Alleviant Medical Closes $75M in Financing; Receives FDA IDE Approval for Pivotal Clinical Trial

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This financing will fund the company’s global pivotal trial, ALLAY-HF (Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure).

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Thursday, January 26, 2023
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Medical Devices, Finance, Venture Capital, FDA, Clinical Trials, Professional Services, Cardiology, Start-Up, General Health, Health, Safety, Heart, Efficacy, IDE, EF, Food, Heart failure with preserved ejection fraction, Investigational device exemption, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Medicine, Heart failure, Quality of life, HF, Investigational New Drug, Medical device, Pharmaceutical industry, Patient
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UNITED STATES, NORTH AMERICA, TEXAS
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ALLEVIANT MEDICAL, ALLEVIANT MEDICAL, INC., S3 VENTURES, RIVERVEST VENTURE PARTNERS, VENSANA CAPITAL, LONGVIEW VENTURES, GILMARTIN CAPITAL, SHANGBAY CAPITAL, TEXAS MEDICAL CENTER VENTURE FUND
Summary
Key Points: 
  • This financing will fund the company’s global pivotal trial, ALLAY-HF (Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure).
  • ALLAY-HF is designed to demonstrate the safety and effectiveness of the Alleviant System for the treatment of heart failure through left atrial decompression.
  • The trial will evaluate the safety and effectiveness of the Alleviant System in chronic heart failure patients with preserved (HFpEF) and mildly reduced (HFmrEF) ejection fraction (EF ≥ 40%) who remain symptomatic despite stable guideline-directed medical therapy.
  • “The Alleviant team is a real force in trailblazing novel solutions for heart failure,” said Brian R. Smith, managing director, S3 Ventures.


Alleviant Medical, Inc., a privately-held medical device company developing a no-implant interatrial shunt for heart failure, today announced the closing of a $75 million equity financing co-led by S3 Ventures and RiverVest Venture Partners. This financing will fund the company’s global pivotal trial, ALLAY-HF (Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure). ALLAY-HF is designed to demonstrate the safety and effectiveness of the Alleviant System for the treatment of heart failure through left atrial decompression.

“Alleviant’s mission is to bring a safe, effective no-implant treatment option to millions of patients suffering from heart failure, and this highly informed study is a critical step forward,” said Adam Berman, CEO of Alleviant Medical. “We could not ask for a stronger group of institutional and strategic healthcare investors as we accelerate our global efforts to bring this technology to patients.”

ALLAY-HF is a global prospective, multicenter, randomized, sham-controlled, double-blinded, adaptive trial. The trial will evaluate the safety and effectiveness of the Alleviant System in chronic heart failure patients with preserved (HFpEF) and mildly reduced (HFmrEF) ejection fraction (EF ≥ 40%) who remain symptomatic despite stable guideline-directed medical therapy. The trial will enroll 400 to 700 patients at select sites worldwide. The trial’s composite primary endpoint analysis will be conducted at one year.

“The Alleviant team is a real force in trailblazing novel solutions for heart failure,” said Brian R. Smith, managing director, S3 Ventures. “The team’s thoughtful approach to the ALLAY-HF trial demonstrates great insight into heart failure modalities and we remain bullish about their long-term prospects.”

“Alleviant Medical is poised to significantly improve the quality of life for millions of heart failure patients for whom there has been a lack of meaningful options,” said Jay Schmelter, managing director, RiverVest Venture Partners. “We are thrilled to be part of a strong investment syndicate supporting Alleviant’s talented, experienced management team as they drive forward this truly innovative technology.”

The Alleviant System, which was granted Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA) in November 2022, has demonstrated significant clinical improvement (functional and symptomatic) in studies across 38 heart failure patients to date. In these studies, shunt durability was confirmed through six months and sustained improvement was observed through 12 months.

S3 Ventures and RiverVest Venture Partners, along with investors Vensana Capital, Longview Ventures, TMC Venture Fund, and a strategic investor are joined by Gilmartin Capital, ShangBay Capital and another undisclosed strategic investor in this new financing round.

About Alleviant Medical, Inc.

