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June 2024 Notice of intent received for a new NIH SBIR Phase I award on hydrogen sulfide delivery device.

May 2024 Abstract submitted for presentation at the Hypertension 2024 meeting on “Transcutaneous Hydrogen Sulfide Measurement as a way to Evaluate Skin Blood Flow.”

May 2024 Abstract submitted to the AIChE 2024 Annual Meeting entitled “An in-Situ Hydrogen Sulfide Synthesis and Delivery Technique for Treatment and Healing of Chronic Wounds.”

April 2024 FDA Q-Sub meeting to discuss and receive guidance on its TAGS™ technology regulatory pathway.

February 2024 First office action received on “Hydrogen Sulfide Delivery Device” patent application, PCT/US2023/077974.

October 2023 New patent filed on “Hydrogen Sulfide Delivery Device”, PCT/US2023/077974.

August 2023 Exhalix awarded SBIR Phase II funding for topical application of its HEALS™ technology.

June 2023 New publication on clinical results of TAGS™ appeared in the Journal of Vascular Surgery Cases, Innovations, and Techniques: New Techniques, Lower Extremity Chronic Arterial Disease, Volume 9, Issue 2: https://www.jvscit.org/article/S2468-4287(23)00010-2/fulltext.

February 2023 European Patent No. 3242596 issued for TAGS technology.

October 2022 Exhalix filed a patent application # 63/420454 in the U.S. on ReLIS™/HEALS™ with the USPTO.

September 2022 Publication on early clinical results of TAGS appeared in the Journal of Sensing and Bio-Sensing Research, https://www.sciencedirect.com/science/article/pii/S2214180422000526.

August 2022 Exhalix received a Phase I SBIR grant from National Institute of Aging to develop and test in collaboration with the UNM School of Medicine a prototype of ReLIS for at-risk surgical wound therapy.

July 2022 Exhalix received EU approval of its patent on TAGS.

June 2022 Exhalix received notification of funding from the National Heart Lung and Blood Institute Commercialization Readiness Pilot (CRP) program to further advance TAGS productization and clinical trials in collaboration with the UNM School of Medicine for application in diagnosis of peripheral artery disease.

June 2021 Exhalix received a Phase I SBIR grant from National Institute of General Medical Sciences to develop and test in collaboration with the UNM School of Medicine a prototype of the HEALS technology for treatment of hard-to-heal chronic wounds.

December 2020 Exhalix granted US Patent # 10,856,790 on “Transdermal Sampling Strip and Method for Analyzing Transdermally Emitted Gases.” https://patents.google.com/patent/US20210068719A1/en

Learn More

Roles of H2S in Microvascular Functions

There is already extensive knowledge of the role of H2S as an endogenously-produced signaling molecule and its beneficial endothelial functions [6,7]. It is synthesized by the action of the cysthathionine γ-lyase (CSE) enzyme [8-10], and its physiological benefits include regulation of inflammation, angiogenesis, vasodilation, cytoprotection, modulation of cell death and apoptosis [11-13]. Significant evidence from animal and human subject studies links reduced levels of H2S to diabetes [11], resulting in diminished vascular endothelial growth factor (VEGF) among other factors critical to angiogenesis and tissue regeneration [14]. Systemic restoration of H2S levels demonstrate marked improvement in VEGF expression, increased levels of tissue granulation and faster healing [15].

Roles of H2S in Microvascular Functions

There is already extensive knowledge of the role of H2S as an endogenously-produced signaling molecule and its beneficial endothelial functions [6,7]. It is synthesized by the action of the cysthathionine γ-lyase (CSE) enzyme [8-10], and its physiological benefits include regulation of inflammation, angiogenesis, vasodilation, cytoprotection, modulation of cell death and apoptosis [11-13]. Significant evidence from animal and human subject studies links reduced levels of H2S to diabetes [11], resulting in diminished vascular endothelial growth factor (VEGF) among other factors critical to angiogenesis and tissue regeneration [14]. Systemic restoration of H2S levels demonstrate marked improvement in VEGF expression, increased levels of tissue granulation and faster healing [15].

Additional Information

1. B. Matheson, R. Osofsky, D. Friedrichsen, B. Brooks, J. Giacolone, M. Khotan, R. Shekarriz, V. S. Pankratz, E. J. Lew, R. Clark and N. Kanagy., “A Novel, Microvascular Evaluation Method and Device for Early Diagnosis of Peripheral Artery Disease (PAD) and Chronic Limb Threatening Ischemia (CLTI) in Individuals with Diabetes,” J. Vasc Surg Cases and Innov Tech, vol. 9, no. 2, pp. 1-10, 2023. Read Here

    2. S. Virani, A. Alonso, E. Benjamin, M. Bittencourt, C. Callaway, A. Carson and e. al., “Heart disease and stroke statistics—2020 update: a report from the American Heart Association,” Circulation, vol. 141, no. 9, pp. e139-e596, 2020. Read Here

      3. CDC, “Peripheral Arterial Disease (PAD),” 8 September 2020. [Online] Read Here

      4. A. C. Salisbury and D. J. Cohen, “Economic Analysis in Peripheral Artery Disease,” Endovascular Today, vol. 15, no. 10, pp. 53-57, 2016. Read Here

        5. C. Walker, “THE SAGE GROUP Releases New Estimates for the United States Prevalence and Incidence of Peripheral Artery Disease (PAD) and Critical Limb Ischemia (CLI),” Vascular Disease Management, 25 October 2016. [Online] Read Here [Accessed 15 February 2021].

