Recent significant news and accomplished milestones.
Recent significant news and accomplished milestones.
ST. PAUL, Minn., Feb. 14, 2017 /PRNewswire-USNewswire/ -- St. Teresa Medical, Inc, a company developing and soon to be commercializing an innovative hemostatic dressing that treats cancellous bone bleeding, announced today that a 2017 Award for Excellence in Technology Transfer was granted to The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) and the Uniformed Services University of the Health Sciences (USU) for licensing of the dressing that does not swell in the body.
The award will be presented April 26 by the Federal Laboratory Consortium (FLC) for work by Dr. Stephen Rothwell, Professor of Anatomy, Physiology and Genetics at The USU's F. Edward Hébert School of Medicine and his colleagues for the licensing of SURGICLOT®, a dissolvable dressing that leaves behind the essential human clotting proteins, fibrinogen and thrombin, at the injury site. Dr. Rothwell is a co-inventor of the formulation and manufacturing technique for the production of the hemostatic bandages. He and other researchers at USU under a Cooperative Research and Development Agreement with St. Teresa Medical, performed the initial swine pre-clinical work and published the results in The Journal of Trauma-Injury Infection & Critical Care.
St. Teresa Medical exclusively licensed the technology from HJF and Virginia Commonwealth University (VCU) in 2010. "We offer our congratulations to the teams at HJF and USU and are grateful for our ongoing affiliations with these esteemed organizations," says Philip A. Messina, President and Chief Executive Officer of St. Teresa Medical, Inc.
About St. Teresa Medical, Inc.
St. Teresa Medical, Inc. has developed a platform technology called FASTCLOT®. SURGICLOT®, the technology's product used in human clinical trials, is comprised of USP grade electrospun dextran and human plasma proteins. Dextran is a branched-chain polysaccharide that has been used in medicine for many decades. It is highly soluble in liquid such as blood. Due to its high molecular weight, it is an excellent osmotic agent. SURGICLOT® is the only dissolvable hemostatic dressing that does not swell in the body making it ideal for cancellous bone bleeding. SURGICLOT® performed well in human trials in the UK, Norway and India. (See St. Teresa Medical's website for more information at www.stteresamedical.com) The company is in the process of submitting its dossier for CE Mark for commercialization in the EU. The electrospun dextran dressing is the ideal carrier for the FASTCLOT® platform technology and for clotting proteins because it is safe, dissolves rapidly and does not leave a trace. FASTCLOT® is a platform nanotechnology that will have many applications.
September 6, 2016 - St. Paul, MN - St. Teresa Medical, Inc. today announced the appointment of Richard Guyer M.D. to its scientific advisory board. Dr. Guyer is a board certified orthopaedic spine surgeon and one of the founders of Texas Back Institute and serves as its President. He also serves as the Chairman of the Board of Directors for the Texas Back Institute Research Foundation and has been Director of the Spine Surgery Fellowship program since its inception in 1986.
Dr. Guyer did his medical school and residency training at the University of Pennsylvania School of Medicine and completed two spine fellowships, one at Case Western Reserve University with Henry Bohlman, M.D. in Cleveland, Ohio and the other with Leon Wiltse, M.D. in Long Beach, California. He holds many patents in spine surgery and has published over 100 peer-reviewed articles and 45 chapters presenting his research at national and international spine conferences. While the majority of the research work has dealt with the diagnosis and treatment of painful degenerative spinal conditions, he is also one of the pioneers in minimally invasive surgery and lumbar and cervical disc replacement. In the early 1980s he worked with his former mentor Parviz Kambin who pioneered endoscopic discectomy. In 2000 he performed one of the first disc lumbar disc replacements in the USA and has been an investigator in nearly a dozen U.S. IDE studies of both cervical and lumbar disc replacements. He continues to research and publish in this area as well as in motion preservation and minimally invasive treatments.
Dr. Guyer has been very active with various spine societies including North American Spine Society (NASS), Cervical Spine Research Society (SSRS), International Society for the Study of the Lumbar Spine (ISSLS), and International Society for the Advancement of Spine Surgery (ISASS) serving as President of NASS during the 2006-2007 year and various committees of the ISASS. He was recently appointed to the board of directors of the American Board of Spinal Surgery.
Philip Messina, President and CEO said, “We are very pleased to welcome Dr. Guyer to our Scientific Advisory Board. He is considered to be among the top spine surgeons in the world. We could not be more pleased to have him on board. “
C. Timothy Floyd, MD, Chief Scientific Officer and Chair of the Scientific Advisory Board said, “Dr. Guyer is a world leader in cutting edge spine surgery and techniques. His counsel, as we move into our global clinical trial on SURGICLOT® will be important.”
July 27, 2016 - St. Paul, MN - St. Teresa Medical, Inc. today announced that the United States Patent and Trademark Office (USPTO) has issued Patent US 9,399,082 ELECTROSPUN DEXTRAN FIBERS AND DEVICES FORMED THEREFROM. This patent forms the key technology base for the St Teresa Medical platform technology called FASTCLOT® and its SURGICLOT® family of hemostasis products. SURGICLOT® uses the FASTCLOT® electrospun dextran nanofiber dressing to deliver human derived clotting proteins fibrinogen and thrombin to surgical, trauma and other injury sites to achieve hemostasis.
