Recent significant news and accomplished milestones.
Recent significant news and accomplished milestones.
Background: Cancellous bone bleeding (CBB) is a significant source of blood loss in spine and pelvis surgery. Current hemostatic methods are either ineffective or interfere with bone healing. A novel fibrin dressing (NFD) controls arterial, solid organ, and CBB in various species. The purpose of this clinical study was to determine the safety and performance of the NFD at controlling CBB.
Methods: Forty patients were enrolled at 9 centers in the UK, Norway and India. In each country Ethics Committee approvals were obtained prior to the study. This was a Level IV single-arm study of patients who met the inclusion eligibility criteria. The follow-up period was 6 weeks. The primary endpoint was control of bleeding at 3 min. Secondary endpoints were control of bleeding at 6 min, as well as clinical and laboratory criteria. Anatomical sites (AS) included posterior spinal fusion (PSF), iliac crest graft (ICG), and pelvic osteotomy (PO). Intraoperatively, the surgeon assessed the severity of CBB (pulsatile, flowing, oozing or none) and applied the dressing for 3 min. Bleeding was then assessed again and if it was not controlled (oozing or none) a second dressing was applied for an additional 3 min. For bleeding not controlled after the second dressing application the surgeon used an alternative method. Patients were assessed at 24 h and 6 weeks clinically (for hematoma, allergic reaction, etc.) and with lab analysis, including CBC, PT, aPTT and INR.
Results: All 40 patients completed the 6 week follow up. Twenty-three patients had PSF, 14 ICG and 3 PO. The dressing was used on a second AS in 11 of these patients for a total of 51 AS tested. Of the 51 treated AS, bleeding was controlled at 3 min in 41/51 (80.4%) and 6 min in 48/51 (94.1%). Three patients required alternative treatment. Bleeding in all 3 of the PO patients, the most vigorous bleeding, was controlled with the dressing. Adverse events (AE) considered to be "possibly device-related" occurred in 4 patients (13.3%).
Conclusions: This Phase I clinical trial demonstrated the safety and efficacy of this novel fibrin dressing, SURGICLOT® in cancellous bone bleeding. A randomized, controlled FDA trial currently is underway.
EAGAN, Minn., Oct. 17, 2017 /PRNewswire-USNewswire/ -- St. Teresa Medical, Inc., ("STM") continuing the development of additional applications for its unique technology, presented two papers at the Annual Meeting of the Congress of Neurological Surgeons in Boston, Oct. 7-11. The papers were presented by Dr. Tim Floyd, the Chief Scientific Officer of STM, and a practicing orthopedic surgeon.
The St. Teresa Medical technology, in addition to its blood-clotting applications, also stops leaking spinal fluid (Cranial Spinal Fluid leaks – "CSF leaks"). Whether created intentionally or accidentally by a surgeon, persistent CSF leaks are a major clinical problem. Persistent CSF leakage can prolong surgical time, cause excessive bleeding, cause persistent headaches and neurological injury. It can also allow infection to enter the nervous system, prolong hospitalization and can lead to complications that can result in death.
The STM technology effectively seals dural injuries in 3 minutes, 80-100% of the time, without adjunctive suture material. Based on the pre-clinical data developed to date, this may be a solution to a vexing clinical problem.
The paper titled, "Use of a Novel Fibrin Dressing on Cerebrospinal Fluid Leaks", demonstrated the technology was highly effective in stopping CSF leaks in dural injuries in the lumbar spine region. The pre-clinical subject animals were survived for 30 days, at which time the injuries were pressurized at super-physiologic pressure (200 mg/Hg) without any further CSF leakage. Histopathology did not demonstrate any residual dressing material or abnormal fibrosis. This feasibility effort determined whether or not further investigation was warranted, which it was.
The second paper presented, titled, "A Novel Fibrin Dressing Stops CSF Leaks in an Ovine Craniotomy Model", subjected the dressing to a more rigorous application, and introduced a control using sutures, which is the standard of care for closure of dural lacerations. A total of 23 injuries were made in the cranial dura of 6 sheep. Suture controlled the leak in only 3 durotomies (13%), while the St. Teresa Medical technology controlled the leak in 20/20 injuries (100%).
