MedTech Pioneers – Promaxo: The Future of MRI Guided Diagnosis and Treatment

Please share the genesis of Promaxo.

(AV) I had been working in urology since 2008 and decided to take a break after my last startup. Both my wife, Abhita, and I decided to pursue our executive MBAs at the same time—while we were parenting a two-year-old child. DON’T DO IT! [Said with a smile on his face].

While working on my MBA at Duke, I was advising companies and I chanced upon an NIH-funded portable MRI technology at a NC Biotechnology Center event. The technology inventor was interested in exploring it for the male urology market. While I was not completely sold on working in the prostate space again, the more I looked at the innovational and platform nature of the technology, I ended up convincing myself that it would be an excellent tool not just for diagnosis but for guided treatment of prostate disorders. I did my due diligence and met the Promaxo co-founder, Michael Bartholomew, via my better half. We spoke with urologists and radiation oncologists to see if they would implement this product in their workflow and the responses were overwhelmingly favorable. We also connected with corporate strategics, including Cook Medical, and again, the feedback was positive.

In January 2016, we incorporated the company and embarked on the exciting Promaxo journey. Over the past five-plus years, we built the MRI from a concept to clinically validated product and brought MicroPort and Zepp Health (NYSE: ZEPP) as strategic partners and investors. And on March 3rd, the FDA cleared our first-of-its-kind single-sided MRI platform for office use.

What is your vision for Promaxo?

(AV) Promaxo’s vision is to improve quality and speed of healthcare delivery to those in need while reducing cost. With our office MRI, robotic, and AI platform, we are fully committed to finding ways that our technology can make lives easier for patients and providers and improve outcomes.

We see ourselves as leaders in MR-guided biopsies and interventions of the prostate. In the long run, Promaxo MRI will be used for different indications and specialties, including breast oncology, orthopedics, and sports medicine.

Why urology as your first application?

(AV) We are focused on transforming prostate cancer management in our beachhead market of urology.  The standard of care involves screening with PSA, followed by blinded transrectal ultrasound biopsies. This current pathway of diagnosing and treating prostate cancer is inefficient and fails patients and urologists. MRI is gaining traction, but its usage remains limited due to lack of access in urologists’ office. MRI-ultrasound fusion pathway is convoluted for patients and physicians and has no additional reimbursements.

We are creating a point of care shift and bringing the MRI and MR-guided interventions closer to the patient and the physician. Think about the patient in a claustrophobic, traditional MRI! It is exceedingly difficult to do a biopsy or treatment in that closed environment. Robotic interventions are now the norm, and our single-sided office MRI, providing access for interventions and compatibility with robotics, is a real gamechanger.

Initially, what was the biggest hurdle to acceptance?

(AV) Introducing an innovational technology in the form of a low-field office-based MR scanner to the urology market is disruptive. We had to ensure that the physicians, MR physicists, and the FDA would accept it. Initially, we were challenged by MR researchers and scientists in the academic domain who were more focused on high-field scanners. However, we were confident that Promaxo platform could optimize clinical workflow and lead to better patient care, while also making economic sense to a practice.

We conducted primary market research to determine the willingness to adopt our technology and various clinical scenarios where our platform technology could be utilized, and the data was overwhelmingly positive. Over the last few months, we have been working on clinically validating our MRI. The impressive data from our feasibility studies was instrumental in achieving our 510k clearance from the FDA.

Tell us about the Promaxo technology and why it is so distinctive.

(AV) The Promaxo technology is a confluence of magnetic resonance imaging, robotics, and artificial intelligence. It isn’t just that we made a smaller MRI unit; we are redefining the MRI experience by developing accessible and adaptable technology, protected by 60+ patents, that can be integrated into a standard doctor’s office.

The Promaxo MRI system’s open configuration is built upon an inherent z-gradient and array of permanent magnets arranged to provide a uniform in-plane magnetic field within the field of view. With a limited footprint and fringe field, the system can be easily moved and placed inside a standard office without any facility upgrades. The single-sided design and quiet operation without the need for endorectal coils lead to a comfortable patient experience. The FDA-cleared MR technology leverages non-linear iterative reconstruction and artificial intelligence-based image denoising and image enhancement.

We are a deep tech company with a medtech focus.

Who is your competition?

(AV) Our competitors include conventional MRIs from Siemens and GE, as well as low-field scanners from Hyperfine, Synaptive, and Esaote.

The Promaxo office-based MRI offers several advantages over the competitors. Our MRI has a limited fringe field and can be placed in an office with no shielding or extensive power requirements. The truly open configuration of our device, its quiet operation and no endorectal coils lead to enhanced patient experience. Most importantly, our scanner can incorporate conventional robotics for live MRI-guided biopsies and interventional procedures due to low field strength and single-sided design.

What is the Promaxo timeline look like from inception to now?

(AV) We developed the Promaxo MRI product in five years, from an early prototype in 2016 to FDA 510(k) clearance in March 2021. We have run the company with a lean and fast startup mindset and got to an FDA-cleared portable MRI with AI-based imaging in less than $20M of dilutive capital. We are immensely proud of this accomplishment. Right now, we have 20 employees and are on the growth curve to double our employee count by 2022.

How did COVID-19 impact Promaxo?

(AV) COVID-19 impacted everyone and especially startups. As the COVID crisis unfolded in 2020, Promaxo was in the midst of raising our Series B-1 round. Simultaneously, we had been working aggressively on meeting our timelines for product realization and regulatory clearance. As a medical technology company developing capital equipment, the process required some of our team members to be physically present at the office to operate the MRI scanner and continually optimize the MR images.

We acted quickly and focused our attention on a plan to operate effectively during the shelter-at-home order. We clarified our classification as an essential business and once we had the confirmation, we implemented a creative, company-wide work schedule. For employees needed to run the scanner, we implemented social-distancing protocols at work and started working in two shifts to keep in-person interaction to a minimum. We consistently communicated the critical timelines and schedules to our team and investors, met virtually through Zoom/Uber conference, and kept the team motivated and engaged.

The quick reaction and adaptability of the team to this adversity allowed us to stay on course and meet our timelines on IRB approvals, clinical studies, and FDA clearance.

Tell us about your latest milestone, achieving FDA clearance.

(AV) We are delighted to share the news that the FDA cleared Promaxo’s first-of-its-kind single-sided MRI platform for office use on March 3rd. The 510(k) clearance will enable practices and hospitals to guide prostate interventions accurately and seamlessly under the Promaxo scanner. The FDA clearance is a testament to our team’s hard work and persistence.

What is next on the horizon for Promaxo?

(AV) The next milestones are around expanding our clinical presence, publishing data, producing clinical evidence, validating our reimbursement and health economics models, and becoming a commercial company. We are data-driven and are building a significant database of our images and procedural data to enable our AI-based tissue characterization.

We plan to expand our indication within prostate and urology and to explore expanded indications for breast oncology, orthopedics, and sports medicine.

What are next steps in fundraising?

(AV) This is an exciting time for us; we are in due diligence process with several VCs, corporate strategics, and hedge funds. We have a few pathways to strategize as it relates to bringing in our next round of financing. It is a good situation to be in!

What about your partners?

(AV) It really takes a village to build a medical technology company. The most important partner in this journey has been my wife, Abhita. Being an entrepreneur is tough on your spouse and kids.

We are lucky to have an amazing team, investors, and partners like Kineticos, MicroPort, Wilson Sonsini, and Zepp Health (NYSE: ZEPP). They have all been fantastic and a big reason for our success to date!

To learn more, visit: Promaxo.com.