gel-e news

Gaithersburg, Md., June 18, 2019 - gel-e Inc., announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its first internal-use flowable device.

gel-e is developing a line of advanced hemostatic and wound treatment products that address unmet needs from the operating room to the backyard.  Following previous clearances for topical and external use of its platform technology (see http://www.gel-e.co/news.html), the Company is now expanding its label to include use for internal and surgical applications.  The first product, now on an accelerated path as a Breakthrough Device, is an expanding injectable hemostat, Life Foam™.   Life Foam can rapidly provide temporary control of bleeding from non-compressible abdominal wounds that are not amenable to tourniquet application in trauma and battlefield conditions.  As the tradename suggests, this product is designed to save the lives of those injured in battle, or that are the victims of traumatic accidents or even terrorist attacks.

Trauma from accidents is the third leading cause of death in the US after only heart disease and cancer (see https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm).  Approximately 85% of all hemorrhage-related deaths result from non-compressible internal bleeding, a condition that results from intracavitary (e.g. abdominal) bleeding that is not accessible to direct pressure and cannot be controlled by traditional methods, such as gauze or a tourniquet.  Life Foam is designed to dramatically expand once it is delivered into the abdominal cavity where it can seek out the cause of bleeding to rapidly and reliably stabilize the patient or wounded warrior.  Once complete, this allows the injured safe passage to a trained trauma surgeon who can repair the damage in a controlled surgical environment, reducing the risks of loss of life or limb. Life Foam is currently in pre-clinical development for the treatment of patients with injuries sustained in battlefield conditions or where life-threatening internal bleeding occurs away from immediate urgent care.

To qualify as a Breakthrough product, a medical device must provide more effective treatment of a life-threatening or irreversibly debilitating condition, and (i) have no approved or cleared alternatives, or (ii) offer significant advantages over existing alternatives, or (iii) be in the best interest of patients.  gel-e provided the Agency with information demonstrating that Life Foam meets all these criteria.  The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to important breakthrough medical devices by accelerating their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.

“Receiving Breakthrough Device Designation is an important milestone in accelerating the development and clinical implementation of Life Foam, which holds so much potential to save lives on the battlefield and in treating traumatic injuries.,” said Dr. Matthew Dowling, Chief Scientific Officer of gel-e. “We look forward to collaborating with the FDA to hasten the clinical development of Life Foam so that it can be used to treat a condition which is otherwise is often deadly or disabling.”

Life Foam is just one of the products gel-e plans to develop for internal and surgical applications, all of which will be based on a technology platform that enhances the adhesive characteristics of abundant and inexpensive natural biopolymers.  Through proprietary modifications, these advanced materials can be designed to be durable, biocompatible, bioresorbable and highly functional. The versatility of gel-e’s approach allows the development and commercialization of easy-to-use products for internal application, including both open and minimally invasive (e.g. laparoscopic) surgical procedures.  Learn more about Surgical gel-e™ and other tools being developed for advanced hemostatic applications by visiting http://www.gel-e.co/products/.

April 3, 2019 - gel-e announces publication of recent study results in the Journal of Surgical Research entitled “Expanding Hydrophobically-Modified Chitosan Foam for Internal Surgical Hemostasis:Safety Evaluation in a Murine Model.” The paper describes the successful use of a flowable hemostatic product in a standard surgical injury model, followed by 6 weeks of observation; see the article here via Science Direct.

The study, led by researchers at the Regenerative Bioscience Center at the University of Georgia, involved delivery of a high dose of hydrophobically-modified chitosan (HM-CS) foam into the abdomen of a rat after a nonlethal liver excision. The HM-CS group (n = 16), was compared to a commercial fibrin sealant, Tisseel® (n =16), an unmodified chitosan formulation (n =16) and no treatment controls (n = 16). In each cohort, half of the animals were evaluated at 1 week, while the balance of the cohorts were evaluated at 6 weeks, all via gross necropsy (upon sacrifice) and histopathology. All subjects treated with HM-CS in the study achieved rapid hemostasis and went on to survive to their designated endpoints with no clinical signs of morbidity or mortality. There was almost complete reabsorption of the HM-CS material at the 1-week timepoint. These results suggest that certain formulations of gel-e may be effective during routine surgical applications, especially where flowable formats are most useful.

