Arsenal Medical Inc.

Watertown, MA, United States

Arsenal Medical Inc.

Watertown, MA, United States
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Patent
Arsenal Medical Inc., Zugates, Lomakin, Mortensen, Groom, Marini and Webber | Date: 2017-08-02

In various aspects, present disclosure is directed to methods, devices and systems whereby one or more low viscosity fluids may be introduced into a catheter and whereby the one or more low viscosity fluids may be converted into a high viscosity fluid in the catheter, which high viscosity fluid may be delivered from an exit port of the catheter.


News Article | June 5, 2017
Site: www.prweb.com

Arsenal Medical announces today that they have received unconditional IDE approval from FDA to conduct a clinical study to examine the safety and effectiveness of ResQFoamTM, a self-expanding material for the treatment of severe internal bleeding in trauma patients. This study will take place in trauma centers throughout the United States and is supported by funding from the US Army Medical Research and Materiel Command (USAMRMC). The study is designed to support ultimate product approval in the United States. ResQFoam is a biocompatible, self-expanding biomaterial, designed to be administered at the point of injury to stop massive blood loss in patients suffering from life-threatening abdominal trauma. The material fills and conforms to the abdominal cavity to control bleeding before being removed at the time of surgery. ResQFoam may provide a life-saving bridge to surgical care for those who may otherwise die before reaching surgical care, both in civilian and military settings. Abdominal bleeding accounts for the majority of preventable fatalities in injured warfighters. “Many patients and military personnel with massive abdominal bleeding will die before they reach surgical care,” said Dr. David King, the Principal Investigator for the study, a trauma surgeon at Massachusetts General Hospital, and a Lieutenant Colonel in the US Army. “Quickly stabilizing these patients can substantially increase their chances of survival.” As a trauma surgeon in the army, Dr. King has served multiple tours of duty in Iraq and Afghanistan. He and his research team have collaborated with Arsenal Medical on the development of ResQFoam. The pre-clinical data on the ResQFoam device has been described in more than ten peer-reviewed manuscripts and at several national trauma conferences. After review of this data, the Food and Drug Administration approved an investigational device exemption (IDE) enabling clinical study of ResQFoam in severely injured trauma patients. The study will be conducted at multiple trauma centers throughout the United States. “Even in our most capable hospitals, almost half of the patients with severe abdominal trauma die before reaching the operating room,” said King. “By conducting the clinical study in these hospitals, we can obtain robust data on the safety and effectiveness of ResQFoam.” “A clinical study of ResQFoam has the potential to save lives while obtaining critical data on the safety and effectiveness of the device.” said Dr. Upma Sharma, Program Director for the USAMRMC contract and Vice President of Research and Development at Arsenal Medical. “This clinical study is the next critical step to an FDA approval, which will enable the use of this device to save patients with injuries who might otherwise die prior to reaching surgical care.” About Arsenal Medical Arsenal Medical is a privately held life sciences company developing advanced biomaterials to improve medical care. The company is advancing multiple therapeutic programs based on its proprietary therapeutic foam technology in trauma and cardiovascular medicine. Arsenal Medical’s investors include Polaris Partners, North Bridge Venture Partners and Intersouth Partners. About USAMRMC The U.S. Army Medical Research and Materiel Command (USAMRMC) is responsible for medical research, development, acquisition, and logistics management for the Army. USAMRMC supports research, development, contracting, and strategic logistics in fields including infectious diseases, combat casualty care, military operational medicine, medical chemical and biological defense, and clinical and rehabilitative medicine. USAMRMC has funded the advanced development of ResQFoam through a contract awarded in 2015.


Patent
Arsenal Medical Inc. | Date: 2012-06-28

Medical implants and methods useful in treating postpartum hemorrhage are disclosed. The implants, in some embodiments, comprise polyurethane foams having advantageous mechanical and other properties selected to promote hemostasis when brought in contact with an inner wall of a uterus. Methods of making and deploying such implants are also disclosed.


Patent
Arsenal Medical Inc. | Date: 2012-01-31

Devices and methods for high-throughput manufacture of concentrically layered nanoscale and microscale fibers by electrospinning are disclosed. The devices include a hollow tube having a lengthwise slit through which a core material can flow, and can be configured to permit introduction of sheath material at multiple sites of Taylor cone formation.


