Vivos Therapeutics, Inc. (VVOS): 5 FORCES Analysis [Nov-2025 Updated]

You're looking at Vivos Therapeutics, Inc. right now, and honestly, the landscape has totally changed since they pivoted from just training dentists to actually owning and running sleep centers as of late 2025. That shift-moving from a B2B training model to direct patient care-fundamentally re-writes their power dynamics across the market. While their Q3 2025 revenue hit $6.8 million and they maintain a solid 58% gross margin, the real question is how this new structure handles the intense competition from CPAP and surgical rivals. We need to map out exactly where the power lies-with suppliers, low-power customers like acquired practices, or the 300+ competitors-to see if this aggressive strategy is built on solid ground. Dive into the full five forces breakdown below to see the precise risks and advantages facing Vivos Therapeutics, Inc. right now.

Vivos Therapeutics, Inc. (VVOS) - Porter's Five Forces: Bargaining power of suppliers

When you look at Vivos Therapeutics, Inc. (VVOS), the power held by its suppliers-those providing raw materials or manufacturing services for its proprietary oral appliances-appears relatively constrained. This is a classic dynamic for a company that owns its core intellectual property.

The power of suppliers is kept in check primarily because Vivos Therapeutics, Inc. controls the blueprints. You see, the company has actively expanded its intellectual property base, acquiring key assets including U.S. and international patents and product rights, such as those related to the POD® and the Night Block™ appliance featuring patented unilateral bite block technology. This deep IP control means that the specific design specifications for the Vivos appliance are not easily replicated by a generic supplier.

Here's a quick look at the evidence supporting this lower power dynamic:

• Proprietary appliance design and patent control limit alternatives.
• Acquired patents protect the core technology base.
• Vivos Therapeutics, Inc. expects to use existing manufacturing relationships.
• FDA clearance for severe OSA treatment mandates strict supplier adherence.

For the contract manufacturers, their role is largely execution based on Vivos Therapeutics, Inc.'s specific design files. Since the final product requires FDA clearance-which Vivos Therapeutics, Inc. has for treating severe OSA-any manufacturing partner must operate within the highly regulated framework dictated by the FDA. This regulatory burden acts as a barrier to entry for new, potentially aggressive suppliers, effectively locking in the existing, qualified partners to Vivos Therapeutics, Inc.'s terms.

Financially, the story supports manageable input costs, even amid strategic shifts. For the third quarter of 2025, Vivos Therapeutics, Inc. reported a Gross Margin of 58%. While this was a slight dip from 60% in Q3 2024, it still represents a robust margin for a medical device and service hybrid business, indicating that the cost of goods sold (COGS), which includes supplier inputs, is well-controlled relative to revenue. The cost of sales did increase by 87% to approximately $2.8 million in Q3 2025, largely due to integration costs from the SCN acquisition, not necessarily input price hikes from core appliance suppliers.

The supply chain for a specialized medical device like a Vivos appliance involves materials that are not easily substituted; they must meet specific clinical and regulatory standards. However, because Vivos Therapeutics, Inc. owns the design and the method, the supplier's leverage is reduced to their capacity to produce the specific item, rather than the power to dictate the price of a commodity component.

The fact that Vivos Therapeutics, Inc. is actively expanding its direct-to-provider model, which is expected to yield contribution margins of 50% to 60% at steady state, suggests that the company is focused on capturing more of the value chain, further diminishing the relative importance and power of the upstream component suppliers.

Finance: draft 13-week cash view by Friday.

Vivos Therapeutics, Inc. (VVOS) - Porter's Five Forces: Bargaining power of customers

You are looking at the customer side of the equation for Vivos Therapeutics, Inc. (VVOS), and the power dynamic here is complex-it shifts depending on whether you are looking at the individual patient or the medical practice channel.

For the individual patient, the high out-of-pocket cost of treatment historically grants them significant leverage, even if they prefer the outcome. We see evidence of this in the recent data from The Sleep Center of Nevada (SCN) patients, where the average dollar amount per case for a Vivos oral appliance treatment was just over $5,000 as of Q3 2025. This is a substantial, one-time outlay for many consumers, which naturally makes them scrutinize the value proposition heavily.

