Shots:
- Blue Earth Diagnostics is advancing precision molecular imaging in prostate cancer through its F-18 PET imaging portfolio, with POSLUMA and Axumin designed to improve disease localization, support earlier clinical decision-making, and enhance physician confidence, particularly in patients experiencing biochemical recurrence.
- At SNMMI 2026, the company presented new evidence highlighting POSLUMA’s strong detection performance at low PSA levels, reduced urinary tract radioactivity compared with piflufolastat F 18, and emerging data supporting its potential role in treatment assessment, disease monitoring, and next-generation theranostic applications across the prostate cancer care continuum.
- PharmaShots welcomes Michael Wysocki, who shares insights on Blue Earth Diagnostics’ molecular imaging innovations, the clinical significance of the latest SNMMI 2026 data, the evolving role of PSMA PET imaging in personalized oncology, collaborative research efforts, and the company’s vision for advancing precision imaging and radiopharmaceutical innovation.
Saurabh: Molecular imaging is rapidly transforming oncology diagnostics. How is Blue Earth Diagnostics positioning itself at the forefront of innovation in prostate cancer imaging?
Michael: Prostate cancer has been at the center of our work from the beginning because healthcare professionals need accurate, actionable information to make important decisions for their patients. Molecular imaging has transformed our ability to see and localize disease with greater precision, particularly in settings such as biochemical recurrence, where conventional approaches may provide limited information.
With Axumin (fluciclovine F 18) and POSLUMA (flotufolastat F 18) we’ve focused on developing innovative radiopharmaceutical imaging agents that can help clinicians better characterize disease and gain earlier insights. We’re continuing to invest in clinical research and innovation because we believe precision molecular imaging plays an important role in helping healthcare professionals navigate an increasingly complex treatment landscape.
Saurabh: Could you provide an overview of the key data being presented at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting 2026 and explain their clinical significance?
Michael: The data being presented at SNMMI 2026 reflect the breadth of research underway across our portfolio and pipeline, with a focus on improving how we detect, characterize and monitor prostate cancer.
The presentations include new evidence supporting POSLUMA in biochemical recurrence, including strong detection performance at low PSA levels. We also presented emerging data exploring how PSMA PET may provide additional insight during treatment, as well as findings from the REFINE study evaluating Axumin in patients with negative or inconclusive PSMA PET scans.
What I find particularly interesting is that the research isn’t focused on a single clinical question. It spans disease detection, treatment assessment and future imaging technologies, which speaks to how quickly the field continues to evolve.
Saurabh: Several presentations highlight POSLUMA (flotufolastat F 18). What differentiates the imaging agent in the increasingly competitive PSMA PET landscape?
Michael: As the PSMA PET field continues to evolve, I think one of the most important questions is how an imaging agent performs in situations that clinicians encounter every day. What stands out about the data presented this year is that they provide insight not only into disease detection, but also into factors that can influence image interpretation.
In a direct comparator study, POSLUMA demonstrated substantially lower urinary tract radioactivity and less interference with scan assessment than piflufolastat F 18, which may be particularly relevant when evaluating recurrent disease in the prostate bed and pelvis where small recurrent prostate cancer lesions can be challenging to distinguish from urinary activity.1 Additional comparative data also suggested lower rates of nonspecific bone uptake compared with 18F-PSMA-1007, another area that can affect image interpretation.2
We’re also seeing evidence across multiple clinical settings that highlights the potential of POSLUMA to provide earlier and more meaningful insights, including information that may complement PSA during treatment assessment.3,4,5
Saurabh: The head-to-head comparator study evaluating urinary bladder radioactivity has attracted significant attention. What were the key findings regarding lesion detectability and image clarity, particularly at low PSA levels?
Michael: This study provided a direct comparison of POSLUMA and piflufolastat F 18 in the same patients with biochemical recurrence and very low PSA levels, allowing investigators to evaluate differences in image characteristics under the same clinical conditions.1
One of the most notable findings was the reduction in urinary tract radioactivity with POSLUMA, which resulted in less urinary interference with scan assessment than piflufolastat F 18.1
That’s particularly relevant in the prostate bed and pelvis, where urinary activity can sometimes make scans harder to interpret. Reducing that interference may help clinicians evaluate subtle findings, especially at very low PSA levels.
Saurabh: How critical is early and accurate localization of recurrent disease in improving treatment planning and long-term outcomes for prostate cancer patients?
Michael: Early and accurate localization of recurrent disease is critical because healthcare professionals need clinically meaningful information about where disease is located and how extensive it may be. The more clearly we can understand disease, the better equipped clinicians are to evaluate management options and make timely decisions for their patients.
One advancement we’ve seen in recent years is the ability to detect and localize recurrent disease with greater precision, even at very low PSA levels. The earlier clinicians can see and understand where disease is located, the better positioned they are to tailor care management strategies to the individual patient and make timely decisions based on the extent of disease.
Saurabh: In real-world clinical practice, how are advances in molecular imaging influencing physician confidence and treatment decision-making?
Michael: One significant change we’ve seen in recent years is the amount of information molecular imaging can provide beyond conventional imaging or PSA alone.
Advances in precision molecular imaging are giving clinicians a more complete picture of where disease is located and how extensive it may be. That can influence everything from salvage therapy planning to systemic treatment selection, particularly when treatment decisions depend on understanding the full extent of disease.
What we’re hearing in clinical practice is that having a clearer view of disease helps reduce uncertainty and allows discussions to be grounded in earlier, more precise information.
Saurabh: How does this latest body of evidence reinforce Blue Earth Diagnostics’ broader vision for advancing precision oncology and radiopharmaceutical innovation?