          6. J. A. Barnes, M. A. Eid, M. A. Creager and P. P. Goodney, “Epidemiology and Risk of Amputation in Patients With Diabetes Mellitus and Peripheral Artery Disease,” Arteriosclerosis, Thrombosis, and Vascular Biology, vol. 40, pp. 1808-1817, 2020. Read Here

            7. H. Kimura, “Production and physiological effects of hydrogen sulfide,” Antioxid Redox Signal, vol. 20, no. 5, pp. 783-793, 2014. Read Here

              8. R. Wang, “Physiological implications of hydrogen sulfide: a whiff exploration that blossomed,” Physiol Rev, vol. 92, pp. 791-896, 2012. Read Here

                9. L. Li, P. Rose and P. K. Moore, “Hydrogen sulfide and cell signaling,” Annu Rev Pharmacol Toxicol , vol. 51, pp. 169-187, 2011. Read Here

                  10. A. K. Mustafa, M. M. Gadalla and S. H. Snyder, “Signaling by Gasotransmitters,” Sci Signal , vol. 2, no. 68, p. re2, 2009. Read Here

                    11. J. Wallace and R. Wang, “Hydrogen sulfide-based therapeutics: exploiting a unique but ubiquitous gasotransmitter,” Nature Rev Drug Discov, vol. 14, pp. 329-345, 2015. Read Here

                      12. J. Candela, M. Baker and T. Koch, “Is Hydrogen Sulfide The Missing Link In Diabetic Wound Care?,” Podiatry Today, vol. 33, no. 8, 2020. [Online] Read Here

                        13. A. R. Jensen, N. A. Drucker, S. Khaneki, M. J. Ferkowicz, M. C. Yoder, E. R. DeLeon, K. R. Olson and T. A. Markel, “Hydrogen Sulfide: A Potential Novel Therapy for the Treatment of Ischemia,” Shock, vol. 48, no. 5, pp. 511-524, 2017. Read Here

                          14. J. L. Wallace, G. P. Ferraz and M. N. Muscara, “Hydrogen Sulfide: An Endogenous Mediator of Resolution of Inflammation and Injury,” Antioxidants & Redox Signaling, vol. 17, no. 1, pp. 58-67, 2012. Read Here

                            15. N. Kanagy, C. Szabo and A. Papapetropoulos, “Vascular Biology of Hydrogen Sulfide,” Am J Physiol Cell Physiol, vol. 312, p. C537–C549, 2017. Read Here

                              16. G. Wang, W. Li, Q. Chen, Y. Jiang, X. Lu and X. Zhao, “Hydrogen sulfide accelerates wound healing in diabetic rats,” Int J Clin Exp Pathol, vol. 8, no. 5, pp. 5097-5104, 2015. Read Here

                                17. D. J. Lefer, “A new gaseous signaling molecule emerges: cardioprotective role of hydrogen sulfide,” Proc. Natl. Acad. Sci., 2007 Nov 13;104(46):17907-8. Read Here

                                  18. B. L. Predmore, D. J. Lefer, and G. Gojon, “Hydrogen Sulfide in Biochemistry and Medicine,” Antioxid Redox Signal. 2012 Jul 1; 17(1): 119–140. Read Here

                                    19. Y. Han, Q. Shang, J. Yao, and Y. Ji, “Hydrogen sulfide: a gaseous signaling molecule modulates tissue homeostasis: implications in ophthalmic diseases,” Cell Death & Disease, 2019, V 10, No. 293. Read Here

                                      20. S. A. Coavoy-Sánchez, S. K. P. Costa, M. N. Muscará, “Hydrogen sulfide and dermatological diseases,” Br J Pharmacol, 2020 Feb;177(4):857-865. Read Here

                                        21. Y. Zhang, Z.-H. Tang, Z.g Ren, S.-L. Qu, M.-H. Liu, L.-S. Liu, Z.-S. Jiang, “Hydrogen Sulfide, the Next Potent Preventive and Therapeutic Agent in Aging and Age-Associated Diseases,” Molecular and Cellular Biology, 2013, Volume 33 Number 6, pp. 1104 –1113. Read Here

                                          Disclaimer

                                          The research results provided in this website are produced by grants supported by the National Heart, Lung, And Blood Institute of the National Institutes of Health under SBIR Award HL121871-01 through -04. The content is solely the responsibility of Exhalix and does not necessarily represent the official views of the National Institutes of Health. The research is conducted following Financial Conflict of Interest (FCOI) policy provided in the attached document.

                                          CAUTION: TAGS™ is an investigational device. Limited by Federal law to investigational use.

                                          TAGS™, HEALS™, and ReLIS™ are trademarks of Exhalix, LLC.