Mission and Vision

Francis Medical is a medical device company committed to developing urological cancer treatments that are tough on cancer yet gentle on patients. Our mission is inspired by the belief that minimally invasive interventions hold the potential to halt cancer’s progress. Rooted in our values of quality, integrity, innovation, excellence, and collaboration, we strive to make a meaningful difference in cancer care.

Prostate Cancer

Our focus is on utilizing water vapor technology to develop Vanquish®, an innovative device tailored specifically for addressing prostate cancer, which ranks as the second most common cancer among American men.

Traditional treatments for prostate cancer often come with significant side effects, including urinary incontinence and erectile dysfunction, that can profoundly impact a patient’s quality of life. Our water vapor technology is designed to offer a promising alternative, minimizing these adverse effects and providing patients with a more favorable treatment experience.

Named after Francis Hoey, the father of our founder, Michael Hoey, Francis Medical is deeply rooted in a personal commitment to improving prostate cancer care. Francis Hoey’s own struggle with the disease and the challenges he faced while undergoing traditional treatments serve as the driving force behind our mission.

Today, Francis Medical is honored to carry on Francis Hoey’s legacy by striving to make a meaningful difference in the lives of prostate cancer patients.

We are more confident than ever that this groundbreaking technology will ultimately become the first-line treatment of choice for men and their doctors.

CEO, Mike Kujak

History

The Beginning

Founded in 2018, Francis Medical Inc. stands as a testament to the deeply personal journey of its founder and chief technology officer, Michael Hoey.

Michael’s trajectory from his rural upbringing in southern Minnesota to his tenure as a distinguished figure in urology research and education at the University of Minnesota reflects a lifetime dedicated to problem-solving.

In 1991, Francis Hoey, Michael’s father, passed away due to prostate cancer complications following treatment that resulted in debilitating side effects. Witnessing firsthand the challenges and limitations of existing treatments, Michael resolved to revolutionize therapeutic approaches in this domain.

Michael’s father, FRANCIS HOEY

Founder and CTO, MICHAEL HOEY

Departing from academia, Michael went on a mission to pioneer novel thermal treatment technologies, motivated by a desire to mitigate the adverse effects he witnessed his father endure. His journey took an unexpected turn when his fervor for medical advancement intersected with his passion for engineering, particularly in the realm of high-performance race cars.

During the rigorous testing of one of his race car engines, Michael had a revelation: the potent thermal energy inherent in vaporized fuel held profound potential for clinical applications. Drawing parallels between the precision required in both the racing and medical spheres, he recognized the transformative possibilities of harnessing sterile water vapor for therapeutic interventions.

This realization marked the genesis of Francis Medical Inc. – a convergence of personal loss, professional expertise, and unwavering determination to redefine the landscape of medical treatment. Through the fusion of cutting-edge technology and a deeply rooted commitment to advancing patient care, Francis Medical Inc. is poised to revolutionize the field of urology and beyond.

NxThera

Established in 2008 by Michael, NxThera was founded with a focus on pioneering advancements in urology through its innovative water vapor platform technology. This technology utilized convective water vapor energy to address various endourological conditions, with a notable emphasis on benign prostatic hyperplasia (BPH).

In 2015, NxThera achieved FDA clearance for its Rezūm system, a significant milestone in urological care. The Rezūm system delivers controlled doses of thermal energy stored in water vapor directly to the prostate gland, offering a targeted solution for alleviating lower urinary tract symptoms associated with BPH.

In 2018, NxThera was acquired by Boston Scientific, further solidifying its position in the treatment of BPH and other non-cancerous urological conditions. Following this acquisition, Francis Medical was formed to explore the potential of water vapor therapy in addressing urological cancers, initially prostate cancer, followed by bladder and kidney cancer.

francis medical: pioneering the next frontier

In 2018, the collaboration between Michael Hoey and Mike Kujak, former executives at NxThera, marked the inception of Francis Medical, a pioneering medical device startup poised to revolutionize prostate cancer treatment.

Francis Medical successfully raised $21 million in Series A financing, led by Arboretum Ventures, with significant contributions from H2Oey Ventures (a Solas Bioventures Fund affiliate), Tonkawa, and Boston Scientific (Press Release). Funding was further bolstered in 2020 when Coloplast injected an additional $4 million, bringing the total Series A investment to $25 million (Press Release).

Armed with this financial backing and clinical data from initial studies in Panama, Francis Medical received an FDA Investigational Device Exemption (IDE) for the VAPOR 1 Early Feasibility Study (EFS), a United States-based study aimed at evaluating its groundbreaking prostate cancer treatment. The study concluded in late 2020, yielding promising six-month primary endpoint results unveiled in June 2021 (Press Release).