To put that $5,000 figure in context against the incumbent, while lifetime costs for CPAP can be estimated higher, the immediate sticker price for a Vivos solution forces a direct comparison, which is a classic driver of buyer power. Here's a quick look at the cost structure that influences this dynamic:

Still, Vivos Therapeutics is actively working to neutralize this power by securing payer coverage. The Centers for Medicare & Medicaid Services (CMS) Pricing, Data Analysis and Coding (PDAC) contractor approved the VidaSleep™ oral appliance for Medicare coverage on July 1, 2025. This is a critical step, as Medicare approval often pressures commercial payers to follow suit, directly reducing the out-of-pocket burden and thus lowering the individual patient's bargaining power over time.

The power dynamic flips when you look at the distribution channel, specifically the acquired medical practices. Vivos Therapeutics completed the acquisition of The Sleep Center of Nevada (SCN) in June 2025. This move was strategic; SCN historically served over 200,000 OSA patients since 2019. By owning the channel, Vivos now controls the presentation of treatment options, effectively turning a former referral source into an internal sales point. The integration is already showing financial results, with new treatment centers launched at SCN locations contributing $1.3 million to Q3 2025 revenue. This vertical integration significantly lowers the bargaining power of the practice as a customer/gatekeeper, as Vivos now owns the distribution.

Patient preference acts as a strong counter-force to the high initial cost, reducing the risk of switching away from Vivos once engaged. Management reported that among SCN patients presented with a full array of options, just under 2/3 choose some form of Vivos oral appliance treatment. Furthermore, it was highlighted that two-thirds of Las Vegas patients prefer Vivos' treatments over CPAP. This strong preference suggests that when Vivos' clinical efficacy and non-lifetime commitment are understood, the customer's willingness to pay-and thus their power to demand lower prices-decreases.

The critical factors influencing customer power can be summarized as follows:

• Individual patient power is high due to the $5,000 per-case cost.
• Power from acquired practices is low because Vivos now owns the channel (e.g., SCN).
• Switching risk is mitigated by strong patient preference, with nearly two-thirds choosing Vivos.
• Future patient adoption hinges on insurance coverage, cemented by the July 1, 2025 Medicare approval for VidaSleep™.

Vivos Therapeutics, Inc. (VVOS) - Porter's Five Forces: Competitive rivalry

You're looking at a market where Vivos Therapeutics, Inc. is fighting for every dollar against established giants and numerous smaller players. The competitive rivalry in the broader sleep apnea space is definitely intense.

The global Sleep Apnea Devices Market was valued at USD 7.11 billion in 2025, and the competitive landscape for devices alone includes exclusive data on 39 vendors. This suggests a fragmented, yet fiercely contested, environment beyond the top tier. The market structure for therapeutic devices is highly consolidated at the top, with the top five players collectively commanding approximately 75% of that specific market share.

Your direct rivals aren't just other oral appliance makers; you're up against surgical implant companies like Inspire Medical Systems. The CPAP segment, which remains the largest product segment at roughly 60% of the therapeutic market, is dominated by leaders like ResMed, which holds an estimated 50-60% market share in OSA treatment.

When you look at Vivos Therapeutics, Inc.'s scale, the rivalry pressure becomes clear. Vivos Therapeutics, Inc.'s total revenue for the third quarter of 2025 was $6.8 million. For the nine months ended September 30, 2025, revenue reached $13.6 million. That revenue is small when stacked against the multi-billion dollar market and the revenue bases of the dominant players.

The strategic pivot to direct patient care via clinic acquisition is an aggressive move to bypass traditional channels, which is a direct response to this rivalry. The acquisition of The Sleep Center of Nevada (SCN) in June 2025 is key to this. This move immediately added service revenue streams, with SCN generating $2.2 million from diagnostic sleep testing and $1.3 million from treatment centers in Q3 2025 alone. This shift aims to capture higher-margin diagnostic and treatment revenues directly, rather than relying on the dental distribution channel Vivos Therapeutics, Inc. historically depended on. Still, this aggressive expansion led to a net loss of $5.4 million in Q3 2025.

