A Paradigm Shift in Skeletal Reconstruction
Plymouth, MI (December 7, 2015) – Today, Materialise and Tissue Regeneration Systems (TRS) announce a partnership to manufacture life-saving 3D-Printed tracheal splints for use in clinical trials.
Plymouth, MI (January 14, 2015) – Tissue Regeneration Systems, Inc. ("TRS") today announced that Sharon Schulzki has joined the company as Senior Vice President of Business Development. Prior to joining TRS, Schulzki served as Vice President of Surgical Affairs for Depuy Synthes Spine, a division of Johnson & Johnson Corporation. She was the Chief Operating Officer of NSpine, a start-up medical device company acquired by Synthes in 2007. Prior to that, Schulzki served as Chief Operating Officer of MacroPore Biosurgery, and Vice President of Marketing for the Howmedica division of Pfizer Corporation.
NEW BRUNSWICK (June 19, 2014) – Johnson & Johnson Innovation, LLC today announced 12 new alliances with life science companies and research institutions around the globe to explore early-stage innovation in a broad range of therapeutic areas and across pharmaceuticals, medical device and diagnostics and consumer healthcare.
"The future of healthcare will be defined by companies, academic institutions and governments that collaborate to leverage existing strengths, while at the same time think outside current paradigms and experiment with new ways of innovating," said Paul Stoffels, M.D., Chief Scientific Officer, Johnson & Johnson and Worldwide Chairman, Pharmaceuticals. "By being where these new frontiers in science and technology are being forged, our goal is to translate these insights into promising treatments for the future."
Launched more than a year ago, the Johnson & Johnson Innovation centers are working globally with life science researchers and entrepreneurs to identify exciting early-stage technologies and translate them into solutions for patients.
Multiple companies have recently used 3-D printing to make implantable devices t hat are customized to specific patients or to improve manu facturing precision
and efficiency. The current activity could be a first step toward establishing a new paradigm of personalized implants, FDA and others suggest.
One initial foray into 3-D printed implants has been for craniamaxillofacial reconstruction products to fill voids in the skull. Tissue Regeneration Systems Inc., founded in 2008, gained 510(k) clearance this August for the first of several planned products - its cranial bone void filler used to repair neurosurgical burr holes. The product is made by 3-D printing a bioresorbable polymer (PCL) that is porous and osteoconductive. The implant is covered wit h a coating to promote bone growth so that it will fully degrade within two to three years.
"To our knowledge, this is the first FDA approval of a coated bioresorbable skeletal reconstruction implant fabricated by means of 3-D printing," TRS President and CEO Jim Fitzsimmons said in an interview.
Ann Arbor, MI, August 26, 2013 – Tissue Regeneration Systems, Inc. ("TRS") today announced that it has received 510K approval from the U.S. Food and Drug Administration for its Cranial Bone Void Filler product, indicated for use in the repair of neurosurgical burr holes. This is first of a family of craniomaxillofacial surgery products being developed by TRS that incorporate the company's novel skeletal reconstruction and bone regeneration technology platform.
The 510K approval process required TRS to meet a high standard of pre-clinical testing and successfully pass a rigorous review by the FDA. "This is a significant milestone for the company," said Jim Fitzsimmons, president and chief executive officer. "With our base material and manufacturing processes now cleared by FDA, the approval pathway for future products can be streamlined," he added. TRS has filed a 510K for its second product, which is currently being reviewed by FDA. Other submissions are in work, according to Fitzsimmons.
Applying a technology platform created at the Universities of Michigan and Wisconsin, TRS is developing advanced skeletal reconstruction implants with unique attributes. They are bioresorbable over time, fully replacing themselves with natural bone. Although their micro-architecture is porous to facilitate bone integration, they can bear load and they are strong enough to support function without need for reinforcement with metal plates. This structural integrity allows them to be used as an alternative to bone harvested from the patient for complex skeletal reconstruction. Using input from patient CT scans, their geometry can be custom constructed. Finally, they are integrated with a proprietary, osteoconductive coating that serves as an excellent substrate for adhesion and local, controlled release of growth factors to enhance bone regeneration.
"To our knowledge, this is first FDA approval of a coated bioresorbable skeletal reconstruction implant fabricated by means of 3D printing," said Fitzsimmons. "This technology is definitely the wave of the future", he added.
It sounds futuristic: Tissue Regeneration Systems Inc. is in the business of using a biodegradable polymer mesh to grow new bone and replace the titanium implants now in use. But the future isn't so far off.
With a fresh round of venture capital funding, including $500,000 from a new state of Michigan fund, and animal trials winding down, the University of Michigan spinoff hopes to be in the market late next year or in 2015 at the latest.
