric power as in the operating room to turn burr hole placement into a one-handed procedure, increasing drilling stability; (4) unique drill bits which provide additional mechanical plunge prevention as well as visual pressure indication and increased drill stability. This drill comes in a kit which additionally includes (5) hardware catheter guidance utilizing the proven Ghajar guide technique, which has been proven to facilitate accurate freehand placement; (6) a guide hub to stabilize the drill angle during burr hole placement; and (7) a variety of drill bit sizes for use in craniotomy and orthopedic procedures such as hip replacement and total reverse shoulder surgery. Larger companies have tried and failed to offer autostop but have failed because they’ve relied on pressure sensing rather than Hubly current monitoring technology. Now, any attempts to copy this current-monitoring technology will be patent infringement. 

Of the 205,000 skull punctures performed U.S. annually, hydrocephalus is by far the most common indication of use (est. 40,000 procedures U.S. annual). Hydrocephalus is a chronic condition of excess fluid in the brain. There is no known cure and no known prevention. 1,000,000 Americans suffer from hydrocephalus, which is one in every 330 people. The only treatment of any kind is the skull puncture procedure, and it’s only a temporary fix. This means Hydrocephalus patients have been known to receive up to thirty procedures over the course of their lives. The very least we can do for these one million Americans out there is make this surgery as safe as it can possibly be. Especially in underserved communities and rural areas, 90% of these bedside procedures (the only surgical treatment) is performed by non-expert physicians, such as nurse practitioners and physician assistants, rather than by neurosurgeons. The very least we can do for other millions of Americans who will undergo a skull puncture procedure in their lifetimes is bring cranial access tools out of the middle ages and into the 2020s. Further, the patients of emergency neurosurgery should have as high a level of care and tools as patients of elective neurosurgery.

That’s why our company has developed an advanced intracranial drill for use both inside and outside of the operating room. Hubly’s mission is to improve patient outcomes and increase quality of care for surgical procedures, inclusively, across standard and underserved settings and to make this procedure safe when performed by non-experts. 

From our interviews with about 200 neurosurgeons, we have concluded the general consensus that drilling beyond the skull occurs in nearly every procedure. This anecdotal evidence is congruent with a study conducted by Welcome, et al. 2021. A single surgeon drilled 10 burr holes with the Integra LifeSciences hand-crank drill. The researchers measured the plunge of the drill bit beyond the inner cortex of the skull. The smallest plunge was 2.95 mm, and the largest was 5.90 mm. The average over-plunge was 4.48 mm. In another study, 65.97% of 95 junior trainees surveyed had experienced at least one self-reported plunge. The extent of over-drilling required for this self-reported plunge is unknown. This self-reported plunging carried a 12% risk of death or brain death. Complications associated with burr hole placement include brain contusion and major sinus laceration, both of which can cause death.ii Another study states, “Most of the critical [craniotomy] complications are caused by plunging of a skull drill.”

92,000 craniotomy complications occur per year in the United States. The average over-plunge of 4.48mm can be very conservatively considered equivalent to one placement attempt of a non-antimicrobial catheter. Ventriculostomy currently yields an average of three catheter placement attempts. To account for the average over-plunge, we can consider ventriculostomy to yield an average of four catheter placements attempts, and non-catheter craniotomies to require one. Each catheter placement attempt increases likelihood of hemorrhage by 306%, and 8% of these hemorrhages lead to neurological injury or death.

Infection is the most well-researched complication. The first catheter placement (our label for over-plunge) results in a 6% infection rate. We apply this statistic to all 205,000 annual craniotomy procedures. We can therefore consider 12,300 craniotomy complications to occur due to over-plunge. For the 35,000 annual ventriculostomy procedures, the first, second, and third additional catheter placements together result in 73.3% infection. Subtracting the 2,100 ventriculostomy patients who would already have been infected by over-plunge leads to 24,100 additional infections. Thus, 36,400 of the 92,000 annual craniotomy complications may be avoided through eliminating plunge and an average catheter placement of one. This number is from infection alone and does not account for hemorrhage, stroke, or death.

On our team, we’ve got Julie who has 13 years leading quality and regulatory teams. CTO Tyler has 15 years leading medical device R&D from ideation to launch. We have two career neurosurgeons both with MBAs. And we have a Sales Leads who led commercialization at four startups from early stage through to four successful exits.

My (Casey Grage) background is in neuroscience and software engineering, and I’m a graduate student in applied math at Johns Hopkins. I founded Hubly Surgical because I have a long family history of Alzheimer’s and Parkinson’s diseases and I’ve seen first-hand how antiquated and dangerous this procedure is.

