Tuesday was the beginning of a new era for Paragon Intellectual Properties (Charleston, West Virginia) as the company reported it has restructured, moving from a limited liability company with seven subsidiaries to a single C-corporation to form Nexeon MedSystems. The company said the change was made to prepare for clinical trials and commercialization of its lead technologies.
But wait, that's not all: The company also reported raising a $24 million round of financing and kicking off a first-in-man trial to evaluate its Protex coronary stent.
"I founded the company as a way to house some of my personal intellectual property and build out to create value, moving forward, where today we're looking at a potential legacy company that has multiple products," Mark Bates, MD, Nexeon CEO, told Medical Device Daily. "We've been on budget, on track ... we've hit every clinical milestone along the way."
Bates is also a professor of medicine and surgery at West Virginia University (Charleston) and a leading interventional cardiologist at CAMC Vascular Center of Excellence (Charleston). He said the company has come a long way since 2005 when it had just two employees, compared to the 25 employees it has today.
"What's become exciting to us is [that] our forward momentum has exceeded everyone's expectation," Bates said.
The $24 million equity funding round included financing provided by SurModics (Eden Prairie, Minnesota), Guidant (Indianapolis; now Boston Scientific (Natick, Massachusetts) and private investors.
Nexeon said it plans to use the financing proceeds to support a clinical trial of its Protex heart stent, a device designed to overcome the pitfalls associated with both bare metal (BMS) and drug-eluting stent (DES) systems.
In today's financial climate, raising $24 million for a new medical technology is not exactly a walk in the park. But Bates told MDD that its investors believed in the long-term prospects for the company and that the money, "honestly, was not difficult to raise."
"Our investors, [including] a lot of private investors, were investing more in the vision of the company and the fact that we're building a company that is based on the fundamentals," Bates said. Those same fundamentals, he added, have led to the success of such large med-tech companies as Boston Scientific.
If one thing sets Nexeon apart from other companies, Bates said, it is a "physician-driven end-user innovation mindset."
The Protex system integrates Nexeon's low-profile (0.86 mm) cobalt alloy stent platform with the Finale prohealing extracellular matrix coating supplied by SurModics. Bates said the stent's unique design and its protein coating intended to accelerate the healing process set it apart from other heart stents on the market. The system is designed to reduce or eliminate rates of late stent thrombosis, a complication sometimes associated with DES devices, and that of restenosis the re-narrowing of the stented vessel which occurs in about 20% of BMS procedures.
Also, the company noted, the Protex stent system may eliminate the need for long-term antiplatelet therapy. The device is the result of the collaboration between Nexeon and SurModics, reported last year (Medical Device Daily, July 12, 2007).
Bates said DES devices are designed to slow the healing process. The upside to this, he said, is the reduction of restenosis after stent placement, the downside that "in many ways it never completely heals."
"The protex stent helps nature along by coating a stent with a normal protein found in the lining of a normal artery," Bates said. "This coating helps recruit normal cells to line the stent and accelerate the healing process of the stent."
The company said it would also use the new funding to develop its other lead technologies, including a family of peripheral stents and nanotechnology-based devices.
"This show of support from investors reflects confidence in our team to execute on our core mission of improving lives through the development of breakthrough therapies for cardiovascular disease. It is also a testament to our strong intellectual property portfolio and our nimble approach to innovation," Bates said. "We are pleased with the tremendous progress the Paragon team has made since the company's inception. The same passion, resolve and commitment to innovation that led to the early success of Paragon will fuel the forward momentum of Nexeon MedSystems."
The company noted several milestones achieved to date, including: the expansion of its product portfolio from an initial list of six early-stage concepts to more than 20 products; the opening of its R&D center in Carlsbad, California, last year; its partnerships with SurModics and Unidym (Menlo Park, California) in the domains of coronary stenting and nanotechnology, respectively; establishing its scientific advisory boards; acquisition of the Biflex bistable stent technology, foundation of the company's peripheral stent family; development of its Protex stent; attainment of ISO 13485 certification to facilitate future commercialization in Europe and Canada; and now the initiation of its feasibility study of the Protex.
"The enrollment of the first patient in Nexeon's initial clinical trial marks a significant milestone for the company and is the culmination of many years work from talented clinicians, engineers and scientists," Bates said. "Preclinical studies suggest that this prohealing alternative to the delayed healing seen with DES systems may give way to an entirely new class of stents that combat restenosis while eliminating the risk of late stent thrombosis."
Nexeon said the PROTEX I trial will enroll 50 patients at five sites in Europe. Professor Eberhard Grube, chief of cardiology and angiology at Heart Center Siegburg (Siegburg, Germany), enrolled the first patient.
Follow-up examinations will be performed at 30 days, six months and nine months. The six-month follow-up examination will evaluate both neointimal volume by intravascular ultrasound and percent binary restenosis by angiography. William Wijns, MD, of the Cardiovascular Center Aalst (Aalst, Belgium), will be principal investigator of the clinical trial.
"There is a significant clinical need for a low-restenosis stent that does not carry the late-thrombosis risk of drug-eluting stents," Wijns said. "I am excited about the potential of this type of breakthrough coating on a highly deliverable coronary stent."