Regulatory Green Lights Are Powering the Next Phase of the AI Health Boom
VANCOUVER – Baystreet.ca News Commentary – Artificial intelligence is rapidly transforming the healthcare landscape, unlocking new possibilities for early detection, patient care, and operational efficiency. Startups across the sector are deploying AI-driven tools to expand patient access, streamline workflows, and generate scalable revenue models that appeal to forward-looking investors. With usage accelerating among both patients and providers, AI-powered diagnostics and treatment platforms are quickly becoming standard practice. As regulatory hurdles begin to fall, several innovators are approaching key commercial inflection points—including Avant Technologies, Inc. (OTCQB: AVAI), Treatment.com AI Inc. (CSE: TRUE) (OTCQB: TREIF), Schrödinger, Inc. (NASDAQ: SDGR), Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX), and Rallybio Corporation (NASDAQ: RLYB).
The AI healthcare market is expected to top US$110 billion by 2030, but Accenture suggests the upside could be far greater—projecting over US$461 billion in additional value creation by 2035, layered on top of a sector already forecasted to exceed US$2.26 trillion.
Avant Technologies, Inc. (OTCQB: AVAI) and joint-venture partner Ainnova Tech are continuing to raise visibility for their AI-powered diagnostic platform, with Ainnova CEO Vinicio Vargas recently featured as a speaker at Roche's 'Macular Spectacular' Ophthalmology Conference in Cartagena, Colombia.
The event brought together leading voices in visual health from across Latin America, with discussions focused on advancing patient outcomes through AI innovation. Vargas, who also sits on the board of Ai-nova Acquisition Corp. (AAC), presented Vision AI as a transformative tool to expand access to early diabetic retinopathy screening and reduce preventable blindness throughout the region.
Vargas also highlighted a Q4 2024 alliance with Roche and prepaid‑health‑plan provider Salud 360 that is piloting Vision AI among high‑risk diabetic patients; if successful, the program will be rolled out in the United States, Canada, and Europe through Ai ‑ nova Acquisition Corp. (AAC), which holds worldwide rights to Ainnova's technology portfolio .
This momentum builds on a recent regulatory breakthrough in the U.S. market. Avant and Ainnova recently completed a key pre-submission meeting with the FDA for Vision AI, the companies' flagship diagnostic platform for diabetic retinopathy and other retinal diseases.
'We're truly excited about this next phase,' said Vinicio Vargas, CEO at Ainnova and a member of the Board of Directors of Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova's technology portfolio. 'We're getting ready to begin data collection across primary care clinics in the U.S. with a study that is simple, yet rigorous—comparing our AI-based retinal screening to the readings of three retinologists.
The July 15 meeting marked a critical step toward securing 510(k) clearance for Vision AI. The FDA session offered clear feedback on study design, site selection, and execution strategy—enabling Ainnova and its clinical trial partner, Fortrea, to finalize preparations for U.S.-based trials.
'This milestone not only brings us closer to validating our platform in the world's largest healthcare market, but it also paves the way for the upcoming approval of our new automated retinal camera,' added Vargas. 'We believe will [it] be a game changer—making diabetic retinal screenings faster, more accessible, and available from virtually any point of care.'
While regulatory efforts advance in the U.S., the company has already launched a groundbreaking chronic care model across Latin America. The program, now live through Grupo Dökka's Fischel and La Bomba pharmacy chains, offers free, walk-in retinal risk assessments—delivering real-time AI results and connecting at-risk patients directly with clinics and specialists.
Over 30% of diabetics develop diabetic retinopathy, a leading cause of preventable blindness. Vision AI offers early, low-cost screening without the need for an ophthalmologist onsite. The model has gained support from pharmacies, insurers, and pharmaceutical partners—demonstrating real traction across the healthcare value chain.
Avant' s role in these efforts continues to grow. Through Ai-nova Acquisition Corp., which it co-founded and structured, Avant maintains global licensing rights to Ainnova's platform and stands to benefit from both U.S. and international commercialization. The Latin American pilot programs are already generating momentum, with U.S. trials positioned to unlock a vastly larger market.