Here's a quick look at how Vivos Therapeutics, Inc.'s recent performance stacks up against the market context:

The competitive dynamics Vivos Therapeutics, Inc. faces include:

• Rivalry intensity driven by the $7.11 billion 2025 market valuation.
• Dominance by incumbents like ResMed holding 50-60% of the OSA treatment share.
• Direct competition from surgical implant makers such as Inspire Medical Systems.
• The need to rapidly scale the new direct care model to overcome high operating costs of $8.7 million in Q3 2025.
• Competition across the entire spectrum, from diagnostics to therapeutics, involving at least 39 device vendors.

The pivot is an attempt to gain leverage by controlling the patient pathway, but it puts Vivos Therapeutics, Inc. in direct, head-to-head competition with established medical practices and larger entities that already own significant diagnostic capacity.

Vivos Therapeutics, Inc. (VVOS) - Porter's Five Forces: Threat of substitutes

The threat of substitutes for Vivos Therapeutics, Inc. (Vivos) is substantial, rooted in established, widely adopted, and technologically advancing alternatives for treating Obstructive Sleep Apnea (OSA).

Very high threat from Continuous Positive Airway Pressure (CPAP) machines, the current standard of care.

Continuous Positive Airway Pressure (CPAP) machines remain the entrenched first-line therapy. The broader Sleep Apnea Devices Market was valued at an estimated USD 8.9 billion in 2025. Within the specific Continuous Positive Airway Pressure (CPAP) Market, CPAP devices are projected to dominate with a 65% share in 2025, with an estimated market size of USD 561.8 million for that year. This dominance signifies a massive installed base and established clinical pathway that Vivos Therapeutics, Inc. must overcome. The therapeutic devices segment, which includes CPAP, is set to witness the highest growth within the overall market, indicating continued reliance on Positive Airway Pressure (PAP) equipment.

Significant threat from surgical alternatives and neurostimulation devices (e.g., Inspire).

Surgical and implantable options present a growing, albeit smaller, segment of the threat. The Sleep Apnea Implants Market was estimated to be worth USD 466.6 million in 2025. The market is heavily concentrated, with the three major players-Inspire Medical Systems, Respicardia, Inc., and Medtronic Plc-holding 92.6% market share in this segment. Inspire Medical Systems, specifically, leads with its hypoglossal nerve stimulation technology. However, this segment faces its own near-term execution risk, as Inspire Medical Systems disclosed a sharp reduction to its 2025 earnings guidance tied to weak demand for its Inspire V device.

The competitive landscape of substitutes can be viewed by segment size as of late 2025:

Vivos' unique FDA clearance for severe OSA in adults and moderate-to-severe in children provides differentiation.

Vivos Therapeutics, Inc.'s differentiation rests on its proprietary, non-surgical oral appliance treatment, which has received FDA clearance for all severities of OSA in adults and for moderate-to-severe OSA in children ages 6 - 17. This specific pediatric indication and the treatment of severe adult OSA offer a distinct value proposition against alternatives. The company's strategic pivot toward direct medical sleep center alliances, highlighted by the June 2025 acquisition of The Sleep Center of Nevada, is already showing traction, with third quarter sequential revenue up 78% and year-over-year revenue increasing 76% for the nine months ended September 30, 2025. In the first quarter of 2025, Vivos sold 3,736 oral appliance arches for approximately USD 1.8 million.

Non-compliance with CPAP drives demand for oral appliance alternatives.

