Perimeter Medical Imaging (TSXV: PINK; OTCQX: PYNKF) has announced it has been selected to receive a contribution from the INOVAIT Pilot Fund to advance next-generation AI capabilities for its flagship product Claire, which received FDA approval earlier this year as the first AI-enabled device for use during breast cancer surgery. The project was one of 10 selected for funding in the latest round of the INOVAIT Pilot Fund call for applications.

The project will focus on building more robust and scalable AI to support continued improvement of Perimeter’s OCT+AI platform. The Company expects to receive up to nearly $148,000 in INOVAIT contributions. An additional $100,000 Mitacs Business Strategy Internship award will support graduate student participation through the university collaboration. The project is conducted in partnership with Dr. Ervin Sejdić, professor in the Edward S. Rogers Sr. Department of Electrical and Computer Engineering at the University of Toronto.

In a statement, Adrian Mendes, CEO of Perimeter, commented, “We’re grateful for INOVAIT’s support of this work. While advances in breast cancer treatment have accelerated over the past decade, surgeons still have limited tools in the operating room to assess microscopic disease. This project helps to advance what Claire’s AI can do in the operating room. Better tools lead to better decisions. And better decisions can change what’s possible for patients on the day of their surgery.”

David Rempel, co-founder and INOVAIT project lead at Perimeter, added, “This project goes beyond a single model update—it’s about building the next layer of Claire’s AI infrastructure. By improving how we label data, characterize performance, and deploy AI on operating-room hardware, we can aim to make future enhancements faster, more robust, and more directly connected to the surgical workflow. The goal is to give surgeons increasingly precise intelligence at the moment it matters most.”

The work supported by this contribution will target four specific areas: developing tools to reduce the burden of manual expert labeling required to train AI models; building a clearer understanding of how the AI performs across different tissue types and disease presentations; designing a two-tier AI architecture that combines fast initial screening with more detailed follow-up analysis; and optimizing the system for efficient performance on the hardware used in operating room environments. The future deployment of these capabilities will proceed in accordance with standard FDA review processes for class III devices.

Raphael Ronen, Co-Executive Director of INOVAIT, remarked, “Perimeter represents exactly the kind of company the INOVAIT Pilot Fund is designed to support—one that has demonstrated real clinical impact and is now building on that foundation to go further. Pilot Fund projects have the potential to transform patient outcomes, and we are proud to support Perimeter’s work at this important stage.”

Claire combines wide-field optical coherence tomography (OCT) imaging with proprietary AI to help surgeons see microscopic cancer in the operating room, guiding them to areas that warrant a closer look, particularly in the critical margin zone where cancer is most likely to be missed. The technology works alongside other intraoperative margin assessment techniques, giving surgeons additional intelligence that combines real-time imaging with AI detection support before post-operative pathology evaluation.

INOVAIT is a pan-Canadian network funded by the Government of Canada and hosted at the Sunnybrook Research Institute with the objective of building a truly integrated image-guided therapy and AI ecosystem, fueling continuous innovation that revolutionizes healthcare globally. Funding for this project was provided in part by INOVAIT through the Government of Canada’s Strategic Response Fund.

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Pentixapharm Holding (Frankfurt Prime Standard: PTP) has announced that the FDA has cleared its Investigational New Drug (IND) application for its lead CXCR4-targeted diagnostic program in treatment resistant hypertension with underlying primary aldosteronism.

According to Pentixapharm, the clearance authorizes the company to initiate its U.S.-focused, multi-center Phase 3 PANDA clinical study evaluating its novel imaging approach for patient stratification in hypertension.

In a statement, Dirk Pleimes, CEO of Pentixapharm, commented, “This IND clearance represents a key execution milestone and confirms our ability to deliver on our regulatory strategy. With our flagship PANDA program now advancing into Phase 3 in the U.S., we are entering the next phase of value creation. Primary aldosteronism affects up to 10% of patients with hypertension, yet remains significantly underdiagnosed. We believe our first-in-class PET/CT imaging approach has the potential to transform how these patients are identified and, importantly, to guide treatment decisions by enabling precise subtype differentiation. We are focused on rapid study initiation and disciplined execution, while actively engaging with potential strategic partners across imaging and cardiovascular therapeutics. In parallel, we are advancing financing initiatives to support Phase 3 execution and our continued expansion in the U.S. market.”

