A Brief History of the Kyphoplasty Procedure; Explained

At the beginning, the balloon kyphoplasty Boca Raton was the name given to a procedure that was both created and marketed by a small start-up company called Kyphon Inc. The main focus of this company was to focus on creating and marketing a minimally invasive procedure that would help treat spinal fractures.

They called this procedure balloon kyphoplasty Boca Raton, and the name comes from a Greek word that means bent. Originally, this procedure was meant to be a new, improved way to perform vertebroplasty. During this procedure, surgeons would inject cement into the collapsed vertebra to reinforce them as the fissures healed. However, the vertebra stayed collapsed with vertebroplasty.

The Founding of Kyphon Inc.

Dr. Mark A. Reiley was the person who came up with the idea for the kyphoplasty Boca Raton procedure. He got his undergraduate degree from California’s Claremont College before going on to get a medical degree from Washington D.C.’s George Washington University School of Medicine. Then, he attended the University of California San Francisco to receive five years of orthopedic training. He was also a fellow at the Musculoskeletal Tumor Clinic.

When Dr. Reiley was a fellow here, he had a patient who had several compression fractures in his spine. While attempting to fix the fractures and give the patient pain relief, he was very frustrated because the bones were very unstable, and this caused a lot of pain for the patient. He started looking for ways to stabilize the spine while it healed.

In early 1994, Dr. Reiley incorporated Kyphon in Delaware with the help of Talmadge and Scholten. Talmadge was put in charge of attracting venture capital for the new company to make it operational. However, this was a difficult process. He spent the next three years trying to get support with no success because potential investors had concerns about the company getting clearance from the U.S. Food and Drug Administration.

Despite this, the company started to get input from leading surgeons and doctors in the spine field. They zeroed in on the most skeptical experts with the belief that their approval would carry the most weight in the medical world when the procedure got regulatory approval. In July 1998, the FDA approved companies to use inflatable bone tamps. This is the first year that the balloon kyphoplasty Boca Raton was performed. Kyphon Inc. kept raising venture capital throughout the process to total $40 million.

In early 1999, the company started to put a direct sales and marketing operation together. By the end of the year, their sales totaled $261,000. The company had a full commercial rollout of the KyphX System in May of 2000. Sales began to grow at a very quick rate due to the success of clinical studies. Kyphon Inc’s educational efforts also had a big impact in convincing more and more doctors and experts to consider kyphoplasty Boca Raton. They gave training to doctors who were willing to perform it.

Initial Public Offering of Kyphoplasty

Gary L. Grenter was named CEO and president of Kyphon Inc. in July 2001. He was involved in the spinal fusion, arthroscopy, and fracture healing market. The company started to take steps to go public under his leadership. However, it had one failed attempt at this process before succeeding in May of 2002. Piper Jaffray managed the initial stock public offering, and it raised $103 million.

Sales continued to increase in 2002 to $76.3 million, and the company expanded the sales team in 2003. This lead to the company having the first profitable year since it was founded, and it moved to a new corporate headquarters in Sunnyvale when the company got $27.3 million to support more growth. This facility offered double the space.

The number of spine specialists trained in the kyphoplasty Boca Raton procedure was at 3,900, and this was an increase from 2,700 in 2002 and 1,500 in 2001. The company also launched a dozen new products in 2003 to expand its growth potential. The company also acquired Sanatis GmbH, a German biomaterials company, for $4.5 million. This gave the company the right to manufacture and use a bone filler with calcium.

At this point, Kyphon Inc. couldn’t offer a complete system yet for kyphoplasty Boca Raton. The surgeons had to use bone cement that other companies made. Kyphon couldn’t make claims about the clinical-backed benefits of kyphoplasty Boca Raton. However, these issues were resolved in 2004. During this year, the company had further filings with the U.S. Food and Drug Administration, and Kyphon Inc. got clearance to sell bone cement that was specifically designed to go into your spine. At this point, the FDA said that the clinical date Kyphon Inc. provided about kyphoplasty’s effects was enough for the company to start talking about how effective it was for a treatment for spinal fractures.

In 2004, sales increased to $213 million. This helped to allow the company to grow. At this time, the Centers for Medicare & Medicaid Services set up reimbursement codes for the balloon kyphoplasty Boca Raton surgical procedure. The American Medical Association approved this move, and this set the stage for hospital and doctor reimbursement for the kyphoplasty Boca Raton procedure across the United States. In 2004, roughly 50,000 patients around the world had balloon kyphoplasty Boca Raton. By 2005, this number jumped to roughly 73,000.

Sustainable Growth

To help get a little diversity while supporting strong growth, Kyphon Inc. came to an agreement on three different acquisitions in late 2006. It acquired a company called InnoSpine Inc. early in the year. This company had FDA-cleared technology to help diagnose and treat low back pain in the axial spine caused by disc degeneration.

By the end of 2006, the company made two agreements with Disc-O-Tech Medical Technologies, Ltd., and this was an Israeli company. They acquired any spine-related assets this company held. This included a B-Twin Expandable Spinal System and a vertebroplasty system. The system uses an expandable interbody device to help treat issues with degenerative discs in the cervical and lumbar spine.

Kyphon Inc. also agreed that it would acquire St. Francis Medical Technologies Inc. They completed this deal in early 2007. This was a California-based company that brought the X-STOP System with it to help treat lumbar spinal stenosis.

Key Dates to Keep in Mind

  • 1994: Founding date for Kyphon Inc.
  • 1998: The Food and Drug Administration approves the use of inflatable bone tamps
  • 2004: The Food and Drug Administration approves bone cement
  • 2007: Kyphon Inc. acquires St. Francis Medical Technologies

Contact Florida Spine Associates

The balloon kyphoplasty Boca Raton surgical procedure is relatively newer, but it has very positive clinical proof that it works to help stabilize compression fractures in the spine while reducing pain levels. Today, it’s a minimally-invasive procedure that you can talk to the experts at Florida Spine Associates to find out more and schedule a consultation today.