The company is also preparing a standalone venture to house a potential therapeutic candidate for diabetes—bringing leadership, data, and IP into one streamlined structure for diagnostics and treatment alike.
Looking ahead, Vision AI could serve as a frontline tool for broader disease detection. Ainnova's future roadmap includes a cloud-connected retinal camera for rural clinics and new modules aimed at identifying Alzheimer's, cardiovascular conditions, and other chronic diseases through retinal or blood biomarkers.
A structural simplification may be on the horizon as well. A previously announced non-binding LOI remains active for Avant to acquire 100% of Ainnova Tech —potentially consolidating all IP, leadership, and commercial rights under one public entity. Such a move would give investors pure-play exposure to this fast-evolving tech stack, while deepening operational alignment between the firms.
Treatment.com AI Inc. (CSE: TRUE) (OTCQB: TREIF) and its digital health platform Rocket Doctor have diverted thousands of low-acuity patients from overwhelmed Canadian emergency rooms using smart triage, AI tools, and virtual MD visits.
'We see so many patients in our rural, remote and even urban communities going to ED, often when they recognize that they could be seen outside the hospital.' Said Dr. William Cherniak, CEO of Rocket Doctor. 'There has been a lot of good content from the Canadian Association of Emergency Physicians (CAEP) to recognize that we need to support patients to access healthcare where they see most appropriate. We often see patients choose an ED with low-acuity issues simply because of a lack of access to family doctors, or other accessible out-patient choices.'
Their program at Georgian Bay General Hospital alone saved an estimated CA$1.4 million and resolved 97.5% of patient cases virtually. With over 12,000 recent visits in Alberta and continued provincial expansion, the AI-powered system is proving its value at scale
Schrödinger, Inc. (NASDAQ: SDGR) received FDA Fast Track designation for its AI-discovered MALT1 inhibitor, SGR-1505, targeting relapsed/refractory Waldenström macroglobulinemia.
"We are excited to receive Fast Track designation for SGR-1505, which underscores the significant need in patients with Waldenström macroglobulinemia," said Karen Akinsanya, Ph.D., president, head of therapeutics R&D and chief strategy officer, partnerships at Schrödinger. "Despite the continued therapeutic advances in the treatment of hematologic malignancies, treatment failure and disease progression due to BTK resistance remains a challenge for a growing number of patients. This unmet need represents an opportunity for novel mechanisms such as MALT1 as monotherapy and as part of new combination regimens."
The drug candidate, developed using Schrödinger's proprietary computational platform, has shown promising early results across several B-cell malignancies. This milestone highlights the growing role of AI-driven molecular discovery in accelerating cancer drug development.
Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX) has acquired full rights to REV102, a potential first-in-class oral therapy for hypophosphatasia (HPP), a rare genetic bone disorder with limited treatment options. Developed in collaboration with Rallybio Corporation (NASDAQ: RLYB), REV102 targets the ENPP1 enzyme and is being positioned as a convenient, non-immunogenic alternative to costly injectable enzyme replacement therapies.
'We extend our sincere thanks to Rallybio for their invaluable partnership in advancing this program to its current stage,' said David Hallett, Chief Scientific Officer of Recursion. 'Having full ownership of this important program allows Recursion to accelerate the development of the first potential oral disease-modifying treatment to HPP patients, who currently face significant challenges with limited access to existing therapies. While this is a preclinical asset that will require further study, we look forward to leveraging the full power of the Recursion OS to gain even deeper insights and accelerate delivery of the potential treatment.'
Recursion used its proprietary AI-driven Recursion OS to design and optimize the drug, which has shown promising preclinical results and is expected to enter Phase 1 trials in 2026.
'The Rallybio team has long been committed to targeting ENPP1 to address a significant unmet need in patients with HPP,' said Stephen Uden, M.D., CEO of Rallybio. 'By combining Rallybio's expertise in HPP preclinical and translational research with Recursion's integrated AI/experimental platform, we transformed this concept into the first potential oral disease-modifying treatment for HPP. We look forward to the advancement of REV102 through key milestones and, ultimately, to the delivery of this important treatment to patients in need.'
Under the deal, Rallybio will receive equity, milestones, and royalties as Recursion advances development.
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