Michael: One of the goals of precision oncology is to provide clinicians with earlier, more meaningful insights about a patient’s disease. The studies presented here support that objective by exploring how precision molecular imaging can improve disease detection, increase confidence in image interpretation and provide insights that may extend beyond traditional biomarkers such as PSA.
Importantly, the research spans both current clinical needs and future innovation—from comparative imaging data in recurrent prostate cancer to investigations of treatment response assessment and next-generation radiopharmaceutical and radiohybrid technologies.
Saurabh: What role do collaborations with nuclear medicine physicians, oncologists, and academic institutions play in accelerating the adoption of next-generation PET imaging agents?
Michael: Collaboration is fundamental to advancing molecular imaging because some of the most important insights come directly from clinical practice.
We work closely with nuclear medicine physicians, oncologists, researchers and academic institutions to better understand where unmet needs remain and where imaging can provide additional value. Those collaborations help shape study design, generate evidence and ensure that innovation remains connected to the realities of patient care.
Partnerships with organizations such as Emory University, the Technical University of Munich and Scintomics have been especially valuable because they bring together different perspectives and areas of expertise. That’s often where new ideas emerge and where meaningful progress in precision molecular imaging begins.
Saurabh: From a patient-centric perspective, how can enhanced imaging precision help reduce unnecessary interventions while optimizing therapeutic strategies?
Michael: For patients, uncertainty can be one of the most difficult parts of the cancer journey. The more clearly clinicians can understand where disease is located and how extensive it may be, the better equipped they are to discuss options and develop an appropriate treatment strategy.
More precise imaging can help avoid situations where decisions are made with incomplete information. It can also help identify patients who may benefit from a particular therapy while reducing the likelihood of unnecessary interventions.
At its core, molecular imaging is about providing clear answers at moments when patients and healthcare teams are looking for direction and need information they can act on with confidence.
Saurabh: As theranostics continues to gain momentum globally, how do you see imaging agents like POSLUMA contributing to the future of personalized cancer care?
Michael: One of the most exciting aspects of theranostics is that it brings imaging and treatment closer together than ever before.
Imaging agents such as POSLUMA play an important role because they help clinicians understand where disease is located and how it is behaving before treatment decisions are made. That information becomes increasingly valuable as therapies become more targeted and personalized.
As the field continues to evolve, we expect molecular imaging to play an even greater role in connecting patients with the therapies most appropriate for their disease. That’s one of the reasons we’re continuing to invest in next-generation radiopharmaceuticals, with the goal of delivering earlier insights and more precise information across the entire patient journey.
About Michael Wysocki
Michael Wysocki is the Senior Vice President, Global Sales, of Blue Earth Diagnostics Inc. In this role, Mike leads sales in the U.S. and international markets. He brings two decades of commercial leadership experience in the healthcare sector with significant imaging industry expertise. Prior to joining Blue Earth Diagnostics from Rapid Micro Biosystems, he served as the Senior VP of Global Sales & Marketing at this innovative life sciences company providing mission critical automation solutions to help companies drive efficient manufacturing and fast, safe release of healthcare products. Prior to Rapid, he spent approximately 19 years at GE and GE Healthcare growing various business segments ranging from PET/CT scanners to SPECT cameras to diagnostic radiopharmaceuticals. His passion for working closely with customers to solve their most difficult challenges, building strong diverse teams, and designing winning strategies for growth have been consistent throughout his professional journey. He is a graduate of Boston College, and he holds a Bachelor of Science in Biology (Pre-Medical).
References:
1Kuo P, Sykes J, Penny R, Cohen T; on behalf of the BED-PSMA-411 Study Group. Intra-patient contemporaneous comparator study of the qualitative assessment of urinary radioactivity of 18F-piflufolastat and 18F-flotufolastat PET/CT in patients with low PSA biochemical recurrence of prostate cancer after radical prostatectomy. J Nucl Med. 2026;67(suppl 1):Abstract 261637. Available at:
2Kuo P, Sykes J, Penny R, Cohen T; on behalf of the BED-PSMA-411 Study Group. Intra-patient contemporaneous comparator study of normal-organ distribution of PSMA-targeting PET radiopharmaceuticals, 18F-piflufolastat and 18F-flotufolastat, in patients with low PSA biochemical recurrence of prostate cancer after radical prostatectomy. J Nucl Med. 2026;67(suppl 1):261643. Available at: http://jnm.snmjournals.org/content/67/supplement_1/261643.abstract
3Sasse D, Rauscher I, Horn T, D’alessandria C, Franz C, Combs S, Weber W, Eiber M. Real-world detection efficacy of 18F-flotufolastat PET/CT. J Nucl Med. 2026;67(suppl 1):262312. Available at: http://jnm.snmjournals.org/content/67/supplement_1/262312.abstract
4Sasse D, Hein S, Lorenzini T, Schwamborn K, Horn T, Weber W, Eiber M. Positive predictive value of 18F-flotufolastat PET in patients with biochemical recurrence of prostate cancer: radio-guided salvage surgery and histological validation. J Nucl Med. 2026;67(suppl 1):262066. Available at: http://jnm.snmjournals.org/content/67/supplement_1/262066.abstract
5Shah H, Liu M, Thapa B, Choudhury A, Cheng SC, Harrington K, Gailloud M, Labreque N, Crumbaker M, Emmett L, Ravi P, Jacene H. Tracking changes in PSMA-PET during initial therapy for metastatic hormone-sensitive prostate cancer (mHSPC): initial results from PSMATrack. J Nucl Med. 2026;67(suppl 1):262165. Available at: http://jnm.snmjournals.org/content/67/supplement_1/262165.abstract
