In the medical device industry, perseverance, adaptability, and commitment are vital for improving patient outcomes. Tony Pare, CEO of BIOPORTO A/S, truly embodies these values after 25 years in medical devices and diagnostics.
Throughout his career, he consistently recognized a gap in diagnosing and treating Acute Kidney Injury (AKI), a complication from another serious illness that causes kidneys to stop functioning properly. His drive to change this therapeutic shortfall inspired him to join a company determined to change this.
Channelized Family Crisis
After graduating with a Marine Engineering degree, Tony worked with a major shipbuilder to test nuclear submarines for the US Navy. He then went on to manage a large service organization for an industrial automation systems manufacturer.
Like many, Tony witnessed clinicians struggling due to limited diagnostic tools, resulting in needless patient deaths. This became painfully evident when his mother passed away at 54 and his father died in the ICU at 70 without a clear diagnosis. After his mother’s death, he changed careers, joining a blood processing device and diagnostics manufacturer. During his journey in medical devices and diagnostics, Tony encountered numerous families experiencing the same frustrating hospital experiences he had; doctors lacking proper tools to diagnose and treat their loved ones. This drives his passion to make a difference through his work, leading him to join BioPorto as CEO.
Roles & Responsibilities as a CEO
At the helm, Tony spends most of his time developing strategy, hiring and leading the right team that can drive execution, and ensuring that he secures the appropriate capital. BioPorto’s specific expertise in antibodies and assay development enables it to generate IVD products addressing areas with substantial medical needs, such as AKI. Its IVD business has technical and regulatory teams delivering products worldwide. In addition, its antibody business is noted as offering unique and high-quality products. The strategy Tony developed has resulted in revenue and product quality increasing annually.
Tony’s role is to ensure the company has the funding, resources, and focus to drive global market awareness and adoption of this life-saving test. BioPorto is fortunate to have access to educated and skilled people in Denmark.
The CEO is proud of the Hellerup Cube Space Copenhagen team and enjoys the Danish work life and biking to work when he is in Denmark.
The Ground-breaking Technology
Acute kidney injury can occur without ever being detected. AKI is a rapid loss of kidney function that typically occurs as a complication of another serious illness or intervention in the hospital. However, AKI can be difficult to identify because it doesn’t typically cause pain or other symptoms but can result in minor loss of kidney function to complete kidney failure. To improve chances for survival, it is essential that AKI is detected early and treated promptly.
Right now, when it comes to evaluating AKI, doctors mainly look at changes in serum creatinine and urine output. However, these indicators are slow to respond to the start of an Acute Kidney Injury, are not very specific, and can be influenced by things like diet and muscle mass. This means that many patients with hospital-acquired AKI are unaware of their AKI diagnosis as it is often not detected, leading to potential kidney complications further down the road.
As AKI manifests, patients may suffer both structural damage and functional impairment. BioPorto’s flagship product, The NGAL Test, is a clinical chemistry assay that quantifies neutrophil gelatinase-associated lipocalin (NGAL) in plasma or urine. NGAL is a protein that rises rapidly (within 2 to 4 hours) in response to kidney injury, days earlier than serum creatinine which detects functional damage. According to research by Dr. Prasad Devarajan, Chief of Nephrology and Hypertension at Cincinnati Children’s Hospital, and a consultant with BioPorto, serum creatinine does not increase until approximately 50% of the kidney’s functional capability is already gone.
Product and Services Offerings
By using The NGAL Test for earlier AKI diagnosis, doctors can make better treatment decisions tailored to each patient. NGAL values can be helpful in various medical situations, from the emergency room to surgery preparation and specialized care units like those for heart, children, or newborn patients. This helps healthcare teams identify structural kidney damage, whether it happened before or during the hospital stay, and guides them in choosing the right treatment approach. If a clinician can identify AKI early, they can take preventative measures to diminish the injury and progression of kidney disease.
The BioPorto team has strong relationships with clinicians and clinical researchers and support investigator initiated studies in areas which meet their strategy. This continues the educational loop from the leaders in the field to a broader audience and strengthens the knowledge about NGAL and structural damage.
Today’s standard of care diagnostics are too late in diagnosing AKI, which unfortunately means clinicians could miss an opportunity to prevent chronic kidney disease, and the potential for a lifetime of dialysis.
The Geopolitical Angle
The U.S. is the biggest market for BioPorto’s NGAL Test, where its clearance remains under review by the FDA. It already has clearance to sell in the European Union and elsewhere through a CE Mark registration.
Prior to Tony joining, BioPorto did not focus commercially on these other approved markets, and therefore clinicians were not aware of the The NGAL Test or its clinical value.
Therefore, under Tony’s guidance, BioPorto is now investing in commercializing specific markets in Europe, Korea and around the world. This is through a combination of marketing and adding medical affairs and commercial staff in Europe. The collaborations with clinical researchers such as Professor Christian Hassager, Department of Cardiology at Rigshospitalet, further the field of novel biomarker work. The ultimate measure of success will be increased market adoption and revenue for its flagship product, The NGAL Test.
“For BioPorto’s distribution and antibodies business, we have hired commercial executives with experience driving success from offices in Denmark. They have quickly connected with the partners and identified opportunities to expand.”
Roadblocks and Resolutions
Tony has taken a proactive step to benefit investors in BioPorto, by focusing the company’s efforts on BioPorto’s primary objective: creating a valuable product for AKI with life-saving potential. This strategic move ensures that resources are concentrated on a singular, impactful goal, promising better long-term results and increased value for investors. In the world of smaller public companies, a common challenge arises from shareholders’ desire for a continuous flow of positive news and new products, aiming to enhance the company’s value and generate quick trading gains. However, this enthusiasm can become counterproductive if the company takes on too many projects simultaneously. This can lead to significant resource and time investments, delaying project completion. Tony understands this inherently, and has kept the company’s singular focus, while keeping investors engaged.
First-in-class Strategy
Tony’s strategy in every leadership position is:
- Set the “North Star” for the organization. In other words, what big goal will we accomplish in the next 1-2 years?
- Define in detail the 3 areas of focus or “pillars” to achieve the North Star. Most of the time this is a Commercial strategy, an Operational strategy and a People strategy.
- Hire the right people to lead, foster a team approach, and guide as required.
- Set the right metrics and consistently communicate.
The Journey Ahead
Once BioPorto has FDA clearance and market adoption has crossed the chasm from early adopters to the early majority, it will need to create a powerful commercial organization. In addition to Tony ‘s experience in this area, two members of his leadership team have significant experience in building sales channels and direct sales organizations.
From the Leader
“Focus, focus, focus and constantly remind yourself that the mission is to save lives while building shareholder value. Don’t be distracted by every ‘shiny object’ that is presented and always remember to treat shareholder capital like it is your own.”
