Acutus Medical, Inc. (AFIB): Marketing Mix Analysis [Dec-2025 Updated]

You need to understand that the Acutus Medical, Inc. (AFIB) marketing mix is no longer about innovation; it's a pure operational efficiency play. The company completely shifted from selling complex electrophysiology (EP) mapping systems to being a specialized contract manufacturer for Medtronic, selling off flagship assets like AcQMap™ in July 2025. This means their Product is now just left-heart access devices, Place is Medtronic's global reach, and Promotion is an internal B2B relationship, not end-user marketing. Crucially, the Price is a fixed transfer cost, not market-competitive, driving the continuing operations revenue of $20.2 million in 2024 with a defintely improved gross margin of 5%. Read on to see how this dramatic pivot changes every strategic decision you need to model.

Acutus Medical, Inc. (AFIB) - Marketing Mix: Product

The product strategy for Acutus Medical has fundamentally shifted from a high-growth, innovative electrophysiology (EP) platform developer to a specialized contract manufacturer. You need to understand that their product offering is no longer a portfolio of proprietary EP solutions, but a single, focused line of access tools and the associated manufacturing service for a major industry player.

Left-heart access products are the sole continuing product line.

The company's entire product focus is now on its suite of left-heart access devices, which were originally sold to Medtronic in 2022. This portfolio is critical for procedures like catheter ablation and structural heart interventions, which require crossing the atrial septum to access the left side of the heart. The key products that remain in production and distribution under the agreement include:

• AcQCross® line of sheath-compatible septal crossing devices.
• AcQGuide® MINI integrated crossing device and sheath.
• AcQGuide® FLEX steerable introducer with integrated transseptal dilator and needle.
• AcQGuide® VUE steerable sheath.

These products are distinguished by their ability to simplify the transseptal crossing process, often by integrating the dilator and needle to reduce the number of exchanges required during a procedure. The revenue from these products represents the company's exclusive source of revenue.

Flagship AcQMap™ EP mapping assets were sold to EnChannel Medical in July 2025.

The company decisively exited the electrophysiology mapping and ablation business, which previously housed its most innovative product. The sale of the AcQMap™ High Resolution Imaging and Mapping platform assets to EnChannel Medical Ltd. was finalized in July 2025. This transaction included substantive intellectual property, quality and regulatory documentation, clinical data, and a limited number of systems and catheter devices for research purposes. This move was the final step in shedding the high-cost, high-risk innovation side of the business to focus entirely on the manufacturing and supply chain model.

Focus is on manufacturing and quality control for Medtronic's portfolio.

Acutus Medical's product value proposition is now centered on its operational capability as an Original Equipment Manufacturer (OEM) for Medtronic. The company's remaining operations are scaled solely to meet its obligations under the Asset Purchase Agreement and Distribution Agreement with Medtronic. This means the product is essentially a high-quality, reliable manufacturing and supply service for Medtronic's left-heart access portfolio. The financial impact of this shift is clear when looking at the most recent full-year data for this continuing product line.

Here's the quick math: The massive 181% revenue increase in 2024, reaching $20.2 million, and the jump to a positive 5% gross margin, shows the immediate financial benefit of focusing only on this manufacturing product. This is a business built on efficiency now, not market penetration.

The product strategy shifted from innovation to operational efficiency and supply chain.

The core product strategy has completely inverted. The company's focus is no longer on developing new features or next-generation devices, but on supply chain stability, quality assurance, and manufacturing efficiency to fulfill the Medtronic contract. This operational downsizing included a workforce reduction of approximately 70%, which was substantially completed in the first quarter of 2025. The goal is to meaningfully reduce cash burn and ongoing operating expenses, which is the only sustainable product strategy left.

Product development investment is minimal, focused only on existing manufacturing obligations.

Any remaining investment in product development is minimal and strictly limited to what is necessary to maintain the quality and regulatory compliance of the left-heart access devices for Medtronic. The dramatic reduction in operating expenses to just $1.1 million in 2024 for continuing operations, down from $8.6 million, illustrates this point perfectly. The company is effectively in a product maintenance and contract fulfillment phase, not an innovation phase. They are a defintely a lean manufacturing specialist now, not an R&D powerhouse.

Acutus Medical, Inc. (AFIB) - Marketing Mix: Place

Exclusive distribution is governed by a formal Distribution Agreement with Medtronic

The entire distribution strategy for Acutus Medical's left-heart access product portfolio is locked into an exclusive, long-term Distribution Agreement with Medtronic. This shift is the single most important factor in the company's 'Place' strategy as of late 2025. The agreement, originally signed in 2022, dictates that Medtronic is the sole commercial distributor for the products, including the AcQCross line of septal crossing devices and the AcQGuide family of sheaths and introducers. This structure completely de-risks Acutus's commercial exposure, but it also means the company has zero control over end-user market access.

This pivot was a necessary, hard step to reduce cash burn. For the full year 2024, the company's revenue from continuing operations was $20.2 million, an increase of 181% year-over-year, which primarily reflects the revenue stream from this Medtronic arrangement.

