Secant Group has developed a biomaterial platform technology that provides a resorbable, implantable polymer to drive further innovation in the medical device, pharma, and biopharma markets. Secant Group President Jeff H. Robertson discussed the company’s innovative approach with Pharma’s Almanac Managing Editor Emilie Branch.

Product Design History

Building on decades of experience engineering textile structures for industrial, fashion, and aerospace applications, Secant Group, LLC, was formed in 2016 as the parent company for Secant Medical Components and Secant Technical Materials. Secant works closely with sister company SanaVita Medical, LLC — a U.S. FDA–registered contract manufacturer for medical devices — to provide end-toend contract manufacturing and process services for customers developing medical devices and combination products. Through this partnership, Secant leverages its research capabilities to extend its biomaterial drug delivery platform, while SanaVita Medical conducts validation and scale-up activities for commercial production for their pharma customers. Secant also works very closely with another sister company, Charter Medical, Ltd., to provide essential products and services to life science companies.

Biomaterials Innovation

Secant Group’s R&D team focuses on invention and innovation, whether that means creating new textile geometries that challenge current manufacturing technologies or developing an advanced biomaterial platform on the cutting edge of regenerative medicine. The R&D group brings a range of experience encompassing medical devices, polymer chemistry, analytical chemistry, and cell biology to their efforts spanning biomedical textile technology development, polymer processing, implantable polymer research, textile formation, and multiple extrusion methods, both internally and through academic and industrial collaborations and strategic partnerships.

Biomedical textile structures are already used in cardiovascular, general surgery, neurovascular, and orthopedic applications. Secant is bridging the technologies for traditional biomedical textiles with regenerative medicine to create high-performance materials that will support innovative medical technology to improve the quality of life. These new biomaterials have the potential for use in many additional areas, including novel implantable drug-delivery devices.

Secant’s implantable medical components cover applications, including endovascular aneurysm repair, heart valve replacement and repair, spine repair, neurovascular aneurysm repair, soft tissue repair, and a range of orthopedic applications. The company’s implantable drug delivery platform enables the controlled and localized release of active pharmaceutical ingredients.

Novel Bioresorbable Resin

Secant’s bioresorbable resin platform Regenerez^®, based on the elastomer poly(glycerol sebacate) (PGS), offers a unique combination of attributes, including multiple nonpharmacological modulating properties. PGS is a synthetic polymer manufactured from two benign materials that are metabolized naturally in the body via the Krebs cycle and thus do not accumulate, a differentiator compared with other available synthetic materials.

Regenerez also has antimicrobial properties and may reduce the incidence of local infection when used as a polymer coating or implant in medical device applications. Regenerez further elicits tissue-appropriate mechanobiological responses, stimulating regeneration and growth of native tissue. It is also nonimmunogenic and has immunomodulatory properties that promote healing without chronic inflammation, leading to reduced scar tissue formation.

“This combination of properties makes Regenerez ideal for the production of implantable devices for sustained drug release, which can lead to improved patient compliance. Notably, the surface erosion degradation rate of Regenerez can be tailored by tuning the physical and chemical characteristics of the polymer,” says President Jeff Robertson.

Similarly, modifying the polymer morphology of the PGS elastomer by changing the initial reaction stoichiometry allows for tailoring of the mechanical and elastomeric properties of Regenerez to match the physical properties of different tissues in different medical device and pharma target applications, such as cardiovascular, nerve, and bone tissue. PGS can also be shaped into many forms. Regenerez has potential use in functional bioresorbable coatings, biomedical textiles, and medical devices, as well as in novel drug-delivery solutions, tissue engineering, and regenerative medicine.

Combining Strengths to Generate Powerful Innovation

“We are focused on providing clients with consistent value, quality, and technical expertise while continually advancing biomaterials technology into practical applications for the medical device and pharmaceutical industries,” stated Robertson. “Within the next 18 months to two years, Secant expects to launch the first of many new innovative biomaterial products, with more innovations and products reaching the market every subsequent one to two years.”