“These results from an in vivo survival study are significant, demonstrating the capability of gel-e’s core material” said Dr. Grant Bochicchio, MD, Clinical Advisory Board member at gel-e and Chief of Acute and Critical Care Surgery at Washington University in St Louis School of Medicine. “With any new biomaterial, there is always a risk to leave foreign substances inside the body to degrade over extended periods. This study provides a foundation from which to build an internal surgical hemostat that may not require compression and can be safely left behind without risk of post-surgical complications.”

gel-e is developing a line of high-performance surgical products based on a technology platform which enhances the adhesive characteristics of abundant and inexpensive natural polysaccharides. Through proprietary modifications, advanced biopolymers can be designed that are durable, biocompatible, bioresorbable and highly functional. The versatility of gel-e’s approach allows our products to be delivered to the OR for open, or laparoscopic procedures and even incorporated, or coated onto, complimentary product platforms. You can learn more about surgical gel-e and other tools being developed for advanced hemostatic applications by visiting our products page.

January 21, 2019 - gel-e Expands Patent Estate

gel-e announces the issuance of United States Patent Number 10,179,145 by the U.S. Patent and Trademark Office, which broadly claims and discloses uses of the Company’s core technology.

This new issuance expands the Company’s patent estate which covers bandages, gels, foams, and powders for the treatment of wounds and the rapid management of bleeding. This intellectual property, in combination with gel-e’s deep process know-how, protects a broad range of products designed to enable effective hemostasis (the process which causes bleeding to stop) through easy-to-use applications for professional healthcare providers, caregivers, and consumers. This new patent covers the use of gel-e’s core technology, that has been integrated into the Company’s currently cleared products - Vascular gel-e and gele FLEX. See http://www.gel-e.co/products.html.

“These claims provide the next level of exclusivity around our technology, further protecting our platform and growing line of products,” said Larry Tiffany, Chief Executive Officer of gel-e. “These intellectual property rights are a significant next step in the evolution of our patent estate, and quite timely given our plans to commercialize Vascular gel-e and gel-e FLEX products for clinical and consumer applications.” gel-e’s line of high-performance products is enabled by a technology platform which enhances the natural characteristics of highly abundant polysaccharides. Through proprietary modifications, our advanced biopolymers are designed to be durable, biocompatible, and highly functional, such that it can also be infused into, or onto, market leading products to improve their hemostatic performance.

Nov 27, 2018 - gel-e will be presenting at the MedTechStrategist Innovation Summit at The Hyatt Regency in Burlingame, CA along with several other life sciences companies from around the US. To register and attend the event, go here.

September 20, 2018 - gel-e will be presenting today at @MAVACapCon’s #TechBUZZ2018 at The Hotel at the University of Maryland along with several other companies, from start-ups to Fortune 500's. To register and attend the event, go here.

June 29, 2018 - gel-e expands its OTC label

gel-e Inc., announces the 510(k) clearance of gel-e FLEX by the U.S. Food and Drug Administration (FDA) for the over-the-counter (OTC) use of its first flowable hemostat.

This new clearance expands the Company's label that now includes the use of gels and bandages in the local management of bleeding, such as lacerations and minor bleeding. These products are specifically designed to create rapid hemostasis through easy-to-use applications for professional healthcare providers, parents, coaches, adult caregivers and even patients themselves. gel-e FLEX also complements the Company's already FDA cleared vascular closure device, Vascular gel-e®, as it can be worn home by patients to manage any residual bleeding from an out-patient diagnostic or interventional procedure, see http://www.gel-e.co/products.html.

"This clearance is the next step in expanding our OTC product line, and will be a key component of gel-e's 21st Century First Aid Kit™," said Dr. Matthew Dowling Chief Scientific Officer at gel-e. "We are continuing to develop a tool kit that will provide the best possible options for all manner of chronic and acute wounds. The versatility of these flowable and bandage formats represents an important progression towards our next-generation kit and eventually to products that can be used in surgery."

gel-e's line of high-performance first aid products is enabled by a technology platform which enhances the natural characteristics of highly abundant natural polysaccharides. Through proprietary modifications, this advanced biopolymer is designed to be durable, biocompatible, and highly functional. It can also be infused into, or onto, complementary products to improve their hemostatic performance.

You can learn more about our technology, gel-e FLEX and other tools the Company is developing including an overview by Stephen Hawking at http://www.gel-e.co/overview.html.