Acutus acts as an Original Equipment Manufacturer (OEM) for the sold portfolio

Acutus Medical has fundamentally transformed its business model from a full-scale electrophysiology technology developer to an Original Equipment Manufacturer (OEM). The company's operations are now scaled only to meet its contractual obligations for the production and supply of the left-heart access products to Medtronic. This means Acutus is a manufacturer, not a commercial entity. This OEM role is a low-margin, high-volume model, but it provides a predictable revenue channel, which is exactly what the company needed.

The revenue Acutus earns comes from the sale of these products at transfer prices specified in the Distribution Agreement, plus potential earnout payments through January 2027. This OEM focus is the new core of the business.

Direct sales force to electrophysiology labs, previously 47 representatives, is largely eliminated

The direct-to-hospital sales channel, which required a significant investment in a specialized electrophysiology (EP) field team, has been eliminated. The previous model, which included a direct sales force to electrophysiology labs, is no longer viable under the OEM strategy. The company is no longer responsible for driving adoption or managing relationships with end-user clinicians or hospitals.

The massive operational downsizing completed in the first quarter of 2025 was the clear action that sealed this change. The headcount reduction removed the commercial infrastructure needed to support a direct sales model.

Commercial reach is now entirely dependent on Medtronic's global sales channels

Acutus's commercial reach is now entirely dependent on the scale and efficiency of Medtronic's global sales organization. Medtronic's established infrastructure provides access to a much broader network of electrophysiology labs and hospitals worldwide than Acutus could ever afford to build or maintain itself. This is a trade-off: you lose control, but you gain immediate, massive distribution leverage.

The entire commercial pipeline is now an extension of Medtronic's Cardiovascular Portfolio, which reported Q3 FY2025 revenue of $3.037 billion, growing 5.0% organically. This is the distribution engine Acutus is now plugged into.

The company's physical footprint was reduced by a roughly 70% workforce downsizing in early 2025

The most drastic change to the 'Place' infrastructure was the operational downsizing, which reduced the workforce by approximately 70%. This move was substantially completed in the first quarter of 2025 and directly led to a massive reduction in the company's physical and operational footprint.

The restructuring costs incurred were between $1.4 million and $1.8 million in pre-tax charges, which included severance and retention bonuses. This downsizing is reflected in the dramatic drop in operating expenses for continuing operations, which fell from $8.6 million in 2023 to just $1.1 million in 2024. The company is now a lean manufacturing and supply operation.

Here's the quick math on the shift:

The company's remaining physical footprint is focused on manufacturing, quality assurance, and supply chain management to fulfill the Medtronic contract. That's the entire game now.

Acutus Medical, Inc. (AFIB) - Marketing Mix: Promotion

External Marketing to End-Users Effectively Discontinued

You need to understand that Acutus Medical's promotional strategy for 2025 is a complete reversal of a traditional medical device company's approach. The external marketing to end-users, primarily electrophysiologists (EPs), has been effectively zeroed out. This is a deliberate, necessary step following the sale of the left-heart access portfolio to Medtronic in 2022 and the subsequent exit from the electrophysiology mapping and ablation business in late 2023.

The company is no longer promoting the AcQMap Mapping System or the AcQBlate Force-Sensing Ablation Catheter, as those businesses were wound down. The entire organization was downsized by approximately 70%, with the operational expenses for continuing operations reduced by 47% year-over-year in the second quarter of 2024, reflecting this drastic cut in commercial and marketing resources. They simply don't have a sales force or marketing budget for the physician market anymore. That's the reality.

Promotion Focuses Internally on Maintaining a Strong B2B Relationship with Medtronic

The new, core promotional focus is strictly business-to-business (B2B), aimed at a single, critical customer: Medtronic. Acutus Medical now functions almost exclusively as a contract manufacturing business for the left-heart access products, like the AcQCross line of septal crossing devices. Their exclusive source of revenue is tied to this relationship, which is why their internal 'promotion' is about operational excellence, not market share.

The goal is to be a reliable, high-quality supplier to ensure the continued acceptance and purchase of products by Medtronic, which is the key to unlocking future contingent payments (earnous). This is a quality-control and supply-chain promotion strategy, not a traditional marketing one. You're trading physician influence for manufacturing compliance. It's a defintely different game.

The Strategy is to Ensure Medtronic's Continued Acceptance and Purchase of Products

The financial health of Acutus Medical hinges entirely on fulfilling the terms of the Asset Purchase Agreement and Distribution Agreement with Medtronic, which is why their internal communication and resource allocation are structured around this mandate. The earnout structure provides a clear incentive, with Acutus eligible to receive a percentage of quarterly Net Sales of the products achieved by Medtronic over a four-year period.

The company's revenue from continuing operations grew by a remarkable 172% year-over-year to $4.1 million in Q2 2024, driven by this manufacturing volume for Medtronic. This growth is the ultimate proof of their successful B2B 'promotion' through execution.

