Sports fans know how a knee injury ruined the last season for beloved New England Patriots quarterback Tom Brady, and many other athletes before him. Now Connective Orthopaedics , a Waltham, MA, medical devices startup, is quietly researching new products that could potentially improve recoveries for people after they undergo knee surgery.

Connective CEO Dean Banks told me that the vision of the company is to eventually provide products that help torn ACLs (short for anterior cruciate ligaments) in the knee to heal themselves, as opposed to the standard treatment of replacing the damaged ligaments with tissue taken from other parts of a patient’s body or from a donor source. The startup has been attracting attention in the sports world by adding Boston Celtics CEO Wyc Grousbeck to its board of directors in June. (It turns out that Connective’s Banks and the Celtics’ Grousbeck go way back—they used to work together at Highland Capital Partners in Lexington, MA.)

Banks declined to give specifics about his company’s technology, but he showed me a recently published study to give me an idea. The study indicated that pigs that had reconstructed ACLs that were wrapped in a collagen-platelet scaffold healed back to normal better than the pigs that went without the scaffolds to help mend their ACLs after reconstructive surgery. Collagen is the ubiquitous protein that supports organ structure in the body, and platelets are blood cells that contain growth-stimulating proteins. Though Connective isn’t saying whether it’s developing a collagen-platelet product, the firm is clear that it wants to develop products that promote tissue healing. The secrecy is one indication of the fierce competition Connective is facing.

“We are really, really intent on staying in stealth mode because …Next Page »

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ConforMIS, an orthopedic device maker in Burlington, MA, said today it is introducing the third product in its line of implants designed to make knee surgery less invasive. Made to order for each patient based on data from CT or MRI scans; these implants replace only the areas of the knee showing signs of osteoarthritis. By sticking to the affected areas, the surgeon can spare ligament and bone that would be cut in conventional knee surgery, which ought to help preserve the joint’s range of motion, ConforMIS CEO Philipp Lang explained when Rebecca profiled the company and its minimally invasive strategy back in November.

As probably anybody who watches or likes to play sports knows, knee surgery is pretty common. About 500,000 to 600,000 people every year in the U.S. end up getting the most serious form of surgery, total knee replacement. The number will continue to grow as the Baby Boomers keep getting older. ConforMIS’s latest implant, called the iDuo, could provide an alternative to full-blown surgery for patients with arthritis in just two of the knee’s three compartments; an implant that the company launched in February, called the iUni, is designed for patients with damage in just one compartment. One-third to one-half of patients who currently undergo total knee replacement only have arthritis in one or two compartments, said Jong Lee, senior vice president of marketing, in an e-mail.

Interestingly, ConforMIS has its eye on Generation X every bit as much as the Boomers. Since knee replacements don’t last forever, surgeons are looking for alternatives for younger patients. “The iDuo provides a less invasive alternative for young and active patients that maintains their ability to move to a total knee (replacement) in the future if necessary,” said CEO Lang in a statement.

ConforMIS doesn’t disclose how many salespeople will be pitching the iDuo, although the company has a “rapidly expanding direct salesforce as well as distributors” who will carry the product, Lee says. If they end up capturing any significant percentage of the $5 billion market for knee replacements, I’m pretty sure we’ll hear a lot more news from them.

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I pride myself on having an extraordinarily high tolerance for medical gore, but I have to admit that the phrase “bone saw” always gives me the willies. Which is probably why I was intrigued when I first heard that there was a company out in Burlington, MA, that makes a new kind of implant for knee surgery—one that can be installed with none or little of what orthopedists so demurely call “bone resection.” That, and the fact that, given family history, I fear that one of these days I’m going to be one of the hundreds of thousands of people in the U.S. each year who winds up having a knee or two replaced.

Indeed, it turns out that the implants that ConforMIS is making offer alternatives to standard total knee replacement. Several of them fall into an emerging category of “resurfacing devices” that cover bone damaged by arthritis or trauma with smooth pieces of plastic or metal—while leaving the bulk of the joint intact. ConforMIS’s trick for minimizing the slicing and dicing that needs to be done to implant these devices, explains Philipp Lang, the company’s chairman and founder, is to tailor each one to precisely fit the patient’s existing anatomy.

“The fundamental challenge is that a joint is a complex 3-D structure, and it has tremendous variability between patients,” says Lang, who in his day job is the director of musculoskeletal radiology at Boston’s Brigham and Women’s Hospital and associate professor at Harvard Medical School. Traditional knee implants are not fitted to a particular patient, so surgeons must cut bone “to fit the patient to the implant.”

What ConforMIS does instead is use data from MRIs or CT scans taken before surgery to generate a 3-D model of a patient’s knee and design an implant to conform exactly to the area in need of repair (hence the first part of the firm’s name—the second part is for Minimally Invasive Surgery). The company then uses computer-driven machining or prototyping tools to fabricate the implant, a process that takes four to six weeks, as well as custom surgical tools for implanting it.

From the patient’s perspective, preserving bone is important for a couple of reasons, Lang says. For one thing, it makes for much faster short-term recovery. Though a central aim of the surgery is to relieve pain, conventional knee replacement leaves a notoriously painful aftermath. Lang says that hard data on recovery is difficult to come by, but one study showed that it took an average of seven weeks for patients to get back to their pre-operative levels of pain. In a clinical trial of ConforMIS’s smallest implant, which doesn’t require any bone resection, patients already showed improvements over their pre-op pain levels at the time they were discharged from the hospital, he says. (ConforMIS’s larger implants do require a little bit of bone cutting, but not nearly as much as a conventional device.)

The other consideration is that orthopedic implants don’t last forever, and many patients wind up needing repeat surgeries down the road. Each time a surgeon cuts the bone to fit it to an implant, “that’s bone you’ve lost for future surgeries,” Lang says. “You’re burning bridges.”

The made-to-order approach has a business advantage as well: it eliminates the need for the company …Next Page »

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