About St. Teresa Medical
St. Teresa Medical, Inc.®, based in Eagan, Minnesota, is a biomedical-device company developing and commercializing a new unique dissolvable hemostatic dressing, SURGICLOT®, for use in treating cancellous bone bleeding. SURGICLOT® is fabricated from electro-spun dextran nano- fibers infused with human-sourced fibrinogen and thrombin. SURGICLOT®is the only blood-clotting technology with a rapidly dissolvable delivery mechanism, enhancing the body's natural clotting mechanism. The dextran nano-fibers dissolve 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. The St. Teresa Medical technology may also be applicable to stopping leakage of cranial spinal fluid ("CSF").
For more information, see www.StTeresaMedical.com or contact Brian Jackson, CFO at 651-789-4633.
SOURCE St. Teresa Medical, Inc.
EAGAN, Minn., Sept. 7, 2017 /PRNewswire-USNewswire/ -- Today, St. Teresa Medical, Inc® and Orb Orthopedics Ltd. in Auckland New Zealand, which is St. Teresa Medical's exclusive distributor, announced the first commercial use of its novel hemostatic fibrin-based surgical dressing – SURGICLOT®. Dr. John Ferguson, an internationally renowned spine surgeon from Auckland, New Zealand was the first surgeon to use SURGICLOT® commercially. Dr. Ferguson was performing an elective two-level posterior lumbar spine fusion on a patient at Ascot Hospital in Auckland. Upon completion of the surgery, Dr. Ferguson made the following observations on SURGICLOT® and its successful clinical usage in this procedure.
After his first application on bleeding cancellous bone, Dr. Ferguson was asked how he would characterize the bleeding, he said, "There is none. It's pretty darned dry, really." As the surgery continued, he said, "It is amazing how quickly SURGICLOT® is disappearing on contact with the blood. You can see it disappearing right before your eyes." Later he was asked about whether the dextran nanofiber carrier dissolved, he said, "Yes, it's gone. It's completely gone."
While closing the surgery site, he said, "There is no blood coming out of the wound. Normally, the blood is welling at this point. But, with SURGICLOT® there is nothing coming out of the wound at all. Sometimes in these surgeries I will need to put a drain in the wound. Today, I don't need one."
Visualization during Surgery
Regarding the clot several minutes later he said, "It's translucent enough that you can see through it. You can visualize a plane between the SURGICLOT® and the tissues so you can continue your work."
Comparison to Competing Technologies
During the procedure Dr. Ferguson used SURGICLOT® on one side of the surgical site and his standard method of hemostasis on the other. When asked to compare the two, he said, "It's quite nice looking at the contrast between the two sides. The only blood that is present on the SURGICLOT® side is arriving from the other side that is still bleeding."
He also said, "You can't use the other technology like this." "It contains collagen, and can't be left in the body near the spinal cord because it swells in contact with blood and that causes a paralysis risk." So, you must pluck it out before closing and then the wound re-bleeds. The fact of the matter is that with SURGICLOT® you can suction clean the surgical site so you can see your dura and know that the spinal cord is ok, and then you can close without having to pluck it out and making it bleed again."
About St. Teresa
St. Teresa Medical, Inc.®, based in Eagan, Minnesota., is a biomedical-device company developing a unique dissolvable hemostatic dressing called SURGICLOT® for use in treating cancellous bone bleeding. SURGICLOT® is fabricated from electro-spun dextran nano-fibers infused with human-sourced fibrinogen and thrombin. SURGICLOT® is the only blood-clotting technology with a rapidly dissolvable delivery mechanism, enhancing the body's natural clotting mechanism. The dextran nano-fibers dissolve 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.
For more information, see www.StTeresaMedical.com. For more information, contact Brian Jackson, CFO at 651-789-4633.
SOURCE St. Teresa Medical, Inc.
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.