Carbon Medical Technologies
Biocompatible Innovations for Urology Implants

In an era of significant reevaluation of treatments for stress urinary incontinence (SUI) due to suboptimal options, including the use of pessary devices, bladder training, pelvic floor exercises, and dietary modifications that do not offer lasting relief to patients, combined with the uncertainty surrounding the use of surgical mesh slings, patients and physicians are seeking alternatives, including more permanent and infallible solutions that can address the challenges of SUI. However, they need not seek any further. Carbon Medical Technologies (CMT), an R&D and implantable medical devices manufacturing company, leverages its proprietary pyrolytic carbon coating technology to develop industry-leading products for minimally invasive applications. One of CMT’s flagship products is the injectable bulking agent Durasphere for the treatment of SUI, containing pyrolytic carbon-coated graphite beads suspended in a waterbased carrier gel. It is one of the most efficient treatments for SUI caused by intrinsic sphincter deficiency (ISD). Durasphere helps obtain closure from the bladder neck to mid-urethra and prevents urine leakage. It is an officebased procedure, done under local anesthesia, and can be administered in about 15 minutes, allowing the patient to be more comfortable and physicians more efficient with their time. “With over 20 years of R&D expertise, we have created tools and training, including the proprietary ‘Bent Needle’ periurethral injection approach, which simplifies injection and contributes to positive patient outcomes,” states Stephanie Kent, the President and CEO at CMT. In fact, Durasphere can be implanted into patients using both transurethral and periurethral methods, providing the versatility that allows physicians the option to use their preferred approach while performing the procedure. In addition, Durasphere is a low-cost, safe, and effective option, with appropriate provider reimbursement, for treating patients with SUI due to ISD.

CMT also developed a complete line of implantable carbon-coated fiducial markers (BiomarC) to address the challenges often encountered in radiation treatment of prostate cancer. The BiomarCfiducial markers offer clear visual images deciphering healthy tissues from the radiation target area allowing for rapid and more precise radiation treatment planning. The unique carbon coating in combination with the core materials of these markers are compatible with all forms of radiation therapy and can be seamlessly used for IGRT/IMRT, proton therapy, CT, MRI, and portal imaging.

With over 20 years of R&D expertise, we have created tools and training, including the proprietary ‘Bent Needle’ periurethral injection approach, which simplifies injection and contributes to positive patient outcomes

Treatment teams can use BiomarCfiducial markers to deliver the maximum radiation dose to patients while sparing the surrounding healthy tissue. Available in different designs, sizes, shapes, and with varied core materials, BiomarC applies to almost any part of the body where radiation therapy is contemplated.

Carbon is a common element found in the human body. As a result, CMT’s pyrolytic carbon coating process produces a coating that is not recognized by the body as a foreign material. The properties of CMT’s carbon coating include strength, high wear resistance, thromboresistance, and unparalleled biocompatibility, making it an ideal implant material for a wide variety of medical devices.

CMT’s R&D prowess has enabled it to develop a strong foothold in the urology space with various medical devices and products. The company is an FDA-registered medical device manufacturer with ISO 13485 certified CGMP compliant quality systems. It operates an ISO Class 7 Cleanroom environment and provides contract manufacturing. “With over 27 years of institutional knowledge, our company has had an impeccable track record with the FDA and EU notified bodies with over 20 products developed and approved or cleared for sale on the market”, states Tina Wittchow, the COO at CMT, adding “the R&D focus, manufacturing capabilities, regulatory and quality expertise is core to our company.” The company focuses on offering robust solutions to address SUI and encouraging competitive partnerships in the marketplace for a flawless combination treatment plan for addressing the patient’s needs.

Taking CMT to the next phase of its expansive growth, its team continues developing new products, expanding sales of its current product portfolio, and raising awareness among the physician and patient community. The company’s newest product BiomarC Restore is a lumpectomy fiducial marker designed to provide patients with comfort and physicians with confidence by positioning and maintaining the marker in the surgical cavity created during a lumpectomy procedure recently received FDA clearance. “We are excited about BiomarC Restore and are looking forward to a market launch in 2022”, adds Stephanie. CMT is looking to grow its contract manufacturing services and expand the presence of its products worldwide by exploring new partnerships overseas with a focus on Asian markets, including Japan.