April 27, 2018 - gel-e recognized by MedTech Daily as one of the 10 hottest medtech startups of 2018. The list includes companies from Silicon Valley, Boston and Europe; we are happy to rep the mid-Atlantic. Read the full article here.

February 19, 2018 - gel-e,Inc. gel-e Receives Grant to Develop New Internal Use Hemostats

gel-e Inc. announces two new grants that support the development of internal use hemostats. gel-e has been awarded a $1.4M grant from the Department of Defense (DoD) through the US Army Medical Research and Material Command (USAMRMC) to develop advanced solutions for prolonged field care. The grant supports the development of an expanding foam hemostat for the treatment of internal non-compressible hemorrhage. Internal non-compressible hemorrhage typically results from being struck by shrapnel or a significant concussive force. As an expansion of gel-e's hemostatic platform (see existing FDA clearances at http://www.gel-e.co/news.html), the Company has been optimizing flowable formulations for internal and surgical use. Consequently, certain product candidates have been identified that can be administered in far-forward locations to quickly stabilize internal injuries, allowing time for evacuation of the wounded to a field surgical OR.

Learn more about gel-e's product pipeline at http://www.gel-e.co/products.html.

“We are honored to be working with our military to develop such an important hemostatic application. This project is a natural extension of our previously published work using flowable formulations, from our biopolymer-based platform, to treat aggressive internal bleeding." said Dr. Matthew Dowling, CSO of gel-e. "It is gratifying to have the DoD recognize our technology platform and support the synergy of this project with the expansion of our product line from the broad treatment of external wounds to those arising from combat.”

“Internal non-compressible hemorrhage remains the single largest cause of in-combat hemorrhage-related death," said Dr. David King, MD, LTC and former Chief, Division of Trauma Surgery, 86th Combat Support Hospital, Baghdad, Iraq. "The evaluation of new approaches, like the one gel-e is using, will be important to improve outcomes for our wounded service men and women, both on and off the battlefield.”

gel-e has also been awarded an expansion of its SBIR Phase II grant, to support additional seminal research into the development of new flowable, internal-use hemostatic formulations. This award by the National Science Foundation, is based on the Company’s previous success as a Phase I and II recipient.

January 9, 2018 - gel-e,Inc., adds Dr. Grant Bochicchio to its Clinical Advisory Board.

gel-e,Inc., a clinical-stage medical device company developing versatile hemostatic products for surgical, medical, and consumer applications, announces the expansion of its Clinical Advisory Board (CAB) to include Dr. Grant Bochicchio, Chief of Acute and Critical Care Surgery at Washington University School of Medicine. The company's progress and proven platform, that includes two US FDA-cleared hemostatic indications, have allowed the Company to continue to attract key talent. Dr. Bochicchio brings significant expertise to gel-e from developing multiple marketed surgical hemostats. His 130 peer reviewed articles and national presentations have been supported by ~$30M in funding from agencies such as DARPA, the Department of Defense and the National Institutes of Health. As the designated Principal Investigator, Dr. Bochicchio has taken several advanced hemostats from the bench to the bedside, including a fibrin sealant patch and a fibrin sealant powder. Dr. Bochicchio joins an impressive advisory board that includes key opinion leaders from Harvard/Mass General and Weill Cornell Medical Center.

"Dr. Bochicchio was involved as an early collaborator in published efficacy studies based on our biopolymer-based platform. More recently, he's worked with us to test new product candidates." said Dr. Matthew Dowling, CSO of gel-e. "It's exciting to have Grant collaborating with our current advisors on this project, adding to gel-e's reservoir of clinical insight and surgical talent to guide, evaluate and validate surgical and other hemostatic products."

Visit www.gel-e.co/team.html to learn more about Dr. Bochicchio's background.

"I'm enthusiastic about joining the gel-e team," said Dr. Bochicchio. "The Company has built a solid scientific and regulatory foundation for external hemostasis and wound treatment and is poised to expand the platform into the surgical suite. I'm looking forward to help the team at gel-e design and evaluate new products that can be integrated into routine surgical practice."

