After more than a decade of crafting small bone orthopedic implants from its innovative PyroCarbon biomaterial, Ascension is hoping to reach its full potential by obtaining regulatory approval for a line of carbon shoulder replacement systems that might change the way the joint is treated.
Ascension Orthopedics' Fate May Rest on the Shoulder
Article preview from IN VIVO- May, 2010
Pyrolitic carbon – or PyroCarbon – has been a fixture on the medical device landscape for four decades, providing a clot-free material for heart valve devices. But Ascension Orthopedics sees a broader potential in the biomaterial, which shares many of the same structural qualities of natural bone. Ascension was founded in the early 1990s to construct PyroCarbon-based implants and spacers for repairs of small bones in the hands and feet.
Now, it is ready to bring PyroCarbon to shoulder replacement. But first it will have to contend with the FDA, payors, and at least one high-profile potential competitor. The extremities market is seen by many as the last great battleground, the final frontier for an orthopedics industry built upon tried-and-true procedures like hip and knee implants. Repairing and restoring the small bones and joints in the fingers, toes, ankle and shoulder represents a relative green field for orthopedics companies, albeit a considerably smaller one than hips and knees.
The largest extremities opportunity centers around the shoulder, a joint that shares both a design lineage with its large joint cousins below the waist and, since orthopedic surgeons operating on shoulders often also focus on elbows, wrists and hands, a strong clinical connection to small bone extremities.
This is where Ascension Orthopedics Inc. is picking its next battle. A small player in the extremities market, the privately held company is launching a line of shoulder implants this year internationally and in the US to compete against the veterans in this space including Biomet Inc., Smith & Nephew PLC, Stryker Corp., Wright Medical Group Inc. and Zimmer Holdings Inc. As always, the US presents the largest market opportunity. But Ascension's fortunes – at least short-term – will lie overseas, where the company intends to introduce a new line of shoulder implants with components made from its unique pyrolitic carbon (PyroCarbon), potentially a bone- and cartilage-preserving material that Ascension says will eliminate much of the wear and tear associated with orthopedic implants. PyroCarbon won't be available in the US until 2015 at the earliest.
PyroCarbon is no stranger to device companies – it's used frequently in the
construction of heart valves, where its biocompatibility is critical. Extremely
dense and inert, pyroCarbon is of critical importance in heart valves because
blood cells don't collect on its surface. This helps stave off the formation of
dangerous clots, a considerable risk in an artificial implant responsible for
pumping blood nearly every second of the day. Ascension was one of the first
companies to apply pyrolitic carbons to orthopedics. Now, however, it's facing
competition from Tornier
SA's Tornier
Inc. – already a significant player in shoulder implants – which
acquired a line of PyroCarbon implants in 2007 with the acquisition of Nexa
Orthopedics. Today,
Ascension remains a bit player in the extremities market, but it's also one of
the faster growing companies.
Ascension received renewed investor support in 2008, when Frazier Healthcare Ventures bought out earlier investors in a $21 million Series D financing and became the company's majority shareholder. Then, last fall, the venture firm paired Ascension with now president and CEO Guy Mayer, who at one time served as president of the orthopedics implant division of Zimmer. Mayer had been CEO of Tutogen Medical, a biological implant company he helped to steer into an acquisition by to RTI Biologics Inc. for $247 million. Ascension founder Jerry Klawitter, PhD, the company's chief scientific officer, has been working with PyroCarbon for close to 40 years and complements Mayer's device experience.
- Tom Salemi
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