Sanjeev Bhatia, Joint Preservation Innovations - Arthroscopic Bone Resection Tool | LSI USA '24

Sanjeev Bhatia  0:02  
Sanjeev, good afternoon, and thank you for coming. My name is Sanjeev Bhatia, founder and CEO of joint preservation innovations. I'm also an orthopedic surgeon specializing in minimally invasive surgery. Today, I'm excited to share with you our transformational platform for articulating bone resection, which we hope will allow more patients to experience the benefit of minimally invasive surgery. Bone resection is a critical step in orthopedic surgery and is frequently determinative for patient outcomes. One of the problems in minimally invasive surgery is our current tools are often inadequate. Straight burrs, which are the workhorse tools for orthopedic bone resection, often have limited excursion in the in an endoscopic environment because they have an inability to articulate at the distal tip. This often leads to poor tilt angle of cutting flutes, suboptimal visualization, accidental soft tissue disruption, and a steep learning curve, because surgeons are learning surgical techniques with or trying to gain proficiency with non ergonomic techniques, articulation of orthopedic cutting tools would be a natural solution to this problem. But hurdles in mechanical and economic hurdles have limited have limited innovation, historically, from an engineering standpoint, articulating a seven millimeter surgical tool that goes that requires a high RPM, high torque technical profile is often very difficult, because improper design can often lead to overheating and breakage in certain in certain situations. Additionally, it is very difficult to retain the stiffness of an articulated angle against force, which is a requirement for precision and safety of a surgical tool. From an economic standpoint, overcoming these mechanical challenges is often very difficult, particularly since viable designs often cost 10 times the average ASP for a specialty arthroscopic burr after years of collaboration with surgeons as well as design and verification validation with an interdisciplinary engineering team, we are grateful to present for you the articulator Burr, which aims to be the world's first FDA cleared articulating rotor articulating rotary cutting tool for arthroscopic applications adaptable to any power system, this tool can enter the joint straight through a cannula and then can articulate to three preset angles in a rigid fashion, allowing unparalleled control using a one handed ergonomic control mechanism that imparts stability. This tool also upgrades the cutting surface area of a standard burr by 601% to illustrate what this looks like, here are two arthroscopic videos from one of our test surgeons. This is on a left hip in a hip arthroscopy patient in the video, on the left the standard tool has a very difficult time reaching bone pathology at the distal and posterior aspect of the femoral neck. This often requires the surgeon to operate the tool in a very careful manner, which slows down efficiency and many times, can lead to revision surgery being required. In contrast, the articulator in the video on the right is able to contour itself to the rounded bone structure, which allows unparalleled access to bone pathology, while also allowing the surgeon to create a perfect femoral osteoplasty In a time efficient way. We believe that JPI articulator burr offers a lot of different stakeholders to benefit. From a patient standpoint, more accurate bone resection reduces the risk of revision surgery. From a surgeon perspective, both veteran and younger surgeons can can benefit from the intuitive dexterity that the tool provides and hospitals are positioned to save as more patients experience the benefits of minimally invasive surgery in a time efficient manner, there are various procedures that can benefit from the small radius of movement that articulator provides. In the short run, we plan on applying this technology to the minimally invasive spine market, as well as ENT procedures where bone resection is required. In the future, we do have plans to apply this technology to the robotic surgical market, where we can marry the accuracy of robotic navigation with the increased cutting surface area that articulator provides. In fact, in 2023 the FDA awarded JPI a breakthrough device designation for its potential in reducing the surgical exposure required for many open surgical procedures. To illustrate this on the images on the left. A toll shoulder replacement today is typically performed by severing one of the rotator cuff tendons, namely the subscapularis tendon. In order for the surgeon to bring in bone resection tools to resect disease bone, we believe that an articulator currently is in the concept phase for robotic surgery could allow this procedure to be performed in. A rotator cuff sparing approach through the rotator interval, as shown here in green. In a similar fashion, toll knee replacement is performed when with this approach in red, in which which requires a quadricep tendon to be partially cut. This often results in increased morbidity, difficult, increased recovery time, and slows and considerably increases patient pain. We believe that an articulator tool married with the accuracy of robotic navigation could allow this procedure to be done in a quad sparing approach, significantly increasing recovery time while reducing surgical morbidity and complications. We've been grateful to partner with one of the top 10 medical device law firms in developing our intellectual property, which broadly and specifically protects applications of this technology in the fields of endoscopy, spine as well as robotic surgery. We currently have nine issued patents with additional IP pending. From a regulatory standpoint, we were optimistic to receive 510 k approval in 2025 for a class two medical device. Thus far, we've done a FDA pre submission meeting in 2021 where they validated our 510 k pathway and also confirmed for us the lack of any FDA clearance for any other articulating rotary cutting tool. In 2023 an FDA breakthrough device designation was awarded for spinal and robotic applications, and we are currently finalizing our scalable quality system manufacturing in preparation for a final 510, K submission later this year. From an economic standpoint, arthroscopy is poised to grow at a 6% compound annual growth rate globally to almost 85 billion by 2028 as we zero in on the arthroscopic burr market, we believe there's a very significant market transformation opportunity to convert this product from a generic loss leader to a high margin anchor. The bar graph on the left demonstrates skew level sales data for arthroscopic burrs in the United States, both in 2019 as well as in 2023 excluding Zimmer, dollar sales for arthroscopic burrs were flat from 2019 to 2023 Zimmer, however, has quickly gained market share with its innovative Tricera line, which boasts a price point five times the market average, at $260 primarily driven by its ability to save time in the operating room. We believe JPS articulator represents breakthrough innovation that delivers better performance and fewer minutes over the standard of care. Our comprehensive pricing studies indicate that articulator could command a price point of 250 to $350 per unit, representing an expansion of the total addressable market for arthroscopic burrs from $130 million today to 500 million. This represents the immediate opportunity for articulator, for articulator, and it's poised to grow at a 6% rate over the next 10 years, along with the rest of arthroscopy. Beyond arthroscopy, however, we believe there's significant opportunity to apply articulating, Rotary bone cutting technology to the fields of endoscopic spine and robotic procedures, which are poised to grow at an explosive rate, although bone resection is a small component of these specific fields, we believe that a tool with the dexterity of articulator could serve as an innovative catalyst that provides value to both patients surgeons as well as hospitals. In closing, we're grateful for your time and attention this afternoon, and would invite inquiries from anyone interested in helping us bring this product to market. We are grateful for your time, and if you're interested, please feel free to follow along our journey on our website as well as our LinkedIn page. Thank you. Applause.