Dr Peter Walsh: Leading Biomedical Technology 

In biomedical technology, one of the most pressing challenges revolves around developing advanced solutions for cardiovascular health. New innovations are crucial for addressing widespread conditions that pose significant threats to global public health, particularly when focusing on improving patient outcomes and reducing mortality rates.

It's with this mind that the team here at WorldHealthCare Magazine sees Dr Peter Walsh, Founder & CEO at QHeart Medical, as an esteemed figure in biomedical engineering, who embodies a visionary approach to healthcare innovation. His journey has been shaped by a deep-seated commitment to understanding and combating cardiovascular diseases through groundbreaking research and technological advancements.

At the forefront of this transformative effort stands QHeart Medical, a groundbreaking entity dedicated to revolutionizing cardiovascular care. Through its innovative portfolio, QHeart Medical aims to redefine treatment standards, offering solutions that are not only effective but also accessible and affordable for a broad spectrum of patients worldwide.

QHeart Medical continues to push the boundaries of medical technology, forging ahead with a mission to enhance quality of life and address critical unmet needs in cardiovascular health. With a steadfast focus on research excellence and strategic partnerships, the company is poised to lead the industry in delivering impactful innovations that make a tangible difference in global healthcare.

Driven by Personal Loss

Peter has a deep understanding of the global health crisis posed by high blood pressure (hypertension), affecting a significant portion of the population and serving as a precursor to fatal conditions such as heart failure, stroke, and renal disease.

Peter witnessed firsthand the devastating impact of these diseases on individuals and their families through the experiences of his grandparents. They succumbed to heart disease, heart failure, and stroke, which severely compromised their quality of life and ultimately led to their demise. One grandfather passed away from a second heart attack at 66 years old while his wife was at his side. The other grandfather endured eight weeks of hospitalization due to progressive heart failure following an initial heart attack. Peter's grandmother suffered from progressive heart failure that worsened until her death, while his other grandmother spent her final years bedridden and unable to communicate after a severe stroke.

These personal experiences profoundly influenced Peter's career path. During his undergraduate engineering studies, he pursued his interest in the medical field, which was further ignited by collaborations with cardiologists at a prominent teaching hospital and engagement in cardiovascular research during his master's studies in applied science.

Peter's academic journey continued with a PhD in biomedical engineering at the Graduate School of Biomedical Engineering, University of New South Wales (UNSW). His doctoral research focused on cardiovascular disease, specifically investigating how blood flow-induced forces impact vascular biological responses. His advisors during this time were Professor Klaus Schindhelm, head of school, and Professor Barry Gow, a physiologist at the University of Sydney.

Following his PhD, Peter undertook a post-doctoral fellowship in Florida, USA, under the mentorship of Professor James Moore, a renowned figure in cardiovascular engineering. Here, he continued his research on vascular cellular responses and explored the influence of stent strut design on the vessel endothelial regeneration post-stenting

Returning to UNSW for another fellowship in the Department of Surgery, Peter focused on aortic compliance research alongside Professors Bill Walsh, Albert Avolio, and Michael O'Rourke.

It was during this period that Peter made a critical decision to leverage his expertise and entrepreneurial spirit by founding his own company to explore advancing cardiovascular health through innovative research and development. After several competitive grants from the Queensland Government, the NHMRC, and AISRF, he showed his “pumpless” aortic recoil repair therapy technology has commercial promise, and with the supportive relationships he developed along the way, a new commercial company, QHeart Medical Pty Ltd was founded to complete development and commercialise this technology.

Innovative Solutions for Heart and Renal Health

Founded by a team of dedicated cardiac device professionals, QHeart Medical is committed to addressing significant unmet clinical needs, prioritizing solutions that are both low-risk and affordable.

The company's vision includes:

- Significantly enhancing quality of life

- Improving the cost-effectiveness of treatments

QHeart Medical Pty Ltd is presently focused on bringing innovative, minimal-risk, and cost-effective therapies to market. These treatments aim to enhance heart and renal function, specifically targeting underserved conditions such as hypertensive heart failure and resistant hypertension, including cases of acute heart failure accompanied by renal dysfunction.

