By Dr. Amit Vohra, President and CEO of Promaxo
Prostate cancer overview
According to the American Cancer Society (ACS), approximately 1 in 8 men will be diagnosed with prostate cancer; in 2022, the ACS projects approximately 268,490 new cases of prostate cancer will be diagnosed with 34,500 deaths. Prostate cancer is the second leading cause of cancer death in men, behind lung cancer, and approximately 1 in 41 men will die of the disease. However, most men diagnosed with prostate cancer do not die from it due to the fact it is typically an indolent, or slow-growing cancer, and more than 3.1 million men with prostate cancer in the US are still alive today.
Limitations of current prostate cancer tests
Standard prostate cancer screening methods, including digital rectal exams (DREs) and prostate-specific antigen (PSA) assays, have major limitations. These diagnostic methods are not 100% accurate and are known for producing false positive and negative readings, oftentimes leading to unnecessary biopsies, radiation, or surgery that may lead to sexual dysfunction and incontinence, or a false sense of security.
Results from two large studies, evaluating the accuracy of DRE and PSA tests found that annual testing—although successful in detecting more cancers than in men who did not receive the tests—failed to lower the death rate from prostate cancer. As most prostate cancers grow slowly, many men die of other causes without even knowing they had the disease. Many patients diagnosed with prostate cancer may never experience any symptoms or die directly from it; however, due to the risk of metastasis, physicians often recommend further testing, including imaging and biopsy.
Despite diagnostic limitations, early detection of prostate cancer, while it is still confined to the prostate, is often key for successful treatment. As prostate cancer is generally such an indolent cancer it often presents few, if any symptoms. Critical to treatment is distinguishing indolent from aggressive cancers. In some men, accurate diagnosis arrives too late, leading to advanced disease and poor outcomes. Clinicians seek more dependable cancer diagnostics. This includes improved imaging or lesion detection techniques.
Image-guided biopsies
Imaging techniques are used to reinforce DRE/PSA testing as a second important step in confirming a prostate cancer diagnosis. Once a patient is initially suspected of having prostate cancer as a result of an abnormal DRE and/or elevated PSA level, a core needle biopsy is typically performed using guidance from transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI), or both. Imaging is required to precisely guide the needle— either through the wall of the rectum (transrectal) or through the perineum (the skin) between the scrotum and anus (transperineal)—to remove several small samples of prostate tissue (the procedure is repeated multiple times to obtain up to a dozen samples from different areas of the prostate).
The necessity of MRIs in diagnosing and staging prostate cancer
MRIs use radio waves and strong magnetic fields to image body tissues. The MRI scan provides clear images of the prostate and nearby anatomy. MRI scans are multifunctional; they can help determine if a patient with symptoms and/or a positive PSA or DRE should receive a biopsy; pinpoint target areas where cancer is most likely located prior to conducting a biopsy; accurately guide the needle during biopsy; help stage prostate cancer once it is found to see if it has spread outside the prostate to surrounding areas, guide radiation therapy, determine treatment options and perform regular follow-up scans.
Addressing unmet needs—using novel, portable Promaxo MRI technology at the point-of-care (POC)
To address the shortcomings of prostate cancer diagnosis and intervention, Oakland, California-based startup, Promaxo, has developed a groundbreaking, next-generation MRI system. The Promaxo MRI system is the first FDA-cleared, single-sided, low-field, portable and open architecture platform that brings MRI scanning directly to the patient in the physician’s office. The proprietary Promaxo MRI is also adaptable and intelligent, combining an ecosystem of artificial intelligence (AI), robotics (under development), and minimally invasive MRI imaging into one compact, machine.
The Promaxo MRI system comprises a cart that houses the magnet, gradient coils, radiofrequency (RF) coil, and an auxiliary rack that houses the electronics and electrical components. In addition to a small footprint (compared to standard MRI systems that are typically very large), the system features an easy-to-use, intuitive touch-screen interface, and selection of the most common pre-programmed image sequences, with no need to adjust parameters every time. Its compact size and ease of use are critical, as it can be an important advantage for both physician and patient, facilitating efficient use and proper care.
The imaging platform was developed in collaboration with nine academic and hospital development partners, including Stanford University, Vanderbilt University, Harvard Medical School, and Massachusetts General Hospital.
Promaxo MRI benefits over traditional MRI
Promaxo MRI offers numerous benefits over traditional MRIs. The system not only offers physicians and patients greater accessibility and convenience but using next-generation digital technologies, provides superior imaging capabilities for guidance.
These technologies, involving several safety and accuracy improvements over traditional MRIs, helps diagnose more prostate cancers (earlier) at the POC through MRI guided biopsies, versus expensive, inconvenient hospital-based imaging centers that often require lengthy appointment waiting periods. Easily accessible and less costly MRI could lead to more MRI guided procedures and readily accessible medical care for a greater number of patients—particularly for patients in remote or rural areas or at resource-constrained-community hospitals.
To further expand utility, Promaxo received FDA 510(k) clearance in March 2021 for use of its MR-guided procedures throughout the patient journey—starting with diagnosis in the physician’s office with either manual or robotically-guided biopsy; treatment planning with nerve-sparing; margin localization; radiation treatment; and post-treatment follow-up to confirm results. The company says its technology can help physicians target “high-risk” prostate lesions with its in-office MRI system alongside its MRI-compatible robot. Using the Promaxo MRI in an office setting provides live biopsy guidance for targeted biopsy and treatment. The system is used by urologists and interventional radiologists to “perform surgical localization of prostate lesions under MRI guidance to seamlessly guide prostate interventions using the Promaxo MRI scan.”
