RenovoRx, Inc. (RNXT): Business Model Canvas [Dec-2025 Updated]

So, you want the real mechanics behind RenovoRx, Inc. (RNXT) as they try to pivot from clinical-stage R&D to commercial reality? Honestly, it's a tight spot: they are pushing the pivotal TIGeR-PaC trial while holding just $10.0 million in cash (Sept 2025) against quarterly burn rates near $1.7 million for both R&D and SG&A. This Business Model Canvas cuts through the noise, showing exactly how their patented TAMP™ platform and the FDA-cleared RenovoCath device-which has only generated about $900,000 in revenue so far-must scale through direct sales to those 14 cancer centers to justify the risk. Check out the nine blocks below to see their near-term path.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Key Partnerships

You're looking at the alliances that support RenovoRx, Inc.'s operations as of late 2025. These relationships are critical for both the ongoing pivotal trial and the early commercial rollout of RenovoCath.

Device Manufacturing Partner: Medical Murray Inc.

The manufacturing backbone for the FDA-cleared RenovoCath device is anchored by Medical Murray Inc., located in North Barrington, IL, U.S.. This partnership was expanded with a new project work order signed in September 2024, which included performance incentives for Medical Murray.

To incentivize manufacturing milestones, RenovoRx will issue Medical Murray a warrant to purchase up to 709,500 shares of RenovoRx common stock. The efficiency of this supply chain is showing up in the financials; the gross margin for RenovoCath was approximately 64% in the second quarter of 2025.

Clinical Trial Network: U.S. Cancer Sites for TIGeR-PaC

The Phase III TIGeR-PaC trial, evaluating the Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, relies on a network of U.S. clinical cancer sites. The trial protocol requires randomization of 114 patients, with a final analysis contingent on 86 protocol-specified events (deaths).

The enrollment timeline has been adjusted; completion is now expected in early 2026. As of May 2, 2025, 91 patients had been randomized, and 56 events had occurred, which triggered the second interim analysis. The independent Data Monitoring Committee (DMC) recommended continuing the trial after reviewing this data.

The commercial side is also building on this clinical base. As of September 30, 2025, 14 cancer centers were approved to purchase RenovoCath, with 5 of those centers actively treating patients.

Here's a look at the TIGeR-PaC trial status:

Academic Collaboration: Johns Hopkins Medicine

Johns Hopkins Medicine joined the TIGeR-PaC trial network, initiating patient enrollment at their Sibley Memorial Hospital campus. This academic site contributes to the study of the drug-device combination for locally advanced pancreatic cancer (LAPC).

Key personnel from Johns Hopkins Medicine are involved in the trial oversight:

• Dr. Valerie Lee, MD, appointed as the TIGeR-PaC Principal Investigator at Johns Hopkins Medicine.
• Dr. Michael J. Pishvaian, MD, PhD, continues to serve as the Trial Chairman for the entire TIGeR-PaC study.

Commercial Distribution Exploration

RenovoRx, Inc. is actively pursuing avenues to scale its commercial footprint beyond its in-house efforts. The company plans to continue exploring revenue-generating activity either independently or in tandem with a medical device commercial partner to satisfy anticipated demand for RenovoCath.

The estimated initial Total Addressable Market (TAM) for RenovoCath as a stand-alone device is approximately $400 million in peak annual U.S. sales. The company reported year-to-date revenue through Q3 2025 of approximately $900,000.

Specific entities mentioned in the context of potential partnerships include:

• Actively exploring a strategic medical device commercial partner.
• Boston Scientific (BSX) is noted as a prior Series B lead investor, believed to still hold a 4% stake.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Key Activities

You're looking at the core engine driving RenovoRx, Inc. (RNXT) right now-the activities that consume capital while simultaneously building future revenue and clinical validation. It's a dual-track approach, balancing the commercial push for the RenovoCath device with the critical, long-term work on the TIGeR-PaC trial.