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ZEO ScientifiX (OTCQB: ZEOX) has announced the expansion of its medical advisory board with the addition of nine physicians and scientific innovators across key disciplines in regenerative and longevity medicine.

The new advisory board members include: Andrea Asseff-Llanes, DDS, board-certified dentist specializing in regenerative dental medicine; Elizabeth Parrish, founder and CEO of closely held BioViva Sciences and a pioneer in gene-based longevity biotechnology; Faryal Farooqi, MD, physician specializing in longevity medicine and metabolic health; Michael Swartzon, MD, board-certified orthopedic sports medicine physician; Mark A. Rosenberg, MD, president and medical director of closely held Advanced Medical Therapeutics and closely held Integrative Cancer Therapeutics; Constantino Mendieta, MD, board-certified plastic surgeon known for innovations in regenerative surgical approaches; Neel Amin, MD, board-certified anesthesiologist and interventional pain medicine specialist and founder of closely held Advanced Relief Institute; David Karli, MD, board-certified orthopedic surgeon and regenerative medicine researcher; and Jacob Sanchez, CRNA, APRN, founder and CEO of closely held Get Refreshed and certified registered nurse anesthesiologist specializing in aesthetic medicine and provider education.

In a statement, George C. Shapiro, MD, FACC, chief medical officer of ZEO, as well as director and chairman of its advisory board, commented, “Medicine has traditionally focused on treating disease after it appears. Our long-term goal is to better understand and influence the biological systems that drive aging itself. Building a medical advisory board of this caliber reflects ZEO ScientifiX’s commitment to advancing regenerative medicine responsibly and with scientific discipline.”

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The nonprofit organization Healing the Hero is bringing hope to U.S. military personnel, veterans, first responders, and Gold Star Families by leveraging neurolinguistic programming (NLP)-informed methods to directly address trauma at its root. Rather than focusing solely on symptom management, the organization’s approach targets what it describes as the neurological imprint of trauma and its by-products, including anxiety, depression, and emotional dysfunction.

“We believe that post-traumatic stress (PTS) is not a disorder, but rather a slow-burn brain injury leading to an overactive nervous system shaped by the body’s natural fight, flight, or freeze response to traumatic events,” Dan Jarvis, founder and board president of Healing the Hero, says in an interview with BioTuesdays.

He explains that by reframing and releasing maladaptive emotional triggers, Healing the Hero’s protocol aims to restore nervous system balance and help individuals who have experienced trauma return to functional, stable lives.

“Our method is profoundly simple in its application, learning, and receiving—but it’s delivering life-changing results,” he adds.

Following extensive research, Healing the Hero developed a proprietary intervention—a protocol designed for rapid nervous system reset called the Trauma Resiliency Protocol-Peer Rescue (TRP-PR). Unlike traditional exposure-based therapies, which often rely on prolonged verbal recounting of traumatic events, TRP-PR minimizes re-traumatization by working directly with the nervous system response.

The process focuses on guiding individuals into a parasympathetic state—often described as “rest and digest”—to help regulate an overactive stress response. According to Mr. Jarvis, this shift allows the brain to reconsolidate traumatic memories without the same emotional charge that previously accompanied them.

“In practice, we’re not changing the memory,” Mr. Jarvis contends. “We’re changing the emotional response attached to it.”

Sessions typically last 45 minutes to one hour, with most individuals completing between one and five sessions. Coaches work with clients to identify and decouple emotional responses from traumatic memory networks, with the goal of reducing triggers and restoring emotional regulation.

He adds that, as a nonprofit organization, there are no fees for veterans, active-duty military, law enforcement, first responders, or their families to access the program.

While prior peer-reviewed work related to earlier iterations of the protocol has already been published, current studies continue to show promising outcomes. At present, Healing the Hero is collaborating with Arizona State University in an effort to advance research and clinical study. In an on-going research initiative involving pre- and post-treatment EEG brain scans of veterans and first responders using Firefly Neuroscience’s (NASDAQ: AIFF) FDA 510(k)-cleared, AI-powered EEG/ERP platform, the collaborators aim to objectively measure changes in brain activity associated with trauma resolution and nervous system regulation.