Other benefits over standard MRI imaging include a unique open architecture that allows cancer treatment using a variety of technology platforms, from robotic interventions to target high-grade lesions, guiding biopsy needles, to specific regions for sampling. Unlike traditional MRI, the system offers greater convenience and safety as it does not require special cooling, shielding, or floor reinforcement.
A summary of technological benefits of Promaxo MRI includes:
- A smaller, modular footprint for portability and convenient use in physician’s offices or outpatient surgical centers
- The first FDA-cleared, open, single-sided MRI design with quiet operation and with no requirement for endorectal coils, allowing substantially more comfort for patients who may perceive claustrophobia inside a closed system
- A limited fringe field system that can be easily installed in an office with no shielding requirements, hazardous cryogenic materials, or costly installation and facility upgrades necessary.
- High safety, with minimal tissue heating that is well below safety thresholds
- Optimized image quality as patented AI technologies capture, reconstruct and display MRI images of the prostate and surrounding tissues; pre-programmed sequences and AI are used to enhance image quality
- A thermally stable, novel combination of linear and genetic optimization algorithms to precisely shape the magnetic field within the field of view.
The Promaxo MRI is particularly useful for “active surveillance.” More men with low-risk prostate cancer are increasingly choosing active surveillance to postpone potential side effects of treatment and surgery, such as sexual dysfunction and incontinence. Active surveillance, which involves close monitoring and commencing treatment only when cancer shows signs of aggressiveness, can involve one or two PSA blood tests a year, a DRE at least once a year, and an MRI scan with prostate biopsy every 1-3 years, especially for patients with intermediate prostate cancer who may be on the border between active surveillance and surgery.
Promaxo MRI offers imaging at a lower cost than traditional MRIs, with an attractive ROI, established CPT codes for reimbursement, and the ability to perform MR-guided robotic procedures and substantially reduce the wait times between diagnosis and treatment, which can lower mortality rates and improve patient outcomes.
A Promaxo MRI guided biopsy shows clinical superiority over standard of care, with a 71% cancer detection rate, and has identified 23% more clinically significant cancers, with a Gleason score greater than 3+3 with an average of just 3 cores per patient. Overall, the company’s goal is to help solve the problems of limited access to MRIs and MRI-guided interventions due to high cost, infrastructure requirements, and limited availability in imaging centers and hospitals worldwide. Promaxo technology effectively removes several barriers to care by bringing the equipment directly to urologists, surgeons, and patients.
Clinical reviews
Promaxo was reviewed by key opinion leaders (KOLs) in the August 2021 edition of European Medical Journal Urology (EMJ Urology). According to the article, “Office-Based, Point-of-Care, Low-Field MRI System to Guide Prostate Interventions: Recent Developments,” the authors concluded that the portability and ease-of-use of the Promaxo MRI system provide the opportunity to diagnose prostate cancer earlier via targeted biopsy and treatment in physician’s offices using the transperineal approach, and that the new technology may result in higher cancer detection rates, lower infection rates in targeted biopsies and effective therapeutic applications.
Dr. Ashutosh K. Tewari, Professor and System Chair, Department of Urology and Director of the Center of Excellence for Prostate Cancer, Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai, New York, and the senior author leading the EMJ Urology review believes that the compact footprint of the Promaxo MRI system, combined with easier usage, “is ideal for office-based procedures and allows board certified urologists to perform prostate interventions in outpatient settings.”
Key financing and strategic growth plans
In April 2022, Promaxo announced an additional $1.4 million in key strategic financing from Som Tech Pty Ltd, a family office led by Krishna Bhupal, an established investor in the AI-medtech and life-sciences space. In April, the company also received undisclosed additional investments from Zepp Health.
Promaxo has made numerous long-term and strategic partnerships with investor groups and corporations to advance commercialization of the Promaxo MRI system worldwide and has sold several in-office systems to urology practices in the U.S. over the past few months since FDA clearance.
Promaxo is well-positioned to create a paradigm shift in a multitude of adjacent markets, such as breast oncology, OB/GYN, and women’s urology, to name a few. The company intends to leverage its existing product designs and technical know-how to swiftly move into these markets and improve access to affordable high quality care for patients around the world. Overall, Promaxo’s strategic plan is to expand its pipeline with revolutionary cancer-fighting technology to address unmet needs in oncology diagnosis and treatment and expand patient access to potentially life-saving, portable Promaxo MRI technology.
Editor’s note: Dr. Amit Vohra, President, and CEO of Promaxo, is a serial entrepreneur, business strategist, and advisor to several healthcare and technology startups. Amit is a Partner in Advanced Biopharma Consulting, a management consultancy offering strategic business development and commercialization services in the life sciences space. He also serves as a board member at Navaux and an advisor to Fanisko, Triocula, and UnityDx.
Prior to Promaxo, Amit was the CEO/President of Convergent Life Sciences wherein he took a MRI-US fusion product, for targeted laser ablation of soft tissue cancer, through FDA clearance within 18 months of company formation. Previously, as VP of strategy and Operation at Eigen, he led the development and successful commercialization of two class II medical devices in the prostate biopsy space.
In 2009, Amit co-founded Navya Biomedical Technologies, a non-invasive imaging and destruction of solid tumors. Amit has a Doctorate in Mechanical Engineering from the University of Florida, and an MBA (Fuqua Scholar) from Duke University’s Fuqua School of Business.