Executing the pivotal Phase III TIGeR-PaC clinical trial

The execution of the pivotal Phase III TIGeR-PaC clinical trial is a primary key activity, focusing on the novel drug-device combination product candidate, intra-arterial gemcitabine delivered via RenovoCath, known as IAG. This activity is heavily funded by R&D, which stood at $1.7 million for the quarter ended September 30, 2025. The trial is on track, with enrollment completion targeted for early 2026 and the final data readout anticipated in 2027. The independent Data Monitoring Committee (DMC) reviewed the second pre-planned interim analysis in Q2 2025 and recommended the study continue, which is a strong signal of potential. As of August 12, 2025, the study had randomized 95 patients, recording 61 events at that point. RenovoRx believes its cash position of $10.0 million as of September 30, 2025, is sufficient to fund the remaining enrollment activities.

The trial's progress involves several crucial operational milestones:

• Completing Phase III TIGeR-PaC enrollment in early 2026.
• Anticipating final data readout in 2027.
• Maintaining blinding across the team, outside of the Chief Medical Officer, for FDA integrity.
• Successfully launching a new post-marketing observational registry study, PanTheR, to gather real-world evidence.

Commercializing the FDA-cleared RenovoCath device in the U.S.

Commercialization is the immediate revenue-generating activity, centered on the FDA-cleared RenovoCath device as a standalone product. This effort started generating revenue in Q1 2025, which was the first full quarter of sales. The momentum is clear, though revenue is still ramping up from the initial base. Selling, general, and administrative (SG&A) expenses for Q3 2025 were approximately $1.7 million, reflecting the investment in this commercial build-out. The initial Total Addressable Market (TAM) for RenovoCath as a standalone device is estimated at a peak annual U.S. sales opportunity of $400 million.

Here's a look at the device sales performance through the first three quarters of 2025:

The adoption rate is tracked by the number of approved centers, which is a key metric for future revenue scaling. The company is focused on increasing the frequency of procedures at these sites.

Developing the Trans-Arterial Micro-Perfusion (TAMP™) therapy platform

This activity is foundational, as the RenovoCath device powers the patented TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform. This platform is what underpins the company's belief in a potential several-billion-dollar U.S. TAM as they expand into additional cancer indications beyond the current focus. The R&D spend supports the ongoing development and refinement of this targeted drug-delivery methodology.

Expanding the intellectual property portfolio

Protecting the TAMP therapy platform and the RenovoCath device through intellectual property is a non-negotiable activity. RenovoRx's strong and growing intellectual property portfolio provides key support for its commercialization efforts. You should track the portfolio expansion, which includes 19 patents globally as of Q1 2025, according to company statements. This patent strength is viewed as strengthening the competitive position of the entire platform.

Building a lean, focused commercial sales organization

The strategy here is definitely to stay lean while building momentum. Initially, the organic revenue growth in Q1 and Q2 2025 was achieved without a dedicated sales and marketing team. Following the second quarter, the company began building out this function strategically. By Q3 2025, the commercial team structure included the recent hiring of Philip Stocton as Senior Director of Sales & Market Development, plus two regional sales managers. This measured approach aims to drive sustained growth while maintaining a prudent capital deployment philosophy, supported by the $10.0 million cash position at September 30, 2025.

The commercial expansion progress includes:

• Expanding from five cancer center customers approved at the start of 2025.
• Reaching 14 leading cancer centers approved to purchase RenovoCath as of November 7, 2025.
• Securing early repeat orders from initial sites.

Finance: draft 13-week cash view by Friday.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Key Resources

You're looking at the core assets that power RenovoRx, Inc. as of late 2025. These aren't just ideas; they are tangible, protected, and currently generating revenue or driving critical clinical milestones.

The intellectual property surrounding the Trans-Arterial Micro-Perfusion (TAMP™) therapy platform and the RenovoCath device forms a critical barrier to entry. This technology is designed for targeted therapeutic delivery across the arterial wall near the tumor site.

