Carticept Looks to Build Momentum for New Technology

Shaking up the status quo. When a new medical device firm—or any nascent company, for that matter—enters the market with a new product, the goal usually is to stand out, be different or put a new spin on the traditional.

For Timothy J. Patrick, president and CEO of Carticept Medical Inc., his motivation is no different.

This year’s annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) was the first opportunity for Carticept to highlight its newest product—the Navigator DS—following the device’s 510(k) clearance by the U.S. Food and Drug Administration in October last year.

Navigator DS is a computer-controlled drug delivery system with integrated ultrasound guidance that is designed to increase the efficiency, accuracy and safety of administering pain-relieving medications for joint pain.

More than 46 million Americans have doctor-diagnosed arthritis, according to figures cited by the company. Local injections of corticosteroids and anesthetic agents are heavily relied on as early, effective interventions for pain relief. The current standard of practice depends on the expertise of the clinician and the accuracy with which the medications are injected into the affected joint space. A clinician, usually with an assistant, must manually pull the correct dosage of pain killer and steroid out of vials with a syringe that then is injected into the patient—a process that has remained unchanged for years.

According to a recent study published in The American Journal of Sports Medicine, however, injection accuracy rates are significantly higher when imaging is used in conjunction with injection of the knee and shoulder.

That’s where Carticept comes in.

“We’re not aware of any similar technology on the market,” Patrick said.

The system prepares and delivers physician-prescribed injections from standard multi-dose anesthetic and steroid drug vials, eliminating needle exposures to healthcare workers and minimizing the potential for contamination of the medication. It also helps to ensure accurate dose preparation and saves significant labor for a busy physician practice, according to Patrick. The procedure can be conducted by the physician only.

The ultrasound system—provided in partnership with SonoSite Inc. (which also invested in Carticept)—provides the physician with real-time visualization of the needle position, fluid delivery process and prescription volume. After the injection is delivered, the system records the treatment data and automatically creates a record for transfer to an electronic record management system.

The entire unit is housed a compact, upright, mobile cart.

Patrick said that after examining data that indicated imaging of the process could improve accuracy and provide better outcomes, the need for a system became clear—particularly for smaller joints. The company was founded in 2005 to tackle the challenge and respond to a yet untapped market need. The product development cycle took about three-and-a-half year. The company used in-house research and development staff for Navigator’s initial concept, but the company now uses in “a number of” design, manufacturing and engineering firms to produce the system, according to Patrick.

The company now has 40 employees, and is “ramping up its sales staff,” to prepare for the full rollout of the Navigator, Patrick said, adding that the company has about 15 sites using its technology at the moment. Carticept will solicit feedback from the systems initial users and make modifications as appropriate and then expand for a wider launch around April.

Ben DuBois, M.D., orthopaedic surgeon at Grossmont Orthopaedic Medical Group in La Mesa, Calif., told Orthopedic Design & Technology that the device, which he has incorporated into his practice, has “significantly” improved efficiency.

“It allows me to free up an assistant to, for example, to take vitals from the next patient or other important tasks,” DuBois said. “I can do this myself, accurately and efficiently. It makes the patient experience so much better.”

DuBois added that because of the increased accuracy of injection placement, patients seem to be experiencing less pain and discomfort.

“Plus, they can see the placement and be confident that they’re receiving the appropriate dosage in the best location,” he added.

In addition to its use in sports medicine and orthopedics, Patrick believes the technology has future applications in anesthesiology, radiology and other specialties that require accurate dose delivery.

“The clinical response has been very encouraging,” Patrick said. “We’re looking forward to exploring additional indications armed with solid data and outcome in this market.”

Carticept Medical Inc., based in Alpharetta, Ga., is a privately held, private equity-backed firm. Major investors in addition to SonoSite, include Domain Associates and New Enterprise Associates. The company closed a $10 million Series C round of funding in January.

In addition to Navigator, Carticept Medical distributes SonoSite ultrasound products to the orthopedic marketplace. The company’s first product was Cartiva synthetic cartilage implant (SCI), designed to replace or repair worn or damaged cartilage. The implant is made of a proprietary biomaterial with wear and other physical properties similar to human cartilage. Cartiva SCI is currently available in Canada, Europe and South America, but has not yet been approved in the United States.