About our project
The Problem we solve:
Chronic pelvic pain and small bowel obstructions after surgery are a significant source of misery for thousands of patients worldwide. Patients typically experience hopelessness, frustration and desperation as they try to find a lasting solution for their pain. Often, these are due to surgical adhesions (bands of scar tissue between internal organs) and are almost an inevitable outcome after surgery. They occur in up to 93% of patients having undergone abdominal or gynecological procedures. In the past year, 542,000 patients experienced adhesions that were so severe that they required adhesiolysis, a surgical procedure to cut away the adhesions. Unfortunately, this surgical procedure can also lead to the formation of new adhesions resulting in a cycle of repeat surgeries, increasing expenses, and extended hospital stays. Some opinion leaders in healthcare have stated that adhesions are the single most common and costly problem related to surgery yet most people have never heard of them. The limitations of current therapies and lack of awareness means that many doctors end up being unable or unwilling to tackle the problem of adhesions and leave many patients to suffer.
Our Solution:
The Sintact Barrier Film™ is a thin biocompatible film that helps separate organs after surgery and prevents the formation of adhesions. It is composed of a non-degrading polymer that has been traditionally deployed as a thin coating on implanted medical devices such as pacemakers and stents for many decades. As a result, the polymer has a long history of safe use in the body. Never before has this polymer been re-purposed as a stand-alone film for the prevention of complications such as surgical adhesions.
How the Sintact Barrier Film™ Works:
After performing a surgery where adhesions are likely to form, the surgeon will place the Sintact Barrier Film™ onto the abdominal wall opposite organs that have been scarred during surgery. Once placed on the wall, the surgeon will suture it into place to prevent migration of the film. After surgery, the film will serve as a permanent physical barrier between scarred surfaces in the body and allow those surfaces to heal, thus preventing the formation of painful adhesions. The permanency of the film ensures protection against adhesions that form months or years after the initial surgery.
Clinical Proof to date:
The polymer has 40+ years of safe clinical use in humans (http://scscoatings.com/docs/brochures/medical_coatings.pdf) and there exists an FDA Drug & Device Master File with our suppliers that demonstrate the safety and biocompatibility of the polymer itself. We have been characterizing the film properties ourselves throughout the PhD work of our inventor and co-founder Dr. Erik Robinson. In his research, we conducted pre-clinical testing in an established rabbit adhesion model. After 1 month of implantation, we evaluated the extent of adhesions using a 4-point grading system and histological evaluation. The results were encouraging and demonstrated that the Sintact Barrier Film™ is very effective in reducing cell attachment, adherence, and scarring. The Sintact Barrier Film™ was able to achieve an overall reduction in surgical adhesions by 86%. Current products on the market achieve a 51% reduction at best in clinical use. The Center for Medicare and Medicaid Services has already acknowledged the value of using an adhesion barrier after surgery and reimburses their use under ICD code 99.77.
FDA Status:
We are preparing for our initial Surgical Mesh indication 510(k) regulatory submission by the end of 2014. After clearance, this submission will be followed by an IDE for first-in-man clinical trials with our clinical collaborators. We are currently working with regulatory consultants who have had relevant experience in this space to navigate the regulatory landscape efficiently. The Sintact Barrier Film™ is currently not approved for sale.
How We Will Help Patients:
Sintact is committed to solving the problem of adhesions for patients like you or loved ones who suffer from this chronic source of pain. We understand the frustration of not being able to do anything to prevent adhesions from occurring or difficulty in easing the chronic pain. Our aim is to provide patients with an ideal solution that actually works to prevent adhesions before they form in the body after a surgical procedure.
How We Will Help Doctors (or Other Care Givers):
Doctors are experiencing a real pain point. They want to provide the best quality of care for their patients and want to help ease their pain but know the odds of adhesion reformation are not in their favor and many products on the market don’t quite live up to their expectations. Patients end up disappointed and seek other alternatives for a solution, some may even travel to other continents for therapy!
The polymers that compose the Sintact Barrier Films™ surfaces are rooted in a long history of safe clinical use. In our re-purposing of this polymer to address the problems of adhesions, our film will soon provide you with an effective tool combat this persistent complication. It’s transparency will assist you in placement and its ability to be deployed in laparoscopic settings easily will serve you well.