Philip Messina, President and CEO said, “We are very pleased to receive this patent. Our SURGICLOT® product, currently awaiting the CE Mark in Europe, is poised to become the treatment of choice for cancellous bone bleeding, once approved. Because our electrospun dextran nanofiber dressing dissolves when in contact with bodily fluids, SURGICLOT® actually shrinks in physical size as it works compared to competing hemostatic agents which swell. This is an especially crucial advantage in and around delicate tissues like the spine.”
FASTCLOT® is uniquely fabricated from nanoscale electro-spun dextran fibers infused with fibrinogen and thrombin and provides a robust and inexpensive platform for hemostatic products that are ideal for commercial use in surgical and trauma applications. FASTCLOT® is the only blood-clotting technology with a rapidly dissolvable dextran nanofiber dressing. FASTCLOT® works by supplementing and enhancing the body’s natural clotting mechanism. Dextran dissolves within seconds in contact with bodily fluids. Upon dissolving, the thrombin acts on the fibrinogen and converts it to fibrin which forms a natural clot at the injury site which stops bleeding.
SURGICLOT® utilizes thrombin and fibrinogen obtained from human sources.
St. Teresa Medical has obtained the exclusive worldwide license for this patent from Virginia Commonwealth University and The Henry M. Jackson Foundation for the Advancement of Military Medicine.
The company now holds 3 patents in the US with 7 pending and 7 foreign patents with 22 pending.
June 21, 2016 - Eagan, MN - On June 1, 2016, St. Teresa Medical, Inc has successfully treated 10 patients in its hemostasis clinical trial in India. The study was designed to provide additional safety and performance data on the ability of the SURGICLOT® Hemostatic Dressing to achieve hemostasis of cancellous bone bleeding. All ten patients treated with SURGICLOT® underwent elective spinal fusion surgery. SURGICLOT® was applied to the bleeding surface of one or two spinal segments. Bleeding severity at each SURGICLOT®-treatment site ranged from oozing to flowing. A total 12 bleeding sites were treated with SURGICLOT®. At all treatment sites, application of a single SURGICLOT® dressing for 3 minutes successfully stopped the bleeding.
The spine surgeries were performed at STAR Hospital in Hyderabad, India by Dr. Sukumar Sura (Principal Investigator), Dr. Sai Sudarsan and Dr. Bala Raja Shekar. Upon completion of the study, Dr. Sura sent an email to St. Teresa regarding the use and performance of SURGICLOT®. Dr. Sura made the following comments about the study:
It was nice to be associated with your clinical research study. SURGICLOT® is phenomenal and performed far better than other products I have used as hemostats, e.g., bone wax, Gelfoam®, Floseal®, etc., during spine surgeries, especially for cancellous bone bleeding. Application of SURGICLOT® is simple and easy and does not interfere with completion of the surgical procedure. Another great feature of the product is that it dissolves fast and hemostasis is absolute.
After using SURGICLOT® in 10 spinal fusion cases, I now have additional ideas and potential areas where SURGICLOT®can be used, e.g., in cases of large brain tumors (meningiomas and gliomas) to prevent tumor bed hematomas.
I am also looking forward to starting the dural repair clinical study once the follow-up visits of our subjects in the current study are completed in July 2016.
Overall, this product is here to stay and will be a good addition to the hemostasis armamentarium available for neurosurgery in the future."
The trial was conducted by 8C Healthcare Pvt. Ltd., # 1207, 13th Street, Vijaya Bank Road, Gandhi Nagar,Hyderabad, Telangana, India 500080
July 13, 2015 - St. Paul, MN - St. Teresa Medical, Inc. today announced the enrollment of the first patient into its human clinical trial for its product, SURGICLOT®, which is classified by the U.K.’s regulatory agency MHRA, and Nemko PreSafe, a global testing and certification company specializing in medical devices, as a medical device class 111 with medicinal ancillary action. On June 18, St. Teresa Medical received approval for a 40-patient study from MHRA in the U.K.
According to CEO and Co- Founder Philip Messina, on July 6 Mr. Sanjeev Madan, a consultant orthopaedic surgeon at Doncaster & Bassetlaw Hospital in South Yorkshire, U.K., performed a pelvic osteotomy (bone is shortened, lengthened, or alignment is changed) using the SURGICLOT® dressing on the first patient in St. Teresa’s human trial. Dr. Tim Floyd, chief scientific officer for St. Teresa Medical, was present at the first surgery.
"It was Mr. Madan's impression, as well as mine, that the reduction in blood loss was significant and dramatic, and that its use will lead to less morbidity for patients, shorter surgical times, lower costs, fewer transfusions, and less time in hospital," said Floyd.
SURGICLOT® may reduce length of hospital stays
"Mr. Madan was very pleased with the results, and commented it will allow him to send patients home sooner because of vastly reduced blood loss. The SURGICLOT® dressing is the only hemostatic dressing available with both dissolvable and resorbable qualities. The dressing dissolves in seconds to minutes, and leaves behind a robust clot to obtain hemostasis in less than three minutes," Messina added.
The dressing achieves its primary mode of action through the solid electrospun dextran, which initially creates a physical barrier to oozing, flowing or pulsatile bleeding. The SURGICLOT® dressing will be the first hemostatic dressing indicated for use in cancellous bone bleeding when the dressing is CE Marked (a European Union safety requirement) after the human trial is completed during the Fall of 2015.
St. Teresa Medical's Good Laboratory Practice animal studies required by both the MHRA and the U.S. FDA have scientifically proven the U.S. Pharmacopeia-grade electrospun dextran, human thrombin and fibrinogen are completely resorbed by the tissue.