Patent
Arsenal Medical Inc. | Date: 2015-01-23

According to one aspect of the invention, multicomponent fiber comprising (a) a polymeric core that comprises a core-forming polymer and (b) a polymeric sheath that comprises a hydrophilic polymer, wherein the core-forming fiber is more hydrophobic than the hydrophilic polymer and wherein the polymeric core, the polymeric sheath, or both, further comprises a hydrophilic excipient material. Other aspects of the present invention pertain to methods of forming such multicomponent fibers. Still other aspects of the present invention pertain to meshes and other articles that are formed using the multicomponent fibers.


Patent
Arsenal Medical Inc. | Date: 2012-06-25

Systems, methods and kits relating to in-situ forming polymer foams for the treatment of aneurysms are disclosed. The systems include an insertable medical device and an in-situ forming foam that is formed from a polymer that reacts in an aqueous environment. When used to treat an aneurysm, the foam is placed into contact with at least a portion of an exterior surface of the medical device and/or the tissue surface of the aneurysm.


Patent
Arsenal Medical Inc. | Date: 2011-08-12

Systems and methods related to polymer foams are generally described. Some embodiments relate to compositions and methods for the preparation of polymer foams, and methods for using the polymer foams. The polymer foams can be applied to a body cavity and placed in contact with, for example, tissue, injured tissue, internal organs, etc. In some embodiments, the polymer foams can be formed within a body cavity (i.e., in situ foam formation). In addition, the foamed polymers may be capable of exerting a pressure on an internal surface of a body cavity and preventing or limiting movement of a bodily fluid (e.g., blood, etc.).


Patent
Arsenal Medical Inc. | Date: 2011-02-22

Disclosed is a self-expanding medical implant for placement within a lumen of a patient. The implant comprises a woven or non-woven structure having a substantially tubular configuration, and is designed to be low-profile such that it is deliverable with a small diameter catheter. The implant has a high recoverability and desired mechanical properties.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 227.67K | Year: 2016

DESCRIPTION provided by applicant Significance Traumatic pelvic bleeding is a significant cause of morbidity and mortality and many patients die from potentially survivable injuries These injuries claim up to lives every year in the United States This fact highlights an emergent need for innovative technologies to control bleeding in the most severely injured patients Approach This FastTrack SBIR application will develop novel self expanding polyurethane foam systems for treatment of exsanguinating pelvic hemorrhage In Phase I of the proposal Arsenal Medical will collaborate with Massachusetts General Hospital MGH to create a novel clinically relevant animal model of pelvic hemorrhage A trimodal approach incorporating vascular injury soft tissue injury and tissue disruption will be utilized To estabish baseline performance and areas for optimization existing treatments will be tested including Arsenal Medicalandapos s ResQFoam technology designed for intraabdominal use In Phase II of the proposal a foam will be developed for efficacy and removal in the pelvic space by modulating open cell microstructure and improving foam mechanical properties tensile strength elasticity of the polyurethane struts The appropriate dose of this self expanding foam for effectiveness in pelvic bleeding will be determined through a dose ranging study The net result will be an effective biomaterial intervention for treatment of pelvic bleeding After optimizing the foam a comprehensive physiological study of ischemia reperfusion dynamics will be conducted Phase II will culminate in the preparation of a preliminary regulatory submission to the FDA Innovation The trauma community lacks a robust animal model for the assessment of therapeutics surgical approaches and devices for the treatment of pelvic hemorrhage Establishing this animal model as well as critical research in ischemia reperfusion injuries will provide substantial benefit to the trauma community Self expanding foam treatment will be effectively developed for clinical use in retroperitoneal pelvic bleeding based on the aims of this proposal resulting i a new life saving therapy An established productive interdisciplinary team established regulatory pathway and existing manufacturing infrastructure increase the probability of success and commercialization of self expanding foams for pelvic trauma The proposed research will develop the first closed cavity lethal model of pelvic exsanguination and create a minimally invasive foam platform for pelvic hemostasis that will be superior to the existing standard of care PUBLIC HEALTH RELEVANCE The goal of this SBIR proposal is to develop a novel animal model for exsanguinating pelvic hemorrhage and develop a self expanding polyurethane foam system to treat this injury This project will advance basic science and will lead to the development o a novel lifesaving clinical device


Patent
Arsenal Medical Inc. | Date: 2012-02-09

Disclosed is a self-expanding medical implant for placement within a lumen of a patient. The implant comprises a woven or non-woven structure having a substantially tubular configuration, and is designed to be low-profile such that it is deliverable with a small diameter catheter. The implant has a high recoverability and desired mechanical properties.

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