How We Will Help Hospitals, Institutions, and/ or Medical Facilities:
By addressing the needs of patients and improving the overall quality of care provided at your facility, everybody wins. Patient satisfaction increases when their needs are being met and readmissions due to adhesion complications will drop. With reimbursement codes already available for adhesion barrier use and similar products currently used in medical facilities worldwide, it will be easier to incorporate the Sintact Barrier Film™ into your workflows to improve the quality of care.
How We Help Our Partners:
The problem of adhesions has been a persistent blight on post-operative surgical recovery for decades. While we are focusing initially on the problem of abdominal adhesions, we’ve got several other plans in the works for expanding our product portfolio and establishing a sustainable platform for future growth. We will help you get in on the ground floor of Sintact Medical, see what is cooking behind the curtain, and begin a dialog to see how we can help each other.
How We Will Spend Your Contributions:
Sintact is gearing up for regulatory 510(k) submission but it is no secret that getting regulatory clearance isn’t cheap. With direct quotes from our entire supply chain, we will use your contributions to manufacture an initial production run of our films, conduct the necessary biocompatibility and sterility process validations for our Quality Systems check in advance of the submission. This testing is necessary for our continued progress towards improving the quality of life for adhesions sufferers.
Who We Are:
Founders
Erik Robinson, PhD, co-founder and CEO LinkedIn
Erik received his PhD in Mechanical Engineering from Northwestern University in 2012. Erik’s dissertation work was based on the development of polymeric films upon which the Sintact Barrier Film™ technology is derived from. He was a participant of the NUvention Medical course and has certificates from the Kellogg School of Management, the Farley Center for Entrepreneurship. He is a certified Leadership Coach, which he received from the Center for Leadership at Northwestern University and a Non-Commissioned Sargeant with the US Army Reserve since 2004.
Gali Baler, PhD, co-founder and COO LinkedIn LinkedIn]
Gali has a Biomedical Engineering PhD from Northwestern University and BS in Materials Science from Cornell University where he first caught the entrepreneurship bug. He has also served as an advisor to the InNUvation program fostering entrepreneurship events and activities at Northwestern University. He is also working as a Medical Device Innovation Fellow and the Center for Device Development at Northwestern.
Erik and Gali met in 2010 while fixing freeze dryer vacuum pump systems during their various research projects and have been friends ever since. They both participated in the NUvention Medical Device entrepreneurship course from the Farley Center for Entrepreneurship in 2011 and the Management for Entrepreneurs and Scientists course from the Kellogg School of Management in 2011. From these courses, they gained an appreciation of the other’s work ethic, passion for medical device entrepreneurship, and leadership capabilities.
Some of our advisors and collaborators include:
James Kelly, MD, MBA, FACS, Former cardiac and thoracic surgeon. Founded a Strategy Consultant and Investment Firm specializing in disruptive medical device technologies, also Medical Director of a Thoracic Oncology Clinic.
Dean Ho, PhD, is a Professor in the Division of Oral Biology and Medicine, Division of Advanced Prosthodontics, Biomaterials, Co-Director of the Weintraub Center for Reconstructive Biotechnology at the UCLA School of Dentistry. Co-inventor of Sintact technology.
David Wiseman, PhD, founder of Synechion, Inc. and International Adhesions Society (IAS). Recognized expert in the science and business of surgical adhesion prevention with 28 years experience. Expertise in preclinical, clinical, regulatory, and marketing aspects of medical products.
Jim Whittle, MBA, General Business Counsel and Managing Director of The Business Resource. High tech business development experience in the pharmaceuticals and medical devices market with specialization in business strategy, multi-channel marketing, supply chain management, portfolio optimization, and product lifecycle management.
Thank you for considering supporting our project on MedStartr. We look forward to your feedback. Please use the comments tab and we will see you there.
Thanks also to HealthTECH Summit for your support of our idea and for selecting us as finalists! See you on October 23rd!
Sincerely,
Erik and Gali
How to Find Us:
Twitter: @sintactmed
Website: www.sintactmed.com"
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