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FemPulse

Dr. Suzette Sutherland, Director of Female Urology, University of Washington School of Medicine, presented the results of the FemPulse in-home study completed at three centers, in a video podium presentation at the American Urological Association (AUA) Annual Meeting. The presentation titled “Evaluation of a Non-Implanted, Transvaginal, Electrical Stimulation Continence Device for Overactive Bladder: EVANESCE-OAB” concluded, “In a controlled clinical trial, the wearable FemPulse neuromodulation device is safe, comfortable and provides a promising bioelectronic alternative for the treatment of OAB.”

Dr. Suzette Sutherland, Director of Female Urology, University of Washington School of FemPulse Corporation announced today the completion of its Series B financing. The capital will support FemPulse in completing its wireless wearable neuromodulation product for FDA clearance in the US and CE Mark in the European Union, as well as obtaining additional clinical results on the efficacy of the FemPulse solution. New investors joined FemPulse’s existing value-added investor base in completing the round., presented the results of the FemPulse in-home study completed at three centers, in a video podium presentation at the American Urological Association (AUA) Annual Meeting. The presentation titled “Evaluation of a Non-Implanted, Transvaginal, Electrical Stimulation Continence Device for Overactive Bladder: EVANESCE-OAB” concluded, “In a controlled clinical trial, the wearable FemPulse neuromodulation device is safe, comfortable and provides a promising bioelectronic alternative for the treatment of OAB.”

FemPulse Corporation announced its participation in the Entrepreneur Panel I session on bioelectronic medicine in the 2019 Bioelectronic Medicine Forum taking place Thursday, April 4th, in New York City. This is the second annual meeting of the Bioelectronic Medicine Forum, a management and investment conference focused exclusively on the new and emerging bioelectronic medicine industry.

FemPulse Corporation announced enrollment of first patients at each of the centers participating in the Company’s EVANESCE-OAB™ (Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder) U.S. clinical trial. This study will evaluate the treatment of OAB in a home or at-work setting using the Company’s proprietary medical device, the FemPulse System.

The FemPulse clinical results were presented at the American Urology Association (AUA) annual meeting in San Francisco. Dr. Suzette Sutherland, University of Washington, presented that primary objectives regarding fit, comfort and safety were met, as well as positive secondary outcomes regarding patient preference, a reduction in incontinence events and an increase in time between voids.

FemPulse Corporation announced completion in the first quarter of 2018 of a private financing round, which will enable acceleration of the development of its novel and proprietary bioelectronic therapy for overactive bladder (OAB) in females. Proceeds will be used for technical and clinical evidence development in preparation for commercialization of the therapy in the US and EU.

The results of the FemPulse clinical study will be presented at the International Urogynecological Association (IUGA) annual meeting to be held in Vienna, Austria on June 27 – 30, 2018. The invitation provides an opportunity to share the exciting potential of FemPulse with a premier global audience in the field of urogynecology. Dr. Suzette Sutherland, University of Washington, Seattle, will be making the presentation.

Dr. Suzette Sutherland, University of Washington, Seattle has been invited to make a podium presentation of the FemPulse clinical study results at the American Urology Association (AUA) annual meeting to be held in San Francisco on May 18 – 21, 2018. This invitation reflects well on the clinical and scientific merit of the FemPulse study, as well as the innovation of the platform.

FemPulse announced completion of a conversion from its original legal structure, a Limited Liability Company, to a “C” corporation to be known as FemPulse Corporation. This conversion positions the company for accelerating growth and development of its commercial operations. All LLC members converted their member interests into shares in FemPulse Corporation.

FemPulse will be presenting on the status and direction for the Company at the Medical Alley Innovation Summit sponsored in conjunction with The MedTech Strategist. The conference brings the proven format of annual Dublin Innovation Summit to the epicenter of medtech innovation, Minneapolis-St. Paul, MN. The Company is honored to have the opportunity to share its exciting progress and plans with participants.

The 15-subject enrollment level approved for the company-sponsored clinical study has been met. The final subject is expected to complete the multi-day protocol in approximately six weeks. The enrollment limit was reached in just 9 weeks, providing another indication of the tremendous number of women afflicted with OAB and the urgent need for new and innovative therapies for their symptoms of overactive bladder.

The Company is pleased to announce the first enrollment in its clinical evaluation to assess fit, comfort, patient placement and safety of the FemPulse therapy, as well as the potential for improvement in symptoms associated with OAB. The subject, a 69 year old female, was afflicted with urgency and urinary urge incontinence.

FemPulse LLC announces the formation of a formal board of directors (BoD) to help guide the strategic direction for the fast-moving organization. Members of the BoD includes the co-founders, Alexandra Haessler, MD and Peter Fredericks, MBA/PhD, Jeff Korn, Darrin Uecker and Flip Gianos. Peter and Jeff serve as Chariman and Corporate Counsel for the company, respectively. Darrin is CEO of Pulse Bioscience (Nasdaq: PLSE) and brings extensive experience in women’s healthcare having served in CEO/executive roles with Progyny, Gynesonics and Conceptus. Flip is Managing Director at InterWest Partners, a venture capital firm located in Menlo Park, CA, which has raised $2.8 billion, completed 85 IPOs, and participated in over 80 upside acquisitions. Flip brings 35 years of investing and technology platform experience at InterWest.

