News | May 15, 2017

Exactech Receives 510(k) Clearance For Computer-Assisted Shoulder Arthroplasty Technology

GAINESVILLE, FLA.--(BUSINESS WIRE)--

Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today it has received clearance from the U.S. Food and Drug Administration to market the ExactechGPS® Shoulder Application. Combining preoperative planning with computer-assisted surgery, the industry-leading technology allows for greater intraoperative visibility in both standard and challenging shoulder arthroplasty.

“The ExactechGPS Shoulder Application offers groundbreaking technology that is unique to the industry and should continue our selling momentum that delivered 21% growth in the first quarter,” said Darin Johnson, Vice President, Extremities Marketing. “Allowing surgeons to preoperatively plan the surgery and then execute it with a computer-assisted solution will help patients by ultimately improving outcomes. Importantly, it also reflects Exactech’s philosophy of keeping intraoperative decision making and control in the surgeon’s hands.”

An introduction to the new technology was the focal point at the recent 2017 Exactech Shoulder Masters Course, with live broadcasts of two surgeries performed by Pierre-Henri Flurin, MD, in Bordeaux, France.

“The live surgeries featuring the new ExactechGPS shoulder application for both anatomic and reverse total shoulder cases were incredible as it felt like we were in the operating room. It was exciting to witness the most advanced innovation in shoulder arthroplasty since reverse shoulders were first introduced,” said attendee Samuel Antuña, MD.

Setting a new standard in medical education, the Masters Course’s comprehensive scientific program featured 35 presentations by distinguished faculty who shared their experiences and philosophies with more than 150 surgeons from 17 countries around the world. Faculty member Joseph Zuckerman, MD, said, “This was one of the highest quality educational meetings I have participated in during my professional career. Between the scientific and technical presentations, debates, live surgeries and interactions between our surgeon peers, it was a truly unique and rewarding experience.”

The ExactechGPS Shoulder Application’s preoperative planning tool is designed to help surgeons understand their patient’s anatomy prior to surgery. Intraoperatively, ExactechGPS provides visibility into the glenoid vault in real time and allows for consistent, accurate glenoid placement.1 A recent study showed that more accurate glenoid placement minimizes complications and theoretically increases implant survivability.2 In addition, ExactechGPS provides a real-time view of retroversion and inclination, reaming and drilling depth, screw placement and the ability to adjust surgical plan intraoperatively, offering surgeons more flexibility.

The ExactechGPS Shoulder Application has been used successfully in the U.K., Spain, France and Australia. The initial launch in the U.S. is planned for this quarter. It is the latest addition to the Equinoxe® Shoulder System, which has been one of the fastest growing shoulder lines on the market since its introduction more than a decade ago. This year marks the 10th anniversary of the first implantation of the Equinoxe reverse shoulder; Equinoxe products will be implanted in the 100,000th patient before the end of this year.

  1. Data on file at Exactech*
  2. Walch G et al. Results of a convex-back cemented keeled glenoid component in primary osteoarthritis: multicenter study with a follow-up greater than 5 years. J. Shoulder and Elbow Surg. (2011) 20; 385-394.

* In vitro (bench) test results may not necessarily be indicative of clinical performance.

About ExactechGPS

ExactechGPS combines surgeon expertise with an advanced computer system to perform the patient’s surgery with a goal of improved accuracy and precision. Personalized for a patient’s unique bone structure and anatomy, ExactechGPS is designed to allow surgeons to decide where to remove bone and place the implant in the optimal position. Exactech first introduced ExactechGPS to surgeons in the United States for total knee arthroplasty, and has since broadened its reach by providing medical education and supporting surgeries in more than 11 countries. The technology has steadily gained market acceptance and worldwide reach.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

A current investment profile on Exactech (Nasdaq: EXAC) is available online at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.


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