In fact, we came together because every single one of us has a deep personal tie to this procedure.

Founding Story: Casey Grage (CEO) and Dr. Amit Ayer (Director) met at Northwestern over their shared interest in neurology: Casey because of her long family history with neurological disease and Amit because he was a neurosurgeon at Northwestern Hospital. Together they identified the low satisfaction and high failure rates of today's bedside cranial access tools, invented the Hubly Drill System, and assembled the other team members via close network connections. Hubly was incorporated in May 2019. 

So far, we exclusively work with urban areas in the United States, the rural midwest, and in Chile, but our mission and propensity of impact mandates that we expand to rural areas of the United States and to the Middle East and Africa (which accept US FDA Clearance). We don't currently have connections in those countries or areas and would like support in reaching and working within these communities.

The patent-pending Hubly Drilling System - innovative both at the bedside and in the OR - includes (1) automatic, electrical plunge prevention; (2) battery power — rather than wired, electric power as in the operating room; (3) hardware catheter guidance utilizing the proven Ghajar guide technique, which has been proven to facilitate accurate freehand placement; and (4) unique drill bits which provide additional mechanical plunge prevention. Hubly’s Drilling System could save 15,000 lives each year through catheter guidance alone and also eliminate plunging into brain tissue, which in total, costs the U.S. healthcare system $4 billion annually.

In just the United States, 205,000 skull punctures and 4 million orthopedic procedures in which our Drilling System can be applied are performed each year. These skull puncture indications are ever expanding with medical innovation and growing at a rate of 5% each year. As we expand our product pipeline, we expect the number of orthopedic indications and specialties Hubly can address to also expand, increasing the number and quality of lives we can save through the Hubly Drilling System. In a post COVID world, Hubly frees up ICU beds – getting patients out of hospitals earlier and reducing readmits and revision surgeries. Hubly’s Drilling System is an easy and fast way to reduce costs and allow inexperienced doctors to have better outcomes. 

We are launching at the end of 2022. So in 12 months, we will be 6 months post-revenue and we hope to impact 50 patients' lives. In five years, we hope to impact 4,000 patients' lives.

We will measure impact by three metrics: (1) total number of intracranial access procedures our drill is used for; (2) complication rates for procedures in which our drill is used in - the current solution yields a 20% failure rate in all intracranial access procedures and we plan to at least halve that; and (3) number of indications our drill is used in - we conservatively estimate 25 neurosurgical and orthopedic indications but this number is ever growing and we continue to expand our product pipeline.

From our interviews with over 100 neurosurgeons, we have concluded the general consensus that drilling beyond the skull occurs in nearly every procedure. This anecdotal evidence is congruent with a study conducted by Welcome, et al. 2021. A single surgeon drilled 10 burr holes with the Integra LifeSciences hand-crank drill. The researchers measured the plunge of the drill bit beyond the inner cortex of the skull. The smallest plunge was 2.95 mm, and the largest was 5.90 mm. The average over-plunge was 4.48 mm.[1] In another study, 65.97% of 95 junior trainees surveyed had experienced at least one self-reported plunge. The extent of over-drilling required for this self-reported plunge is unknown. This self-reported plunging carried a 12% risk of death or brain death.[2] Complications associated with burr hole placement include brain contusion and major sinus laceration, both of which can cause death.ii Another study states, “Most of the critical [craniotomy] complications are caused by plunging of a skull drill.”[3]

92,000 craniotomy complications occur per year in the United States. The average over-plunge of 4.48mm can be very conservatively considered equivalent to one placement attempt of a non-antimicrobial catheter. Ventriculostomy currently yields an average of three catheter placement attempts.[4] To account for the average over-plunge, we can consider ventriculostomy to yield an average of four catheter placements attempts, and non-catheter craniotomies to require one. Each catheter placement attempt increases likelihood of hemorrhage by 306%,[5] and 8% of these hemorrhages lead to neurological injury or death.v

Infection is the most well-researched complication. The first catheter placement (our label for over-plunge) results in a 6% infection rate.[6] We apply this statistic to all 205,000 annual craniotomy procedures. We can therefore consider 12,300 craniotomy complications to occur due to over-plunge. For the 35,000 annual ventriculostomy procedures, the first, second, and third additional catheter placements together result in 73.3% infection. Subtracting the 2,100 ventriculostomy patients who would already have been infected by over-plunge[7]-[8] leads to 24,100 additional infections. Thus, 36,400 of the 92,000 annual craniotomy complications may be avoided through eliminating plunge and an average catheter placement of one. This number is from infection alone and does not account for hemorrhage, stroke, or death.

