 |
Year in Review
Summary
US Spine’s Fiscal Year 07/08 ended effective March 31, 2008, and represented a year of substantial progress for US Spine. The company achieved several important milestones, including:
- Saw sales more than double over FY06/07 figures
- Strengthened our field management team substantially
- Saw successful Alpha & Beta release of our Facet Fixation Systemä (FFS)
- Completed our first full financial audit (with an unqualified opinion)
- Successfully completed our first FDA audit
- Attracted new investors in 2007 and secured financing to continue growth through 2008 and beyond
Sales
The most significant indicator of progress, sales, more than doubled in FY 07/08. The growth was driven by our Core Products (pedicle screws, cages, cervical plates and biologics), but it is important to note that the number also included our first international sale (to Australia) as well as OEM sales to another spinal implant company based on our intellectual property.
Distribution
Our network of agents also grew at a healthy pace. Efforts have been focused on adding new agents in previously uncovered territories, as well as upgrading distribution in non-productive territories. There are now over 200 domestic sales representatives that market US Spine products. US Spine has also recently earned the ISO 13485 Certificate for our Quality System. This allows the company to sell products in the European Union and other countries, leaving us well positioned to expand internationally in the New Year.
Research and Development
We continued to invest heavily in R&D, bolstering our product lines and securing our future with innovative technologies. The company’s Intellectual Property portfolio continues to grow, and now encompasses Minimally Invasive Surgery, Motion Preservation and Facet Technologies, with nearly 50 patents filed.
Regulatory
The company successfully completed its first FDA audit in 2007. This was a routine audit, which the FDA conducts on all medical-device manufactures, typically every three years. We also had a successful annual audit to maintain our CE mark, which allows us to sell product in Europe and elsewhere outside the United States.
Capital
Substantial efforts were continued in 2007 to raise capital, and the company was successful in raising more than $4 million in 2007 from new and existing investors. The Board decided unanimously to accept a term sheet for an 18-month, $10 million line of credit. Based on current plans, this credit line should be sufficient to finance planned growth into 2009.
Facet Fixation System (FFS)
Timing of the introduction of the FFS is as follows:
- An Alpha release of the system was made in 2007. Thirty-five surgeries were performed by eight surgeons. These procedures confirmed our beliefs that the FFS is less invasive, faster and results in shorter patient hospital stays than pedicle screw fixation. Feedback from surgeons has been incorporated into design changes in the Facet Gun.
- A Beta release of the FFS occurred in the first quarter of 2008, centered on an improved design based upon feedback from the Alpha release. An additional 35 surgeries were completed with this design, with even greater success than the Alpha version.
- A full rollout of the FFS has begun as of May 1, 2008.
Development continues on the other facet-related devices, including a percutaneous version of the device, a reusable gun for sales internationally, and a facet–sparing cage for posterior insertion (avoiding a separate incision to place a cage in the disc space).
In 2007, the company won the prestigious “2007 North American Frost & Sullivan Award for Product Differential Innovation” for the FFS (press release attached).
Management
In 2007, we were able to strengthen our management team with strong managers with extensive industry experience. In particular, we were pleased to announce the additions of Dan Bernarde, VP Business Development; Darrell Jackson, VP Sales; and Linda Golob, VP Professional Education. They are responsible for identification, recruitment, training and retention of surgeons and sales agents to accelerate our growth, especially with the introduction of the FFS.
Dan Bernarde has been with US Spine since July 2007. Dan comes to the company with 14 years of spine experience, with the previous seven in senior management positions. Prior to joining US Spine, Dan served as Vice President, Corporate Development at Alphatec Spine. Additionally, he has held sales management positions at Interpore Cross International, Surgical Dynamics and Cross Medical Products. Dan earned a Bachelor of Science degree from Marquette University in Milwaukee, Wisc.
Linda Golob has focused 15 of her 25 years in the medical-device industry, leading Professional Education Departments within emerging spine-technology companies. She has built strategic surgeon and sales professional training programs that have led to product adoption, increased sales and expedited FDA approval of first-to-market, minimally invasive technologies. The companies include: Zimmer/SpineTech BAK, Endius Atavi FlexPosure and, most recently, Applied Spine Stabilimax NZ Dynamic Stabilization System. She has enhanced corporate visibility and surgeon product adoption by developing key opinion leaders through faculty-led training, professional meeting presentations and preceptorship programs. Ms. Golob has delivered educational programs and clinical support throughout the United States and abroad for over 20 years, including living and working in Japan for two years. She graduated from the University of Minnesota with a B.A. in Studio Arts and gained a post-graduate Associate of Arts degree in Registered Nursing.
Darrell Jackson Jr. has been with US Spine since June 2007. Darrell has 15 years of sales and management experience in the Spine and Orthopedic device industry. His responsibilities have included field sales and sales management for a large independent agency. Darrell also owned, operated and sold a successful agency/distributorship before serving as a Regional Director for Alphatec Spine. Darrell’s extensive corporate and entrepreneurial backgrounds are integral to the future success of US Spine. Darrell earned his Bachelor of Arts degree from Westminster College in Fulton, Mo.
Claton Odor joined US Spine in December 2007, and comes to the company with 14 years of medical-device experience. He has extensive experience with quality systems with an emphasis on design and production controls. Prior to joining US Spine, Clayton served as Director of Process Engineering for Boston Scientific’s Miami facility. Clayton earned a Master’s Degree in Chemical Engineering from the University of South Carolina, Columbia, and a Master of Business Administration degree from Thunderbird. |
|