• Maximize manufacturing throughput for Medtronic.
• Maintain regulatory compliance (e.g., ISO 14971:2019) for products.
• Support Medtronic's distribution with uninterrupted supply chain.
• Capture earnout payments, which are expected to continue until January 2027.

Key Promotional Activity is Investor Relations, Managing Expectations for the OTC-Listed Stock

For the public market, investor relations (IR) is the primary promotional channel. Since the common stock was delisted from Nasdaq in May 2024 and now trades on the OTC Pink Market (OTC:AFIB), the company's communication is focused on transparency and managing shareholder expectations amid a major strategic shift and financial distress.

The IR focus is on debt management and cash flow stability. For example, in late 2024, the company announced an amendment to its credit agreement, rescheduling a $7.5 million principal payment due in June 2025 into three equal quarterly installments of $2.5 million each, due on June 30, September 30, and December 31, 2025. This kind of disclosure is the new promotional content, signaling a managed wind-down and debt servicing capability.

Here's a quick snapshot of the financial data that forms the basis of their current IR narrative:

Communication Centers on Compliance and Fulfilling Remaining Contractual Obligations

The public communication from Acutus Medical's leadership consistently reinforces the theme of compliance and obligation fulfillment. The message is clear: the company's sole purpose is to execute the remaining contract with Medtronic for the production of left-heart access products.

This narrow focus is a risk-mitigation strategy, ensuring they collect the maximum potential earnout payments, which is the last major source of value for shareholders. The communication is highly technical, centered on manufacturing, quality, and supply chain, reflecting a business in transition to a final, value-realizing stage.

Acutus Medical, Inc. (AFIB) - Marketing Mix: Price

The pricing strategy for Acutus Medical is defintely not a traditional market-driven competition model; it is fundamentally a cost-plus approach dictated by a single, large-scale distribution agreement. Your revenue stream is secured through a fixed transfer price for products sold to Medtronic, supplemented by performance-based contingent earn-out payments.

This structure means the company's profitability hinges entirely on manufacturing efficiency and Medtronic's end-market sales performance, rather than competitive pricing or direct customer negotiations. It's a low-risk, low-volatility revenue model, which is a significant shift from the previous, high-burn strategy.

Revenue is generated via a fixed transfer price for products sold to Medtronic.

Your entire continuing operations revenue is derived from the Distribution Agreement with Medtronic, following the sale of the left-heart access portfolio. This agreement specifies a fixed transfer price for the left-heart access products you manufacture and distribute to Medtronic. This is the definition of a contract manufacturing relationship, where the price is set to cover your costs plus a defined margin, providing a predictable, albeit capped, revenue stream.

For the full-year 2024, the revenue from continuing operations-which is the current business under the Medtronic agreement-was $20.2 million. This figure represents the total sales generated at the pre-determined transfer price, demonstrating the scale of the fixed-price component of your current business model.

Pricing is supplemented by potential contingent earn-out payments through 2027.

Beyond the fixed transfer price, the pricing model includes a crucial variable component: contingent earn-out payments. These payments are based on a percentage of Medtronic's total net end-user sales of the acquired products, and you remain eligible to receive them through January 2027.

This structure aligns your long-term financial interest with the market success of the products now commercialized by Medtronic. For example, the company recorded a gain of $8.1 million from Medtronic's left-heart access net sales earnouts for the nine months ended September 30, 2024, which is a substantial addition to the fixed-price revenue.

Full-year 2024 revenue from continuing operations (the current business) was $20.2 million.

To ground your analysis, the last full-year data available closest to your November 2025 cutoff is the 2024 fiscal year. Revenue from continuing operations for 2024 was $20.2 million, a significant increase of 181% compared to the $7.2 million reported in 2023. This growth reflects the full ramp-up of the manufacturing and distribution volume under the Medtronic agreement and the strategic focus on this single product line.

Gross margin for continuing operations improved to 5% in 2024 from negative 44% in 2023.

The stability of the fixed transfer price combined with operational efficiency is clearly visible in the gross margin improvement. In 2024, the GAAP gross margin for continuing operations reached 5%, a dramatic turnaround from the negative 44% margin reported in 2023. This shift is a direct result of higher production volumes and reduced manufacturing overhead expenses, proving the viability of the cost-plus model when operations are streamlined.

The pricing model is a cost-plus approach, defintely not market-driven competition.

The current pricing strategy is a textbook example of cost-plus pricing, where the selling price is determined by adding a fixed markup to the unit cost of the product. This approach is common in contract manufacturing, especially when dealing with a single, dominant buyer like Medtronic. It removes the need for competitive market analysis on the sell-side, as your customer is locked in by the distribution agreement. The focus shifts internally to cost control and production volume, which directly impacts the gross margin you earn on the fixed transfer price.

Here is a quick comparison of the financial performance metrics that define this pricing environment:

The path to maximizing returns is clear: minimize your manufacturing costs to widen the gap between your cost base and the fixed transfer price, plus maximize the volume of products sold by Medtronic to boost those contingent earn-outs.