• Patented TAMP™ therapy platform and RenovoCath device.
• FDA clearance for RenovoCath as a standalone drug-delivery device, initially received in 2014.
• The company began generating revenues from RenovoCath commercial sales in December 2024.

The company's financial foundation as of the third quarter end is a key resource supporting near-term operations.

Cash and equivalents of $10.0 million as of September 30, 2025. This cash position is believed to be sufficient to fund ongoing commercialization efforts and the completion of enrollment in the Phase III TIGeR-PaC trial into mid-2026 under the current operating plan. This cash position follows year-to-date revenue of approximately $900,000 through the end of the third quarter.

The intellectual property portfolio is growing, which is essential support for both commercial scale-up and the pivotal trial.

The RenovoCath device, as a standalone product, has an estimated initial peak U.S. sales opportunity of $400 million annually. Commercial adoption is building, which is a direct measure of this resource's current value.

• Number of cancer centers approved to purchase RenovoCath as of Q3 2025: 14.
• Number of active centers treating patients with repeat orders: 5.
• Number of additional centers requesting formal product quotes: 10.

The clinical data from the ongoing TIGeR-PaC trial is perhaps the most significant long-term resource, as it supports the combination product candidate (IAG) for locally advanced pancreatic cancer.

The trial's progression is validated by external oversight. The Independent Data Monitoring Committee recommended the trial continue after reviewing the second pre-planned interim analysis. That second analysis was triggered by the 52nd patient death. Also, a post-marketing registry launched in July 2025, with the first registry patient treated in September 2025, generating real-world data.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a physician or patient would choose RenovoRx, Inc. (RNXT)'s approach over the existing standard. It boils down to getting the drug where it needs to go with less collateral damage.

The central value proposition is the use of the patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, which utilizes the FDA-cleared RenovoCath device to achieve targeted drug delivery directly to solid tumors.

• Targeted drug delivery directly to solid tumors via RenovoCath.
• Potential for reduced systemic toxicity versus standard IV chemotherapy.
• RenovoGem interim data showed 8-month median PFS benefit in LAPC.
• A novel, patented mechanism for treating difficult-to-treat cancers.

The mechanism is designed to bathe the target tumor across the arterial wall near the site, which is intended to minimize the toxicities commonly associated with systemic intravenous (IV) therapy.

Here's a look at the clinical data supporting the value proposition, comparing the TAMP™ approach to the standard of care for Locally Advanced Pancreatic Cancer (LAPC):

The company is actively commercializing RenovoCath as a standalone device, which generated approximately $266,000 in revenue in the third quarter ended September 30, 2025. Year-to-date revenue through Q3 2025 reached approximately $900,000. This commercial traction supports the estimated total addressable market (TAM) for RenovoCath as an initial $400 million peak annual U.S. sales opportunity.

The TAMP platform's potential extends beyond LAPC, as investigator-initiated studies and a post-marketing registry launched in July 2025 are generating real-world data to support broader use across other solid tumors.

The company's financial position as of September 30, 2025, was $10.0 million in cash and cash equivalents, which management anticipates will fund commercial scale-up and continued progress in the Phase III TIGeR-PaC trial into the middle of 2026 under current plans. As of Q3 2025, the number of leading cancer centers approved to purchase RenovoCath expanded to 14.

The TIGeR-PaC Phase III trial is designed to validate the clinical benefit, with a primary endpoint of a 6-month Overall Survival benefit versus standard of care.

Finance: review the cash runway projection based on Q3 2025 burn rate and projected revenue growth for mid-2026 funding coverage.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Customer Relationships

You're looking at how RenovoRx, Inc. builds and maintains its connections with the oncology community as they scale commercial sales of RenovoCath. The relationship strategy is clearly centered on deep engagement with the institutions actually using the technology, which makes sense given the specialized nature of the TAMP™ (Trans-Arterial Micro-Perfusion) platform.

Direct, high-touch relationship management with cancer centers.