Mr. Jarvis emphasizes that the organization’s work is grounded in measurable outcomes rather than anecdotal reports alone. “We are seeing, in most cases, near-full symptom remission—and in many instances, complete recovery.”

One de-identified case study published on the Healing the Hero website examines outcomes following just three sessions of TRP-PR in a Vietnam veteran and retired firefighter. According to the report, the individual experienced dramatic reductions across multiple validated clinical scales.

PTSD symptoms, measured by the PCL-5—the standard 20-item self-report instrument used to track treatment progress—were reduced from a severe score of 60 to zero. Depression scores on the PHQ-9—a widely used patient health questionnaire—dropped from 21 to zero. Anxiety scores on the GAD-7—a rapid screening tool for anxiety—also fell from 18 to zero, indicating full remission of self-reported symptoms following treatment.

Beyond psychological measures, the case study also documented improvements in cognitive performance. Overall neurocognitive function increased from 53% at baseline to 88% post-intervention. Specific domains showed similarly strong gains, including executive function and attention rising from 46% to 83%, emotional regulation improving from 42% to 83%, and verbal fluency increasing from 50% to 88%.

Physiological markers of stress regulation shifted as well. Heart rate decreased from 88 beats per minute to 70, while heart rate variability—a key indicator of autonomic flexibility—increased significantly from 17 milliseconds to 60 milliseconds. Total autonomic nervous system power also increased from 129 ms² to 621 ms², suggesting improved physiological resilience.

The case further reported changes in quantitative EEG readings consistent with reduced cortical hyperarousal and improved neural efficiency. Ratios associated with attentional and stress-related activity normalized toward baseline ranges following TRP-PR treatment.

Figure A1. Pre-Intervention Evoke Eyes-Closed qEEG Brain Map
Baseline Evoke Neuroscience (Firefly) qEEG showing elevated posterior excess activity and increased theta: beta ratio, which Healing the Hero describes as consistent with elevated cognitive-emotional load.

Figure A2. Post-Intervention Evoke Eyes-Closed qEEG Brain Map
Post-treatment Evoke Neuroscience (Firefly) qEEG showing improved cortical organization and reduced excess activity following three TRP-PR sessions.

While Mr. Jarvis acknowledges these findings are preliminary, he points to them as an example of how quickly some individuals respond. “What we are seeing is a multi-system change happening in a very short period of time,” he notes. “When the nervous system is able to reset, everything else follows—sleep, cognition, emotional stability, and even physical regulation.”

Recalling his own personal path through trauma, Mr. Jarvis highlights that the protocol’s development is deeply informed by his military and law enforcement history. While serving in the U.S. Army for approximately 12 years, including deployments in Iraq and Afghanistan, he experienced repeated exposure to combat trauma and sustained multiple traumatic brain injuries.

One defining incident occurred in 2011 during a night patrol in Afghanistan when he stepped on a pressure plate IED. “I was pretty dazed and blasted from that moment, and I really didn’t sleep after that. Every time I tried to sleep, I would hear the explosion and my heart would stop,” he says.

The psychological toll intensified with subsequent events, including the loss of fellow soldiers under his command and the emergence of survivor’s guilt. After medical retirement from the military, he returned to law enforcement, where he felt stabilized. “I thought I had beaten PTS, but I soon realized I was operating in an environment that kept my nervous system in fight or flight, which felt normal.”

When he eventually retired from law enforcement, the trauma symptoms returned in full force, including nightmares, hypervigilance, and emotional instability.

Mr. Jarvis says he sought treatment through the Department of Veterans Affairs, where he was prescribed medication and participated in prolonged exposure therapy. While widely used in trauma care, he describes the experience as destabilizing.

“You’re activating your nervous system over and over again,” he asserts. “For many of us, it felt like it made things worse. The care was also inconsistent, with appointments often postponed for weeks, during which time my emotions would spiral out of control.”

Mr. Jarvis later explored other modalities, including eye movement desensitization and reprocessing (EMDR), but found limited relief. These experiences, he says, ultimately led him to investigate alternative frameworks involving memory reconsolidation, nervous system regulation, and NLP-based approaches.

