Apyx Medical Corporation

Company snapshot

• Incorporated: 1982 (Delaware)
• Principal office: 5115 Ulmerton Road, Clearwater, FL 33760
• Business focus: Surgical aesthetics and related medical devices
• Core technology: Helium Plasma Platform Technology (Renuvion and J-Plasma) and AYON Body Contouring System
• Operating segments: Surgical Aesthetics and OEM
• Corporate status: Public company listed on Nasdaq (ticker: APYX)

Business model and segments

• Surgical Aesthetics (primary focus)
  • Products: Helium plasma technology marketed as Renuvion (cosmetic surgery market) and J-Plasma (hospital surgical market); includes single-use handpieces, multiple generations of generators (e.g., Apyx One Console), and accessories
  • AYON Body Contouring System: FDA-cleared, all-in-one system for comprehensive body contouring (infiltration, aspiration, ultrasound-assisted liposuction, electrocoagulation, Renuvion treatment, etc.)
  • Commercial strategy: Direct U.S. sales force plus international distributor network; ongoing training and clinical support
  • 2025 developments: FDA clearance for AYON (May 13, 2025); soft launch followed by commercial launch beginning September 2025
• OEM
  • Provides design, development, and manufacturing of electrosurgical generators and related accessories to third parties
  • Revenue in this segment is reported as cost of sales; generally a smaller, contract-driven portion of the business
  • Expectation: Revenue from OEM to decrease over time as focus shifts to Surgical Aesthetics

Products and technology

• Helium Plasma Platform (Renuvion) and J-Plasma: energy-based systems that deliver controlled heat to tissue via helium plasma
• Apyx One Console: multifunction generator (3-in-1 energy system) introduced in the U.S. in 2023; supports Renuvion, monopolar and bipolar energy; cloud connectivity, presets, diagnostics
• APR handpieces and Renuvion Micro Handpiece: newer ergonomic/size variants that expand procedural capabilities
• AYON: integrated, all-in-one body contouring system combining infiltration, aspiration, liposuction, and Renuvion/tissue contraction
• IP position: 41 U.S. patents, 61 foreign patents; 11 U.S. pending patents, 21 foreign pending; 10 U.S. trademarks, 32 international trademarks; ongoing patent activity to protect the technology

Customers and market reach

• Distribution: Direct sales force in the U.S.; international sales primarily through distributors
• Global clinical support: a medical affairs and clinical support team supports adoption and training

Manufacturing, operations, and geography

• Primary manufacturing facilities:
  • Clearwater, Florida, USA
  • Sofia, Bulgaria (Apyx Bulgaria EOOD)
• Quality and regulatory compliance: ISO 13485:2016 certified; subject to FDA and international regulatory oversight; MDSAP audits (January 2026) completed with no observations
• Joint venture: 51% ownership in a China-based joint venture with a Chinese supplier to manufacture and sell products in China; operations commenced in Q2 2025

Financial highlights (year ended December 31, 2025)

• Revenue mix
  • Surgical Aesthetics: 85.8% of consolidated revenue
  • OEM: 14.2% of consolidated revenue
• Operating income and cash flow
  • Loss from operations for 2025: $6.4 million
  • Cash used in operations (net): $8.0 million in 2025
  • Cash and cash equivalents (as of 12/31/2025): $31.7 million
• Headcount
  • Total full-time employees: 205 worldwide
  • Breakdown: 4 executive officers, 42 supervisory, 21 sales, 138 technical support/administrative/production
• Expenses and cost containment
  • 2025 operating expenses reduced to below $40.0 million (vs. $48.2 million in 2024 and $53.7 million in 2023)
  • 2024 restructuring reduced U.S. workforce by ~25%, with estimated annualized savings of ~$4.3 million; one-time pre-tax severance/benefits charges of ~$0.6 million in Q4 2024
• Financing and liquidity
  • Perceptive Credit Agreement (Nov 2024): up to $45 million senior secured term loans; amended Nov 7, 2024 with revised revenue targets and covenants; requires maintaining $3.0 million in cash
  • Compliance: As of 12/31/2025, in compliance with amended covenants
  • Equity raises:
    • Nov 7, 2024: Registered direct offering raising $7.0 million; issued 3,000,000 shares and 2,934,690 pre-funded warrants
    • Nov 18, 2025: Underwriting agreement for sale of 2,762,431 common shares; net proceeds approximately $9.1 million
  • Shelf registration: filed Dec 1, 2025 to register up to $100 million of securities (replacing the prior shelf)
• Dilution and equity-related notes
  • Outstanding equity instruments as of 12/31/2025:
    • Employee/board options: 7,579,377 shares (about 18.1% of outstanding)
    • Debt-related warrants: 1,500,000 shares
    • Pre-funded warrants from 2024 offering: 2,934,690 issued, with 1,923,623 remaining outstanding and unexercised
  • Overall estimated dilution: 4.6% as of 12/31/2025
• Revenue visibility and risk
  • The company reported ongoing losses and the need for additional financing; potential dilution and debt covenants are identified risks

Capital structure and financing activities (highlights)

• Perceptive Credit Agreement (Nov 2024): up to $45 million facility; amended Nov 7, 2024; requires $3.0 million cash balance and adherence to revenue/expense covenants
• Equity financing
  • Nov 7, 2024: $7.0 million direct offering with 3.0 million shares and 2.93 million pre-funded warrants
  • Nov 18, 2025: $9.1 million net from sale of 2.76 million common shares
• Shelf registrations
  • Dec 1, 2025: Filed shelf to raise up to $100 million

Intellectual property and regulatory environment

• IP: Broad patent portfolio (41 U.S. patents, 61 foreign patents; 11 U.S. and 21 foreign patent applications pending)
• Regulatory regime
  • FDA clearance/approval process for new indications and devices
  • EU Medical Device Regulation (EU MDR) compliance and UK governance post-Brexit
  • Environmental and export considerations (RoHS, REACH, Prop 65, EtO sterilization considerations)
  • MDSAP-compliant manufacturing audits and ongoing global regulatory oversight

Corporate developments in 2025

• AYON: FDA clearance received May 13, 2025; soft launch followed by commercial launch beginning September 2025
• AYON label expansion: 510(k) premarket notification filed Oct 13, 2025 for label expansion to include power liposuction; expected clearance in Q2 2026
• China market entry: Renuvion launched in China after initial clearance (July 28, 2025)
• China JV operations: 51% ownership in a joint venture with a Chinese supplier; operations commenced in 2025
• Global reach and marketing: continued investment in clinical support, training, and marketing to expand adoption of Helium Plasma Technology

People and culture

• Employee focus: emphasis on equal opportunity, training, and development
• Safety: no lost-time accidents in 2025 and 2024; safety culture supported by a Safety Committee and open-door policy