The core of the relationship strategy involves direct engagement with cancer centers, moving them from initial approval to active, repeat users. This is a classic high-touch approach for a novel medical device. You can see the traction in the center approvals since the organic commercial launch in December 2024. The company has successfully onboarded new institutions, including several high-volume National Cancer Institute-designated centers, which suggests a focused, targeted sales effort even before the full commercial team was in place.

Here's the quick math on customer acquisition through late 2025:

If onboarding takes 14+ days, churn risk rises, so maintaining a smooth activation process for these 14 centers is key.

Fostering physician-to-physician advocacy for the TAMP™ platform.

The company is actively encouraging word-of-mouth within the medical community. Management specifically noted being encouraged by the increasing physician-to-physician advocacy for the TAMP™ platform as of their Q3 2025 update. This organic endorsement is critical because it validates the clinical utility of the targeted delivery system beyond initial trial data. While specific advocacy metrics aren't public, the fact that centers are moving to repeat orders strongly implies positive feedback from the treating physicians.

Focus on securing and fulfilling repeat purchase orders from active users.

The real measure of customer satisfaction, especially in a capital-efficient model, is repeat business. The growth in procedures at the initial active centers has directly translated into an increase in repeat purchase orders, which is a strong indicator of clinical satisfaction and growing demand for RenovoCath. You saw this trend emerge early:

• In Q2 2025, 4 of the 13 approved centers had used the device and all 4 subsequently made repeat purchase orders.
• The Q3 2025 revenue of approximately $266,000 was explicitly driven by both new customer orders and these repeat purchases.

The year-to-date revenue through Q3 2025 reached approximately $900,000, showing the compounding effect of these recurring orders.

Dedicated commercial team, led by a new Senior Director of Sales.

RenovoRx, Inc. executed a planned shift from an in-house, non-dedicated sales structure to building out a formal commercial team in the second half of 2025. This move was designed to widen market penetration in 2026. The foundation of this team includes the hiring of Philip Stocton as Senior Director of Sales & Market Development, alongside two regional sales managers.

The SG&A expenses for Q3 2025 were approximately $1.7 million, up from $1.2 million in the same period last year, reflecting this investment in personnel and consulting fees to support commercialization efforts.

Finance: draft 13-week cash view by Friday.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Channels

You're looking at how RenovoRx, Inc. gets its RenovoCath device into the hands of clinicians, which is a critical part of their strategy as they scale up from clinical trials to commercial sales. Right now, the focus is heavily on a direct approach, but they are clearly signaling an openness to partnerships down the line.

The initial commercial rollout, which started in December 2024, has been managed organically, meaning they achieved initial traction without a dedicated, large sales and marketing team, though they did hire a Senior Director of Sales and Market Development in August 2025 to coordinate expansion. The company plans to strategically add a small number of sales personnel in the second half of 2025 to help widen market penetration in 2026.

The direct commercial sales channel targets medical institutions using a phased approach:

• Customer Acquisition Milestones: As of November 7, 2025, RenovoRx had 14 cancer center customers approved to purchase RenovoCath, a significant increase from 5 approved centers at the start of the year.
• Active Adoption: Of those approved centers, four were actively using the device in patients and had already initiated repeat purchase orders as of August 2025.
• Revenue Generation: The second quarter of 2025 saw revenues of approximately $422,000 from commercial sales of the device. Year-to-date revenue through the third quarter of 2025 grew to approximately $900,000.
• Market Potential: RenovoRx estimates the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an approximately $400 million peak annual U.S. sales opportunity.

The focus on high-volume National Cancer Institute (NCI)-designated cancer centers is clear, as these institutions are explicitly mentioned as part of the expanding customer base. This network includes both NCI-designated academic and community centers.

Here's a quick look at the current commercial footprint versus the pipeline of potential customers from the TIGeR-PaC trial:

The conversion of TIGeR-PaC clinical trial sites is a major near-term channel opportunity. RenovoRx believes many of the 18 cancer centers that participated in the Phase III TIGeR-PaC trial could become commercial customers once trial enrollment is complete. Enrollment completion for the TIGeR-PaC trial is expected in early 2026. As of August 12, 2025, the trial had 95 patients randomized with 61 events recorded.