January 2, 2018 - gel-e Presenting at the 10th Annual Biotech Showcase™ 2018 Conference

gel-e Inc. a privately held, clinical-stage medical device company, will be featured as a presenting company at The 10th Annual Biotech Showcase 2018 Conference. The conference is being held on January 8-10, 2018 at the Hilton Union Square in San Francisco, CA. Larry Tiffany, President, and Dr. Matthew Dowling, Chief Scientific Officer, are scheduled to provide a corporate presentation on Tuesday, January 9, 2018 at 9:30 AM PT. Additionally, gel-e will be presenting at the Digital Rx Showcase on Wednesday, January 10, 2018 at 10 AM PT. Mr. Tiffany and Dr. Dowling will be available to meet with investors who are registered to attend the conference. If you are an investor and wish to attend the Company's presentation or schedule a meeting, please click the following link: https://ebdgroup.knect365.com/biotech-showcase/.

December 22, 2017 - gel-e Expands Board of Directors with Domain & Commercial Strategy Expert

gel-e Inc. a privately held, clinical-stage medical device company, announces the expansion of its Board of Directors to include industry veteran Jim Buck.

gel-e's proven platform and continued success is attracting key talent. Chosen for his ability to guide the Company from an early-stage developer of cleared medical devices to becoming a global hemostatic brand, Jim brings highly relevant skillsets, experiences and relationships from over 25 years of working in the medical device field, particularly in the development and commercialization of hemostatic product lines. .

"We're fortunate to have talent the likes of Jim joining our Board, bringing with him experience in developing and commercializing hemostatic devices," said Alexander K. Arrow, MD, CFA, Director of gel-e. "I look forward to serving with him. Currently the President and CEO of Mardil Medical, Jim has a solid history of leadership within successful medical device developers, including St. Jude Medical, InnerPulse and SetPoint Medical. This, coupled with his experience in developing surgical hemostats at Johnson & Johnson's Closure Medical, provides a unique foundation for guiding strategy at gel-e as we expand the use of our platform from treating external to internal hemostatic clinical needs."

You can learn more about Jim's background by visiting www.gel-e.co/team.html.

"I'm enthusiastic about joining the gel-e team," said Buck. "The foundation that exits already at gel-e in technology, intellectual property and regulatory success are the core assets I've watched grow into other similar, now successful, medical device enterprises. Having watched the use of surgical hemostats expand over the past 20 years and with the marked increase in blood thinner prescriptions over the past few years, gel-e has the opportunity to be "the" platform for bleeding control in the operating room and in the backyard."

December 15, 2017 - gel-e receives US FDA clearance to expand its bandage product line for Rx and OTC use

gel-e Inc., a privately held, clinical-stage medical device company, announces the 510(k) clearance of its adhesive bandage by the U.S. Food and Drug Administration (FDA) for prescription (Rx) and over-the-counter (OTC) use.

This new bandage clearance expands the Company’s label to include the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision, this new adhesive bandage may be used for the management of pressure sores, diabetic ulcers, leg ulcers, donor sites and graft sites, surgical wounds, skin abrasions and lacerations, 1st and 2nd degree burns and traumatic wounds. No medical supervision is required for usage in the management of minor cuts, minor scalds and 1st degree burns, and minor abrasions and lacerations. This newly cleared bandage complements gel-e’s existing vascular closure device cleared for the “management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes.”

“This clearance is the next step in expanding our external wound product line, and will be a key component of gel-e's 21st Century First Aid Kit™,” said Elsa Abruzzo, Head of Regulatory at gel-e . “We are developing a tool kit for clinicians and caregivers that will provide the best possible options for all manner of chronic and acute wounds and injuries. This bandage represents just the first tool in the kit.”

gel-e's technology platform harnesses the natural characteristics of an abundant and inexpensive natural polysaccharide. Through proprietary modifications, this advanced biopolymer is designed to be a durable, biocompatible, and highly functional tool for the treatment of human wounds and injuries.

November 15, 2017 - At the MTECH 30th Anniversary Maryland Industrial Partnerships (MIPS) Ceremony held on Nov 7 at The Hotel in College Park, gel-e was granted the University Spinout Company Award, highlighting the company as a standout in a rich history of Maryland-based start-ups based upon University technology. The Company thanks MIPS for early grants related to the gel-e platform, which allowed us to go on to achieve key milestones in our product development pipeline via non-dilutive grant funding.