A turning point came through exposure to reconsolidation-based trauma protocols and peer-led interventions, which he credits with helping him regain stable sleep and emotional regulation.

“With our approach, we’re not just reducing symptoms—we’re changing the way the nervous system responds to memory itself,” he says.

For individuals seeking a more spiritual framework, Healing the Hero offers a faith-based adaptation called the “Jesus Protocol.” The underlying process remains the same, but participants are encouraged to incorporate their faith into the reframing and emotional reconsolidation work.

“Participation in the program is not limited by belief system—the protocol is adapted to align with each individual’s world view,” Mr. Jarvis says.

He adds that beyond clinical outcomes, Healing the Hero also provides training for peer coaches, first responders, and community-based organizations. The goal is to expand access in underserved areas and reduce reliance on an over-burdened mental health system.

In addition to his work with military and first responder populations, Mr. Jarvis has also co-founded a fee-based, civilian-focused program called The Anxiety Guys, which applies the same TRP-PR framework to individuals outside uniformed service roles. He notes that his motivation for expanding the model into civilian settings was shaped in part by his experience with the suicide and struggle of personal contacts, who were not military or first responders, but were dealing with untreated anxiety and trauma-related distress nonetheless.

The Anxiety Guys extends TRP-PR coaching to civilians living with the chronic anxiety, panic, and emotional dysregulation resulting from traumatic events. With an emphasis on rapid nervous system regulation and reducing the physiological intensity of fear-based responses, the goal is to make the same nervous system-focused interventions accessible beyond high-risk professions.

Looking ahead, Mr. Jarvis believes the organization is approaching a point of rapid scalability through training expansion and emerging technology integration. “We want to work ourselves out of existence because if we’re successful, there won’t be a need for us anymore.”

With approximately 28 trained coaches currently and additional training cohorts underway, Healing the Hero is focused on expanding peer-to-peer delivery models that allow the protocol to reach individuals regardless of geography or access to traditional care.

“At its core, Healing the Hero is built around a single premise—trauma is not only psychological, but neurological—and potentially reversible when addressed through the nervous system itself,” he concludes.

“Our mission is to change how trauma recovery is understood and delivered. We’re just trying to save one person at a time—change one family tree at a time.”

• • • •

To connect with Healing the Hero or any other companies featured on BioTuesdays, send us an email at editor@biotuesdays.com.

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Eledon Pharmaceuticals (NASDAQ: ELDN) announced updated results from an investigator-initiated trial evaluating tegoprubart, its investigational anti-CD40L antibody, as part of a calcineurin inhibitor-free immunosuppression regimen in patients with type 1 diabetes undergoing allogeneic islet cell transplantation at the University of Chicago Medicine Transplant Institute.

According to Eledon, all 12 patients in the study achieved insulin independence, producing their own insulin and no longer required exogenous insulin therapy to manage their T1D. The results were presented by trial investigator Piotr Witkowski, MD, PhD, director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the American Diabetes Association 86th Scientific Sessions, taking place June 5-9, 2026, in New Orleans.

In a statement, David-Alexandre C. Gros, MD, CEO of Eledon, commented, “T1D patients have been waiting decades for a potential functional cure, and it is exciting to see the progress being made in that direction through the emerging promise of tegoprubart. For people who have difficulty managing T1D, a regimen that may protect an islet cell graft without the long-term burden associated with calcineurin inhibitors, the current standard of care, could be transformational. We are proud to support this important research effort led by Dr. Witkowski and the team at UChicago Medicine. We also look forward to working closely with the FDA towards our goal of receiving regulatory guidance on a path to market for tegoprubart in islet cell transplantation later this year.”

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Seaport Therapeutics (NASDAQ: SPTX) has announced positive data from the multiple-ascending dose portion of its Phase 1 proof-of-concept clinical trial evaluating repeat dosing of GlyphAgo (SPT-320), a novel, Glyphed oral prodrug of agomelatine, in healthy volunteers.

