Office Injection Art Meets Science- Carticept’s “Navigator DS” at the AAOS 2012….

Written By: Jeff Chandler, OrthoSpineNews, jeff@tdg-llc.com

Historically, orthopedic drug administration for osteoarthritis (~27m Americans) and cartilage injuries (~2m/yr) has been very orthodox and consistent so we thought, but now has been made very archaic. At the 2012 Annual AAOS meeting, now enter Carticept Medical’s “Navigator DS™”- the newly launched intelligent injection system that integrates an optional ultrasound guidance to produce instant info live and dynamically. Typically and while often in a busy Orthopedic office, the PA manually draws the “medicinal cocktail” for the patient injection. However, what’s the precise measurement, what’s the contamination risk, where’s it being injected, how much volume was delivered blindly to each injection target, how accurate are the documentation records? The Navigator DS is a computer-controlled drug delivery system with integrated point-of-care ultrasound guidance designed to increase the efficiency, accuracy, and safety of administering pain-relieving medications for joint pain.

Tim Patrick (Carticept Medical- President & CEO) states that “office-based injections of corticosteroids and anesthetic agents haven’t changed protocol in well over 50 years. We’re simply offering a new technology play to enhance the 35m+ orthopedic injections given in the United States each year for joint pain.” The Navigator DS™ is truly proprietary and a state-of-the-art technology with potential use throughout the medical community. “We’re quite pleased to be the 1^st mover of an integrated system for dynamic injection preparation, management, dosage delivery, and record documentation.”

“The Carticept integrated system allows me to consistently hit the (delivery) spot, as it increases the accuracy of needle placement to properly fill the targeted cavity”, according to Dr. Ben DuBois (Orthopedic shoulder specialist, Grossmont Orthopedic Medical Group- La Mesa, CA). “My practice has considerably improved with the combination of the diagnostic ultrasound and automated injection. In fact, it appears to be evolving into a standard of care industry-wide. Since its real-time visualization, this introduces a new doctor-patient interaction, as the patient becomes part of the diagnosis. The Carticept systems provide instant info today for the patient and could eliminate the need for a return patient visit and time off work. Plus, it’s significantly more cost-effective that other diagnostic modalities, for example up to 65%-75% cheaper than MRI.” The Navigator DS can also be used independently of its integrated ultrasound guidance counter-part.

Dr. Brian Cole (Professor of Orthopedics, Rush University Medical Center- Chicago, IL) indicated that “injections given with the Navigator DS™ have been incredibly well tolerated given the consistent pressures used during agent delivery and it has created significant efficiencies in the office by eliminating the need to pre-draw what often amounts to dozens of syringes for a typical office day.” He further added that “while the risk of infection is incredibly low with injections, we believe that this system improves the safety profile of this frequently performed office-based procedure.”

Dr. DuBois boasts a patient care attribute in that “Patient satisfaction has dramatically improved as they like technology and gadgets, especially with the Navigator DS™. More importantly, the effectiveness of the integrated ultrasound guided injection has increased substantially, yielding a significant pain decrease from accurately hitting the spot the 1^st time vs. blind.” Additional improved injection accuracy peer-reviewed support and results can be found in The American Journal of Sports Medicine¹. Notably, “it’s an ancillary revenue generator,” as most 3^rd party payors cover this injection protocol with two reimbursable CPT codes, one for the injection and another for ultrasound guidance.

The Navigator DS™ redefines medication delivery with computer-controlled preparation, state-of-the-art administration, and automated record keeping. As a ham & egg solution, Carticept also distributes a portable, point-of-care ultrasound guidance system for real-time diagnosis of musculoskeletal diagnosis on-site (manufactured by Sonosite). This system is easily controlled by the user via a touch-screen, and provides a high resolution color image. While not only cool technology for the patient to view, the combined systems display an on-screen overlay of the real-time injection quantities adjacent to joint imagery for the medical professional. Then, it automatically records the injection delivery site matched to the dosage amount, and that’s archived in multiple formats (e.g. JPEG) future print form or video replay.

Dr. DuBois strongly pointed out that “the quality is equivalent to MRI in diagnosing superficial structures, such as with one of the leading sports injuries- Rotator Cuff Tears (RCT).” Whereby numerous industry sources imply that RCT’s are represented by up to 500,000 annual surgical procedures. “However, diagnostic ultrasound does have limitations, as other modalities (e.g. MRI) are required for diagnosis of intra-articular structures such as the shoulder labrum.”

The Carticept Navigator DS™ is easy to use and features a hardware component that drives the daily and patient specific disposable sets. The disposable set is designed to maximize economic efficiencies by offering a daily use cassette that’s augmented by a cost-efficient patient delivery tubing set. Plus, it minimizes the potential for contamination of the medication by dramatically reducing the number of times the drug vials are accessed. The Navigator DS™ provides other cost reductions by eliminating items such as the need for prep needles (e.g. 18 g). Time is reduced with the Navigator DS™ multidrug injection set-up as it allows for automated preparation of the prescribed dose.

Patrick adds that “while early in the going, we’ve seen positive ancillary economic effects within the orthopedic surgeon’s business engine. Given the fact that our combined systems offer labor efficiencies (up to 61% reduction in prep time), many of our MD offices have been able to add a few more patient visits to their daily office schedule.” Thus do the math, multiply this over the course of a year and it creates another significant revenue driver.

Carticept’s industry-leading technology, the newly launched Navigator DS™, is made available in the US  via their direct field sales team (www.carticept.com). Internationally, Carticept’s products are  distributed by Sonosite Inc. (www.sonosite.com).  In addition, Carticept provides a low barrier to entry for this capital investment by offering a variety of purchase programs to accommodate multiple buying options. Patrick points out that “our systems are designed primarily for the mid-high volume orthopedic practices. Although, our technology is quite effective for the low volume users as well, and is a good marketing tool.”

It appears that Carticept has nicely done its part to further enhance a key and stoic area within the orthopedic surgeon’s continuum of care, especially in OA- the leading debilitating orthopedic disease. Let’s face it in this day and age, the combination of effectiveness, efficiencies, and accurate records are a mandatory requirement in patient care…

¹ Daley, Erika, Bajaj, Sarvottam, Bisson, Leslie, and Cole, Brian. Improving Injection Accuracy of the Elbow, Knee, and Shoulder- Does Injection Site and Imaging Make a Difference? A Systematic Review. The American Journal of Sports Medicine; 2011;39(3):656-662

About the Author

Mr. Chandler is an accomplished medical device industry innovator and executive with over 25 years experience from venture capital backed startups to industry leaders. Most recently, he has been engaged by medical device companies as a consultant focusing on sales, marketing, business development, recruiting, clinical advisory board development, and product innovations. Mr. Chandler features a successful history in directing technologies and companies, developing direct and independent sales channels, and launching paradigm-shift medical technologies and surgical techniques.  He draws upon a highly decorated corporate management and sales career, has co-founded startups, driven OTL, OEM, and distribution licensing agreements, and holds patents. Mr. Chandler has an expansive network of global Key Opinion Leaders, recruiting many influential surgeons to a variety of Scientific Advisory Boards and as customers. He offers business expertise in team building, fundraising, operations, marketing, reimbursement, business development, sales/distribution, and IDN/GPO agreements globally. Mr. Chandler has held escalating responsibilities in sales, marketing, and general management in former companies such as Aquarius Medical, Zimmer, Smith & Nephew and Linvatec.