October 16, 2017 - gel-e will be presentating at the Q3 Ernerging Medical Technologies (EMT) Spotlight event on Friday Oct 20, 2017

September 13, 2017 - gel-e Expands Core Team with Regulatory, Manufacturing and Financial Talent

gel-e Inc. a privately held, clinical-stage medical device company, announces the recent expansion of its core team, adding Elsa Abruzzo as Head of Regulatory, Bruce Choi as Head of Manufacturing, and Rich Vincent as the CFO.

Supported by its recent financing, the Company has been able to attract an experienced and talented group to support key corporate objectives: expanding gel-e’s initial U.S. FDA regulatory clearance to a broader hemostatic product line for the treatment of external wounds, establishing cGMP manufacturing of gel-e's active ingredient, and preparing for the commercialization of its growing product line.

“Elsa, Bruce and Rich have already started making contributions as part of our expanded gel-e team," said Larry Tiffany, President and Director of gel-e "Elsa has been instrumental in designing and implementing our regulatory strategy in order to expand our label claims for a variety of hemostatic products. Integrated into this strategy, Bruce is leading our core team to establish a manufacturing facility using a modular manufacturing approach that will support scale-up while ensuring we meet our quality, productivity and efficiency goals. Rich helped us close the recent equity round, and brings his expertise from many successful West Coast life science start-ups and commercial companies, including raising $650M in private and public financings, most recently for Genoa Pharmaceuticals." To learn more about each of their backgrounds, please visit our team page.

July 13, 2017 - gel-e Secures $3.1 Million Financing

gel-e Inc., announces that it has raised $3.1 million in a private financing, led by early-stage investment funds and life science investors.

The financing allows gel-e to expand its initial U.S. FDA regulatory clearance for the management of bleeding wounds, including vascular access sites (Vascular gel-e®) to a broader hemostatic product line for the treatment of external wounds. In parallel, this funding allows the company to establish cGMP manufacturing of gel-e's active ingredient. If you'd like to learn more visit http://www.gel-e.co.

"gel-e exemplifies an ideal investment for us," said Jim Hughes, Director, UM Ventures. "By strategically deploying grants, gel-e has built an impressive corporate foundation, such as achieving its first regulatory clearance, securing an issued patent estate, and recognition through numerous peer-reviewed publications. We are excited to be a part of this financing that supports the next phase in the company's growth."

gel-e's mission is to develop a broad range of game-changing hemostatic and wound treatment products, including bandages for the treatment of routine cuts and scrapes, foams and putties for traumatic and military injuries, and surgical gels and powders. The path created by Vascular gel-e® facilitates expansion of the company's portfolio, while gaining greater confidence about the platform's safety and efficacy for future indications, including internal surgical use.

Prior to this financing, gel-e was funded by grants from the National Science Foundation (through the SBIR), the United States Army Research Lab, Maryland Industrial Partnerships, and the Technology Development Corporation (TEDCO).

"I've had the chance to apply the technology in a few research studies," said Dr. Mayur Narayan, attending trauma surgeon and Associate Program Director of the Surgical Critical Care Fellowship at Weill Cornell Medical College/ New York Presbyterian Hospital. "These studies involved lethal bleeding in large animal models, where we were able to achieve rapid hemostasis using gel-e hemostats with superior results to competitive products."

February 1, 2017 - New Notice of Trademark Allowance

The USPTO issued a notice of trademark allowance on the name "gel-e," which is at the core of our branding. This allowance continues the build of our intellectual property estate, and we believe it to be an important asset moving forward.

See Trademark Serial Number: 87/045,953

January 15, 2017 - Biz Dev deal signed with the Jai Group

The Jai Group (JG) is a West Coast business development firm with a focus on pharmaceutical and medical device partnerships in Latin America. gel-e and JG just inked a deal through which JG will identify the best Latin American partners for gel-e's currently cleared Vascular Access product as well as future products. JG has an excellent track record of obtaining valuable licensing and distribution partnerships in Latin America for their clients.

September 15, 2016 - New Supplemental Grant from the National Science Foundation

gel-e is the recipient of a supplemental grant to our current SBIR Phase II Award from the National Science Foundation for $100,000. The award, called Small-Business / ERC (Engineering Reserach Center) Collaborative Opportunity (SECO), will go towards evaluating the safety of our chitosan-based foam in internal surgical applications. The Company will collaborate with Dr. Steven Stice who works at the Regenerative Engineering and Medicine Research Center, University of Georgia, where the studies will be conducted. This is an exciting development for our internal surgical research program.