Lex R. Giltai MD

VP Europe & Business Development, Managing Director

Q Spinal Surgery News: Last time we talked it was in spring 2008. What technological innovations has Pioneer Surgical Technology introduced in Europe since then?

A In the last year, we have introduced new products as part of our unique Pioneer Peek on Peek line, known as the P3 Technology™ and also new products for spinal fusion.
The products added to the P3 Technology are BacJac™, the unilateral Interspinous Decompression System and NuNec™, the Cervical Disc Arthroplasty System.
The BacJac combines all our knowledge of existing interspinous decompression devices with a unique unilateral design which simplifies the surgery even more and shortens surgery time. The BacJac achieves spinal decompression by limiting the symptomatic extension while maintaining physiologic motion.

The NuNec Cervical Arthroplasty System is the next generation of cervical Total Disc Replacement (TDR). The NuNec features a unique cam locking mechanism which provides a superb fixation without keel cutting as well as an HA coating on the outer surfaces of the PEEK plates to facilitate consistent fixation. Unlike most other cervical disc devices, the radiolucency of the PEEK material in NuNec causes no artifact in MRI or CT imaging.

The P3 line contains also our well established NuBac™ Lumbar Disc Arthroplasty System, which is the worlds’ first Disc Arthroplasty System that can be implanted from posterior and which has published clinical outcomes that are potentially better than a TDA. Over 300 patients have received NUBAC Disc Arthroplasty with good to excellent clinical results up to two year represented by an improvement of pain (VAS) with 70.5% and in improvement of the ODI score with 81.1%

For fusion, we have introduced the SlimFuse™ Anterior Cervical Plating System and the Quantum™ Complex Spine. The SlimFuse plates have the great advantage of requiring only one screw per level which cuts surgical time and require less retraction leading to less surgical site irritation and avoids the typical postoperative issues with swallowing.

Q What are the main advantages of your P3 line?

A Our P3 products, NuBac™, Bacjac™ and Nunec™ offer advantages through excellent wear resistance, established biocompatibility, biodurability and radiolucency.

Q Do you plan new launches in Europe?

A One of our main upcoming launches In Europe will be the NanOss™ Cervical Interbody Fusion Device that is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue, such as allograft and autograft. The NanOss™ Cervical Interbody Fusion is an orthobiologic breakthrough utilizing nanotechnology and biopolymers to deliver bone growth where it is needed most. We also plan to introduce our HA (hydroxyapetite) coated version of the BulletTip.

Q What is the company focus and what do you offer the spinal industry?

A Our core business is the degenerative disc and we offer clinically proven solutions from mobility preservation to fusion in spinal surgery. We aim at delivering cost-effective solutions for surgical procedures which have proven difficult for both surgeons and patients. Pioneer Surgical Technology is inspired by the current challenges in the surgical procedures and creates innovative medical devices which relieve pain and suffering while positively impacting the lives of our patients, employees and partners.

Q What is unique about Pioneer Surgical Technology?

A The uniqueness of Pioneer Surgical Technology resides in its origins: our spinal devices are designed by surgeons for surgeons to really make a difference. Through our unique strong background as Original Equipment Manufacturer for industry professional partners and the strong input from surgeons, we have shown to be able to develop spinal technologies that really make a difference. We have thus, the vision, energy and knowledge to innovate the spinal surgery technologies.

Q Do you foresee much expansion?

A Our fast growing distribution is an acknowledgement of our expertise and quality of our products which endorses our development in new markets such as Middle East, Asia and Africa.

Q How are you committed to quality?

A Our Company is certified following the medical standard as ISO 13485: 2003 and our products released in Europe are CE marked according to 93/ 42 CEE directive.

Q What is your approach toward your customers?

A Our corporate culture embraces an open dialogue with our customers and it is genuinely shared by our leadership and employees. We are driven by knowledge and innovation and we are inspired by the relations we develop with all our stakeholders.