The inherent limitations of CPAP therapy create a persistent demand pool for alternatives like Vivos Therapeutics, Inc.'s oral appliances. In the U.S. alone, an estimated 39 million adults have OSA, yet only about 6 million are formally diagnosed, indicating a massive undiagnosed or untreated population. Furthermore, even among the diagnosed, compliance is a known issue. The high volume of untreated or under-treated patients, stemming from factors like CPAP intolerance, directly fuels the market for non-CPAP solutions. Vivos is attempting to capture this latent demand by shifting its model to capture both diagnostic and treatment revenue directly from patients.

• CPAP devices are forecast to hold a 70% share by operation type in 2025, driven by automatic CPAP (APAP) systems.
• The 40 to 60 years age segment shows the highest growth in the overall sleep apnea devices market, at 7.33%, driven by OSA prevalence.
• Vivos Therapeutics, Inc.'s cash and cash equivalents stood at USD 2.3 million as of March 31, 2025.

Vivos Therapeutics, Inc. (VVOS) - Porter's Five Forces: Threat of new entrants

The threat of new entrants for Vivos Therapeutics, Inc. remains relatively low, primarily due to the substantial regulatory, capital, and educational hurdles required to establish a comparable market presence in the obstructive sleep apnea (OSA) treatment space.

High barrier to entry due to the need for FDA regulatory clearance for medical devices.

Entering the medical device market requires navigating the U.S. Food and Drug Administration (FDA) clearance process, which is a significant deterrent. For a novel treatment like Vivos Therapeutics' approach, a new entrant would likely face the Class II pathway, requiring 510(k) clearance, which can cost an estimated $50 k-$200 k+ in total, excluding testing and consulting fees, for a standard submission in 2025. Furthermore, the FDA standard user fee for a 510(k) submission in fiscal year 2026 is set at $26,067. Vivos Therapeutics has already secured a critical first-mover advantage: its Complete Airway Repositioning and Expansion (CARE) devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first to receive clearance for treating moderate-to-severe OSA in children ages 6 to 17.

Significant capital required for R&D, clinical trials, and establishing a provider training network.

The financial commitment necessary to develop and prove a novel medical technology is immense. For Class II devices that require clinical data, the estimated total cost can range from $2 million-$30 million. Clinical trials alone, which are often necessary to demonstrate safety and efficacy, can account for an estimated 40-60% of the total budget. Vivos Therapeutics' own operating expenses demonstrate the high ongoing capital requirement to support operations and integration; for the six months ended June 30, 2025, operating expenses totaled $12.4 million, and for the third quarter ended September 30, 2025, they reached $8.7 million. Beyond R&D, establishing the necessary infrastructure, such as a provider training network, demands continuous investment.

The capital intensity of the regulatory and operational environment can be summarized as follows:

Vivos holds patents on its proprietary CARE devices and clinical protocols.

Intellectual property creates a significant moat against direct replication. Vivos Therapeutics' core technology is protected by patents. The company expanded its intellectual property base by acquiring U.S. and international patents, PCT patents, and applications from Advanced Facialdontics, LLC in March 2023. Specifically, the newer VidaSleep™ oral appliance features Vivos' patented and FDA-cleared Unilateral Bite Block technology. Furthermore, the entire Vivos Method, which includes the proprietary CARE appliance therapy and associated protocols, is a key asset that new entrants would need to circumvent or legally challenge.

New entrants must replicate Vivos' successful clinical outcomes and provider education.

Regulatory clearance is only the first step; market acceptance hinges on proven results and a trained professional base. Vivos Therapeutics has demonstrated significant patient adoption and provider engagement, which is difficult for a newcomer to match quickly. You need to build trust with both patients and the medical community.

• Patients treated with Vivos' patented oral appliances totaled approximately 58,000 worldwide as of December 31, 2024.
• The Vivos Method has been utilized by more than 1,900 trained dentists as of April 2024.
• The company secured new AMA CPT codes effective January 1, 2025, which helps facilitate commercial insurance payer reimbursement for all Vivos CARE oral medical devices.

A new entrant faces the challenge of not only achieving regulatory parity but also generating the clinical evidence and establishing the provider education network necessary to compete against Vivos Therapeutics' established installed base and reimbursement pathways.