Revolutionizing Heart Health with Innovative Implants

QHeart Medical's Aortic Recoil Repair (ARR^TM) implants represent a cutting-edge therapeutic solution designed to address aortic stiffness and associated hypertension, and heart failure. These investigational devices are distinguished by their "pumpless" passive design, eliminating the need for power or control systems. This unique feature positions them as low-risk and cost-effective treatments poised to serve a burgeoning global market with unmet needs.

Clinical validation conducted at Monash Health and The Victorian Heart Hospital has demonstrated promising results. Pilot testing involving six patients revealed significant enhancements in cardiac performance:

- Increased cardiac output (CO) by 25% to 29%

- Expanded stroke volume (SV) by 21% to 41%

Professor Julian Smith, Principal Investigator at Monash Health, highlighted the study's findings, describing them as a substantial advancement in cardiac function and underscoring the potential benefits of QHeart's implants for patients dealing with heart failure and hypertension.

Funded by a competitive CRC Project grant from the Australian government, QHeart Medical has since developed a novel endovascular minimally invasive interventional product, demonstrating technical feasibility through rigorous bench and pilot animal studies. This advancement holds promise as an effective solution for acute heart failure, offering critical support to enhance kidney and heart performance during emergency hospitalizations for millions of patients worldwide.

Addressing Global Health Challenges

Resistant Hypertension (RH) and Hypertensive Heart Failure (HHF) pose significant global health challenges, affecting approximately 20%-33% and 2%-3.5% of the population, respectively. These conditions also incur substantial economic burdens, with Heart Failure alone costing over US$100 billion annually and Hypertension exceeding US$200 billion annually.

QHeart Medical aims to address these issues by developing affordable, low-risk medical devices to treat RH and HHF. Their mission is to reduce mortality rates and enhance the quality of life for these patient populations.

QHeart is prioritising its product development on the treatment of acute decompensated heart failure (ADHF) with its new endovascular device for in-hospital use on over 1 million ADHF emergency admissions in the USA per year alone.

Deployed swiftly within the thoracic aorta using standard interventional techniques, the implant offers in-hospital application aimed at stabilizing and managing heart and renal dysfunction. Its goal is to accelerate patient recovery, reduce mortality rates, and ideally mitigate subsequent unscheduled emergency hospitalizations following discharge.

In the USA alone, there are currently over 1.25 million emergency hospitalizations annually for acute heart failure, underscoring the urgent need for effective interventions like the TARR implant.

Resistant Hypertension Treatment

Furthermore, there are more than 22 million patients suffering from resistant hypertension who are currently inadequately managed, putting them at risk for stroke, renal disease, and heart failure. Both the QHeart Surgical Aortic Recoil Repair (SARRTM) and Transcatheter Aortic Recoil Repair (TARRTM) implants are being evaluated as potential longer-term therapy options aimed at fostering recovery of heart and renal function. The objective is to enhance quality of life and decrease the elevated mortality rates among these underserved patient populations.

Strategic Goals for Medical Innovation

Peter is focused on several strategic initiatives:

i) He aims to cultivate a passionate team and foster a culture dedicated to developing and guiding these products through clinical trials and eventual market launches.

Peter outlined how he formed QHeart’s core team below.

“I met Mr Umesh Goel, a high-ranking CFO in Brisbane in September 2014 at a business information seminar for Australian and Indian business opportunities. We remained in contact and as I progressed from a DFAT-sponsored clinical research study at Frontier Lifeline in Chennai, India, to the first private research group to receive Australia-India Strategic Research Funding (AISRF) with Dr KM Cherian Heart Foundation and Chairman at Frontier, we continued to develop our relationship which led him to be founding director and CFO at QHeart.

I first met Dr Cherian in March 2015 when we tested 2 CABG patients with an early SARR device. We obtained clinical evidence showing an inflated balloon attached to the ascending aorta, a passive recoil “pumpless” device improved the patient’s left coronary artery (LCA) blood flow prior to their scheduled CABG. This was a great finding and  confirmed the findings of a previous animal study showing 39% LCA blood flow improvement. We then both filed for the AISRF grant with our respective governments for this very competitive program and we were awarded funding from 2017 to 2021. I was able to grow my team, design and prototype new devices, and conduct animal studies with Dr Cherian showing cardiac output improvement in pigs with the improved SARR device of up to 30% was possible.

