MONTVALE, N.J., Oct. 28, 2020 /PRNewswire/ -- PENTAX Medical, a healthcare industry leader in diagnostic and therapeutic endoscopy solutions, announced today a distribution agreement with Sofregen Medical Inc. for its Silk Voice Injectable Implant. Under the terms of the agreement, PENTAX Medical will serve as the exclusive United States sales agent of the Silk Voice product.
Silk Voice is the first and only1 silk protein injectable with FDA 510(k) clearance2 for tissue bulking in vocal fold medialization and vocal fold insufficiency. When injected, Silk Voice provides immediate volume augmentation to the vocal fold tissue. The porous particles remain at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated silk scaffold provides the long-term restoration and augmentation. Silk particles combined with a hyaluronic acid carrier, enables initial volume restoration which is replaced with new healthy tissue over time. Silk Voice has been shown to provide immediate medialization of the vocal fold and is projected to last more than 12 months. A slow absorption profile sets silk apart from other biomaterial such as collagen, elastin, and keratin.
"Silk Voice has the potential to change the way I treat vocal fold paralysis. In my experience, the material is easy to inject percutaneously or via an endoscope," said Dr. Michael M. Johns, Division Director, Laryngology, University of Southern California. "Ongoing study should help elucidate the durability of the product; however, preliminary findings make me optimistic that Silk Voice will be a safe and effective product expanding our armamentarium."
"We are committed to advancing endoscopy and voice care with innovations that help improve clinical and economic outcomes, as well as solutions that enhance the patient and provider experience," said Rainer Burkard, Chief Commercial Officer, PENTAX Medical, Americas. "The Silk Voice injectable for vocal fold augmentation demonstrates our dedication to introducing advanced endoscopic and innovative voice-related products for clinicians and their patients. Silk Voice is a natural addition to our line of speech, voice, and dysphagia products, delivering enhanced voice care and treatment."
"We are thrilled to have PENTAX Medical as a partner," said Jonathan T. Hartmann, Sofregen Chief Executive Officer. "PENTAX brings decades of experience in delivering quality products and this partnership accelerates access to our innovative treatment for patients who suffer from vocal fold insufficiency."
Silk Voice was showcased in the PENTAX Medical virtual booth during the Fall Voice Conference on October 23–24, 2020. To learn more about Silk Voice, visit http://silkvoice.pentaxmedical.com.
About PENTAX Medical
PENTAX Medical is a division of Hoya Group. Its mission is to improve the standard of patient care and enhance patients' and providers' experience by providing the best endoscopic products and services with a focus on QUALITY, CLINICALLY RELEVANT INNOVATION, and SIMPLICITY. Through leading-edge R&D and manufacturing, PENTAX Medical provides endoscopy solutions to the global medical community. Headquartered in Japan, PENTAX Medical has a worldwide focus and presence with R&D, regional sales, service, and in-country facilities around the globe. PENTAX Medical employees represent the diverse countries where we do business, allowing us to provide innovative solutions tailored to meet local needs. For more information, visit PENTAXMedical.com/US.
About Sofregen Medical
Sofregen began its commercial operations following the acquisition of SERI Surgical Scaffold® from Allergan PLC, the first and only surgical implant made from silk fiber. Sofregen is a pioneer in soft tissue engineering with an advanced platform based on silk protein, also known as fibroin, which has been shown to have unique properties for tissue support and regeneration. Silk Voice is carefully engineered to match the biomechanics of soft tissue for immediate bulking and long-term tissue replacement.
1. As of October 22, 2020
SOURCE PENTAX Medical