 The mission of our company is to improve patient outcomes and increase quality of care for surgical procedures, inclusively, across standard and underserved settings. We see complications from surgeries as a serious societal problem which takes too many lives each year, and through our work we hope to address it. With this in mind, our goal closely aligns with the UN’s Sustainable Development Goal #3: Ensure healthy lives and promote well-being for all at all ages. In alignment with this goal we would be able to have a concrete, measurable impact on patient populations through the extensive data which hospitals provide about their surgical operations. As noted in the above section, we see a direct path to avoidance of 36,400 craniotomy complications, a considerable number of lives to be saved. We see a great opportunity here to promote health by reducing complications, and we are confident that this outweighs any risks associated with our operations.

[1] Welcome, B. M., et al., “Comparison of manual hand drill versus an electric dual-motor drill for bedside craniotomy,”

Interdisciplinary Neurosurgery, Volume 23, 2021, 100928, ISSN 2214-7519.

[2] Caird JD, Choudhari KA. 'Plunging' during burr hole craniostomy: a persistent problem amongst neurosurgeons in Britain and

Ireland. Br J Neurosurg. 2003 Dec;17(6):509-12. doi: 10.1080/02688690310001627722. PMID: 14756476.

[3] Masanori Ito, et al. “Penetrating injury of the brain by the burr of a high-speed air drill during craniotomy: case

report,” Journal of Clinical Neuroscience, Volume 8, Issue 3, 2001, ISSN 0967-5868.

[4] Schuind, S., et al. “Accuracy and Complications of Free-Hand External Ventricular Drain Placement: Preliminary Results of a

Prospective Observational Study.” World Neurosurgery, 2013, doi:10.1016/j.wneu.2013.07.043.

[5] Miller, C., & Tummala, R. P. (2017). “Risk factors for hemorrhage associated with external ventricular drain placement and

removal”, Journal of Neurosurgery JNS, 126(1), 289-297.

[6] Lo, Cheng H., et al. "External ventricular drain infections are independent of drain duration: an argument against elective

revision". Journal of Neurosurgery JNS 106.3 (2007): 378-383.

[7]Sundbärg G, et al. “Complications due to prolonged ventricular fluid pressure recording.” Br J Neurosurg 2, 1988.

[8] Wong GKC, et al. “Failure of regular external ventricular drain exchange to reduce cerebrospinal fluid infection: result of

a randomised controlled trial.” J Neurol Neurosurg Psychiatry 73:759–761, 2002.

Hubly Surgical has identified a phenomenon wherein a spike in electrical current draw by a motor is seen as the penetrating medical instrument punctures through the desired skull or tissue target. An electrical sensing circuit and algorithm will use the instantaneous spike in current drawn by the motor as the puncture load reduces upon successful plunge as a signal to stop motion.

When hiring full-time staff and contractors, we strongly prioritize diverse skill sets and perspectives. We are extremely committed to furthering diversity in entrepreneurship and medtech! We  host the Hubly Surgical Paid Internship program, which provides financial support, one-on-one mentorship, and unique neurotrauma R&D opportunities to socially and economically disadvantaged students: exclusively women and people of color. We also served as a 2021 host for the U.S. State Department Youth Leaders of the Americas Initiative (YLAI) and plan to continue. YLAI supports socially and economically disadvantaged founders across Latin America, and I (Casey) mentored and worked with a Chilena non-profit founder. I traveled to Viña del Mar, Chile of my own accord/not required by the program to work with this fellow female founder in person and still work with her today. I serve as a judge for YLAI as well as for the Halcyon Social Impact Incubator. I have also spent the past two years as a mentor and guest speaker for Northwestern University’s Propel Program, which provides mentorship and grant funding to first-time female entrepreneurs!

We have not yet entered the market with our drilling system, but plan to do so in Q4 2022 after gaining FDA clearance. Today’s bedside, hand-cranked drill kits sell for $1200/single- use disposable kit. Hubly Drill will be sold at $2,000/single-use disposable kit with a 91% margin, and entirely covered under reimbursement code 61210. We will price match at launch with an 85% margin. With our safety features reducing patient complications, limiting operating room time, and reducing readmits, we conservatively estimate our device could save hospitals $10,000 per procedure. 

 

The estimated market size for intracranial access alone is $400M in North America and $2B globally — that's the maximum potential revenue we could get, with $2000/kit pricing. Our secondary market is in orthopedics, where the Hubly Ventri Drill can be useful for all orthopedic procedures for which over-drilling into nerves is a risk. This presents $8.4B of potential revenue in North America alone. In total, Hubly has a global market of $70B - which is ever growing as skull puncture becomes a safer procedure and as we expand our product line to address more neurosurgical and orthopedic indications.