Metro Urology, St. Paul, MN has received institutional review board approval to become the second center in the clinical study sponsored by the Company. Approval of Metro Urology by the Western IRB (WIRB) allows for the evaluation of this novel therapy in private practice, as well as in the previously approved academic institution. The Company welcomes Dr. Steve Siegel, a world-renowned expert in neuromodulation for OAB, to its ongoing efforts to build clinical evidence.

The Company announced today approval of its first clinical study of its novel, wearable neuromodulation platform for treating overactive bladder (OAB) in females. The Western IRB (WIRB) approved participation of up to 15 subjects in a study assessing fit, patient placement and safety of the FemPulse device, as well as potential for improvement in symptoms associated with OAB. The first center planned to participate in the study is the University of Washington, where Dr. Suzette Sutherland will serve as primary investigator.

Dr. Haessler was invited to present a talk titled, Neuroanatomy of Micturition, at the Neuromodulation: The Science conference. She shared the panel with international thought leaders Drs. de Groat, Grill and Hassouna. In her talk, Dr. Haessler addressed the neuroanatomy and neurophysiology of micturition, and potential mechanisms for neuromodulatory OAB therapy.

The journal, Start Up, featured an interview with Dr. Haessler highlighting her inspiration for the FemPulse system and motivation to create the company.  The article, titled “FemPulse Pioneers on Multiple Fronts”, highlighted that a female device entrepreneur in Silicon Valley is rare.  Dr. Haessler emphasized the importance of her connection with and compassion for her patients.  She described how her role as a sole practitioner gave her a keen awareness of her patients’ experience and frustrations with managing their conditions, and how this deep insight provided the personal drive to make things better.  And being situated near Silicon Valley created the environment where she believed anyone with a great idea could make something of it.  The article closed with a summary of the company’s aspiration to make a significant difference in the lives of women around the world.

FemPulse was featured in the February edition of MedTech Insights in an article titled “Neuromodulation Devices Stimulate Opportunities in Urology”. The article provided a comprehensive assessment of future innovation in the rapidly growing fields of neuromodulation for Overactive Bladder (OAB). While currently marketed devices provide effective therapy, they can be costly, invasive and require a significant time commitment from the patient. FemPulse was cited for its innovation intended to lower barriers to patient acceptance. The article highlights plans by the company to bring this life-changing therapy to millions of women around the world.

FemPulse completed a private financing round to support the company’s clinical, regulatory and R&D objectives. The round, which was oversubscribed, brought in experienced, value-add investors who are expected to contribute to the success of the company.

FemPulse was invited to present during the I3 forum sponsored by the North American Neuromodulation Society. I3, representing Innovation, Investment and Invigoration, provides a fitting context for a presentation regarding this leading edge company. The FemPulse system is a first-of- its-kind wearable neuromodulation system providing discrete, simple and continuous neuromodulation therapy for OAB. Dr. Haessler shared her vision for how “wearable” neuromodulation, such as that being developed by FemPulse, will revolutionize the field and greatly expand access for women around the world to this important therapy.

FemPulse was one of seven companies featured in the 14th annual Neurotech Leaders Forum. This year’s meeting included a day dedicated to the rapidly expanding field of wireless, noninvasive neuromodulation technology. FemPulse is on the forefront of this revolution.

Ben joined the five other medical and medical device experts on the FemPulse Advisory Board, after previously advising the founders informally. Ben is an MIT-educated engineer, who has become a leading medical device executive and innovator in Silicon Valley over the past 30 years. Ben has served as Vice President of product development at Ventritex (implantable defibrillators, acquired by St. Jude Medical), Vice President of R&D for Pacesetter, CTO/COO of NeuroPace (responsive electrical stimulation for epilepsy), and most recently CEO of Autonomic Technologies (neurostimulation for headache). He has served on the boards of numerous medical companies, including Inspire Medical Systems, Angelmed, and Proteus Digital Health. He serves on the board of the recently-launched Neurotechnology Innovations Translator (NIT) formed in collaboration with over a dozen partners, with a mission to develop and commercialize pioneering neurotechnology solutions. Ben is a named inventor on over 100 patents and patent applications.

FemPulse is one of only ten companies from around the world selected to present at the International Neuromodulation Society (INS) “Innovations in Neuromodulation” panel on June 6, 2015 in Montreal. This biennial event is part of INS’s 12th World Congress, featuring the most innovative neuromodulation companies.

Dr. Alexandra Haessler, founder of FemPulse, is presenting the patented FemPulse non-implanted neuromodulation platform, designed as 1st-line therapy for OAB and other indications. Dr. Haessler said: “After three years of building our strong intellectual property and developing our technology, it is a pleasure to present at INS’s biennial conference. Our cost-effective approach to serving women around the world with patient-friendly non-implanted neuromodulation fits well with the Innovation Day focus on value and global patient access.”