In a significant milestone, September 2021 witnessed the culmination of a $55 million Series B equity financing round, earmarked to advance Francis Medical’s proprietary prostate cancer treatment through FDA 510(k) approval (Press Release). This funding facilitated the initiation of VAPOR 2, a pivotal clinical study designed to treat 235 patients with intermediate-risk localized prostate cancer across 30 U.S. clinical sites (More on VAPOR 2).

Data from the VAPOR 1 EFS were published in the Journal of Endocrinology in November 2022 (Article), and in July 2023, the first patient was treated in the Francis Medical VAPOR 2 pivotal clinical study (Press Release).

Marking another important milestone, in August 2023, the FDA granted the Vanquish minimally invasive water vapor ablation therapy Breakthrough Device Designation to help expedite its development, assessment and review so patients have more timely access to the treatment (Press Release).

Looking Ahead

Aligned with a commitment to rigorous regulatory standards and patient care, Francis Medical is diligently working towards securing U.S. regulatory clearance by late 2025, closely followed by international approvals. The company remains dedicated to advancing medical technology responsibly and ethically, with a focus on improving patient outcomes globally.

Utilizing the same underlying water vapor technology, Francis Medical plans to broaden its product development scope to include applications targeting bladder and kidney cancers.

Types of Cancer to be Treated

Water vapor technology is showing promise for several types of cancer.

Prostate Cancer

In the United States, prostate cancer is the second most common cancer in men and the second leading cause of cancer death in men. The American Cancer Society estimates 299,010 new cases and 35,250 deaths due to prostate cancer in 2024. Currently, more than 3 million men in the United States have the disease with it more likely to develop in older men and non-Hispanic Black men.1

The Lancet Commission on prostate cancer projects the new number of cases will more than double: from 1.4 million in 2020 to 2.9 million by 2040.2

Many men with clinically localized prostate cancer and their physicians would prefer a less invasive, targeted cancer treatment versus the traditional approach of removing (radical prostatectomy) or using radiation therapy on the entire prostate.

1] American Cancer Society. Key Statistics for Prostate Cancer | Prostate Cancer Facts. www.cancer.org. Published January 19, 2024. www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html.
2] James ND, Tannock I, N’Dow J, et al. The Lancet Commission on prostate cancer: planning for the surge in cases. Lancet. Published online April 1, 2024. doi:https://doi.org/10.1016/s0140-6736(24)00651-2.

Kidney Cancer

According to the American Cancer Society, in 2024, about 81,610 new cases of kidney cancer will be diagnosed, and 14,390 people will die from this disease. The average age of diagnosis is 65, with most people being diagnosed between the ages of 55 and 74. It is about twice as common in men than in women and more common in African American, American Indian, and Alaska Native peoples.1

Early detection can improve the prognosis. Treatment for kidney cancer varies depending on whether the cancer has metastasized (spread) or is localized to the kidney. Localized kidney cancer is most often treated with surgery. Metastasized kidney cancer is also most often treated with surgery and may include targeted therapy drugs and immunotherapy. Occasionally, radiation therapy is used.2

1] Key Statistics About Kidney Cancer. www.cancer.org. https://www.cancer.org/cancer/types/kidney-cancer/about/key-statistics.html
2] Cancer.org. Published 2017. https://www.cancer.org/cancer/kidney-cancer/treating/by-stage.html

Bladder Cancer

The American Cancer Society estimates that in 2024, there will be 83,190 new cases of bladder cancer and 16,840 deaths from the disease.

Overall, about 1 in 28 men will develop this cancer during their lifetime (making it the fourth most common cancer in men). For women, the chance is about 1 in 89. As with most types of cancer, the risk of bladder cancer increases with age, with 73 being the average age for bladder cancer diagnosis.

About half of all bladder cancers are first found when the cancer is still located only within the inner layer of the bladder wall. About one in three of these cases spreads into deeper layers while remaining completely inside the bladder wall.¹

Standard treatment options for bladder cancer include surgery, radiation therapy, chemotherapy, and immunotherapy. The type of treatment chosen can vary depending on the specific type and stage of cancer.2

1] Cancer.org. Published 2017. www.cancer.org/cancer/types/bladder-cancer/about/key-statistics.html.
2] Treatment of Bladder Cancer, by Stage. www.cancer.org. www.cancer.org/cancer/types/bladder-cancer/treating/by-stage.html.

Leading the Way

Helping fulfill the mission with passion and integrity.