We’re going to sell our device as a premium product at $2,000 — and it will be offered in a kit for quick off the shelf access, just like the current hand-crank solution. We are selling at this premium price because for each procedure we can save hospitals $10,000. And we’ll have a 90% margin at launch. Now of course, to sell, we’ll need proof. For initial launch in Q1 2022, we will offer discounts to price-match the competitor price of $1200.

Immediately upon that 2022 FDA Clearance, we’re launching with a limited market release to our partner institutions—that’s currently Northwestern and Stanford, and maybe in the future Hopkins. We’ll gather post-market clinical data to make additional claims with the FDA proving the efficacy of our product. Then, we’ll sell directly to hospitals nationwide. In Phase I, we’ll sell the drill designed for emergency skull punctures. That’s single use disposable and will cost $2,000 compared to the $1200 hand crank drill (except for the first launch with discounts up to $1200 for the Hubly Drill). In Phase II, we will sell a reusable version for operating room neurosurgeries, and one for orthopedics. The reusable model will rely on a razor-blade model, for which the drill is a one-time sale and we make recurring revenue on high profit margin drill bits monthly. These additional versions will be offered as we expand geographically.

DISTRIBUTION. Key opinion leaders in both neurosurgery and general surgery, including the Vice Chairs of Neurosurgery at Northwestern Hospital, are excited and ready to use our product once we achieve regulatory clearance via our Class II 510k pathway. We have also had preliminary conversations with those at Medtronic, Integra, and J&J. When we launch we will begin with Northwestern Hospital and Stanford Hospitals. These are two of the top 5 American institutions for neurosurgery, yield some of the highest numbers of neurosurgical procedures performed per year, and they each have a member of Hubly’s leadership team working as a neurosurgeon. We will penetrate the Bay Area and Chicago, and then, we will expand distribution to the Midwest and California.

 

PROMOTION. KOLs in the U.S. have a massive impact abroad which is how we will grow our relationships and our sales. Journal publications outlining our cadaver and animal studies and post-clearance trials (utmost importance), circulated through our neurosurgeon and hospital networks, will serve as crucial promotional for us. Promotional material will be handled by the Marketing and Communication Strategies team. Hubly will focus on developing public relations between the company and the media, not only creating favorable publicity but also providing security in the face of negative situations. We also consistently send marketing updates through loyal email lists and regularly post branded messaging on our website as well as social media platforms Facebook, LinkedIn, Twitter, and Instagram. We will also create training videos that we will post on our social media. Such training videos will feature top KOLs in the industry as a promotion. Our product launch will be made online and with large advertisements at trade shows. Large hospitals and private practices should be marketed to differently, yet surgeon interaction is key in both.

FUNDING: We have secured $250K in grant funding from several sources including the National Science Foundation and the Chilean government and $1.3M from investors like Halcyon Fund, SWAN Impact Network, River Valley Investors, and First Fund VC.

PITCH COMPETITIONS:

• Johns Hopkins Carey Business Competition 1st Place $25,000 Winner, Issued by Johns Hopkins Carey School of Business · May 2022

• WMNtech Pitch Competition 2nd Place $18,000 Winner, Issued by 1871 Chicago · Apr 2022

• Tulane Business Model Competition 1st Place $75,000 Winner, Issued by Tulane University · Mar 2022

• Human Health Grand Prize $50,000 Winner, Issued by BD (Becton, Dickinson and Company) Medical Devices · Feb 2022

• CrabTrap Semifinalist, Issued by BioHealth Innovation, Inc. · Sep 2021

• Healthcare Safety Challenge Kicker Cash Prize of $3,000, Issued by Jewish Healthcare Foundation · Apr 2021

• National AlphaLab Hardware Cup [2021] 1st Place winner of $5,000

• Rice Business Plan Competition Semifinalist, Issued by Rice University · Feb 2021

• Top 50 Startup of the Year, Issued by Startup of the Year · Sep 2020

• 1st Place Most Investable Startup, winner of $4,000 Issued by Start-Up Chile at CORFO · Jul 2020

• 2nd Place Best Pitch, Issued by Start-Up Chile at CORFO · Jul 2020

• 2nd Place Silicon Valley Entrepreneurs Demo Day, Issued by SVE.io · Jul 2020

• 1st Place at Startup Boost Demo Day, Issued by Startup Boost Chicago · Nov 2019

• 1st Place Lightning Round at New Venture Championship, Issued by University of Oregon New Venture Championship · Apr 2019

• 3rd Place at PitchTX SXSW, Issued by University of Texas — Austin · Mar 2019

• VentureCat Semifinalist, Issued by Northwestern University · May 2020