Regarding wider market access, RenovoRx is actively exploring options beyond its current in-house commercialization efforts. The company stated it will continue to actively explore further revenue-generating activity, either on its own or in tandem with a medical device commercial partner.

Finance: draft 13-week cash view by Friday.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Customer Segments

You're hiring before product-market fit, so knowing exactly who buys and who uses your device is the first step in building out the rest of the Business Model Canvas for RenovoRx, Inc. (RNXT). Here is the breakdown of the customer segments as of late 2025.

U.S. Cancer Centers and Active Users

The immediate commercial customer segment is the medical institution itself, specifically those approved to purchase the FDA-cleared RenovoCath device for use in interventional procedures. As of early November 2025, RenovoRx, Inc. had expanded its commercial footprint to 14 leading cancer centers approved to purchase RenovoCath. This is a significant jump from the five approved centers at the start of 2025.

Within these centers, adoption is showing early signs of stickiness, which is what you want to see. Four of these approved centers have already used the device in patients and subsequently made repeat purchase orders. The year-to-date revenue through the end of the third quarter of 2025, approximately $900,000, reflects this growing clinical adoption.

The initial estimated peak U.S. addressable market for the RenovoCath as a stand-alone device is pegged at $400 million in annual peak sales.

Here's a look at the commercial traction:

Interventional Specialists

The actual users driving the procedure volume are the specialists within these centers. This segment comprises:

• Interventional oncologists performing targeted intra-arterial procedures.
• Interventional radiologists using the FDA-cleared device for temporary vessel occlusion and drug infusion.

The growing physician-to-physician advocacy for the Trans-Arterial Micro-Perfusion (TAMP) platform is a key driver for expansion.

Primary Patient Population: Locally Advanced Pancreatic Cancer (LAPC)

The most immediate patient segment is those diagnosed with locally advanced, unresectable pancreatic cancer, the focus of the pivotal Phase III TIGeR-PaC trial. This trial is designed to evaluate the drug-device combination of intra-arterial gemcitabine delivered via RenovoCath (IAG).

The statistical requirements for trial completion define the immediate patient cohort size needed for the next major clinical milestone:

• Total randomized patients required by protocol: 114 patients.
• Events (deaths) necessary for final analysis: 86 events.
• Patients randomized as of August 12, 2025: 95 patients.

The goal for this segment is to move from clinical trial enrollment to standard of care integration, which is supported by the Orphan Drug Designation for pancreatic cancer.

Future Expansion Patient Segments

RenovoRx, Inc. is actively positioning for expansion beyond LAPC, leveraging the Orphan Drug Designation for RenovoCath with gemcitabine, which also covers bile duct cancer. This points to the next target patient group:

• Patients with extrahepatic Cholangiocarcinoma (bile duct cancer).
• Patients with other solid tumors, as indicated by the launch of the PanTheR Post-Marketing Registry Study to evaluate real-world safety across diverse cancer types.

The company sees potential for a several-billion-dollar U.S. Total Addressable Market over time by expanding into these other indications.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Cost Structure

You're looking at the primary cost drivers for RenovoRx, Inc. as of the third quarter of 2025. For a company in this stage, costs are heavily weighted toward clinical development and building out commercial infrastructure, even while generating initial device revenue.

The operating expenses for the third quarter ended September 30, 2025, show a significant commitment to both research and general operations. Honestly, these figures are what you'd expect when pushing a pivotal trial toward completion while simultaneously scaling a new device.

Here's a breakdown of the key expense categories:

• High Research and Development (R&D) expenses were reported at $1.7 million for the quarter ended September 30, 2025.
• Selling, General, and Administrative (SG&A) costs were approximately $1.7 million for the same quarter.