The trial, which included 174 participants, was conducted in multiple parts to evaluate the safety, tolerability, and PK of GlyphAgo and to compare the PK of GlyphAgo to agomelatine alone. According to Seaport, across all dose levels evaluated, GlyphAgo was well tolerated, with no serious or severe adverse events, no liver-related adverse events, and no clinically significant changes in liver-related laboratory parameters observed.

In a statement, Daphne Zohar, co-founder and CEO of Seaport, commented, “We are enthusiastic about the data from our Phase 1 program for GlyphAgo, where we’ve now observed consistent safety, tolerability, and PK across all cohorts. We believe these results substantially derisk our future clinical development approach and strengthen the differentiated profile of GlyphAgo. The complete Phase 1 data package further validates our Glyph platform and supports the advancement of GlyphAgo into two parallel Phase 2 trials as we work to bring a new treatment option to patients with generalized anxiety disorder who have not had a new medicine approved in almost 20 years.”

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Shattuck Labs (NASDAQ: STTK) has announced data from its Phase 1 trial evaluating the safety, tolerability, pharmacokinetics, receptor occupancy, pharmacodynamics, and immunogenicity of SL-325, its lead DR3 blocking antibody candidate.

In a statement, Taylor Schreiber, MD, PhD, CEO of Shattuck, commented, “SL-325 is now the first antibody that blocks the receptor for TL1A, known as DR3, to generate human clinical data. The profile of SL-325 is highly encouraging, including a potentially best-in-mechanism immunogenicity profile, saturation of DR3 at low doses of SL-325, and durable inhibition of TL1A binding for months after a single dose.”

Dr. Schreiber added, “These data indicate that blocking DR3 with SL-325, or with our DR3 by IL-23 receptor blocking bispecific antibody candidate, SL-846, may substantially improve upon the efficacy shown to date with the TL1A inhibitor class, providing an opportunity to maximize potential efficacy for TL1A blockade in IBD and beyond.”

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Anteris Technologies Global (NASDAQ: AVR; ASX: AVR) has received full regulatory clearance from the French National Agency for Medicines and Health Products Safety (ANSM) enabling patient recruitment to begin in France for the DurAVR Transcatheter Heart Valve (THV) global PARADIGM pivotal trial in patients with severe calcific aortic stenosis.

According to Anteris, the PARADIGM trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available THV replacements.

In a statement, Wayne Paterson, vice chairman and CEO of Anteris, commented, “Securing French regulatory clearance is an important step in the execution of the PARADIGM trial. France represents a strategically important market with highly experienced centers and investigators, reinforcing the quality and conduct of the study.”

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MindBio Therapeutics (CSE: MBIO; Frankfurt: WF6; OTCQB: MBQIF) has launched its lead commercial software Intox AI for validation and testing of intoxication and fatigue.

Intox AI enables new analytical capabilities to detect cocaine, cannabis, alcohol, psychedelics, narcotic use and human fatigue non-invasively, from voice.

In a statement, Justin Hanka, CEO of MindBio, commented, “The launch of Intox AI is a significant advancement for drug and alcohol testing across a range of substances that affect human performance and safety. The company is on track to deliver its first prototype testing kiosks shortly and is delighted the core software is ready for testing and validation.”

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Tempest Therapeutics (NASDAQ: TPST) has appointed two independent directors, Drake Richey and John Yee, MD, MPH, to its board of directors (BoD), effective June 4, 2026.

Mr. Richey and Dr. Yee collectively bring decades of experience in corporate finance and therapeutic product development to Tempest’s BoD.

Mr. Richey serves as president of Bush & Company, a financial advisory firm that advises high-net-worth families and business owners on investment strategy, risk management, and multi-generational planning. Dr. Yee is SVP, medical affairs, at closely held Apnimed.

In a statement, Matt Angel, PhD, president and CEO of Tempest, commented, “Over the past several months, we have built a portfolio of CAR-T cell therapy product candidates targeting safe, effective treatments for patients with advanced cancers. The addition of Drake and John to the board could further enable us to realize our vision of providing meaningful treatment options to cancer patients that have either failed or relapsed from prior therapies, while supporting Tempest’s focus on driving growth and disciplined capital allocation. I look forward to Drake’s and John’s insights as we continue to position the company for long-term success.”

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