It was through the AISRF program I also developed relationships with 2 leading heart surgeons, Mr Aubrey Almedia and Professor Julian Smith. Aubrey has since been involved in refining the SARR and assisting the principal investigator Prof Smith in testing the SARR on 6 patients at Monash Health for an HREC approved study with this device. We found that up to 29% cardiac output improvement was possible which was very impressive. Aubrey joined the team as the founding Chief Medical Officer at QHeart and both himself along Professor Smith are involved with the TARR device under development.

I met Dr Phil Nowell in Brisbane in July 2016, a former USA medical device executive at a globally successful company. I saw his experience on LinkedIn and noted he had recently moved to Brisbane. We had a coffee meeting and we have had an ongoing relationship since around strategic advice on product clinical indications, target unserved market sectors, and commercialisation planning among other areas.

The formation of these core skills with my own offers a very experienced and multidisciplinary team each with their own crediable track record. I believe this team with existing partner Monash Health and new partner Prof Wang at the AIBN, University of Queensland, and our proposed focus on the research and development of the TARR device, led to our Collaborative Research Centre (CRC) Project Grant success in 2022.

ii) Peter is dedicated to establishing and nurturing strong relationships with clinical opinion leaders and health organizations. This approach ensures that product development aligns closely with the critical needs of underserved patient populations.

iii) He prioritizes the establishment of successful partnerships with hospital groups and research organizations. These collaborations are essential for accessing necessary resources to support ongoing development efforts.

iv) Peter highlights the importance of staying informed by reviewing the literature on research advancements and market trends. This practice ensures that QHeart Medical remains abreast of new developments, techniques, and emerging treatments relevant to its product portfolio.

v) Finally, he focuses on maintaining and expanding a robust patent portfolio that safeguards QHeart's innovations and supports its competitive edge in the market.

Strategic Considerations for Medical Innovations

Peter underlines strategic considerations for the company's investigational products:

The focus is on developing low-risk, cost-effective therapies tailored for a vast global patient population, necessitating a regional marketing strategy to achieve adoption and value creation.

Even after securing pre-market approval, effective marketing and promotion of new technologies remain challenging. Establishing a robust market presence in key jurisdictions requires meticulous planning.

Critical success factors include demonstrating efficacy in the target patient population, with goals centered on improving quality of life, reducing mortality, minimizing unscheduled hospital admissions, and lowering ongoing treatment costs. Ensuring minimal complications from product usage is equally imperative.

Achieving reimbursement, garnering support from insurance providers, fostering patient acceptance, and gaining clinical adoption are essential steps in integrating products into the healthcare system.

Peter underscores the fundamental role of clinicians in the success of medical implant products. Providing comprehensive training and clinical case support are crucial components for fostering successful product adoption, whether through independent distributors or partnerships with larger medical device companies possessing a global product portfolio.

Leadership in Innovation and Funding

Under Peter Walsh's leadership at QHeart Medical:

- The company boasts a multi-skilled leadership team with a proven track record and collaborations with world-class partners.

- They have demonstrated the capability to secure competitive non-dilutive funding.

- QHeart Medical has achieved proof of concept in bench, animal, and first-in-man studies for their innovations.

- Their patent portfolio includes 10 issued and pending patents, safeguarding their technological advancements.

Ensuring Safety in Medical Device Development

Peter underscores the stringent regulations governing medical device implants. These regulations prioritize patient safety throughout the entire product lifecycle, from development and pre-market approval to post-market surveillance.

Key priorities include:

- Establishing robust quality and risk management systems.

- Developing products designed to mitigate risks associated with device use, ensuring both occurrence and severity are minimized.

- Providing compelling safety and clinical evidence that all anticipated risks have been effectively managed before market launch.

- Implementing post-market surveillance measures to continually monitor product performance and ensure patient safety aligns with intended usage.

Advancing Critical Milestones

The company is actively pursuing several strategic initiatives:

i) Conducting the first-in-man clinical study with the TARRTM implant.

ii) Launching a capital raising campaign to secure necessary funding.

iii) Progressing towards completion of regulated clinical trials and obtaining pre-marketing approvals for their innovative products.

Strategic Principles for Development

The company aims to lead in offering revolutionary therapy for aortic stiffness repair. Their goal is to address the needs of millions of underserved patients experiencing poor quality of life and high mortality rates by delivering safe, effective, low-risk, and affordable product solutions.