The R&D spend reflects continued investment in the TIGeR-PaC trial and support for investigator-initiated and registry studies. The SG&A increase, up from $1.2 million in the prior year period, reflects stable operating expenses while adding targeted commercial capabilities.

The costs associated with the RenovoCath device sales, which fall under Cost of Revenue, can be inferred from the revenue and gross profit figures for Q3 2025. The company reported revenues of approximately $266,000 for the third quarter, resulting in a gross profit of $0.213 million. Management noted that the margin trajectory is improving due to reduced Cost of Goods Sold (COGS) and a strong U.S.-based supply chain, positioning device gross margins to increase as scale builds.

The financial commitment to the Phase III TIGeR-PaC trial is substantial, though the company believes its current cash position is adequate to cover the remaining costs to finish enrollment. Here's how the key financial metrics related to operations and the trial looked at quarter-end:

The costs associated with completing Phase III TIGeR-PaC trial enrollment are being funded from the existing cash balance. The company stated that its cash of $10.0 million as of September 30, 2025, is believed sufficient to fund ongoing commercialization efforts and the completion of enrollment in its Phase III TIGeR-PaC clinical trial, which is now expected in early 2026.

You can see the cost structure is dominated by the two major operational buckets, R&D and SG&A, which together totaled $3.4 million for the quarter, dwarfing the $0.266 million in revenue generated.

RenovoRx, Inc. (RNXT) - Canvas Business Model: Revenue Streams

You're looking at the money-making side of RenovoRx, Inc. (RNXT) as of late 2025. This is where the rubber meets the road for their commercial strategy, focusing on the device they can sell right now and the big potential coming down the pipe.

Commercial Sales of the FDA-cleared RenovoCath Device

The immediate revenue stream is built entirely on the commercial sales of the FDA-cleared RenovoCath device, which is their Trans-Arterial Micro-Perfusion (TAMP) platform delivery system. This is the product they are actively pushing into the market following initial purchase orders received in December 2024. Honestly, the early adoption curve shows some variability, which is typical for a new medical device launch.

Here are the key commercial metrics we've seen through the third quarter of 2025:

• Year-to-date revenue through the end of Q3 2025 was approximately $900,000.
• Q3 2025 revenue itself was reported at approximately $266,000.
• Q2 2025 revenue was over $400,000, specifically around $422,000.
• Q1 2025 revenue was approximately $200,000.

The growth in approved centers is a direct driver for this revenue. As of November 7, 2025, RenovoRx expanded from five cancer centers approved to purchase RenovoCath at the start of 2025 to 14 leading cancer centers. They also have 10 additional centers that have requested product quotes. That's solid traction for a company still building out its dedicated sales and marketing foundation.

The pricing structure for the device itself is what sets the potential ceiling for this stream. Here's a quick look at the expected device value:

Management has cited that they have already reduced their Cost of Goods Sold (COGS) and increased margins through manufacturing collaborations and using U.S.-sourced components. The device has a shelf life of over two years, which helps manage inventory flow.

Future Revenue from the RenovoGem Drug-Device Combination

The significant long-term revenue potential hinges on the regulatory success of the drug-device combination candidate, known as IAG (RenovoCath with gemcitabine). Right now, this combination product candidate is under investigation and has not been approved for commercial sale by the FDA. It is being evaluated under the FDA's 21 CFR 312 pathway.

This future revenue stream is tied directly to the TIGeR-PaC Phase III clinical trial. The timeline has shifted a bit, but the milestones are clear:

• Enrollment completion for the TIGeR-PaC trial is now expected in early 2026.
• Final data readout from the trial is anticipated in 2027.

The upside here is substantial, as RenovoCath with gemcitabine has Orphan Drug Designation for pancreatic cancer and bile duct cancer, which grants seven years of market exclusivity upon New Drug Application (NDA) approval. The company's cash position as of September 30, 2025, was $10.0 million, which management believes is sufficient to fund commercialization and complete enrollment in the Phase III trial.

Finance: draft 13-week cash view by Friday.