Alleviant Medical, Inc. is a medical device company developing a minimally invasive, implant-free device under clinical investigation for the treatment of chronic heart failure. The Alleviant System was granted U.S. FDA Breakthrough Device Designation in 2021. Headquartered in Austin, Texas, Alleviant is a privately held company backed by S3 Ventures, RiverVest Venture Partners, Vensana Capital, Broadview and Longview Ventures, Gilmartin Capital, ShangBay Capital, TMC Venture Fund, and undisclosed strategic investors. For more information, visit http://alleviantmedical.com.

Note: The Alleviant System is an Investigational Device and is limited by federal (or U.S.) law to investigational use. Exclusively for clinical investigation.

About S3 Ventures

Based in Austin, S3 Ventures (http://www.s3vc.com/) is the largest venture capital firm focused on startups in Texas. Backed by a philanthropic, multi-billion-dollar family for 17+ years, we empower visionary entrepreneurs with the patient capital and true resources required to grow extraordinary, high-impact companies in Business Technology, Consumer Digital Experiences, and Healthcare Technology. With nearly a billion dollars in assets under management, we lead Seed, Series A, and Series B investments with the capacity to follow-on for the life of a company.

About RiverVest Venture Partners

RiverVest is a leading venture capital firm building life science companies to address significant unmet needs of patients and deliver consistently strong returns to investors. With headquarters in St. Louis and offices in San Diego and Cleveland, RiverVest accesses forward-thinking research and clinical expertise at leading institutions across the country to found and fund biopharma and medical device companies.

About Vensana Capital

Vensana Capital is a venture capital and growth equity investment firm dedicated to partnering with entrepreneurs who seek to transform healthcare with breakthrough innovations in medical technology. Launched in 2019, Vensana manages $550M in capital and is actively investing in development and commercial stage companies across the medtech sector, including medical devices, diagnostics and data science, life science tools, digital health, and tech-enabled services. Vensana’s investment team has a history of successfully partnering with management teams behind industry-leading companies including Cameron Health, CardiAQ, Cartiva, CV Ingenuity, Epix Therapeutics, Inari Medical, Intact Vascular, Lutonix, Neuwave Medical, Personal Genome Diagnostics, Sequent Medical, Topera, Ulthera, Veran Medical Technologies, Vertiflex, and Vesper Medical. Learn more at http://www.vensanacap.com.

About Longview Ventures

Longview Ventures is an independent investment vehicle that makes investments in select portfolio companies of Broadview Ventures, a mission-driven investment organization focused on cardiovascular disease and stroke. Longview focuses on clinical-stage companies, Series B – Series C, as a complement to Broadview’s continued dedication to Seed and Series A financings. Longview and Broadview are affiliates of the Leducq Foundation.

About Gilmartin Capital

Gilmartin Capital LLC is focused on private investments in the medical device, life science tools, diagnostic and digital health sectors and targets innovative platforms that influence large or underserved diseases, technologies that accelerate and expand scientific discovery, and solutions that impact the cost, site, and delivery of care. The firm is focused on mid-stage opportunities that are beyond proof of concept and poised for significant development and growth.

About ShangBay Capital

ShangBay Capital is a leading medical technology-focused venture capital firm based in Palo Alto, California founded in 2015. The venture firm focuses on early to mid-stage investments in medical technology, biotechnology, and digital health investments. Since its inception, ShangBay has invested in 61 portfolio companies and has had multiple successful exits to date. The team has a combined 200 years of experience in industry, entrepreneurship, and as executives of leading global healthcare organizations. ShangBay has been ranked as the #1 Most Active New Device VC across the U.S. and Europe by Silicon Valley Bank for 2020, 2021, and 2022.

About Texas Medical Center Venture Fund

The Texas Medical Center Venture Fund (TMCVF) is the venture capital arm of the Texas Medical Center (TMC), the largest medical complex in the world. TMC’s mission is to serve the health, education and research needs of Texas and the world.

TMCVF serves that mission by partnering with entrepreneurs who are shaping the future of health through investment, on-going strategic and operational support, and helping gain an access and connectivity advantage to the world-class healthcare and life science professionals at TMC. TMCVF is an early-stage partner who takes a long-term view to support the commercialization and growth of innovations in medical devices, digital health solutions and therapies. To learn more, please visit our website.

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