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VitaThreads LLC Reports Meeting Primary and Secondary Endpoints in Pre-Clinical Studies Demonstrating Effectiveness of the VitaSuture Wound Management System (VWMS)

Companies mentioned in this article: VitaThreads LLC

WORCESTER, Mass. -- (BUSINESS WIRE) -- VitaThreads LLC today reported that the VitaSuture Wound Management Systems (VWMS) met a primary endpoint of incisional closure and secondary histological endpoints in pre-clinical in vivo animal studies. The study was conducted in a rat skin incision model system, evaluating the behavior of VWMS in 23 animals over the course of 57 days as compared to currently available sutures. VWMS demonstrated successful closure of evaluated wounds with no device-linked complications, with complete absorption of the suture material within 14 days, and minimal histological evidence of inflammation as compared to controls. Review by a board-certified histopathologist revealed less accompanying fibrosis and inflammation in suture absorption and wound healing than controls. Mechanical testing of VitaSuture demonstrated superior break strength to conventionally employed absorbable sutures by a factor of as much as 2x.

Glenn R. Gaudette, PhD1, Associate Professor, Biomedical Engineering, WPI, served as Principal Investigator for the VWMS pre-clinical evaluation commented, "The substantial lack of inflammation of VWMS presents a unique opportunity to reduce common suture complications including scar and granuloma formation while its quick absorption offers a chance for rapid return to native tissue behavior. This is just the beginning as I see the future potential for VitaSuture as an efficient, localized stem cell delivery system."

Frank P. Fechner, MD, Clinical Instructor, Harvard Medical School, (Boston, MA) commented, "After handling the VWMS with a skin model and reviewing the study data at the request of VitaThreads, I am excited to closely follow and assist in the future path of VitaSutures. Given the lack of innovation in the field of suture materials for many years, VitaSutures are unique with features of speedy absorption without significant tissue interaction. Quite certainly, this will translate into improved healing of the wound, will decrease suture-related complications with an ultimately better cosmetic outcome. These positive characteristics of the fibrin threads will allow surgeons to easily transition from other materials to VitaSutures. Personally, I look forward to the opportunity to incorporate VitaSutures into my aesthetic practice. In facial plastic surgery, I expect VitaSutures advantages to first make a difference in blepharoplasty (eyelid lift) and face lift surgery."

Eric W. Overström, PhD, Provost and Senior Vice President of Worcester Polytechnic Institute (WPI) commented, “I am extremely pleased to learn of VitaThreads LLC continued successes in their efforts to commercialize VitaSutures, a fibrin microthread-based therapy that will improve wound healing outcomes in aesthetic surgery. Since the opening of the Life Sciences and Bioengineering Center at Gateway Park in 2007, WPI has made a significant investment in fostering academic research initiatives that promise to translate into solutions for important healthcare problems. The research on fibrin microthreads, which was developed from the collaborative efforts of professors Glenn Gaudette and George Pins laboratories, serves as an exemplar of an academic initiative at WPI that promises to make a profound impact on patient-centered healthcare industry.”

About Frank P. Fechner, MD

Dr. Fechner is currently Clinical Instructor, Harvard Medical School, focused on Facial Plastic & Reconstructive Surgery. During his studies at the University of Freiburg Medical School, he received a prestigious one-year scholarship from the University of Massachusetts Medical School in Worcester to continue his studies. Dr. Fechner completed his surgical internship at Massachusetts General Hospital (MGH) in Boston and a four-year Harvard residency training at the Massachusetts Eye & Ear Infirmary in Boston, where he focused exclusively on surgery of the face, head and neck region. During his sub-specialty fellowship at New York University Medical Center and Columbia/ Cornell, Dr. Fechner focused exclusively of facial plastic surgery. Dr. Fechner performed a large volume of major reconstructive surgery for trauma victims at Manhattan's Bellevue Hospital Center, one of the busiest trauma centers in the Northeast. As a double board-certified facial plastic surgeon, Dr. Fechner teaches aesthetic surgery to plastic surgeons at both national and international conferences.

About Worcester Polytechnic Institute

WPI was founded in 1865 to create and convey the latest science and engineering knowledge in ways that are most beneficial to society. WPI's founding motto of Theory and Practice continues to underlie all academic programs. WPI graduates emerge ready to take on critical challenges in science and technology, knowing how their work can impact society and improve the quality of life.

About the Facial Aesthetic Market

Facial aesthetic repair is a subset of the US aesthetic skin closure market, representing over 5.8M reconstructive surgeries and 1.6M elective cases annually2. The facial aesthetic repair segment represents over 620,000 surgical procedures annually emphasizing blepharoplasty, rhytidectomy, and rhinoplasty. Current patient out of pocket costs represent $3,000-7,000 per procedure and with frequent additional costs associated with treatments for the reduction of scar (estimated to occur in over 10% of surgeries3) to improve post-operative appearance.

About VitaThreads, LLC

Founded in 2012, VitaThreads, LLC is committed to revolutionizing wound healing through its proprietary fibrin microthread technology. Fibrin, a natural substance which occurs during the wound healing process, is rapidly and readily absorbed by the body. VitaThreads leverages this rapid and clean absorption behavior in its flagship product, VitaSuture. VitaSuture empowers clinicians seeking an ideal aesthetic result to close low-tension incisional wounds with a cleanly and rapidly absorbing suture. VitaSuture is typically absorbed within a few weeks instead of persisting for the months typical of most current absorbable sutures. As a result, VitaSuture allows the body to return more quickly to a natural state without the complications associated with long suture persistence in situ. VitaThreads will initially target the cosmetic surgery market, where high-visibility procedures require an uncompromising attention to the quality of surgical closure.

1 Glenn R. Gaudette, PhD, is a founder and shareholder in VitaThreads

2 American Society of Plastic Surgeons. 2013 Plastic Surgery Statistics Report. ASPS National Clearinghouse of Plastic Surgery Procedural Statistics

3 De Blacam C, Colakoglu S, Momoh A, Lin S, Tobias A, Lee B. Early Experience with Barbed Sutures for Abdominal Closure in Deep Inferior Epigastric Perforator Flap Breast Reconstruction. ePlasty 2012: 12 Parell G, Becker GD. Comparison of Absorbable With Nonabsorbable Sutures in Closure of Facial Skin Wounds. Arch Facial Plast Surg. 2003;5(6):488-490. doi:10.1001/archfaci.5.6.488. Guyuron B, Vaughan C. A comparison of absorbable and nonabsorbable suture materials for skin repair. Plast Reconstr Surg.1992;89(2):234–236. Vital V, Printza A. Cartilage-sparing otoplasty: our experience. J Laryngol Otol 2002;116:682e5. Thomas SS, Fatah F. Closed anterior scoring for prominent-earcorrection revisited. Br J Plast Surg 2001;54:581e7.

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