Tissue Engineering

Annually, more than 1.9 million orthopedic and plastic reconstructive surgeries are performed in the United States. Despite the advances of modern science, the materials used in these procedures are often as primitive as metal plates and screws. As a prelude to the introduction of a full range of resorbable tissue- engineered reconstructive products, Therics is rapidly developing a number of powerful new modalities for surgeons, including a line of unique biocompatible bone replacement products. By combining several important advances, Therics is preparing to launch the first of these proprietary, high-value reconstructive products in late 2001 or early 2002.

The Need
Accidents, birth defects, tumors and age-related bone resorption are among the many conditions addressed through reconstructive procedures. Thousands of cases remain untreated due to cost, morbidity and the unavailability of adequate materials and techniques. Facial reconstructions pose particular challenges in achieving desired anatomical features. Many younger patients undergo successive surgeries as their bodies outgrow the materials used in previous procedures. Older patients often are unable to tolerate the morbidity or cost associated with available approaches. There is a strong medical need for products that can improve reconstructions, facilitate procedures and healing, and allow the proper treatment of cases that currently cannot be adequately addressed. But, often, well-touted research advances have been slow to move into clinical practice.

The Technologies
By bundling several distinct new technologies recently licensed from leading academic centers with its own TheriForm™ microfabrication process, Therics is able to design and fabricate implantable biostructures that promise to provide clinicians with unique capabilities and solutions, even for the most difficult reconstructive presentations. With TheriForm technology, these implants can be given exquisitely precise internal microarchitectures in order to provide the environments needed to encourage optimal tissue growth in either degradable or permanent structures. Utilizing new surface-active "comb" polymer technology licensed from MIT, cell-surface interfaces within these implantable biostructures can be endowed with unique molecular properties that can aid appropriate cell migration and tissue in-growth. Additional new technology from Boston University allows Therics to fabricate implants of exceptional strength from well-accepted, biologically relevant materials. Importantly, TheriForm machines have the unique ability to place growth factors and gene fragments at specific geometric locations within the implant, and in gradients, to foster optimal incorporation into bodily tissue. And, as needed, TheriForm microfabrication technology allows Therics to create anatomically accurate biostructures from MRI or CT scans, such as for maxillofacial reconstruction.

The Benefits
Each of these product features will be new to the medical armamentarium and each will significantly improve clinical outcomes. Importantly, no other technology, and no company other than Therics, is capable of fabricating implantable biostructures that contain these features. No other technology can create precise microarchitectures, nor place within such implants, heterogeneous regions with different drugs, growth factors and gene fragments in specific geometric positions or in gradients. Likewise, the cell-surface interfaces provided by the comb polymers uniquely mediate cell migration into the biostructure. And, no other technology can fabricate anatomically accurate implants from the complete range of sensitive, biologically relevant materials. Thus, the features and benefits that ultimately will be provided by Therics reconstructive products will be manifold and of great clinical relevance.

The Products
Bone replacement implants for simpler geometries will lead the roll out of Therics' line of reconstructive products, while increasingly sophisticated implants for complicated maxillofacial reconstructions will be progressively introduced. Likewise, initial products will utilize simpler combinations of well-accepted materials, and emphasize strength, while later products will focus upon designs and materials that facilitate full incorporation into body tissue. Initial product offerings utilize the 510k path for rapid regulatory approval. Full-scale marketing efforts are planned to begin in 2002 supported by a niche Therics sales force concentrating on relevant surgical specialties.

Therics, Inc., 115 Campus Dr, Princeton, NJ 08540. Tel: 609-514-7200; Fax: 609-514-7219.