Sealonix, Inc. is a privately held company based in Bedford, MA that is focused on the development and commercialization of hemostatic sealants using its proprietary biomaterials. The company, founded in January 2023, is the latest by serial entrepreneur Amar Sawhney, PhD who also founded Confluent Surgical (acquired by Tyco International), Ocular Therapeutix (IPO), Augmenix (acquired by Boston Scientific), Instylla, Pramand, and Rejoni among others. Dr. Sawhney is supported by a team that has collectively launched over a dozen hydrogel-based medical devices and products.
Medical advancements are helping people live longer, survive previously incurable diseases, and thrive despite having one or more chronic conditions. A consequence of these advancements is that surgical procedures have become more common and the patients being operated on are frailer and may have comorbidities. Hemostatic agents for controlling surgical bleeding have failed to keep up with patient needs, leading to a higher failure rate and increased risk of post-surgical complications. This in turn leads to higher material costs, increased surgery time, and a higher rate of patient mortality and morbidity.
Sealonix is developing the next generation of hemostatic agents using its proprietary biomaterials. These biomaterials have been successfully used for decades in other medical applications including for cranial, spinal, urological, vascular, and ophthalmologic procedures; these products have helped over 10 million patients achieve better health outcomes. The initial product that Sealonix is developing is a sealant patch providing rapid hemostasis for abdominopelvic procedures.
The PramStat patch is an experimental medical device designed to stop bleeding during surgery when other methods to control bleeding like suturing don’t, won’t, or can’t be used.
This study is being performed to learn whether the PramStat patch is as safe and effective as another commercially available hemostatic agent in stopping bleeding that occurs during abdominopelvic surgery. The results of this study will help regulatory bodies like the FDA determine if the PramStat patch should be approved for use in the general population. In this study, for every two patients that are assigned to receive the PramStat patch, one patient will be assigned to receive a commercially available hemostat product.
You may be eligible for this study if you are scheduled for abdominopelvic surgery, are 21 years of age or older, and meet other specific requirements for study participation.
You and/or your insurance company will be billed for the costs of the procedures in the study in the hospital and the follow-up visit, which are normal and standard medical practice for someone undergoing an abdominopelvic procedure. Tests and procedures required specifically for this study that will not be covered by your medical insurance will be paid for by Sealonix. You will need to pay for any copays and medicines you are prescribed for any other medical conditions not related to the study procedures.
If you have additional questions, please contact the surgeon or medical provider who told you about this study.
Sealonix, Inc.
These statements have not been evaluated by the Food and Drug Administration.
CAUTION – Investigational device. Limited by Federal (USA) Law to investigational use.
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PRA-MKT-0008 Rev. A
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